(Mis)Represented. Our Global Health is UnGlobal. 24/02/2021 Fifa A Rahman, Felicita Hikuam, Nyasha Chingore-Munazvo & Gisa Dang Global health is all but global, says Fifa Rahman, Permanent Representative for NGOs for the WHO-backed ACT-Accelerator The appointment of Ngozi Okonjo-Iweala, the former Nigerian Finance Minister, World Bank development economist and its former Vice President, and black African woman, as head of the WTO, has been heralded as ‘a big deal’, an inspiration, and ‘a sign of the many strides (Africa) has made in gender parity’. While all this is true, and while representation is important, it is but one step towards tackling pervasive racism in global health. On 25th February 2021, twenty black and brown leaders in global health, including implementers, academics, civil society, and communities living with the diseases, will convene in a virtual roundtable to discuss how racism and white supremacy affects global health governance, hiring, and programming. This roundtable, convened by Matahari Global Solutions, a global research and policy group, and the AIDS and Rights Alliance of Southern Africa (ARASA), will define the parameters for an in-depth study to take place this year – and advocacy meetings with global health agencies. A meeting report will be published and sent directly to heads of key global health agencies. COVID-19 Impact of Race on Health The COVID-19 pandemic has brought to the fore clear disparities in infection rates, death rates, and access to diagnostics, vaccines, therapeutics, and care for black and brown communities. It’s a bleak reminder of the enduring inequity in global public health. As early as April 2020, one Brookings Institute article pointed out that the COVID-19 response does not take into account the fact that black individuals in predominantly white geographies are more likely to live in areas with ‘lack of healthy food options, green spaces, recreational facilities, lighting, and safety’, and that black people are more likely to live in densely populated areas. In addition, COVID-19 tools are not well adapted to dark skin, with pulse oximeters showing misleading readings 12% of the time in persons with non-white skin. And contrary to what was expected, Global North responses to COVID-19 have not necessarily been the most efficacious nor the most effective. For example, the United Kingdom, the United States, and Sweden failed to adequately protect their populations, while global south countries such as Rwanda and Taiwan effectively instituted systems and deployed technologies to respond effectively to the pandemic. Yet in the Global Health Security Index, the United States and the United Kingdom were ranked first and second in the world in terms of pandemic preparedness. This underscores the need for us to decolonise and redefine global health and address existing power imbalances within global health structures and debates. Racism as a Systemic Issue Through Organisations The white Global North perspective is inherent in global health. Yet only recently has the impact of race and whiteness on global health governance, hiring, and programming come into focus. Anu Kumar, CEO of IPAS, a non-profit working across Africa, Asia, and the Americas on reproductive rights, asked in a June 2020 op-ed, “Why do we in the global health sector, which is dominated by white people, especially white women, believe that we know how to solve the health problems of people in other countries?” Stephanie Kimou, who has worked extensively on sexual and reproductive health in francophone Africa, commented in a separate op-ed: “[A]t work, nobody looked like me. The person who started the nonprofit, the finance manager, the operations person — all white. All the major money and programmatic decisions — all made by white people being driven around in fancy cars and living in gated communities. It was so clearly neocolonialist.” At its very basis it may seem to the untrained eye that this is solely an issue of hiring more Black, Indigenous and people of colour. We need to recognize that there is intersectionality of oppression and inclusion. However, as mentioned above, tokenistic diversity hires will not address the philosophy behind why black and brown people, in particular women, don’t get hired in the first place. These are entrenched within culture and everyday practice. In the words of Anu Kumar, “What we don’t talk about is how the structures and operations of our organizations are part of white supremacist culture.” What defines global health deliverables and decision-making is membership. Covert racism means that while the parameters of membership go largely unsaid, it is white people that are seen to be reliable and responsible for important documents that guide implementation of programs, setting guidelines on how many diagnostic tests should be deployed to countries that need them, etcetera. White people are considered most suitable to respond to emails promptly, to feedback more eloquently in project design, are promoted into leadership positions and thus get to represent the views of black and brown implementers. This is the de facto modus operandi, even if it would never be uttered in such plain language. The Covid-19 pandemic has revealed existing social fractures and inequalities & the power dynamics and colonial logics of global health have been thrown into sharp relief. (1/4) pic.twitter.com/OZ1QQpMfSJ — Global Health 50/50 (@GlobalHlth5050) July 3, 2020 Real Examples – Race and Whiteness in Global Health 2020 presented several examples of institutional white supremacy culture – notably, how structures and institutions are structured to uphold white dominance. In June last year, a Médecins Sans Frontières internal statement highlighted that while 90% of its staff were hired locally in countries where MSF works, most of its operations were run by European senior managers. So based on absolute numbers alone diverse hiring doesn’t appear to be the issue here. But of course it is an issue when, much like colonial times, positions of power are overwhelmingly filled by white people. MSF insider Arnab Majumdar wrote last year about MSF senior managers assuming national staff were ‘intellectually lazy’, explicitly referring to them as being ‘vulnerable to corruption’. Complaints of racism were met by the accusation of ‘reverse racism’, a recognized signifier of white supremacy. And while the MSF core executive committee responded by saying they would address the difference in compensation in their teams, and that they would continue to address broad issues of harassment, abuse, and discrimination within the organisation, nothing public has emerged since that time on the effects of this work. Also in June 2020, the Women Deliver CEO, Katja Iversen, took a leave of absence after allegations of a toxic work environment, including racist comments about hair of black women, black people being refused for hire multiple times, and that the organisation suffered from a ‘white saviour’ complex. Four months later, reports emerged of the conclusion of investigations into racism at Women Deliver – that no single person was responsible. The verdict was slammed as a ‘slap in the face’, and was accompanied with critique that Women Deliver ‘doesn’t really know what accountability is’. A similar situation transpired at the International Women’s Health Coalition – with a letter being published on racist and toxic culture within the organisation, the President resigning as a result of the allegations, but with investigations clearing the President and senior managers of racism – finding instead that there was a ‘pervading culture of fear and intimidation’. These white-centred power structures result in widespread race-based oppression within organisations and within health systems. Priorities are distorted, sociocultural reasons for disparity in healthcare are ignored and/or misunderstood, and new health technologies end up not being culturally appropriate nor equitably efficacious. Dolutegravir, a major HIV drug on the WHO Essential Medicines List, was predominantly trialled on white populations, missing out key genetically diverse populations. In November 2019, the ADVANCE trial found the risk of major weight gain among black women. Has the system learned from such mistakes? No. Moderna proudly advertised that in its Phase 3 COVE trials for the new COVID-19 vaccine 28% of study participants were from “diverse communities” – i.e. 72% were white. Conversations within the WHO Access to COVID-19 Tools Accelerator (the ACT-Accelerator), specifically designed to bring necessary vaccines, diagnostics, therapeutics, PPE, and oxygen supplies to countries most in need – have been dominated by white individuals from the Global North, leaving a knowledge deficit among countries that would receive these technologies. #Gender & #ethnic disparities remain at senior positions in 15 top #publichealth universities – despite numerous #diversity policies & plans. Action may be accelerated when low staff diversity affects university rankings #diversityCOUNTS #LancetWomen https://t.co/8dArmh1VI6 pic.twitter.com/414y61vJqt — Prof Mishal S Khan (@DrMishalK) February 8, 2019 The Way Forward COVID-19 is showing the world with renewed urgency that representation and participation is essential in formulating public health responses. It is for this precise reason that Matahari Global Solutions and AIDS and Rights Alliance for Southern Africa (ARASA) have embarked on an ambitious project to document the various effects of a lack of diversity and white supremacy, on global health programming, hiring, and governance. With a small amount of funding from Open Society Foundations, we’ll start with a roundtable with black and brown leaders in global health, then conduct an in-depth qualitative study to ascertain how whiteness is experienced in global health. Results will be publicised widely – and discussed directly with key global health agencies. We still have to secure funding for a larger quantitative study of over 300 individuals, and advocacy missions by organisations in the Global South on distorted priorities and colonialist global health, to Geneva and New York-based decision-making bodies. But this work is a start. Racism, white supremacy, and colonialism echo through our global health. The system is unglobal and misses out on equitable representation. Colonialist, (un)global health doesn’t work and it needs to change. Fifa A Rahman is principal consultant at Matahari Global Solutions – Dr Fifa A Rahman is the Permanent Representative for NGOs on the Diagnostics Pillar and the Facilitation Council of the ACT-Accelerator, and principal consultant at Matahari Global Solutions; Felicita Hikuam is Director at the AIDS and Rights Alliance of Southern Africa; Nyasha Chingore-Munazvo is Programmes Lead at the AIDS and Rights Alliance for Southern Africa; and Gisa Dang is Associate Consultant at Matahari Global Solutions. Image Credits: Fifa Rahman. Ambitious Global COVAX Facility Delivers First Doses In Accra Ghana 24/02/2021 Elaine Ruth Fletcher, Svĕt Lustig Vijay & Paul Adepoju Thumbs up: WHO representative in Ghana, Francis Kasolo, on left, with UNICEF’s representative, Anne-Claire Dufay as first COVAX vaccine doses arrive on 24 February in Accra, Ghana. Under cloudy skies, Ghana’s first precious doses of Covid-19 vaccines arrived Wednesday morning at Accra’s Kotoka International Airport. They are also the first supplies to be distributed by the WHO co-sponsored COVAX facility on the African continent. The arrival of some 600,000 vaccines marks a milestone in months of effort by WHO, UNICEF, GAVI and other partners to mount the largest global vaccine campaign in history – and ensure that scarce and often pricey COVID-19 vaccine doses are distributed more equitably to countries around the world. “This day is the culmination of many months of planning, research, negotiation & coordination,” tweeted WHO Director General Dr Tedros Adhanom Ghebreyesus, who co-launched the COVAX initiative nearly a year ago. “But it’s just the beginning. We still have a lot of work to do to realize our shared vision for VaccinEquity by starting vaccination in all countries within the first 100 days of the year.” COVAX hopes to deliver 2.3 billion doses by the year’s end — mostly to 92 low- and middle-income countries that are part of a GAVI-backed Advanced Marketing Commitment scheme. The equity scheme aims to overcome price and supply barriers thrown up by high-income nations, which have already snapped up one billion more vaccines than they need for their populations. At last! This morning the first doses of #COVID19 vaccines shipped by the COVAX facility arrived in #Ghana. Congratulations to all partners including @gavi, @CEPIvaccines & @UNICEF. A day to celebrate, but it's just the first step. 45 days left for #VaccinEquity https://t.co/3TjuJiMzj0 — Tedros Adhanom Ghebreyesus (@DrTedros) February 24, 2021 Ghana was selected as the first African recipient of vaccines after sending a rollout plan to COVAX, demonstrating that its health-care teams and cold chain equipment could support a quick distribution. The WHO Ghana office, known for its efficiency and close collaborations with Ghana Health Services, can be relied upon as a flagbearer for the initiative, insiders say. “This is a momentous occasion,” declared WHO’s representative in Ghana Francis Kasolo, in a joint statement with UNICEF’s representative, Anne-Claire Dufay, just as the first palettes of AstraZeneca/Oxford vaccines, produced by India’s Serum Institute, were unloaded on the airport runway. We will ensure that all persons get vaccinated in a risk-based approach no matter who they are and where they are in the spirit of #UniversalHealthCoverage – Dr Francis Kasolo, WHO Representative to Ghana pic.twitter.com/DHV3XW2GAe — WHO Ghana (@WHOGhana) February 24, 2021 “After a year of disruptions due to the COVID-19 pandemic, with more than 80,700 Ghanaians getting infected with the virus and over 580 lost lives, the path to recovery for the people of Ghana can finally begin,” said Kasolo. The initial COVAX shipments will be used to vaccinate frontline healthcare workers, adults over the age of 60, and people with underlying health conditions in the weeks to come, said the Ghanaian authorities on Wednesday. Ghana’s program manager for immunization, Kwame Amponsa-Akyianu, told reporters earlier this month that the country aims to vaccinate two-thirds of its population of over 31 million people. The historic shipment comes a week after Africa’s coronavirus death toll surpassed the 100,000 mark. That is a fraction of the death toll on other continents, but it is now rising fast as a second wave of infections overwhelms hospitals – most of which lack the oxygen supplies and intensive care units that are standard in more affluent regions. Coronavirus Disease 2019 (COVID-19) Africa CDC Also Welcomes Deliveries John Nkengasong, Director of the Addis-based Africa Centres for Disease Control and Prevention, sounded a similar note, saying: “These first deliveries of COVID-19 vaccines through COVAX are a critical moment in Africa’s fight against the virus.” Nkengasong described the first deliveries as “an important step towards our continental goal of immunising at least 60% of Africa’s population with safe and efficacious vaccines against COVID-19″ over three years. So far, the African Union (AU) has secured some 670 million doses of the AstraZeneca, Pfizer and Johnson & Johnson vaccines – in addition to the COVAX supplies of some 90 million doses that will flow to the continent. Russia has also offered to supply 300 million doses of its Sputnik V vaccine to the AU scheme along with a financing package. Desperate to begin vaccinations soon, South Africa, Uganda and Rwanda, among others, have also made smaller bilateral deals. And China has donated small batches of its Sinopharm vaccine to to countries like Zimbabwe and Equatorial Guinea. Still, the rollouts underway in Europe, the Americas, India and even the Middle East remain the exception rather than the norm. Of the 210 million doses of vaccine that have been administered globally so far, half have been doled out in just two countries, Tedros warned on Tuesday. Ghana’s Minister of Health Kwaku Agyeman-Manu at Accra’s Kotoka International Airport Nigeria Watching Ghana – And Wondering When Their Turn Will Come But just north of Accra, in the continent’s most populous country and the largest economy, Nigerians were eying the local vaccine landscape with concerns about how and when a campaign would commence on home turf. Such plans have yet to be announced by the government. Emeka Nsofor, CEO of EpicAFRIC,a philanthropic impact agency, told Health Policy Watch that while the country’s epidemiological response to the pandemic has been impressive so far, the paucity of information and the non-availability of a timeline for the delivery of COVID-19 vaccines is becoming a source of major concern not only to professionals, but to the public. “It is not good for Nigerians to be watching clips of the vaccines being delivered to South Africa, Zimbabwe and other African countries when no one knows when Nigerians will start receiving the vaccine,” he told Health Policy Watch. Nsofor said the government ought to have made its plans for procuring and administering doses public – whether they are secured through COVAX, the AU or other means. “By now we should have known who will get the vaccines first, where will they be administered, who are the officials that will be involved,” he added. In several countries where vaccines are already being administered, frontline health workers and aged individuals are eager to be the first to receive the jabs in their arms. But in Nigeria, health workers are less optimistic about their prospects. At the Casualty and Emergency unit of Nigeria’s first teaching hospital, the University College Hospital, a physician who was among the first in his unit to test positive for COVID-19 told Health Policy Watch that he dreads getting reinfected. Not knowing when he will be able to receive a jab compounds those fears and is “very discouraging”, he said. “Getting the virus was a very scary experience for me, especially at a time when we knew so little about it. Every now and then, I still dread contracting it again. I believe receiving the vaccine would protect me and allay my fears but realising that no one, probably including the government, knows when we will get it, is very discouraging,” he told Health Policy Watch on condition of anonymity. For its part, the Nigeria Center for Disease Control (NCDC) continues to coordinate testing, messaging and other aspects of the country’s response to the pandemic. It recently released findings of household seroprevalence surveys conducted in four Nigerian states — Lagos, Enugu, Nasarawa and Gombe States. The survey findings revealed that the prevalence of SARS-CoV-2 antibodies was 23% in Lagos and Enugu States, 19% in Nasarawa State, and 9% in Gombe State. “This means that as many as 1 in 5 individuals in Lagos, Enugu and Nasarawa State would have ever been infected with SARS-CoV-2. In Gombe, the proportion is about 1 in 10,” NCDC said in a statement. South African Variant – A Risk In Ghana The fact that the B-1351 variant, first discovered in South Africa, has now spread to eight African countries including Ghana, has further implications for the vaccine campaign in the West African region. In a small South African trial, experts found that the AstraZeneca vaccine had virtually no efficacy in reducing mild or moderate COVID cases among people infected with the B-1351 virus strain – leading authorities in Pretoria to cancel the vaccine rollout and switch to a Johnson & Johnson jab – which has recently demonstrated efficacy against the variant in Phase 3 trials. The WHO nonetheless has said it recommends AstraZeneca’s use across Arica – even in countries infected with the variant. Speaking at a recent press conference, WHO experst maintained that the vaccine is still likely to reduce incidence of severe COVID cases, even among people stricken with the B-1351 strain. However, the African Union has issued a slightly different recommendation – that countries where the strain is “dominant” shift gears to another vaccine. So experts will be closely eyeing Ghana’s AstraZeneca rollout to see how the vaccine performs against the variant in the real world laboratory there. Map of African Union Member States by hotspot level on PERC (Partnership For Evidence-Based Response) dashboard. Expect More African Pressures On COVAX to Roll Out Johnson & Johnson – Following Expected FDA approval Friday COVAX’s preliminary candidate-specific supply of COVID-19 vaccines for 2021 and 2022, as of 20 January. Since then Novavax also committed 1 million more vaccines. The arrival of the AstraZeneca vaccine batches in Ghana also coincides with big news of a likely US Food and Drug Administration emergency approval of the J&J vaccine as early as Friday – following today’s positive FDA expert panel review of the vaccine. The J&J results, reported by the FDA review, showed a 66% average efficacy for the vaccine in preventing moderate and severe disease in Phase 3 trials The trials involved over 44,000 recruits in the US, Latin America, and South Africa. The J&J vaccine was also 64% efficacious in preventing moderate and severe disease in the South African trial arm – a significant finding from the first large-scale trial of a vaccine meeting up with the B.1351 variant. And more important, the vaccine was 85% effective in preventing severe disease – 82% in South Africa. While that is not as good a showing as the 90% or better efficacy results for the mRNA vaccines by Pfizer and Moderna, J&J trial was the first to directly pit a vaccine against the B.1351 variant, which has been the one most resistant to vaccines generally among the recent SARS-CoV2 mutations to emerge. The J&J vaccine also has the advantage of being a one-shot vaccine which can be stored in a normal refrigerator rather than ultra-cold storage conditions – factors that could significantly help rollout in low-income countries where access to cold storage as well as to health services is more challenging. FDA briefing document on J&J Covid vaccine posted. The data are very strong, the J&J vaccine provides robust efficacy across all demographics and variants; and shows rising protection over time, consistent with belief it's eliciting strong T-Cell response. https://t.co/azdgLIjtXs — Scott Gottlieb, MD (@ScottGottliebMD) February 24, 2021 The FDA approval of the J&J vaccine will almost certainly pave the way for a WHO greenlight, leading to a COVAX rollout of the vaccine as soon as commercial supplies are available. But that, in turn, could also give rise to new dilemmas for COVAX distribution plans. In African countries like Ghana, faced with creeping vases of the B.1351 variant – there may also be future pressures to swap out AstraZeneca vaccines for J&J doses. Although J&J has in fact committed to provide 500 million vaccine doses through COVAX facility – AstraZeneca dose still comprise the lions share of the COVAX portfolio, with some 720 million doses already procured. The bottom line is that while the jury is still out on AstraZeneca’s performance against the B-1351 variant, the J&J trial data shows clear efficacy for the vaccine in preventing serious disease in the African setting – where other vaccines have not [yet] been widely tested and tried. And that means that the COVAX rollout – even as it begins, is set to face a new series of challenges in a constantly evolving landscape of science, big pharma deals and geopolitics. Image Credits: WHO Ghana, PERC, Gavi. Some Countries Ease Lockdowns, But Others Battle New COVID-19 Surges 23/02/2021 Raisa Santos & Kerry Cullinan Frankfurt, Germany The United Kingdom, Switzerland, Israel and Turkey are cautiously reopening businesses and relaxing limits on gatherings and travel as COVID-19 cases declined both globally and within these countries. However, parts of France, the Czech Republic, and Sweden are preparing for harder lockdown measures as their cases surge in contrast to worldwide trends. As of 23 February, there were 2,530,101 new cases in the past week. The COVID-19 Epidemiological Update reported a 16% global decline in cases, with over 500,000 fewer cases than the beginning of the month. Five out of six WHO regions were showing double-digit percentage declines in new cases, with only the Eastern Mediterranean Region showing a 7% rise. Europe and the Americas continue to see the greatest drops in absolute numbers of cases while the number of new deaths has also declined in all regions. UK & Switzerland Outline Roadmaps to Relax Restrictions Lockdown “Green” border roads between Switzerland and Germany Switzerland will relax some restrictions from 1 March, allowing museums, shops, and zoos to open at limited capacity. Private outdoor events with up to 15 people will also be permitted. A second phase of reopening should commence on 1 April. On Monday, UK Prime Minister Boris Johnson announced the government’s roadmap to ease restrictions in England, which will be guided at all stages by data as opposed to set dates. Step 1 of the roadmap will begin in March with a return to in-person education in schools and colleges. Most outdoor attractions and settings, as well as non-essential retail, which includes zoos, pubs, restaurants, gyms, and retail stores, will stay closed for at least another month. Step 4, which will see a wider opening of a number of businesses, is expected no later than 21 June. The United Kingdom had implemented a national lockdown in response to the rising cases that resulted from the B.1.1.7 variant, and has even extended the lockdown in Northern Ireland, to 1 April. London, UK: Camden High Street in lockdown Together with an ongoing vaccine campaign, these measures appear to be working, with case rates declining across all age groups and regions, in the most recent weekly surveillance report published. “Our efforts are working as case rates, hospitalisation rates and deaths are slowly falling,” said Dr Yvonne Doyle, Medical Director at Public Health England. Doyle still expressed concern about the new infection numbers, which were still higher than the cases at the end of September. “This could increase very quickly if we do not follow the current measures. Although it is difficult, we must continue to stay home and protect lives.” The UK roadmap for reopening outlines four steps: continued successful vaccine deployment, evidence that demonstrates vaccines are sufficient in reducing hospitalizations and deaths in those vaccinated, reduction in infection rates that prevent a surge in hospitalizations, and assessment of the risks not to be fundamentally changed by the new emerging variants of concern. There will be a minimum of five weeks between each step: four weeks for the data to reflect changes in restrictions; followed by seven days’ notice of the restrictions to be eased. Istanbul, Turkey Turkey also plans to start a gradual normalization process in March, with measures to be lifted “on a provincial basis”. The country’s 81 provinces will be categorized based on risk levels – from very high to low – and progress in vaccinations to determine whether they are ready for normalization. This new process for normalization comes after the Turkish Health Ministry started announcing an average of weekly cases for provinces last week. This data will be used to determine whether restrictions are lifted. Israel Re-opens For Business – Except During Holiday & At Airport Meanwhile, the Israeli government began to reopen hotels, shopping centers, and even cultural events on 21 February after its government approved the second and third phases of the exit plan from lockdown as new COVID cases continued to decline, particularly among people over 60, most of whom have been immunized. Infections rates and serious cases in Israel have declined sharply after more than 80% of people over the age of 60 either were vaccinated or recovered from COVID-19. The campaign has since opened to everyone over the age of 16. However, airports and land borders will be closed for 14 more days, and the country’s borders closed until 6 March. Only 200 people a day are allowed to board “rescue flights”, and this has left thousands of Israeli citizens stranded around the world. Restrictions on mass gatherings have also been relaxed to 20 people outdoors and 10 people indoors, instead of 10 and 5 respectively. At the same time, it was likely that the government would declare a curfew over the upcoming Purim weekend, a holiday traditionally observed by raucous celebrations commemorating the biblical story of the rescue of Persian Jews by the Queen Esther. Coinciding with the relaxation measures, a Green Pass system was put into place to grant Israelis who have had two vaccine doses automatic access to gyms, studios, cultural and sports events, fairs and hotels. Those without the pass have to show proof of a recent COVID test. Children under 16, who can’t be immunized, may still be admitted to some venues, like hotels, along with their immunized parents. Palestine Vaccination Campaign to Begin, Calls on Israel to Reserve More Vaccines for Palestinians Nabi Moussa, Occupied West Bank Palestinians in Gaza were also reportedly due to get their first jabs as another 20,000 vaccines donated by the United Arab Emirates arrived Sunday in the barricaded strip from Egypt via the Rafah crossing. Israel allowed the transfer of 2,000 vaccine doses into the Strip last week. In the Occupied West Bank, vaccine campaigns by the Palestinian Authority with Russia’s Sputnik V vaccine were only just beginning – although West Bank Palestinian infection rates have been comparatively lower than those in Israel, even after the latter had immunized over 50% of its 9.3 million citizens with at least a first dose. A World Bank report on Monday called on Israel to share more of its vaccines with the PA, saying: “While Israel has been leading the world in terms of per capita vaccinations, no one has been vaccinated in the Palestinian territories yet, and the Israeli MoH has not formulated an allocation strategy to support the territories, beyond providing 5,000 vaccines for Palestinian doctors. Humanitarian organizations in both Israel and West Bank and Gaza have called for Israel to reserve a higher amount of vaccines for the Palestinian territories. Given the challenges for the Palestinian Authority to procure vaccines, the statement calls for operational and financial support from Israel to PA.” The Economic Monitoring report further stated: “In order to ensure there is an effective vaccination campaign, Palestinian and Israeli authorities should coordinate in the financing, purchase and distribution of safe and effective COVID-19 vaccines,” noting that the Palestinian Authority faces a US$ 30 million shortfall in vaccine funding, even after support from the WHO co-sponsored COVAX facility. Germany Considers Reopening Even if Cases are Rising Angela Merkel, Chancellor of Germany. Germany’s Chancellor Angela Merkel has also proposed a plan to ease that country’s lockdown which has been in place since November. Merkel reportedly told her Christian Democrat (CDU) party that lockdown measures could be eased in several stages, combined with increased coronavirus testing. The stages would focus on personal contacts (how many people a person meets); schools, sports, restaurants, cafes, and cultural events. However, talk of easing restrictions in Germany belies the upward trend of infections in the country. The Robert Koch Institute reported 4,369 new COVID-19 cases as well as 62 associated deaths. There are major concerns of the COVID-19 variants pushing up numbers. Frankfurt, Germany: Masks required on cycle path France, Sweden, and the Czech Republic – Tougher Lockdowns Paris, France: A woman serves a hot dog in front of a restaurant in the Latin Quarter. French bars and restaurants can no longer accommodate consumers because of the measures taken to combat the COVID-19 pandemic. Some restaurants remain open and serve drinks and take-out meals. While other countries will soon enjoy relaxed restrictions, there have been increases in Nice in France, the Czech Republic, and Sweden. Nice reported 740 new cases per week per 100,000 residents, triple the national average. France has applied a localized lockdown over the next two weekends from Théoule-sur-Mer to Menton, and Nice. French Health Minister Olivier Veran said that measures could include a stricter form of the curfew imposed nationwide in France or a weekend lockdown in the city. “Consultations will be conducted over the weekend to take additional measures to stem the epidemic, ranging from a reinforced curfew to local lockdown at weekends,” Véran said. The Czech Republic is also experiencing a rise, with 11, 233 cases reported on Tuesday, an increase of 7,100 in a single day. Test positivity rate also increased to 40.6%, the highest since 9 January. The Czech Ministry of Health has mandated that masks must be worn in places with larger concentrations of people, especially shops, public transportation, and hospitals, effective Thursday. The Ministry has also submitted to the government a law on emergency measures in an effort to curb the resurgence of COVID-19 in the country, including restrictions on services, a ban on mass events, and the restriction of public transport. “The purpose of the proposed law is to legally enshrine the measures that we issue as a crisis in accordance with the crisis law as part of the COVID-19 epidemic. Thanks to this, it is possible to issue measures for which we have so far needed an emergency, ” explained the Minister of Health Jan Blatný. Uppsala, Sweden: People social distancing Meanwhile, Sweden is preparing the strictest restrictions yet, in an effort to curb a resurgence in COVID-19 cases as the variant first detected in the UK spreads rapidly. “The British variant is increasing very fast. This variant will with fairly high probability be the dominant one within a few weeks or a month… We have a package [of national measures] being readied that will be presented tomorrow,” said Chief Epidemiologist Anders Tegnell at a news conference. Concerns about a possible third wave of the pandemic have been growing since the number of new infections have risen and the new variants have spread. The Swedish government has laid the ground for potential lockdown measures to be tougher than previously measures enacted earlier in the pandemic. The list of businesses that will face mandatory closure in Sweden include shops, hair salons, gyms, and restaurants. The country has also closed its borders to Denmark and Norway. Negative COVID-19 tests are now required for entry into Sweden. Declines Also Seen in United States and India New York City, United States: Outdoor dining during pandemic While declines in serious cases in Israel and the UK may be attributed to vaccines, it remains unclear why numbers are declining globally as some countries battle their second, third, and fourth waves of COVID-19. For the United States, the scale-up of vaccination and the shift in seasons are driving down cases, according to the Institute for Health Metrics and Evaluation (IHME) during a briefing last week. However, variants including the more infectious B.1.1.7 which first emerged in the UK in November 2019, have been detected in the US which could drive transmission. Epidemiologists in India have also questioned the declining cases, pointing to low rates of testing and habitual underreporting of causes of death, particularly in rural India. However, Prime Minister Narendra Modi is hoping that the vaccination drive that began in January will spur wider recovery. Though vaccine uptake remains slower than officials hoped, as of 18 February, more than 98 million vaccine doses have been administered in India. “I don’t think anyone really thinks that without vaccines and a vaccination program being widely available that we can go back to whatever is full normalcy,” said Sireesha Yadlapalli, a Hyderabad-based senior director at the United States Pharmacopeia, a scientific nonprofit organization. “Hopefully this is the slowdown and there’s no second wave.” Bangalore, India: Empty streets during lockdown in early 2020. Despite a nationwide declide, there has been a rise in cases seen in the Indian state of Maharashtra, which has ordered new restrictions on people’s movement and imposed night time curfews. Mumbai, Maharashtra’s capital and India’s financial hub, also banned religious, social, and political gatherings. The state has reported nearly 7,000 new cases on Sunday, a steep rise from 2,000 daily cases earlier this month. The Indian Ministry of Health and Family Welfare has stated that the surge in COVID cases in the state cannot be attributed to strains N440K and E484Q, which have been detected in other countries. WHO Warns Against Complacency Dr Michael Ryan, Health Emergencies Executive Director While some of the declines, such as those in England, Scotland and Israel, may be attributed to massive vaccine campaigns – in other regions, where vaccination is only just getting under way, global health officials have had few explanations for the dip in cases. “We’re certainly not out of the woods yet,” said Health Emergencies Executive Director Dr Mike Ryan at a WHO press conference in Geneva last Thursday. “The virus still has a lot of energy. You’re also dealing with urban settings, many people still living in areas that are overcrowded, multi-generation, multi-family homes. It is very difficult to break chains of transmission in a complex society. Some countries are coming down that hill more quickly than others.” WHO technical lead on COVID-19 Dr Maria van Kerkhove stressed: “We cannot let ourselves get into a situation where the virus can resurge again. Remember what we need to continue to do to drive it down and get cases down into single digits. “We just need to stay the course, hold on to what is working consistently deliberately as we roll out vaccines and make sure that vaccinations start in all countries,” said Van Kerkhove. Ryan also cautioned that, although the global COVID-19 cases are now at their lowest since last October, this could be the result of the natural patterns of the virus. “I do think a good portion of that has been done to the huge efforts made by communities. There have been very stringent lockdowns and stay-at-home orders and other things, but also serum prevalence is rising,” said Ryan. “We need to understand what is driving those transmission dynamics. Is it natural seasonality and wave-like pattern of the disease? Are we building up a level of immunity in the population that’s preventing the disease from finding the next case? Are our control measures having an impact on that?’ asked Ryan. “I think as we move into [northern hemisphere] springtime, we need to drive towards higher levels of vaccinations, getting an equitable distribution of that vaccine, getting rid of the deaths and the hospitalizations and the suffering, but [also] continuing to drive the case numbers down.” Image Credits: Twitter, 7C0/Flickr, Falk Lademann/Flickr, Marc Barrot/Flickr, Sergey Yeliseev/Flickr, Health Policy Watch , David King/Flickr, Ben Hartschuh, 7C0/Flickr, Flickr: IMF Photo/Cyril Marcilhacy. The European Medicines Agency’s COVID-19 Vaccine Leaks: Hacks, Regulatory Pressures And Manufacturing Concerns 23/02/2021 Priti Patnaik & Lucien Hordijk European Medicines Agency headquarters, Amsterdam, The Netherlands EXCLUSIVE – A series of recent leaks of emails and documents surrounding the EMA’s approval of the first COVID-19 vaccine by Pfizer/BioNTech highlight the intense political pressures regulatory agencies are under during the pandemic – as well as an oft-forgotten aspect of vaccine approvals – the quality control of vaccines during the leap from clinical trials to large-scale commercial production. Priti Patnaik & Lucien Hordijk explore. Cyber leaks, public health, geopolitics, vaccine nationalism and political pressure come together in this heady story about the complex challenges that the world’s strongest regulatory agencies are facing as they review and approve new COVID-19 vaccines, developed at unprecedented speed. When a series of emails and documents hacked from the European Medical Agency (EMA) in December 2020 surfaced in early 2021 on the dark web, they revealed a cautionary tale about how even one of the world’s strongest regulatory agencies may be subjected to intense political pressures in their review of COVID-19 vaccines – even as they try to play by the book in their reviews. The hacked documents also shed light on an oft-ignored aspect of vaccine review and approval beyond safety and efficacy – that is quality-assurance of production processes as new vaccine products make the leap from clinical trials to large-scale production. Shortages Led to a Blame Game Ursula von der Leyen, President of the European Commission, speaking at the World Economic Forum in late January – shortly after EMA approval of the first COVID-19 vaccines. And the regulatory approvals did not, ultimately usher in a smooth vaccine rollout. Rather, vaccine shortages have plagued most of Europe on the back of unanticipated production glitches, leading to a political blame game at the very top of the European Commission, (EC). This, in turn, prompted the EU to adopt new rules on export restrictions that have been widely criticised. This story has four parts: what the leaked documents show; how authorities responded to the leaks; the potential motivations for the breaches by hackers seeking to undermine confidence in the vaccines; and what lessons can be learned from the EMA breaches. Part I: The Language of Political Pressure On January 13th 2021 internal emails and documents from the EMA showed up on two hacker forums: Raidforums, an English language marketplace for database breaches and leaks; and Rutor a Russian marketplace on “the dark web”. The dark web is home to encrypted online content not indexed by search engines. These documents, dating from mid- to late November 2020, amounted to nearly 900 pages reports and memos, which included some 20 different email exchanges between EMA officials. They concern the review by EMA’s top management of the Pfizer / BioNTech vaccine in the lead up to its approval. The EMA first reported the cyberattack on December 9th, 2020. The leaks illustrate two important aspects of the regulatory review process: That the EMA was put under intense political pressure by the European Commission to hasten the regulatory process of the first vaccine approvals – particularly those of Pfizer/BioNtech and Moderna; During the Pfizer/BioNTech regulatory process, the EMA had concerns related to the consistency of vaccine quality during the commercial production. Significantly, Pfizer addressed these EMA concerns before the vaccine was approved. But the episode illustrates why such issues would better be shared transparently as part of the regulatory review process, experts say [keeping in mind that US Food and Drug Administration review meetings are even aired publicly online]. As Dr Barbara Mintzes, Associate Professor, The University of Sydney Charles Perkins Centre and School of Pharmacy, and an expert on the interface between clinical research and regulatory decision-making, observed: “I wonder why these issues with production quality were only made public via leaked documents that had become available on the dark web. Why were they not under open and public discussion? These types of exchanges should not be secret.” Leaks Suggest EMA Was Under Pressure to Hasten Vaccine Approvals The cold chain storage for the Pfizer/BioNTech vaccine at Pfizer’s warehouse in Kalamazoo, Michigan. Speedier US FDA and British vaccine approvals added to the pressure on the EMA process. The chain of leaked emails reveals that the EMA was operating under intense political pressure, exerted from the very top of the European Commission (EC), to speed up approvals for COVID-19 vaccines. Without rapid EMA approval of the Pfizer vaccine and others Brussels feared it could not keep its promise to deliver on vaccines for all EU citizens simultaneously and by the end of 2020. Already on 19 November, 2020, Commission President Ursula von der Leyen had publicly announced that both BioNtech/Pfizer and Moderna vaccines could be approved by the EMA by the end of the year. EMA members were uncomfortable with the political promises being made, as reflected in a series of internal emails between the EMA officials from November 12, 19 and 20, 2020, which were among those that came to light in January 2021. And at the same time the pressures to adhere to the EC schedule were immense. While an EU directive allows member states to temporarily use unauthorized drugs in emergencies, the Commission wanted to avoid a situation where countries would begin issuing emergency permits for vaccines at national level, helter skelter. Speedier approvals by other regulatory authorities including UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration also added to the pressure on the EMA. Even so, the email series reflects both the challenges as well as concerns of EMA officials about ensuring adherence to a strict regulatory process, while keeping to Von der Leyen’s ambitious schedule for the approval of the Pfizer and Moderna vaccines. EMA Officials Had Concerns About Commission’s Ambitious Schedule Vials of the Pfizer-BioNTech COVID-19 vaccine. Within EMA expert ranks there was widespread concern that politically-driven deadlines should not compromise the technical review – particularly resolution of the manufacturing quality-assurance issues that also emerged as concerns in the same period: “What is new in my view is that she [Von der Leyen] clearly identifies the 2 vaccines that could be approved before the end of the year. There are still issues with both so it needs to be seen if all this can be sorted out in time, whilst not compromising the robustness of the review”, writes one EMA official in an email on 20 November, 2020 . An email dated November 19, 2020 recounted a telephone conversation between EMA officials and a European Union commissioner. Relates the EMA official to another colleague: “Atmosphere was rather tense….at times even a bit unpleasant.” The official notes that it “provides a hint on what EMA may expect if the expectations are not being met, irrespective if such expectations are realistic or not”. The EMA official goes on to suggest that an interval of even several weeks between an authorisation granted by the FDA & the UK’s Medicines and Healthcare products Regulatory Agency (MHRA); and the EMA will not be acceptable to the European Commission. It would lead to significant “the political fall-out,” the EMA official warned. “We have to be ready for the worst-case scenario,” writes the same EMA official in the email dated November 19, 2020”We will be overwhelmed on all fronts and in the middle of a storm. Whose support can we then rely on?” . According to yet another email dated November 22, the EMA official warned Commission staff: “We are speeding up everything as much as possible, but we also have to make sure that our scientific review is as robust as possible.” EMA and European Commission Deny Political Interference Stefan De Keersmaecker, spokesperson for health, food safety and transport, at the European Commission press briefing 15, January 2021. Asked for comment on the political pressures, an EMA spokesperson replied to us on January 15, 2021 saying: “Despite this urgency (to make vaccines available), there has always been consensus across the EU not to compromise the high-quality standards and to base any recommendation on the strength of the scientific evidence on a vaccine’s safety, quality and efficacy, and nothing else.” The European Commission likewise denied any political interference in the regulatory approval process: “The Commission is fully committed to only authorising vaccines that are deemed safe and effective by its independent scientific agency,” Stefan De Keersmaecker, spokesperson for health, food safety and transport, told us in reply to an inquiry. Only an hour after responding to the queries of our investigative team – which were the first to address this aspect of the email leaks, European Commission authorities hastily convened a press conference on the issue. At the press briefing, Keersmaecker, said that the leaked documents had been “manipulated”: “The EMA has just published its public statement on the cyberattacks of which they are a victim and they have stressed, it is important that you are all aware of that, that some of the correspondence have been manipulated by the perpetrators prior to the publication in a way that could undermine trust in vaccines. I am saying this just to draw your attention that some of the documents that are out there seem to have been manipulated by perpetrators, and therefore have to be considered with utmost care.” PART II: Vaccine Production Quality Assurance Pfizer’s COVID-19 vaccine during the manufacturing process. The EMA’s concerns about quality assurance of the mass production of the Pfizer/BioNtech vaccine (brand name Comirnaty) was a key technical issue to emerge in the regulatory review, as illuminated by the series of leaked EMA emails from November 2020. Here, the regulator’s concerns focused mostly on the Pfizer/BioNtech vaccine candidate, which was the very first vaccine in the EMA regulatory approval pipeline. At the time when the issue arose in November, 2020, some production factories were yet to be inspected, and the regulator was awaiting additional data from Pfizer. The key concern centered around differences in the quality of the vaccine batches produced for clinical trials and batches for commercial production noted by the EMA review experts. According to the leaked documents, the concerns arose over differences in the levels of “mRNA integrity” – an indicator of the purity of the active vaccine drug substance. While the vaccines used in the clinical trials had between 69% – 81% intact mRNA, initial samples of the batches that were destined to be used in large scale manufacturing showed only 59% intact mRNA on average, with some batches as low as 51%. This concerned the EMA – both in terms of safety as well as efficacy of the vaccine doses. According to an email between EMA officials on 23 November, 2020, the EMA stated the following: “…The potential implications of this RNA integrity loss in commercial batches compared to clinical ones in terms of both safety and efficacy are to be defined. “Whether or not the observed compatibility issues could be a blocking point will depend on the relevance of these observations to safety and efficacy and the company will be requested to fully justify the lower %RNA integrity (and other differences noted) “Point for discussion will be whether the comparability issues can be solved only by quality data (additional functional / in vitro biological data + available non-clinical) or that further clinical data (bridging studies are / will be performed) will be needed. It is difficult to make any projections on this.” Ultimately, however, those concerns were resolved to the satisfaction of EMA reviewers, the document leaks also show. Pfizer offered to make manufacturing modifications to ensure that mRNA integrity levels in the commercial production process would remain consistent to those of the clinical trials. The email exchanges refer to manufacturing adjustments ensuring mRNA integrity levels remained at around 75% – although the documents don’t explain how those modifications were made. EMA Responses to Questions About Quality Assurance Review Along with the EMA replieas, a European Commission media briefing on 15 January, 2021, also addressed the email leaks On 15 January, in response to our queries about the quality assurance review of production processes, the EMA said the follow-up data it had received from Pfizer showed “modified forms of mRNA at somewhat higher levels in the batches manufactured with the commercial process as compared to material used in clinical trials.” The EMA clarified to us that such modified mRNA forms were not determined to be a safety risk, particularly in light of the low overall dose of mRNA involved – just 30 micrograms of active ingredient (30 μg): “The amount of any such proteins, is expected to be too low to elicit an immune response of biological relevance.” stated the EMA response. As a result, the risks of any adverse immunological events occurring in reaction to any modified mRNA forms was deemed to be low. Indeed, considering the low dose of mRNA (30 μg), impurities are not considered a safety issue based on general toxicological principles, the EMA said. In their response to our queries, the EMA also acknowledged that the leaked emails reflected the discussions that took place. A spokesperson from the EMA said, “The company was able to address these issues and supply the required information and data to allow EMA to move towards a positive recommendation for this vaccine.” Pfizer, for its part, did not respond to our inquiries on how the company addressed concerns the EMA had raised in November 2020. In a statement in mid-January, the company said: “As the European Medicine Agency’s investigation [of the cyberattack] is ongoing, we defer to them on any updates.” How do mRNA vaccines work? Description of Pfizer’s use of mRNA technology to develop COVID-19 vaccines. Coronaviruses are made up of a single-stranded RNA protein, bounded by protein and wrapped in an envelope of lipid molecules The SARS-CoV-2 virus uses the spike proteins covering its surface to bind to ACE2 receptors found in the lung and other organs. It then fuses with the membrane of the host cell and releases its genetic material. Once the virus has overtaken the cell, it hijacks the cell’s internal machinery to make proteins that help it replicate. Most COVID-19 vaccines have targeted the distinctive spike proteins of the SARS-CoV-2 virus – used by the virus to pry its way into the body’s cells. Typically, vaccines involve injecting a weakened, inactivated or genetically modified form of the pathogen into the body to trigger immune response. However, mRNA vaccines involve the use of messenger Ribonucleic Acid (mRNA) to carry “instructions” for manufacturing a spike protein into the body. That, in turn, triggers the immune response. As described in a Health Policy Watch interview with Moderna’s Chief Medical Officer Tal Zaks from November 2020: “mRNA is a transient copy of the instructions in our genes that instructs the cell’s ribosomes to make protein. ….An mRNA vaccine is not a virus, [or even a weakened virus]. It only gives the cells transit instructions to make that one piece of virus that we want to educate the immune system to recognize. It’s essentially an instruction code. I inject it into the muscle. It gets distributed to the lymph nodes where the immune system works. The messenger RNA encodes for the spike protein and our cells start to make this spike protein. “Now the immune system sees a new protein it’s never seen before. And it goes, ‘Oh, hold on a second. This looks like a foreign threat. …let me go block it.’ And so the immune system starts to generate antibodies and T cells that recognize that spike protein. It focuses the attention of the immune system, just on that one protein.” Independent Expert Confirms – No Vaccine Efficacy or Safety Issue We also interviewed Steve Pascolo, a researcher at the University Hospital of Zurich, an expert on mRNA vaccines, regarding potential impacts of lower mRNA integrity levels on either safety or efficacy of the Pfizer/BioNTech vaccine. Pascolo, also a co-founder of CureVac who left the company in 2006, said that he did not see serious issues of safety or efficacy arising: “In the early trials of BioNTech, they had immune responses with just one microgram of RNA.” (the approved mRNA vaccine has 30 micrograms of RNA per dose), said Pascolo, also author of a recent paper Synthetic Messenger RNA-Based Vaccines: from Scorn to Hype. And what about safety? Could a lower mRNA “integrity” level could impact the vaccine’s safety? Was it possible that the presence of “truncated” mRNA proteins in the vaccine’s active ingredient – other than the exact target mRNA protein – could also have unwanted immune impacts? Said Pascolo: “There is no safety implication of having a shorter mRNA transcript in the vaccine. In fact a shorter transcript will probably not be translated (it misses the functionality important ends) and if it would, may result in production of shorter proteins that may even participate in the overall immune response.” PART III – EMA Says Emails Were Manipulated by Hackers To Sow Vaccine Mistrust When our team published its first story on the leaked documents in Business Insider Germany (on January 15, 2021), an EMA spokesperson said that the agency “would not verify” the authenticity of the leaked documents because they have been stolen by hackers and placed on the dark web. Later on that same day, an EMA press statement acknowledged that the “unlawfully accessed documents.. Included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines.”The 15 January statement added that “Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.” Ten days later, on 25 January, the EMA issued another statement on the cyberattack that had led to the email leaks, with more details on how the series of email leaks had been manipulated by hackers – to create mistrust around the vaccines themselves. “Whilst individual emails are authentic, data from different users were selected and aggregated, screenshots from multiple folders and mailboxes have been created and additional titles were added by the perpetrators in a way which could undermine trust in vaccines”, said the EMA press statement issued on January 25. Analysts Suggest EMA Emails Were Hacked by State Entity Undoubtedly, the way these documents appeared on the dark web, played into the hands of sensationalism muddying the regulatory reviews. The leaked documents from the EMA were named “BIG DATA SCAM of Pfizer’s vaccines” and “Astonishing fraud Evil Pfizer!!” Jean-Michel Doan, an open-source analyst who specialises in cybercrime at Sekoia, an IT security company in France, said, it is likely that the attack was caused by hackers affiliated to a state entity. “This kind of hacking tactic with data theft followed by data leaks has already been practiced by Russian agents (Guccifer 2.0/ Democratic National Convention leaks and World Anti-Doping Agency leaks).” Cyberattacks focusing on undermining confidence around brands of the Covid vaccine have also been undertaken by hacking groups affiliated with China, North Korea, and Iran and Russia, he added. The team also spoke with Mirko Gatto, CEO of Yarix, an Italian company that works in IT security, on whether anti-vaxxers could have orchestrated such an attack. Gatto said, “All is possible, but if anti-vaxers want to damage someone they go in other places, for example on Twitter. They use open source intelligence (OSINT) sources. They want to communicate as much as possible and [the] black market is not a place for this kind of strategy.” Part IV; Balancing Regulatory Processes, Political Pressures & Right To Know Clearly, the leaks reveal the kinds of political pressures that have been faced by even the world’s most stringent regulatory agencies in the pandemic era. They underline the penultimate importance that politicians need to attach to restraint – in order to maintain public confidence in regulatory processes – and the vaccines they produce. Even so, it appears the EU drug regulator adhered to its due diligence process. The EMA issued the Pfizer-BioNTech’s vaccine a conditional marketing authorization on December 21, 2020- a full three weeks after the UK (December 5th) and two weeks after the US FDA actions (December 11th) – suggesting that the EM indeed took time to resolve questions about safety, efficacy and manufacturing quality assurance. . Still, the leaks provide a cautionary tale about the pressures that regulatory authorities may face – with implications for other national regulatory agencies as well as the World Health Organization – which has its own emergency use listing process. If one of the strictest regulators in the world is subjected to such pressures, it is likely the pressures on other authorities may be even more intense. Transparency of Dossier Submissions Professor Brook Baker, Northeastern University, School of Law The other lesson learned may be one about the importance of transparent regulatory reviews. If the exchanges between the EMA and Pfizer about aspects of quality assurance of production processes had been a transparent matter of record – it might have removed the sting of some of the leaked emails – which ostensibly sought to undermine vaccine confidence. Observes Brook Baker, professor of law at Northeastern University in Boston told Health Policy Watch, “Transparency by regulatory authorities and WHO prequalification with respect to COVID-19 vaccines is absolutely critical to vaccine acceptance by medical providers, opinion makers, and ultimately individual patients and the public-at-large. Transparency is particularly important when public anxiety is high, product development and clinical trials have been expedited, political pressure has been exerted by public officials, there is global competition in vaccine development, and emergency use permission is granted short of full regulatory approval. It also certainly hasn’t helped that even stringent regulatory authorities in the U.S., U.K., and Europe have disagreed on what vaccines to approve and conditions and populations of approved use.” As a result, adds Baker, ”transparency about dossier submissions, the evidence submitted, independent and supplementary review by expert committees, and the detailed assessments of the regulator is vitally important. “This should include transparency around known adverse effects, post-approval pharmacovigilance, efficacy with respect to new variants, and on-going studies and time-lines for full regulatory approval,” he says. EMA Not the Only Regulatory Agency Subjected To Pressures Former US President Donald Trump at a White House Coronavirus Taskforce briefing – he used the presidential podium to exert pressure on the FDA for more rapid approval of COVID-19 vaccines. The EMA experience can be contrasted with the US Food and Drug Administration review process of the same vaccines – which was subjected to even more overt and intense political pressure from former US President Donald Trump. Those pressures included Trump’s own tweets and statements, as well as backroom approaches from White House emissaries and Trump’s political appointments in the US Centers for Disease Control, the White House COVID task force and the FDA. “Fortunately, the scientists and leadership at the FDA resisted these pressures, assured that there would be independent expert input, and reviewed the evidence with care and precision,” said Baker. “These internal forces at the FDA were helped by vaccine developers who also made it clear that they wanted there to be rigorous, independent review at the FDA.” Baker also notes the “unprecedented transparency with respect to many aspects of the [FDA] approval process,” including not only the portfolio submissions but also live video coverage of the entire FDA review deliberation. At the same time even across the Atlantic, “advocates are still pressing for even more transparency about company submissions, including underlying clinical trial data and confidential manufacturing information, and about FDA assessments,” Baker observes. Going forward, such transparency may be all the more important to both protect regulatory authorities from undue political interference – as well as building public confidence in the process – and thus in the vaccines that they approve. Ultimately, FDA transparency may also have helped build public confidence in the FDA approval process – and even stave off hackers’ attacks such as those seen in Europe. _________________________ Priti Patnaik is the founding editor of the Geneva Health Files, an independent global health reporting initiative based in Switzerland. Lucien Hordijk is a contributing reporter for the Investigative Desk, a non-profit investigative journalism group that is based in Amsterdam. Ludovica Jona (Italy), Lise Barnéoud (France), and Hristio Boytchev (Germany) also contributed to this article. This article is part of the series #BehindThePledge, a cross border investigation into the money trail of pandemic-related drug and vaccine development and rollout. This is the first publication in English-language media about the EMA leaks. Earlier versions of the story have been published by the team in media in France, The Netherlands, Italy & Germany. The project has received grants from Journalismfund and IJ4EU. Image Credits: BioNTech, Twitter, Pfizer, US Centers for Disease Control, Pfizer, White House/D. Myles Cullen. Global Citizen Launches ‘Recover Better Together’ Campaign – Guinea Launches Ebola Vaccinations – Nigeria & Zambia Studies Show High SARS-CoV2 Infections 23/02/2021 Kerry Cullinan Global Citizen CEO Hugh Evans launches 5-point global recovery campaign Vaccinating all of Africa’s health workers would need half a percent of all the doses that the G-7 countries have purchased, according to Global Citizen CEO Hugh Evans. On Tuesday, Global Citizen launched a five-point ‘Recover Better Together’ plan for the world, aimed at getting millions of citizens behind ending COVID-19 for all, ending the hunger crisis, resuming learning for children, fully protecting the planet, and advancing equity for all. “First we must focus on achieving sufficient worldwide vaccine coverage to break the chain of transmission, including, for the poorest nations,” Evans told a media briefing convened jointly with the World Health Organization, and addressed by world leaders including European Commission president Ursula von der Leyen, US Special Envoy in Climate John Kerry and South African president Cyril Ramaphosa. In his address, Ramaphosa applauded French president Macron who has called on rich countries to donate 5% of their vaccines to needy countries. “Another important step is to enable the transfer of medical technology for the duration of the pandemic. This will allow us to increase the production of COVID-19 vaccines and other medical products, lower prices, and improve distribution so that these vaccines and medical supplies reach all corners of the world,” said Ramaphosa. Guinea Starts Ebola Vaccination Drive – Nigerian and Zambian Studies Show High Levels of SARS-CoV2 Infection Healthworkers during the 2017 Ebola outbreak in the DRC. Guinea started Ebola vaccinations on Tuesday of people at high risk in Gouecke, a rural community in N’Zerekore prefecture where the first cases were detected on 14 February – the first cases since 2016. “All people who have come into contact with a confirmed Ebola patient are given the vaccine, as well as frontline and health workers. The launch started with the vaccination of health workers,” according to a media release from WHO’s Africa region. “The last time Guinea faced an Ebola outbreak, vaccines were still being developed,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “With the experience and expertise it has built up, combined with safe and effective vaccines, Guinea has the tools and the know-how to respond to this outbreak. WHO is proud to support the government to engage and empower communities, to protect health and other frontline workers, to save lives and provide high-quality care.” The WHO sent 11 000 doses of the rVSV-ZEBOV Ebola vaccine from its headquarters in Geneva, while a further 8500 doses are being procured from Merck, the vaccine’s producer in the US, “The speed with which Guinea has managed to start up vaccination efforts is remarkable and is largely thanks to the enormous contribution its experts have made to the recent Ebola outbreaks in the DRC,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “Africans supporting fellow Africans to respond to one of the most dangerous diseases on the planet is a testament to the emergency response capacity we have built over the years on the continent.” Implementing an Ebola vaccination strategy is a complex procedure as the vaccines need to be maintained at a temperature of minus 80 degrees centigrade. Guinea has developed ultra-cold chain capacity with vaccine carriers, which can keep the vaccine doses in sub-zero temperatures for up to a week. There are eight cases (four confirmed and four probable) and five people have died so far. Guinea’s neighbours are on high alert, particularly Liberia and Cote d’Ivoire which are close to the border with N’Zerekore, Guinea’s second-largest city. Meanwhile, a second person died of Ebola last week in the Democratic Republic of the Congo’s North Kivu province. Ebola, a haemorrhagic fever, is transmitted from wild animals and spreads in the humans through direct contact with the blood, and bodily fluids of infected people, and contaminated surfaces and materials. Nigeria’s First SARS-CoV-2 Seroprevalence Study Finds Almost 25% of Lagos Residents Had Antibodies Lagos Almost a quarter of Nigerians living in Lagos may have been infected with SARS-CoV2, according to the results of a seroprevalence study released on Monday by the Nigeria Centre for Disease Control (NCDC) and Nigeria Institute for Medical Research (NIMR) The household seroprevalence survey was conducted in Lagos, Enugu, Nasarawa and Gombe States in September and October last year and involved blood samples from over 10,000 people. SARS-CoV-2 antibodies were found in 23% of people sampled in Lagos and Enugu States, 19% in Nasarawa State, and 9% in Gombe State. “These rates of infection are higher than those reported through the national surveillance system and reveal that the spread of infection in the states surveyed is wider than is obvious from surveillance activities,” according to a statement by the NCDC and NIMR. The survey also showed that men had higher infection rates than women (21% of men and 17% of women in Nasarawa), and urban areas had higher infection rates than rural areas (28% of urban residents and 18% of rural residents in Enugu). The survey is currently being expanded to more states in the North-West and South geopolitical zones which were not included in the initial round of surveys. Zambia Post-Mortems Find High Level of SARS-CoV2, Minimal Testing Post-mortem surveillance of 364 Zambians who died between June and September last year detected SARS-CoV2 in 70 (19%), according to a study published in the BMJ last week. PCR tests were administered on people at the University Teaching Hospital morgue in the capital of Lusaka within 48 hours of death. Fifty of the 70 with COVID-19 had died in their communities without ever having been tested for the virus. Only five of the 19 who died in hospital had been tested. Seven children were part of the study and only one had been tested before death. The most common co-morbidities among those who died of the virus were tuberculosis (31%), hypertension (27%), HIV/AIDS (23%), alcoholism (17%), and diabetes (13%). Image Credits: WHO, Wikipedia. ‘Rapid Response Platforms’ Enabled COVID-19 Vaccine Development, Says Fauci 23/02/2021 Madeleine Hoecklin The Epidemic and Pandemic Preparedness and Response panel at the GVIRF event on Monday. Rapid response platforms, particularly the messenger RNA (mRNA) platform, have changed the landscape of vaccine development, enabling the rapid response to the COVID-19 pandemic, said Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) on Monday. Fauci, speaking at the opening of the Global Vaccine and Immunization Research Forum (GVIRF), co-organized by WHO, the Bill & Melinda Gates Foundation, and the NIAID, highlighted the innovations in vaccinology that made the speedy development of COVID-19 vaccines possible. “There are a number of new technologies that have now really dominated our approach to COVID-19. For example, there’s genetic immunisation using RNA and DNA vaccines,” said Fauci. “We are well aware now of the successes, for example, of the mRNA vaccines.” Rapid response platforms are systems that can be adapted against different pathogens. In the case of mRNA vaccines, these have been developed over a number of years to address influenza, Zika and rabies and have shown a high level of efficacy against SARS-CoV2. The Pfizer/ BioNTech and Moderna SARS-CoV2 vaccines have both had over 95% efficacy against symptomatic COVID-19 and nearly 100% efficacy against severe disease. “I think it’s fair to say that rapid response platforms have been a revolution in vaccinology over 2020 with COVID-19,” said Melanie Saville, Director of Vaccine Research and Development at the Coalition for Epidemic Preparedness Innovations (CEPI). “These can be further developed and prepared for future outbreaks, epidemics, and pandemics.” Barney Graham, deputy director of the Vaccine Research Center at NIAID, added that, over the past 12 years in particular, “new technologies have improved our ability to both prepare for and respond to emerging threats, like structural biology protein engineering and rapid platform manufacturing.” Prototype Pathogen Approach Both Graham and Fauci described the prototype pathogen approach to pandemic preparedness vaccine research used at the NIAID. This refers to studying pathogens of a particular group to build on prior experiences and use strategies to inform vaccine design for related viruses. In developing vaccines for SARS-CoV2, structure-based vaccine designs from Middle East Respiratory Syndrome (MERS-CoV), which is in the family of coronaviruses, were used and “enabled us to rapidly get a successful vaccine, particularly with mRNA [technology],” said Fauci. With the technological advances and the unprecedented R&D work conducted over the past year with COVID-19, “I think we’ve probably moved forward a decade…with COVID-19 vaccines being developed in only 300 days, whereas usually, they would take multiple years, if not decades,” said Saville. The timeline of the mRNA COVID-19 vaccine development. “One thing to point out [is] the speed with which we went from appreciating the new virus, in this case SARS-CoV2, on January 10 of 2020, to starting a phase one trial, about 65 days later, a phase 3 trial both with Moderna and with Pfizer, on 27 July and now having both vaccines already being administered here in the United States and elsewhere. [This is] the fastest in the history of vaccinology from the identification of a particular pathogen to the actual administration of a vaccine,” said Fauci. Challenges with mRNA Platforms While mRNA technology has had great advances, there is still a lot that is unknown about this type of vaccine, including what type of RNA to use and what long-term immune response durability may be. The continued development of the rapid response platforms is needed to make progress on COVID-19 and future epidemics and pandemics. “In all cases, the more robust the platform, in terms of what safety data you have from the platform, what type of immune profile, and importantly, the manufacturing process – which is often really the rate-limiting factor, [the better it is to]…get them as fine-tuned as possible,” said Saville. The manufacturing the Pfizer/BioNTech and Moderna vaccines is limited and is largely centered in Europe and North America. A map of the manufacturing sites for mRNA COVID-19 vaccines globally. “What we need to really look at in the medium and longer-term [is]…how can that manufacturing footprint be much more amenable with regional manufacturing capacity,” said Saville. “Looking at manufacturing innovation…that could be amenable to the low- and middle-income countries [is] something that really needs to be followed.” Innovations in Manufacturing While numerous accomplishments have emerged from the COVID-19 pandemic, several shortcomings, particularly in vaccine development and manufacturing, have occurred. “There’s no question that COVID has demonstrated the potential of vaccine development and R&D, but it has also exposed some pretty major gaps in the system and [has shown] what happens when a disease strikes the entire world at the same time,” said Selwyn. These gaps include the limitedd supply of vaccines secured for low- and middle-income countries; high-income countries pre-ordering large amounts of vaccines for themselves; the reduction in production capacity for other diseases, which may increase the risk of outbreaks; and the dependency on tech transfers. “In COVID, there were multiple companies who had quite limited experience with vaccine manufacturing and bringing vaccines through licensure, [who were] planning for upwards of 10 tech transfers in a single year,” said Casey Selwyn, senior officer in Vaccine Development and Global Health COVID-19 Response at the Gates Foundation, at a workshop that followed the opening session. Normally a company may undertake one transfer a year. The Innovations in Vaccine Manufacturing workshop at the GVIRF session on Monday. “To maximize global supply, we need to have innovative ways to ease and encourage tech transfer…A tech transfer requires time, it requires resources and sharing of know-how, not just intellectual property,” Selwyn added. The most efficient way to scale up vaccine production and supply over the long term is to build “ever-warm” vaccine facilities that are multi-platform and multi-purpose with a trained workforce, so that the facilities can be prepared when an outbreak occurs, proposed Selwyn. Another recommendation for innovating global manufacturing was to implement a hub and spoke distribution model, which would create a centralized network where products are received in central locations before being sent directly to their destinations. According to Selwyn, this could ease the pressure of tech transfers and establish a better geographical reach, creating a more flexible, accessible and cost effective system. Alternatively, increasing standardization of manufacturing protocols and regulatory requirements – which could include the labeling of products, serialization, and design of protocols – could also improve speed, flexibility, and cost-efficiency. “Probably one of the most important sets of innovations, sets of lessons and sets of actions for the future is really continuing to pursue uniformity and harmonization, especially for a set of diseases and pathogens that require rapid response,” said Anant Shah, New Product Lead for Global Vaccines for COVID-19 and Ebola at Merck. “We have to pursue uniformity, flexibility and efficiency if we want to continue ensuring global equitable access,” said Shah. Image Credits: NBC, GVIRF. Global Health Diplomacy In The COVID-19 Era – Can Failure Usher In A New Era of Success? 22/02/2021 Svĕt Lustig Vijay More than a year into the world’s largest global health emergency, health diplomats have fought hard to ensure that every country across the globe secures access to lifesaving coronavirus health products, including vaccines, treatments, and diagnostics. That has not happened yet, given that 80% of countries that are now rolling out vaccines are either high-income or upper middle-income countries. Export bans on essential health products in 80 countries, ranging from personal protective equipment to ventilators, have not helped either. And in the absence of clear global guidance, up to 130 countries have imposed an uneven patchwork of travel restrictions in an attempt to keep more contagious variants at bay – mostly to no avail. A panel of some two dozen leading diplomats and health policy experts from WHO, government, academia and media pondered the current state of affairs, at the Global Health Centre’s (GHC) launch of a new Guide to Global Health Diplomacy, authored by GHC founder Ilona Kickbusch along with a former Hungerian Health Minister, Haik Nikogosian, former head of the Framework Convention on Tobacco Control, Mihály Kökény; and a preface from WHO’s Director General Dr Tedros Adhanom Ghebreyesus. The guide, co-sponsored by the Swiss Confederation, offers a compass to navigate the complexity of global health diplomacy through “practical insights” and “sound wisdom”, said Norway’s leader of the labor party Jonas Gahr Stør at the launch event on Thursday. Norway’s Labour Party leader, Jonas Gahr Støre The event featured some of the bright stars in the world’s global health constellation, including former WHO DG Margaret Chan; Trudi Makhaya, economic advisor to South Africa’s President Cyril Ramaphonsa, Suhasini Haidar, editor of India’s The Hindu Newspaper, Juan Jorge Gómez Camacho, Mexico’s Ambassador to Canada, and Swiss Federal Councillor Alain Berset. The event, moderated by Kickbusch, was co- sponsored by the World Health Organization and the Swiss Federal Council. Said Kickbush: “As you can see from the subtitle of this book [better health – improved global solidarity – more equity], the three words, health, so that health moves to the centre of negotiations, solidarity, and equity – those truly are the goals of global health diplomacy.”Better health – improved global solidarity – more equity Ilona Kickbusch, Founding Director of the Graduate Institute’s Global Health Centre in Geneva. Crisis Has Shown The Failures of The Current International Health Regulations System For Pandemic Preparedness & Response Michel Kazathchkine, former Executive Director of the Global Fund and a member of the Independent Panel for Pandemic Preparedness and Response The pandemic has uncovered “many flaws” in global preparedness and response, said Michel Kazathckine, former executive director of the Global Fund to fight AIDS, Tuberculosis and Malaria, and currently serving as a member of the Independent Panel for Pandemic Preparedness and Response, mandated by the World Health Assembly in May, to explore how and why the SARS-CoV2 pandemic caught the world so badly off guard. “The international system we have established for health security did not really work as a system,” he said. “There were clear gaps in preparedness management of the response coordination.” If there is anything that diplomacy has “certainly” not achieved in the midst of the pandemic, it is “firm and binding commitments” at the international level, added the Global Health Centre’s co-director Suerie Moon. Suerie Moon, Co-Director of Global Health Centre at Geneva Graduate Institute Same Challenges Were Apparent in H5N1 Avian Flu Epidemic The challenges are not new. Some 15 years ago after the eruption of the H5N1 Avian Influenza epidemic, Indonesia protested the fact that after low- and middle-income Asian countries had shared samples of the emergent pathogen with research networks around the world, rich countries then bought up most of the vaccines thus produced – leaving other countries vulnerable. In 2021, the continued lack of clear and binding agreements to ensure equitable access to health products during health emergencies remains largely unresolved, Moon said. “We’ve known this for quite some time, but actually we have very weak, frankly, quite non-existent rules and agreements at the international level to make sure that countries get access to vaccines, so this is not a surprise,” she said. “This is not something that is new to the global health community, but it’s something that we have not yet managed to address.” While some global frameworks do exist to allow LMICs to gain emergency access to lifesaving health products – such as the pre-existing donor-financed vaccine pool for 92 LMICs managed by Gavi, The Vaccine Alliance, or tools like the WTO’s TRIPS agreement (Trade-Related Aspects of Intellectual Property Rights) – the global south still struggles to take advantage of available IP flexibilities, partially due to fear of retaliation from stronger nations and big pharma. And recent negotiations over a South African and Indian proposal for a more far-reaching TRIPS waiver have “not been easy” either, noted Trudi Makhaya, who is economic advisor to South Africa’s President Cyril Ramaphonsa. Trudi Makhaya, Economic Advisor to South Africa’s President Cyril Ramaphonsa. Another alternative, the WHO-backed voluntary licensing pool, has also failed to garner pharma support for now. Still, there is a growing appreciation that technology transfer and the development of more local health product manufacturing capacity is crucial for low- and middle-income countries going forward, said Makhaya. Notably, new World Trade Organization Director General Dr Ngozi Okonjo-Iweala has talked about a “third way” that would encourage big pharma to sign more voluntary deals with countries for local production – without impinging on intellectual property rights. However, Makhaya remains wary: “There is an appreciation that there’s got to be technology transfer [to LMICs], there’s got to be local manufacturing and that current other alternative arrangements to do that, in the absence of the TRIPS [waiver], are going to be very difficult,” she said. Economy Among the Myriad Of Global Health Challenges But access to vaccines is only one of a myriad challenges facing low- and middle-income countries in the pandemic response. Makhaya also talked about the economic response to COVID : while some “important” ideas have been floated by the international community to bolster fragile economies – such as special IMF drawing rights for low-income countries – fiscal measures have remained stunted in poorer nations, in comparison to advanced countries that have pumped up to 20% of their GDP into local economies for temporary relief to businesses and the unemployed, she said. “There have been significant calls that there should be resources at the global level that should be injected [into emerging economies],” said Makhaya. “ A key example was special drawing rights at the IMF…[but] it hasn’t found much expression.” “We have a situation where amongst advanced countries’ central banks there’s cooperation, but none has been extended to many other developing countries.” Added Juan Jorge Gómez Camacho, Mexico’s Ambassador to Canada: “Health is not just about health itself,” he said.“Health means prosperity, or the lack of. Health means economic growth, or the lack of. “Health means wealth or poverty. Health is everything. In other words, health criss-crosses all the spectrum of human activity – socially, politically, economically.” Some Successes: COVAX is Unprecedented Dr Tedros Adhanom Ghebreyesus speaking at Thursday Global Health Centre event Even so, some successes have been apparent since the pandemic struck. If the global health community has achieved anything, it is the WHO co-sponsored COVAX global vaccine facility, which has successfully brought together 190 countries “out of thin air” in the aim to provide more equitable distribution of coronavirus vaccines around the world, said Moon. “The access to COVID-19 tools accelerator is health diplomacy in action,” added Dr. Tedros. “It is an unprecedented collaboration between countries, international agencies, the private sector, and other partners to ensure vaccines, diagnostics and therapeutics are shared equitably as global public goods. Vaccine equity is a litmus test for solidarity and global health diplomacy.” Just last Friday, G7 leaders committed an additional $4.3 billion to the ACT Accelerator initiative, which includes COVAX, as well as parallel efforts for tests and treatments and health systems strengthening. That brings the total commitment to ACT for 2021 to $10.3 billion – although global health leaders say that another $22.9 billion is still needed for all arms of the initiative. Local Manufacturing Of New Vaccines Scaling up generic manufacture of COVID-19 vaccines could help expand supply and stimulate local economies Meanwhile, some vaccine-makers have made strides in advancing more local production of their vaccines around the world. Russia’s Sputnik V vaccine, for instance, which showed impressive results in the publication of recent Phase 3 results in The Lancet, is already being produced in India, South Korea, Brazil, China. And production is set to begin in Kazakhstan and Belarus, among other countries like Turkey and Iran – although Sputnik has yet to receive formal regulatory approval from a western regulatory agency or the World Health Organization. India’s Serum Institute is manufacturing a local version of the Oxford/AstraZeneca, recently approved by the European Medicines Agency. The vaccine, locally branded as Covishield, is set to play a big part in advancing the access agenda through the COVAX facility as well as through bilateral deals. Over the past two weeks, India has exported 23 million doses of the locally-produced “Covishield” vaccine to low- and middle-income countries, said National Editor for The Hindu media outlet Suhasini Haidar, who also spoke at the panel event. Still, despite the big ambition for COVAX to distribute more than 2 billion vaccines by the end of 2021, it is a rather sobering fact that COVAX-supplied countries will only be able to vaccinate 3% of their population over the first half of this year, said Moon, adding, “frankly, we need to aim far, far, higher than that.” Meanwhile, countries like Canada have already ordered five times more vaccines than they need, and the EU has ordered twice as many vaccine doses than it needs. That has opened a debate about vaccine sharing of surplus stocks by rich countries to poorer ones – an exchange which WHO would like to encourage through the COVAX facility instead of through uneven bilateral deals and donations. Global Solutions Are Important – But Regional Solutions Also Required India’s prime minister Narendra Modi as he recently announced a South East Asia regional initiative. Finally, while global frameworks are crucial in the pandemic response, countries shouldn’t wait for Geneva to take action, added other panelists. Notably, the African continent has come together in unprecedented ways through initiatives like the African Response Fund, the African Medical Supplies Platform, or the African Vaccine Acquisition Task Force, among others, said Makhaya. “Instead of looking at the world as one large area of cooperation, perhaps [we need smaller] building blocks, much more about the regions and then come to some kind of success,” added Haidar. “If we only look at the solutions as an all-or-nothing huge global system, I think we’re going to close off,” added Moon. “It’s a very complex multipolar ecosystem with lots of different solutions being figured out by different actors who are not waiting for the answers to come from Geneva.” Indeed, as this event was happening, other new regional initiatives were also taking shape – including Europe’s announcement of an emergency biodefense plan and a SouthEast Asia regional initiative for pandemic preparedness and medical emergencies mooted by Indian Prime Minister Narendra Modi. This, however, does not mean “we don’t need Geneva”, said Moon. “We absolutely need global frameworks and global agreements, but when we think about how have countries figured out how to solve their problems, it has not always been through massive global agreements and so I think we have to think creatively about how does the entire ecosystem work, including what needs to truly be global versus [regional].” One of the newer global frameworks that is now gaining steam is a “Pandemic Treaty”proposed by DG Tedros at the World Health Assembly. The treaty aims to garner stronger political commitment towards pandemic preparedness and response, noted the WHOs regional director for the EMRO region Jaouad Mahjour, also appearing at the panel debate. But until such initiatives are put into force, it “isn’t difficult” to guess who will emerge as a winner in the pandemic response, warned Kazathckine. “Health is a political choice that can and must transcend politics,” Dr Tedros said at the Thursday event. “That’s why this book is so important to build the health diplomacy capacity of both diplomats and health experts around the world.” But as Moon reminded the panel: “At the end of the day, the big challenge will not be what needs to be done, but actually how to do it. “And this is the work of diplomats – just how to implement, and how to navigate the politics… reminds us that the work of diplomats is really just beginning and that there’s a huge agenda ahead of us.” Other Key Points By Panelists “Sharing expertise and information should be at the heart of global health diplomacy. Global collaboration is key to a more equal and sustainable world that benefits all of us” said @JosepBorrellF during the launch of our Guide to Global Health Diplomacy. @EU_Commission pic.twitter.com/CBGyb2MOAx — Global Health Centre (@GVAGrad_GHC) February 18, 2021 Juan Jorge Gómez Camacho, Ambassador of Mexico to Canada.“The only way we can address this pandemic is by moving all together. We cannot address [the pandemic] country by country. It is self-defeating not only collectively [but also] individually as a country, if we focus on us instead of focusing on working together. For a diplomat, to understand in this case it is not my own interest versus everybody else’s interests. In fact, everybody else’s interest is in my best interest. Joseph Borrell Fontelles, High Representative of the EU for Foreign Affairs and Security Policy Vice-President of the European Commission -“Sharing expertise and information should be at the heard of global health diplomay.” Dr Tedros, WHO Director General “If we have learned anything, this past year, it’s that none of us can go it alone. We can only thrive when we work together across institutions across borders,” he said. “That’s why it’s truly a pleasure to join you for the launch of the guide to global health diplomacy.” Margaret Chan, former WHO Director General “Without diplomacy, we cannot begin to negotiate,” she said.“And we cannot begin to [advance] the important policy decisions that impact the health and well being of the world’s population.” Alain Berset, Federal Councillor of Switzerland “The value of global health diplomacy has probably never been more apparent as it is today,” he said. “In this crisis, we need skilled diplomacy to find good solutions.” Michel Kazathchkine, member of the Independent Panel for Pandemic Preparedness and Response “The question for us today…is not whether 2020 has been the year of global health diplomacy, but what has global health diplomacy achieved during the crisis, and where has it failed, and looking forward, which are the challenges.” "The value of global health diplomacy has never been more apparent as it is today. In this pandemic, the international community needs to come together in solidarity. We need skilled diplomacy to find good solutions to global challenges." @alain_berset @BAG_OFSP_UFSP @BAG_INT pic.twitter.com/R0s5F2ASAp — Global Health Centre (@GVAGrad_GHC) February 18, 2021 Global Health Diplomacy Book – Co Published with the WHO and the Swiss Federal Council The new book, published in collaboration with the WHO and the Swiss Federal Council, will be translated into Chinese and Portuguese, among other languages, said Kickbush. Given that health is negotiated across all sectors, the new guide is relevant to a range of stakeholders, including the media, civil society, academia, as well as ministries across various sectors, emphasized the Global Health Centre’s co-director Suerie Moon. “The book makes it quite clear that you don’t need to be a health specialist and you don’t need to be a former diplomat, and in fact some of the most important global diplomats are economic advisors or are coming from media or coming from civil society and academia and foundations and not necessarily from the traditional ranks of diplomacy. “If there’s one lesson we’ve really seen over the past year from COVID it’s that diplomacy is not only the responsibility of ministries of health, but trade, science, technology, intellectual property, travel, tourism, finance…Every single one of these ministries in government needs to be mobilized to negotiate solutions.” Read the Global Health Centre’s new guide here https://www.graduateinstitute.ch/GHD-Guide Image Credits: NBC, European Health Forum Gastein, IHEID, Twitter: @WHOAFRO. EU Cannot Sue AstraZeneca – Germany Commits to Sharing Doses 22/02/2021 Madeleine Hoecklin & Kerry Cullinan Threats from the European Commission to sue AstraZeneca over the delay in deliveries of COVID-19 vaccines hold no weight, according to the EU’s contract with the pharma company in which the right to sue was waived. Following the drugmaker’s announcement in late January of a 60% shortfall in vaccine deliveries for the first quarter after its manufacturing plants in Europe hit a number of snags, furious EU officials examined possible legal avenues to resolve the issue. The release of the full contract by RAI, an Italian broadcaster, makes public several key elements that were redacted from a version previously published by the European Commission. In particular it reveals that the Commission is unable to sue for issues with the storage, transport, and administration of vaccines, including delays in the delivery of vaccines. The exception to the restrictions on the right to legal action is AstraZeneca’s “wilful misconduct or failure to comply with EU regulatory requirements…including manufacture.” While the EU’s hands are tied in terms of filing a lawsuit, there are other pathways open, including suspending payments to AstraZeneca. The initial funding for the doses promised to the EU totals €336 million, of which the Commission already paid two-thirds. The remaining €112 million is supposed to be paid within 20 days of receiving the first installment of doses, however, with the lack of evidence of progress towards manufacturing the doses, “the Commission will have no obligation to pay the second installment and may seek to recover the first installment or a portion of it,” states the contract. It appears that AstraZeneca overestimated its manufacturing capacity and supply to the EU, setting a goal of delivering 300 million doses by the end of 2021, with 30 million doses by the end of 2020, 40 million in January, 30 million in February, 20 million in March, 80 million in April, 40 million in May, and 60 million in June. The company agreed to use its “best reasonable effort” to manufacture the initial doses ordered by the EU and to build its manufacturing capacity. AstraZeneca recently announced that it can deliver 41 million doses by the end of March with its “best reasonable effort.” That estimate is 20 million fewer doses than initially predicted, meaning the drugmaker is over two months behind schedule. Germany Commits to Sharing Vaccine Doses WHO’s Tedros and Germany’s President Frank-Walter Steinmeier address the media. German President Frank-Walter Steinmeier committed his country to sharing some of the vaccines it has ordered with low-income countries at a joint press conference with World Health Organization Director General Dr Tedros Adhanom Ghebreyesus, on Monday. However, Steinmeier said how this would be done and how many vaccines would be shared was still under discussion. Last Friday, Germany announced that it would be contributing an additional €1.5 billion in funding for the multilateral response to the pandemic, including the ACT Accelerator, at the G7 leaders’ meeting last week. Steinmeier also used the briefing to restate Germany’s opposition to the proposal of a waiver on patent protection for COVID-19 related products, as mandated by the Agreement on Trade-Related Aspects of Intellectual Property Rights, known as the TRIPS waiver. “The interest of public institutions and private companies have to be kept alive to invest in research and the development of drugs medicines and vaccines,” said Steinmeier. “So I don’t think the proposal some have made that we have waiver for patents or licensing would be the right approach.” The TRIPS waiver, currently being discussed by the World Trade Organization, has wide support including from the WHO, but it is floundering because of opposition from wealthy countries with powerful pharmaceutical industries, like Germany, the US and the UK. While Tedros welcomed Germany’s financial contribution, he pointed out that while many wealthy countries claimed to support the global vaccine access facility, COVAX, they were still trying to do bilateral deals with manufacturers for more vaccine doses “without stopping to ask whether this was undermining COVAX”. “This pandemic is really unprecedented, and we have to do everything to defeat this common enemy including waivers on intellectual property to increase production,” said Tedros. He added that the WHO was engaging directly with manufacturers and encouraging pharmaceutical companies to “turn over their facilities to produce other companies’ vaccines as Sanofi has done for the BioNTech vaccine”, and issue non-exclusive licences to enable other manufacturers to produce their vaccines. G-7 Commitments Of US$4.3 Billion Not Enough – Rich Countries Need To Stop COVID Vaccine Hoarding to Open Access Bottleneck, Says WHO Director General 22/02/2021 Kerry Cullinan Dr Tedros Adhanom Ghebreyesus, WHO Director General, at the press briefing on Friday. Despite Friday’s commitment by G-7 countries to donate another US$ 4.3 billion to a global COVID vaccine campaign, World Health Organization Director General, Dr Tedros Adhanom Ghebreyesus has accused high-income nations of still undermining equitable vaccine rollout by “doing deals” with manufacturers that deplete supplies available to the COVAX global vaccine facility. Speaking at the WHO’s biweekly media briefing, Tedros thanked the G-7 and the European Union for the new donations – but stressed that money was not enough: “If there are no vaccines to buy, money is irrelevant. Currently, some high-income countries are entering contracts with vaccine manufacturers that undermine the deals that COVAX has in place and reduce the number of doses COVAX can buy,” said Dr Tedros. “Unless we end the pandemic everywhere, we will not end it anywhere. To achieve this, we need more funding. We need countries to share doses immediately. We need manufacturers to prioritise contracts with COVAX. And we also need a significant increase in the production of vaccines.” HIV Provides Global Precedent, Says Anthony Fauci The HIV pandemic provides a “precedent” for how to get life-saving medicines to those who could not afford them – while allowing pharma companies to “maintain a considerable amount of profit”, said Anthony Fauci, US President Joe Biden’s chief scientific advisor and a guest at the WHO briefing. During the early days of the HIV pandemic, there was a lot of discussion about whether expanding the generic manufacture of new HIV antiretroviral drugs would “interfere with the appropriate profit that companies that made major investments in the development of [antiretroviral] drugs”, Fauci recalled. But through various platforms, including the US-sponsored President’s Emergency Plan for AIDS Relief (PEPFAR) as well as the new Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria, life-saving generic drugs reached millions of people and “did not have a deleterious effect on the companies who continued to do well financially and continue to make investments in research”. Even so, the pathway to those breakthroughs was painstaking, observed WHO’s Assistant Director-General for Drug Access, Mariângela Simão, observing that “too many people died unnecessarily” as rich and poor countries battled over access to HIV medicines. Mechanisms such as the Medicines Patent Pool, created to expand generic drug manufacturing in collaboration with the innovative pharma industry have provided “a proven platform to ensure that both voluntary licensing and technology transfer to increase access to medicines for HIV,TB and malaria”, said Simão. Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines But so far, the MPP precedents hasn’t been harnessed to the COVID-19 vaccine roll-out. She lamented: “Why can we not use the platform that WHO has in place, like COVID Technology Access Pool (C -TAP), to make COVID-19 technology accessible and manage intellectual property needs. “Intellectual property is not the endpoint. The endpoint is increasing manufacturing capacity and making sure good quality, efficacious and safe vaccines reach the developing countries,” Simão added. COVAX Sets Up ‘No-Fault’ Compensation Fund Earlier in the day COVAX announced that the WHO had reached an agreement with a global third party insurance provider, ESIS Inc, to administer a no-fault vaccine injury compensation programme for the 92 low- and middle-income countries and economies eligible for donor support to their vaccine campaigns. “As the first and only vaccine injury compensation mechanism operating on an international scale, the programme will offer eligible individuals in AMC-eligible countries and economies a fast, fair, robust and transparent process to receive compensation for rare, but serious adverse events associated with COVAX-distributed vaccines until 30 June 2022,” according to the global vaccine alliance, GAVI, which administers COVAX. By providing a no-fault lump-sum compensation in full and final settlement of any claims, COVAX aims to “significantly reduce the need for recourse to the law courts, a potentially lengthy and costly process”. ESIS, which is part of the Chubb group, will not charge any fees to applicants. “The No-Fault Compensation fund is a massive boost for COVAX’s goal of equitable global access to vaccines: by providing a robust, transparent and independent mechanism to settle serious adverse events it helps those in countries who might have such effects, manufacturers to roll out vaccines to countries faster, and is a key benefit for lower-income governments procuring vaccines through the Gavi COVAX AMC,” said GAVI CEO Seth Berkley. The COVAX no-fault compensation programme will come into operation via a web portal (www.covaxclaims.com) by 31 March, and people will be able to apply for compensation even if they were given a COVAX-distributed vaccine before this date. The programme is financed initially through a levy charged on all doses of COVID-19 vaccines distributed through the COVAX Facility to the AMC eligible economies until 30 June 2022. All vaccines procured or distributed through the COVAX Facility will have received prior regulatory approval from a strict national authority and/or a WHO emergency use authorization to confirm their safety and efficacy. But, as with all medicines, even vaccines that are approved for general use may, in rare cases, cause serious adverse reactions. No Need for People With Allergies to Avoid Vaccination in Fear of Anaphylactic Shock Dr Soumya Swaminathan, WHO Chief Scientist. On a more technical level of the risks of anaphylactic reactions associated with the Pfizer/ BioNTech and Moderna vaccines, Fauci said that these have been very rare events – and are most likely linked to the polyethylene glycol in the vaccine preparation. “There are 4 to 5 per million anaphylactic reactions for the Pfizer vaccine and between 2 and 3 per million to the Moderna, so it’s an unusual, rare interaction,” said Fauci. While people with known anaphylactic reactions may be advised to take special precautions, or in some cases not to be vaccinated with the mRNA vaccines, there is no reason for people with a general history of allergic reactions, to avoid vaccination, he added. Nancy Messonier, of the US Centers for Disease Control and Prevention who is leading the US Centers for Disease Control vaccine effort, told the media briefing that people who have had a history of anaphylaxis were being asked to stay at the health facility for 30 minutes after vaccination “because all the cases in US have occurred within that 30 minutes timeframe”. WHO’s Chief Scientist, Soumya Swaminathan, stressed that “every country has a system in place to do safety monitoring” and this has been coordinated by the WHO. “So far, over 200 million vaccine doses have gone into people around the world and there have been no alarming safety signals, but we will continue to monitor and update, if anything changes,” said Swaminathan. Image Credits: WHO. India Moots Regional Pandemic Platform with 10 Neighbours 22/02/2021 Menaka Rao After donating over 6 million Covid vaccines to more than 13 countries, the Indian government suggested the creation of a regional pandemic platform for preparedness and medical emergencies with its 10 neighbouring countries. At a meeting with health officials, Indian Prime Minister Narendra Modi proposed creating “a special visa scheme” for doctors and nurses to enable swift travel during health emergencies,coordinated air ambulances, a regional platform for “collating, compiling and studying data about the effectiveness of Covid-19 vaccines” and a network for “promoting technology-assisted epidemiology for preventing future pandemics.” India has reported more 11 million COVID-19 cases and over 156,000 deaths. Although cases have been declining since September last year and had considerably reduced by January, there has been an increase of about 31% in the past week, mostly in the Western state of Maharashtra. “Through our openness and determination, we have managed to achieve one of the lowest fatality rates in the world,” said Modi. “This deserves to be applauded. Today, the hopes of our region and the world are focused on rapid deployment of vaccines. In this too, we must maintain the same cooperative and collaborative spirit.” Modi was referring to the Indian government’s “Vaccine Maitri” (meaning vaccine friendship) initiative, through which the Indian government has donated more than 6.27 million doses of COVID-19 vaccines to more than 13 countries, including neighbours Bangladesh, Afghanistan, Bhutan, Myanmar and countries such as Oman, Barbados and El Salvador. It also commercially exported 10.5 million doses of vaccines to 8 countries. Modi was addressing a workshop on COVID-19 management attended by health leaders, experts and officials of Afghanistan, Bangladesh, Bhutan, Maldives, Mauritius, Nepal, Pakistan, Seychelles, Sri Lanka and India. Evoking the “spirit of collaboration” among these countries, Modi said that India and these countries have a lot in common and should share their successful health policies and schemes. “We share so many common challenges – climate change, natural disasters, poverty, illiteracy, and social and gender imbalances. But we also share the power of centuries old cultural and people-to-people linkages. If we focus on all that unites us, our region can overcome not only the present pandemic, but our other challenges too,” he said. Variants May be Associated With Surge in COVID Cases In the last few days, the Maharashtra state government reported a sudden burst of cases in the Vidarbha region, closer to Central India. The genome sequencing of a few cases in Amravati district showed “unique mutations” including E484Q, which is similar to a mutation (E484K) found in South African and Brazilian variants, according to a Times of India report. Maharashtra and Kerala account for more than 74% of the cases in the country while Chhattisgarh and Madhya Pradesh are also seeing a rise. This is in contrast to the steady downward trend of the pandemic in India since last September last year. The country is reporting an average of 12,000 cases a day, as compared to more 90,000 cases in a day in September. Experts have attributed the overall fall in COVID-19 positive cases over the past few months to herd immunity caused by widespread infection, especially in cities such as Mumbai, Pune, and Delhi which saw the largest outbreaks in the country. A recent round of sero-surveillance in Delhi between January 15 to January 23 among 28,000 people found that 56% of those surveyed had antibodies against COVID-19. “Those infected with Covid will only protect themselves but also protect others. Half the population will not transmit to others. Besides, the susceptible population is reduced by 50%,” explained Dr Sanjay Rai, from Delhi’s All India Institute of Medical Sciences. Citing a recently published study in the New England Journal of Medicine, Rai said that those who are infected are protected from disease for at least six months. The study which was conducted with more than 12,000 health workers in the UK, showed that presence of antibodies was associated with a substantially reduced risk of reinfection in six months. More than 9 million people have been at least given one dose of the vaccine. “India has a young population. About 50% of the population is under 25 years, and 65% of the population under 35 years. There could be a very large fraction of the population then which had asymptomatic infections and were not tested. They would also offer some protection to the population,” said Dr Shahid Jameel, a virologist with Ashoka University, Delhi. However, a nation-wide survey showed only one out of 5 people have been exposed to the virus. “The message is that a large proportion of the population remains vulnerable,” said Dr. Balram Bhargava, who heads Indian Council of Medical Research, that helmed the national-wide sero-survey. Meanwhile, there is some evidence that people who have already had COVID-19 can become reinfected with variants. Image Credits: https://dashboard.cowin.gov.in/. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Ambitious Global COVAX Facility Delivers First Doses In Accra Ghana 24/02/2021 Elaine Ruth Fletcher, Svĕt Lustig Vijay & Paul Adepoju Thumbs up: WHO representative in Ghana, Francis Kasolo, on left, with UNICEF’s representative, Anne-Claire Dufay as first COVAX vaccine doses arrive on 24 February in Accra, Ghana. Under cloudy skies, Ghana’s first precious doses of Covid-19 vaccines arrived Wednesday morning at Accra’s Kotoka International Airport. They are also the first supplies to be distributed by the WHO co-sponsored COVAX facility on the African continent. The arrival of some 600,000 vaccines marks a milestone in months of effort by WHO, UNICEF, GAVI and other partners to mount the largest global vaccine campaign in history – and ensure that scarce and often pricey COVID-19 vaccine doses are distributed more equitably to countries around the world. “This day is the culmination of many months of planning, research, negotiation & coordination,” tweeted WHO Director General Dr Tedros Adhanom Ghebreyesus, who co-launched the COVAX initiative nearly a year ago. “But it’s just the beginning. We still have a lot of work to do to realize our shared vision for VaccinEquity by starting vaccination in all countries within the first 100 days of the year.” COVAX hopes to deliver 2.3 billion doses by the year’s end — mostly to 92 low- and middle-income countries that are part of a GAVI-backed Advanced Marketing Commitment scheme. The equity scheme aims to overcome price and supply barriers thrown up by high-income nations, which have already snapped up one billion more vaccines than they need for their populations. At last! This morning the first doses of #COVID19 vaccines shipped by the COVAX facility arrived in #Ghana. Congratulations to all partners including @gavi, @CEPIvaccines & @UNICEF. A day to celebrate, but it's just the first step. 45 days left for #VaccinEquity https://t.co/3TjuJiMzj0 — Tedros Adhanom Ghebreyesus (@DrTedros) February 24, 2021 Ghana was selected as the first African recipient of vaccines after sending a rollout plan to COVAX, demonstrating that its health-care teams and cold chain equipment could support a quick distribution. The WHO Ghana office, known for its efficiency and close collaborations with Ghana Health Services, can be relied upon as a flagbearer for the initiative, insiders say. “This is a momentous occasion,” declared WHO’s representative in Ghana Francis Kasolo, in a joint statement with UNICEF’s representative, Anne-Claire Dufay, just as the first palettes of AstraZeneca/Oxford vaccines, produced by India’s Serum Institute, were unloaded on the airport runway. We will ensure that all persons get vaccinated in a risk-based approach no matter who they are and where they are in the spirit of #UniversalHealthCoverage – Dr Francis Kasolo, WHO Representative to Ghana pic.twitter.com/DHV3XW2GAe — WHO Ghana (@WHOGhana) February 24, 2021 “After a year of disruptions due to the COVID-19 pandemic, with more than 80,700 Ghanaians getting infected with the virus and over 580 lost lives, the path to recovery for the people of Ghana can finally begin,” said Kasolo. The initial COVAX shipments will be used to vaccinate frontline healthcare workers, adults over the age of 60, and people with underlying health conditions in the weeks to come, said the Ghanaian authorities on Wednesday. Ghana’s program manager for immunization, Kwame Amponsa-Akyianu, told reporters earlier this month that the country aims to vaccinate two-thirds of its population of over 31 million people. The historic shipment comes a week after Africa’s coronavirus death toll surpassed the 100,000 mark. That is a fraction of the death toll on other continents, but it is now rising fast as a second wave of infections overwhelms hospitals – most of which lack the oxygen supplies and intensive care units that are standard in more affluent regions. Coronavirus Disease 2019 (COVID-19) Africa CDC Also Welcomes Deliveries John Nkengasong, Director of the Addis-based Africa Centres for Disease Control and Prevention, sounded a similar note, saying: “These first deliveries of COVID-19 vaccines through COVAX are a critical moment in Africa’s fight against the virus.” Nkengasong described the first deliveries as “an important step towards our continental goal of immunising at least 60% of Africa’s population with safe and efficacious vaccines against COVID-19″ over three years. So far, the African Union (AU) has secured some 670 million doses of the AstraZeneca, Pfizer and Johnson & Johnson vaccines – in addition to the COVAX supplies of some 90 million doses that will flow to the continent. Russia has also offered to supply 300 million doses of its Sputnik V vaccine to the AU scheme along with a financing package. Desperate to begin vaccinations soon, South Africa, Uganda and Rwanda, among others, have also made smaller bilateral deals. And China has donated small batches of its Sinopharm vaccine to to countries like Zimbabwe and Equatorial Guinea. Still, the rollouts underway in Europe, the Americas, India and even the Middle East remain the exception rather than the norm. Of the 210 million doses of vaccine that have been administered globally so far, half have been doled out in just two countries, Tedros warned on Tuesday. Ghana’s Minister of Health Kwaku Agyeman-Manu at Accra’s Kotoka International Airport Nigeria Watching Ghana – And Wondering When Their Turn Will Come But just north of Accra, in the continent’s most populous country and the largest economy, Nigerians were eying the local vaccine landscape with concerns about how and when a campaign would commence on home turf. Such plans have yet to be announced by the government. Emeka Nsofor, CEO of EpicAFRIC,a philanthropic impact agency, told Health Policy Watch that while the country’s epidemiological response to the pandemic has been impressive so far, the paucity of information and the non-availability of a timeline for the delivery of COVID-19 vaccines is becoming a source of major concern not only to professionals, but to the public. “It is not good for Nigerians to be watching clips of the vaccines being delivered to South Africa, Zimbabwe and other African countries when no one knows when Nigerians will start receiving the vaccine,” he told Health Policy Watch. Nsofor said the government ought to have made its plans for procuring and administering doses public – whether they are secured through COVAX, the AU or other means. “By now we should have known who will get the vaccines first, where will they be administered, who are the officials that will be involved,” he added. In several countries where vaccines are already being administered, frontline health workers and aged individuals are eager to be the first to receive the jabs in their arms. But in Nigeria, health workers are less optimistic about their prospects. At the Casualty and Emergency unit of Nigeria’s first teaching hospital, the University College Hospital, a physician who was among the first in his unit to test positive for COVID-19 told Health Policy Watch that he dreads getting reinfected. Not knowing when he will be able to receive a jab compounds those fears and is “very discouraging”, he said. “Getting the virus was a very scary experience for me, especially at a time when we knew so little about it. Every now and then, I still dread contracting it again. I believe receiving the vaccine would protect me and allay my fears but realising that no one, probably including the government, knows when we will get it, is very discouraging,” he told Health Policy Watch on condition of anonymity. For its part, the Nigeria Center for Disease Control (NCDC) continues to coordinate testing, messaging and other aspects of the country’s response to the pandemic. It recently released findings of household seroprevalence surveys conducted in four Nigerian states — Lagos, Enugu, Nasarawa and Gombe States. The survey findings revealed that the prevalence of SARS-CoV-2 antibodies was 23% in Lagos and Enugu States, 19% in Nasarawa State, and 9% in Gombe State. “This means that as many as 1 in 5 individuals in Lagos, Enugu and Nasarawa State would have ever been infected with SARS-CoV-2. In Gombe, the proportion is about 1 in 10,” NCDC said in a statement. South African Variant – A Risk In Ghana The fact that the B-1351 variant, first discovered in South Africa, has now spread to eight African countries including Ghana, has further implications for the vaccine campaign in the West African region. In a small South African trial, experts found that the AstraZeneca vaccine had virtually no efficacy in reducing mild or moderate COVID cases among people infected with the B-1351 virus strain – leading authorities in Pretoria to cancel the vaccine rollout and switch to a Johnson & Johnson jab – which has recently demonstrated efficacy against the variant in Phase 3 trials. The WHO nonetheless has said it recommends AstraZeneca’s use across Arica – even in countries infected with the variant. Speaking at a recent press conference, WHO experst maintained that the vaccine is still likely to reduce incidence of severe COVID cases, even among people stricken with the B-1351 strain. However, the African Union has issued a slightly different recommendation – that countries where the strain is “dominant” shift gears to another vaccine. So experts will be closely eyeing Ghana’s AstraZeneca rollout to see how the vaccine performs against the variant in the real world laboratory there. Map of African Union Member States by hotspot level on PERC (Partnership For Evidence-Based Response) dashboard. Expect More African Pressures On COVAX to Roll Out Johnson & Johnson – Following Expected FDA approval Friday COVAX’s preliminary candidate-specific supply of COVID-19 vaccines for 2021 and 2022, as of 20 January. Since then Novavax also committed 1 million more vaccines. The arrival of the AstraZeneca vaccine batches in Ghana also coincides with big news of a likely US Food and Drug Administration emergency approval of the J&J vaccine as early as Friday – following today’s positive FDA expert panel review of the vaccine. The J&J results, reported by the FDA review, showed a 66% average efficacy for the vaccine in preventing moderate and severe disease in Phase 3 trials The trials involved over 44,000 recruits in the US, Latin America, and South Africa. The J&J vaccine was also 64% efficacious in preventing moderate and severe disease in the South African trial arm – a significant finding from the first large-scale trial of a vaccine meeting up with the B.1351 variant. And more important, the vaccine was 85% effective in preventing severe disease – 82% in South Africa. While that is not as good a showing as the 90% or better efficacy results for the mRNA vaccines by Pfizer and Moderna, J&J trial was the first to directly pit a vaccine against the B.1351 variant, which has been the one most resistant to vaccines generally among the recent SARS-CoV2 mutations to emerge. The J&J vaccine also has the advantage of being a one-shot vaccine which can be stored in a normal refrigerator rather than ultra-cold storage conditions – factors that could significantly help rollout in low-income countries where access to cold storage as well as to health services is more challenging. FDA briefing document on J&J Covid vaccine posted. The data are very strong, the J&J vaccine provides robust efficacy across all demographics and variants; and shows rising protection over time, consistent with belief it's eliciting strong T-Cell response. https://t.co/azdgLIjtXs — Scott Gottlieb, MD (@ScottGottliebMD) February 24, 2021 The FDA approval of the J&J vaccine will almost certainly pave the way for a WHO greenlight, leading to a COVAX rollout of the vaccine as soon as commercial supplies are available. But that, in turn, could also give rise to new dilemmas for COVAX distribution plans. In African countries like Ghana, faced with creeping vases of the B.1351 variant – there may also be future pressures to swap out AstraZeneca vaccines for J&J doses. Although J&J has in fact committed to provide 500 million vaccine doses through COVAX facility – AstraZeneca dose still comprise the lions share of the COVAX portfolio, with some 720 million doses already procured. The bottom line is that while the jury is still out on AstraZeneca’s performance against the B-1351 variant, the J&J trial data shows clear efficacy for the vaccine in preventing serious disease in the African setting – where other vaccines have not [yet] been widely tested and tried. And that means that the COVAX rollout – even as it begins, is set to face a new series of challenges in a constantly evolving landscape of science, big pharma deals and geopolitics. Image Credits: WHO Ghana, PERC, Gavi. Some Countries Ease Lockdowns, But Others Battle New COVID-19 Surges 23/02/2021 Raisa Santos & Kerry Cullinan Frankfurt, Germany The United Kingdom, Switzerland, Israel and Turkey are cautiously reopening businesses and relaxing limits on gatherings and travel as COVID-19 cases declined both globally and within these countries. However, parts of France, the Czech Republic, and Sweden are preparing for harder lockdown measures as their cases surge in contrast to worldwide trends. As of 23 February, there were 2,530,101 new cases in the past week. The COVID-19 Epidemiological Update reported a 16% global decline in cases, with over 500,000 fewer cases than the beginning of the month. Five out of six WHO regions were showing double-digit percentage declines in new cases, with only the Eastern Mediterranean Region showing a 7% rise. Europe and the Americas continue to see the greatest drops in absolute numbers of cases while the number of new deaths has also declined in all regions. UK & Switzerland Outline Roadmaps to Relax Restrictions Lockdown “Green” border roads between Switzerland and Germany Switzerland will relax some restrictions from 1 March, allowing museums, shops, and zoos to open at limited capacity. Private outdoor events with up to 15 people will also be permitted. A second phase of reopening should commence on 1 April. On Monday, UK Prime Minister Boris Johnson announced the government’s roadmap to ease restrictions in England, which will be guided at all stages by data as opposed to set dates. Step 1 of the roadmap will begin in March with a return to in-person education in schools and colleges. Most outdoor attractions and settings, as well as non-essential retail, which includes zoos, pubs, restaurants, gyms, and retail stores, will stay closed for at least another month. Step 4, which will see a wider opening of a number of businesses, is expected no later than 21 June. The United Kingdom had implemented a national lockdown in response to the rising cases that resulted from the B.1.1.7 variant, and has even extended the lockdown in Northern Ireland, to 1 April. London, UK: Camden High Street in lockdown Together with an ongoing vaccine campaign, these measures appear to be working, with case rates declining across all age groups and regions, in the most recent weekly surveillance report published. “Our efforts are working as case rates, hospitalisation rates and deaths are slowly falling,” said Dr Yvonne Doyle, Medical Director at Public Health England. Doyle still expressed concern about the new infection numbers, which were still higher than the cases at the end of September. “This could increase very quickly if we do not follow the current measures. Although it is difficult, we must continue to stay home and protect lives.” The UK roadmap for reopening outlines four steps: continued successful vaccine deployment, evidence that demonstrates vaccines are sufficient in reducing hospitalizations and deaths in those vaccinated, reduction in infection rates that prevent a surge in hospitalizations, and assessment of the risks not to be fundamentally changed by the new emerging variants of concern. There will be a minimum of five weeks between each step: four weeks for the data to reflect changes in restrictions; followed by seven days’ notice of the restrictions to be eased. Istanbul, Turkey Turkey also plans to start a gradual normalization process in March, with measures to be lifted “on a provincial basis”. The country’s 81 provinces will be categorized based on risk levels – from very high to low – and progress in vaccinations to determine whether they are ready for normalization. This new process for normalization comes after the Turkish Health Ministry started announcing an average of weekly cases for provinces last week. This data will be used to determine whether restrictions are lifted. Israel Re-opens For Business – Except During Holiday & At Airport Meanwhile, the Israeli government began to reopen hotels, shopping centers, and even cultural events on 21 February after its government approved the second and third phases of the exit plan from lockdown as new COVID cases continued to decline, particularly among people over 60, most of whom have been immunized. Infections rates and serious cases in Israel have declined sharply after more than 80% of people over the age of 60 either were vaccinated or recovered from COVID-19. The campaign has since opened to everyone over the age of 16. However, airports and land borders will be closed for 14 more days, and the country’s borders closed until 6 March. Only 200 people a day are allowed to board “rescue flights”, and this has left thousands of Israeli citizens stranded around the world. Restrictions on mass gatherings have also been relaxed to 20 people outdoors and 10 people indoors, instead of 10 and 5 respectively. At the same time, it was likely that the government would declare a curfew over the upcoming Purim weekend, a holiday traditionally observed by raucous celebrations commemorating the biblical story of the rescue of Persian Jews by the Queen Esther. Coinciding with the relaxation measures, a Green Pass system was put into place to grant Israelis who have had two vaccine doses automatic access to gyms, studios, cultural and sports events, fairs and hotels. Those without the pass have to show proof of a recent COVID test. Children under 16, who can’t be immunized, may still be admitted to some venues, like hotels, along with their immunized parents. Palestine Vaccination Campaign to Begin, Calls on Israel to Reserve More Vaccines for Palestinians Nabi Moussa, Occupied West Bank Palestinians in Gaza were also reportedly due to get their first jabs as another 20,000 vaccines donated by the United Arab Emirates arrived Sunday in the barricaded strip from Egypt via the Rafah crossing. Israel allowed the transfer of 2,000 vaccine doses into the Strip last week. In the Occupied West Bank, vaccine campaigns by the Palestinian Authority with Russia’s Sputnik V vaccine were only just beginning – although West Bank Palestinian infection rates have been comparatively lower than those in Israel, even after the latter had immunized over 50% of its 9.3 million citizens with at least a first dose. A World Bank report on Monday called on Israel to share more of its vaccines with the PA, saying: “While Israel has been leading the world in terms of per capita vaccinations, no one has been vaccinated in the Palestinian territories yet, and the Israeli MoH has not formulated an allocation strategy to support the territories, beyond providing 5,000 vaccines for Palestinian doctors. Humanitarian organizations in both Israel and West Bank and Gaza have called for Israel to reserve a higher amount of vaccines for the Palestinian territories. Given the challenges for the Palestinian Authority to procure vaccines, the statement calls for operational and financial support from Israel to PA.” The Economic Monitoring report further stated: “In order to ensure there is an effective vaccination campaign, Palestinian and Israeli authorities should coordinate in the financing, purchase and distribution of safe and effective COVID-19 vaccines,” noting that the Palestinian Authority faces a US$ 30 million shortfall in vaccine funding, even after support from the WHO co-sponsored COVAX facility. Germany Considers Reopening Even if Cases are Rising Angela Merkel, Chancellor of Germany. Germany’s Chancellor Angela Merkel has also proposed a plan to ease that country’s lockdown which has been in place since November. Merkel reportedly told her Christian Democrat (CDU) party that lockdown measures could be eased in several stages, combined with increased coronavirus testing. The stages would focus on personal contacts (how many people a person meets); schools, sports, restaurants, cafes, and cultural events. However, talk of easing restrictions in Germany belies the upward trend of infections in the country. The Robert Koch Institute reported 4,369 new COVID-19 cases as well as 62 associated deaths. There are major concerns of the COVID-19 variants pushing up numbers. Frankfurt, Germany: Masks required on cycle path France, Sweden, and the Czech Republic – Tougher Lockdowns Paris, France: A woman serves a hot dog in front of a restaurant in the Latin Quarter. French bars and restaurants can no longer accommodate consumers because of the measures taken to combat the COVID-19 pandemic. Some restaurants remain open and serve drinks and take-out meals. While other countries will soon enjoy relaxed restrictions, there have been increases in Nice in France, the Czech Republic, and Sweden. Nice reported 740 new cases per week per 100,000 residents, triple the national average. France has applied a localized lockdown over the next two weekends from Théoule-sur-Mer to Menton, and Nice. French Health Minister Olivier Veran said that measures could include a stricter form of the curfew imposed nationwide in France or a weekend lockdown in the city. “Consultations will be conducted over the weekend to take additional measures to stem the epidemic, ranging from a reinforced curfew to local lockdown at weekends,” Véran said. The Czech Republic is also experiencing a rise, with 11, 233 cases reported on Tuesday, an increase of 7,100 in a single day. Test positivity rate also increased to 40.6%, the highest since 9 January. The Czech Ministry of Health has mandated that masks must be worn in places with larger concentrations of people, especially shops, public transportation, and hospitals, effective Thursday. The Ministry has also submitted to the government a law on emergency measures in an effort to curb the resurgence of COVID-19 in the country, including restrictions on services, a ban on mass events, and the restriction of public transport. “The purpose of the proposed law is to legally enshrine the measures that we issue as a crisis in accordance with the crisis law as part of the COVID-19 epidemic. Thanks to this, it is possible to issue measures for which we have so far needed an emergency, ” explained the Minister of Health Jan Blatný. Uppsala, Sweden: People social distancing Meanwhile, Sweden is preparing the strictest restrictions yet, in an effort to curb a resurgence in COVID-19 cases as the variant first detected in the UK spreads rapidly. “The British variant is increasing very fast. This variant will with fairly high probability be the dominant one within a few weeks or a month… We have a package [of national measures] being readied that will be presented tomorrow,” said Chief Epidemiologist Anders Tegnell at a news conference. Concerns about a possible third wave of the pandemic have been growing since the number of new infections have risen and the new variants have spread. The Swedish government has laid the ground for potential lockdown measures to be tougher than previously measures enacted earlier in the pandemic. The list of businesses that will face mandatory closure in Sweden include shops, hair salons, gyms, and restaurants. The country has also closed its borders to Denmark and Norway. Negative COVID-19 tests are now required for entry into Sweden. Declines Also Seen in United States and India New York City, United States: Outdoor dining during pandemic While declines in serious cases in Israel and the UK may be attributed to vaccines, it remains unclear why numbers are declining globally as some countries battle their second, third, and fourth waves of COVID-19. For the United States, the scale-up of vaccination and the shift in seasons are driving down cases, according to the Institute for Health Metrics and Evaluation (IHME) during a briefing last week. However, variants including the more infectious B.1.1.7 which first emerged in the UK in November 2019, have been detected in the US which could drive transmission. Epidemiologists in India have also questioned the declining cases, pointing to low rates of testing and habitual underreporting of causes of death, particularly in rural India. However, Prime Minister Narendra Modi is hoping that the vaccination drive that began in January will spur wider recovery. Though vaccine uptake remains slower than officials hoped, as of 18 February, more than 98 million vaccine doses have been administered in India. “I don’t think anyone really thinks that without vaccines and a vaccination program being widely available that we can go back to whatever is full normalcy,” said Sireesha Yadlapalli, a Hyderabad-based senior director at the United States Pharmacopeia, a scientific nonprofit organization. “Hopefully this is the slowdown and there’s no second wave.” Bangalore, India: Empty streets during lockdown in early 2020. Despite a nationwide declide, there has been a rise in cases seen in the Indian state of Maharashtra, which has ordered new restrictions on people’s movement and imposed night time curfews. Mumbai, Maharashtra’s capital and India’s financial hub, also banned religious, social, and political gatherings. The state has reported nearly 7,000 new cases on Sunday, a steep rise from 2,000 daily cases earlier this month. The Indian Ministry of Health and Family Welfare has stated that the surge in COVID cases in the state cannot be attributed to strains N440K and E484Q, which have been detected in other countries. WHO Warns Against Complacency Dr Michael Ryan, Health Emergencies Executive Director While some of the declines, such as those in England, Scotland and Israel, may be attributed to massive vaccine campaigns – in other regions, where vaccination is only just getting under way, global health officials have had few explanations for the dip in cases. “We’re certainly not out of the woods yet,” said Health Emergencies Executive Director Dr Mike Ryan at a WHO press conference in Geneva last Thursday. “The virus still has a lot of energy. You’re also dealing with urban settings, many people still living in areas that are overcrowded, multi-generation, multi-family homes. It is very difficult to break chains of transmission in a complex society. Some countries are coming down that hill more quickly than others.” WHO technical lead on COVID-19 Dr Maria van Kerkhove stressed: “We cannot let ourselves get into a situation where the virus can resurge again. Remember what we need to continue to do to drive it down and get cases down into single digits. “We just need to stay the course, hold on to what is working consistently deliberately as we roll out vaccines and make sure that vaccinations start in all countries,” said Van Kerkhove. Ryan also cautioned that, although the global COVID-19 cases are now at their lowest since last October, this could be the result of the natural patterns of the virus. “I do think a good portion of that has been done to the huge efforts made by communities. There have been very stringent lockdowns and stay-at-home orders and other things, but also serum prevalence is rising,” said Ryan. “We need to understand what is driving those transmission dynamics. Is it natural seasonality and wave-like pattern of the disease? Are we building up a level of immunity in the population that’s preventing the disease from finding the next case? Are our control measures having an impact on that?’ asked Ryan. “I think as we move into [northern hemisphere] springtime, we need to drive towards higher levels of vaccinations, getting an equitable distribution of that vaccine, getting rid of the deaths and the hospitalizations and the suffering, but [also] continuing to drive the case numbers down.” Image Credits: Twitter, 7C0/Flickr, Falk Lademann/Flickr, Marc Barrot/Flickr, Sergey Yeliseev/Flickr, Health Policy Watch , David King/Flickr, Ben Hartschuh, 7C0/Flickr, Flickr: IMF Photo/Cyril Marcilhacy. The European Medicines Agency’s COVID-19 Vaccine Leaks: Hacks, Regulatory Pressures And Manufacturing Concerns 23/02/2021 Priti Patnaik & Lucien Hordijk European Medicines Agency headquarters, Amsterdam, The Netherlands EXCLUSIVE – A series of recent leaks of emails and documents surrounding the EMA’s approval of the first COVID-19 vaccine by Pfizer/BioNTech highlight the intense political pressures regulatory agencies are under during the pandemic – as well as an oft-forgotten aspect of vaccine approvals – the quality control of vaccines during the leap from clinical trials to large-scale commercial production. Priti Patnaik & Lucien Hordijk explore. Cyber leaks, public health, geopolitics, vaccine nationalism and political pressure come together in this heady story about the complex challenges that the world’s strongest regulatory agencies are facing as they review and approve new COVID-19 vaccines, developed at unprecedented speed. When a series of emails and documents hacked from the European Medical Agency (EMA) in December 2020 surfaced in early 2021 on the dark web, they revealed a cautionary tale about how even one of the world’s strongest regulatory agencies may be subjected to intense political pressures in their review of COVID-19 vaccines – even as they try to play by the book in their reviews. The hacked documents also shed light on an oft-ignored aspect of vaccine review and approval beyond safety and efficacy – that is quality-assurance of production processes as new vaccine products make the leap from clinical trials to large-scale production. Shortages Led to a Blame Game Ursula von der Leyen, President of the European Commission, speaking at the World Economic Forum in late January – shortly after EMA approval of the first COVID-19 vaccines. And the regulatory approvals did not, ultimately usher in a smooth vaccine rollout. Rather, vaccine shortages have plagued most of Europe on the back of unanticipated production glitches, leading to a political blame game at the very top of the European Commission, (EC). This, in turn, prompted the EU to adopt new rules on export restrictions that have been widely criticised. This story has four parts: what the leaked documents show; how authorities responded to the leaks; the potential motivations for the breaches by hackers seeking to undermine confidence in the vaccines; and what lessons can be learned from the EMA breaches. Part I: The Language of Political Pressure On January 13th 2021 internal emails and documents from the EMA showed up on two hacker forums: Raidforums, an English language marketplace for database breaches and leaks; and Rutor a Russian marketplace on “the dark web”. The dark web is home to encrypted online content not indexed by search engines. These documents, dating from mid- to late November 2020, amounted to nearly 900 pages reports and memos, which included some 20 different email exchanges between EMA officials. They concern the review by EMA’s top management of the Pfizer / BioNTech vaccine in the lead up to its approval. The EMA first reported the cyberattack on December 9th, 2020. The leaks illustrate two important aspects of the regulatory review process: That the EMA was put under intense political pressure by the European Commission to hasten the regulatory process of the first vaccine approvals – particularly those of Pfizer/BioNtech and Moderna; During the Pfizer/BioNTech regulatory process, the EMA had concerns related to the consistency of vaccine quality during the commercial production. Significantly, Pfizer addressed these EMA concerns before the vaccine was approved. But the episode illustrates why such issues would better be shared transparently as part of the regulatory review process, experts say [keeping in mind that US Food and Drug Administration review meetings are even aired publicly online]. As Dr Barbara Mintzes, Associate Professor, The University of Sydney Charles Perkins Centre and School of Pharmacy, and an expert on the interface between clinical research and regulatory decision-making, observed: “I wonder why these issues with production quality were only made public via leaked documents that had become available on the dark web. Why were they not under open and public discussion? These types of exchanges should not be secret.” Leaks Suggest EMA Was Under Pressure to Hasten Vaccine Approvals The cold chain storage for the Pfizer/BioNTech vaccine at Pfizer’s warehouse in Kalamazoo, Michigan. Speedier US FDA and British vaccine approvals added to the pressure on the EMA process. The chain of leaked emails reveals that the EMA was operating under intense political pressure, exerted from the very top of the European Commission (EC), to speed up approvals for COVID-19 vaccines. Without rapid EMA approval of the Pfizer vaccine and others Brussels feared it could not keep its promise to deliver on vaccines for all EU citizens simultaneously and by the end of 2020. Already on 19 November, 2020, Commission President Ursula von der Leyen had publicly announced that both BioNtech/Pfizer and Moderna vaccines could be approved by the EMA by the end of the year. EMA members were uncomfortable with the political promises being made, as reflected in a series of internal emails between the EMA officials from November 12, 19 and 20, 2020, which were among those that came to light in January 2021. And at the same time the pressures to adhere to the EC schedule were immense. While an EU directive allows member states to temporarily use unauthorized drugs in emergencies, the Commission wanted to avoid a situation where countries would begin issuing emergency permits for vaccines at national level, helter skelter. Speedier approvals by other regulatory authorities including UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration also added to the pressure on the EMA. Even so, the email series reflects both the challenges as well as concerns of EMA officials about ensuring adherence to a strict regulatory process, while keeping to Von der Leyen’s ambitious schedule for the approval of the Pfizer and Moderna vaccines. EMA Officials Had Concerns About Commission’s Ambitious Schedule Vials of the Pfizer-BioNTech COVID-19 vaccine. Within EMA expert ranks there was widespread concern that politically-driven deadlines should not compromise the technical review – particularly resolution of the manufacturing quality-assurance issues that also emerged as concerns in the same period: “What is new in my view is that she [Von der Leyen] clearly identifies the 2 vaccines that could be approved before the end of the year. There are still issues with both so it needs to be seen if all this can be sorted out in time, whilst not compromising the robustness of the review”, writes one EMA official in an email on 20 November, 2020 . An email dated November 19, 2020 recounted a telephone conversation between EMA officials and a European Union commissioner. Relates the EMA official to another colleague: “Atmosphere was rather tense….at times even a bit unpleasant.” The official notes that it “provides a hint on what EMA may expect if the expectations are not being met, irrespective if such expectations are realistic or not”. The EMA official goes on to suggest that an interval of even several weeks between an authorisation granted by the FDA & the UK’s Medicines and Healthcare products Regulatory Agency (MHRA); and the EMA will not be acceptable to the European Commission. It would lead to significant “the political fall-out,” the EMA official warned. “We have to be ready for the worst-case scenario,” writes the same EMA official in the email dated November 19, 2020”We will be overwhelmed on all fronts and in the middle of a storm. Whose support can we then rely on?” . According to yet another email dated November 22, the EMA official warned Commission staff: “We are speeding up everything as much as possible, but we also have to make sure that our scientific review is as robust as possible.” EMA and European Commission Deny Political Interference Stefan De Keersmaecker, spokesperson for health, food safety and transport, at the European Commission press briefing 15, January 2021. Asked for comment on the political pressures, an EMA spokesperson replied to us on January 15, 2021 saying: “Despite this urgency (to make vaccines available), there has always been consensus across the EU not to compromise the high-quality standards and to base any recommendation on the strength of the scientific evidence on a vaccine’s safety, quality and efficacy, and nothing else.” The European Commission likewise denied any political interference in the regulatory approval process: “The Commission is fully committed to only authorising vaccines that are deemed safe and effective by its independent scientific agency,” Stefan De Keersmaecker, spokesperson for health, food safety and transport, told us in reply to an inquiry. Only an hour after responding to the queries of our investigative team – which were the first to address this aspect of the email leaks, European Commission authorities hastily convened a press conference on the issue. At the press briefing, Keersmaecker, said that the leaked documents had been “manipulated”: “The EMA has just published its public statement on the cyberattacks of which they are a victim and they have stressed, it is important that you are all aware of that, that some of the correspondence have been manipulated by the perpetrators prior to the publication in a way that could undermine trust in vaccines. I am saying this just to draw your attention that some of the documents that are out there seem to have been manipulated by perpetrators, and therefore have to be considered with utmost care.” PART II: Vaccine Production Quality Assurance Pfizer’s COVID-19 vaccine during the manufacturing process. The EMA’s concerns about quality assurance of the mass production of the Pfizer/BioNtech vaccine (brand name Comirnaty) was a key technical issue to emerge in the regulatory review, as illuminated by the series of leaked EMA emails from November 2020. Here, the regulator’s concerns focused mostly on the Pfizer/BioNtech vaccine candidate, which was the very first vaccine in the EMA regulatory approval pipeline. At the time when the issue arose in November, 2020, some production factories were yet to be inspected, and the regulator was awaiting additional data from Pfizer. The key concern centered around differences in the quality of the vaccine batches produced for clinical trials and batches for commercial production noted by the EMA review experts. According to the leaked documents, the concerns arose over differences in the levels of “mRNA integrity” – an indicator of the purity of the active vaccine drug substance. While the vaccines used in the clinical trials had between 69% – 81% intact mRNA, initial samples of the batches that were destined to be used in large scale manufacturing showed only 59% intact mRNA on average, with some batches as low as 51%. This concerned the EMA – both in terms of safety as well as efficacy of the vaccine doses. According to an email between EMA officials on 23 November, 2020, the EMA stated the following: “…The potential implications of this RNA integrity loss in commercial batches compared to clinical ones in terms of both safety and efficacy are to be defined. “Whether or not the observed compatibility issues could be a blocking point will depend on the relevance of these observations to safety and efficacy and the company will be requested to fully justify the lower %RNA integrity (and other differences noted) “Point for discussion will be whether the comparability issues can be solved only by quality data (additional functional / in vitro biological data + available non-clinical) or that further clinical data (bridging studies are / will be performed) will be needed. It is difficult to make any projections on this.” Ultimately, however, those concerns were resolved to the satisfaction of EMA reviewers, the document leaks also show. Pfizer offered to make manufacturing modifications to ensure that mRNA integrity levels in the commercial production process would remain consistent to those of the clinical trials. The email exchanges refer to manufacturing adjustments ensuring mRNA integrity levels remained at around 75% – although the documents don’t explain how those modifications were made. EMA Responses to Questions About Quality Assurance Review Along with the EMA replieas, a European Commission media briefing on 15 January, 2021, also addressed the email leaks On 15 January, in response to our queries about the quality assurance review of production processes, the EMA said the follow-up data it had received from Pfizer showed “modified forms of mRNA at somewhat higher levels in the batches manufactured with the commercial process as compared to material used in clinical trials.” The EMA clarified to us that such modified mRNA forms were not determined to be a safety risk, particularly in light of the low overall dose of mRNA involved – just 30 micrograms of active ingredient (30 μg): “The amount of any such proteins, is expected to be too low to elicit an immune response of biological relevance.” stated the EMA response. As a result, the risks of any adverse immunological events occurring in reaction to any modified mRNA forms was deemed to be low. Indeed, considering the low dose of mRNA (30 μg), impurities are not considered a safety issue based on general toxicological principles, the EMA said. In their response to our queries, the EMA also acknowledged that the leaked emails reflected the discussions that took place. A spokesperson from the EMA said, “The company was able to address these issues and supply the required information and data to allow EMA to move towards a positive recommendation for this vaccine.” Pfizer, for its part, did not respond to our inquiries on how the company addressed concerns the EMA had raised in November 2020. In a statement in mid-January, the company said: “As the European Medicine Agency’s investigation [of the cyberattack] is ongoing, we defer to them on any updates.” How do mRNA vaccines work? Description of Pfizer’s use of mRNA technology to develop COVID-19 vaccines. Coronaviruses are made up of a single-stranded RNA protein, bounded by protein and wrapped in an envelope of lipid molecules The SARS-CoV-2 virus uses the spike proteins covering its surface to bind to ACE2 receptors found in the lung and other organs. It then fuses with the membrane of the host cell and releases its genetic material. Once the virus has overtaken the cell, it hijacks the cell’s internal machinery to make proteins that help it replicate. Most COVID-19 vaccines have targeted the distinctive spike proteins of the SARS-CoV-2 virus – used by the virus to pry its way into the body’s cells. Typically, vaccines involve injecting a weakened, inactivated or genetically modified form of the pathogen into the body to trigger immune response. However, mRNA vaccines involve the use of messenger Ribonucleic Acid (mRNA) to carry “instructions” for manufacturing a spike protein into the body. That, in turn, triggers the immune response. As described in a Health Policy Watch interview with Moderna’s Chief Medical Officer Tal Zaks from November 2020: “mRNA is a transient copy of the instructions in our genes that instructs the cell’s ribosomes to make protein. ….An mRNA vaccine is not a virus, [or even a weakened virus]. It only gives the cells transit instructions to make that one piece of virus that we want to educate the immune system to recognize. It’s essentially an instruction code. I inject it into the muscle. It gets distributed to the lymph nodes where the immune system works. The messenger RNA encodes for the spike protein and our cells start to make this spike protein. “Now the immune system sees a new protein it’s never seen before. And it goes, ‘Oh, hold on a second. This looks like a foreign threat. …let me go block it.’ And so the immune system starts to generate antibodies and T cells that recognize that spike protein. It focuses the attention of the immune system, just on that one protein.” Independent Expert Confirms – No Vaccine Efficacy or Safety Issue We also interviewed Steve Pascolo, a researcher at the University Hospital of Zurich, an expert on mRNA vaccines, regarding potential impacts of lower mRNA integrity levels on either safety or efficacy of the Pfizer/BioNTech vaccine. Pascolo, also a co-founder of CureVac who left the company in 2006, said that he did not see serious issues of safety or efficacy arising: “In the early trials of BioNTech, they had immune responses with just one microgram of RNA.” (the approved mRNA vaccine has 30 micrograms of RNA per dose), said Pascolo, also author of a recent paper Synthetic Messenger RNA-Based Vaccines: from Scorn to Hype. And what about safety? Could a lower mRNA “integrity” level could impact the vaccine’s safety? Was it possible that the presence of “truncated” mRNA proteins in the vaccine’s active ingredient – other than the exact target mRNA protein – could also have unwanted immune impacts? Said Pascolo: “There is no safety implication of having a shorter mRNA transcript in the vaccine. In fact a shorter transcript will probably not be translated (it misses the functionality important ends) and if it would, may result in production of shorter proteins that may even participate in the overall immune response.” PART III – EMA Says Emails Were Manipulated by Hackers To Sow Vaccine Mistrust When our team published its first story on the leaked documents in Business Insider Germany (on January 15, 2021), an EMA spokesperson said that the agency “would not verify” the authenticity of the leaked documents because they have been stolen by hackers and placed on the dark web. Later on that same day, an EMA press statement acknowledged that the “unlawfully accessed documents.. Included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines.”The 15 January statement added that “Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.” Ten days later, on 25 January, the EMA issued another statement on the cyberattack that had led to the email leaks, with more details on how the series of email leaks had been manipulated by hackers – to create mistrust around the vaccines themselves. “Whilst individual emails are authentic, data from different users were selected and aggregated, screenshots from multiple folders and mailboxes have been created and additional titles were added by the perpetrators in a way which could undermine trust in vaccines”, said the EMA press statement issued on January 25. Analysts Suggest EMA Emails Were Hacked by State Entity Undoubtedly, the way these documents appeared on the dark web, played into the hands of sensationalism muddying the regulatory reviews. The leaked documents from the EMA were named “BIG DATA SCAM of Pfizer’s vaccines” and “Astonishing fraud Evil Pfizer!!” Jean-Michel Doan, an open-source analyst who specialises in cybercrime at Sekoia, an IT security company in France, said, it is likely that the attack was caused by hackers affiliated to a state entity. “This kind of hacking tactic with data theft followed by data leaks has already been practiced by Russian agents (Guccifer 2.0/ Democratic National Convention leaks and World Anti-Doping Agency leaks).” Cyberattacks focusing on undermining confidence around brands of the Covid vaccine have also been undertaken by hacking groups affiliated with China, North Korea, and Iran and Russia, he added. The team also spoke with Mirko Gatto, CEO of Yarix, an Italian company that works in IT security, on whether anti-vaxxers could have orchestrated such an attack. Gatto said, “All is possible, but if anti-vaxers want to damage someone they go in other places, for example on Twitter. They use open source intelligence (OSINT) sources. They want to communicate as much as possible and [the] black market is not a place for this kind of strategy.” Part IV; Balancing Regulatory Processes, Political Pressures & Right To Know Clearly, the leaks reveal the kinds of political pressures that have been faced by even the world’s most stringent regulatory agencies in the pandemic era. They underline the penultimate importance that politicians need to attach to restraint – in order to maintain public confidence in regulatory processes – and the vaccines they produce. Even so, it appears the EU drug regulator adhered to its due diligence process. The EMA issued the Pfizer-BioNTech’s vaccine a conditional marketing authorization on December 21, 2020- a full three weeks after the UK (December 5th) and two weeks after the US FDA actions (December 11th) – suggesting that the EM indeed took time to resolve questions about safety, efficacy and manufacturing quality assurance. . Still, the leaks provide a cautionary tale about the pressures that regulatory authorities may face – with implications for other national regulatory agencies as well as the World Health Organization – which has its own emergency use listing process. If one of the strictest regulators in the world is subjected to such pressures, it is likely the pressures on other authorities may be even more intense. Transparency of Dossier Submissions Professor Brook Baker, Northeastern University, School of Law The other lesson learned may be one about the importance of transparent regulatory reviews. If the exchanges between the EMA and Pfizer about aspects of quality assurance of production processes had been a transparent matter of record – it might have removed the sting of some of the leaked emails – which ostensibly sought to undermine vaccine confidence. Observes Brook Baker, professor of law at Northeastern University in Boston told Health Policy Watch, “Transparency by regulatory authorities and WHO prequalification with respect to COVID-19 vaccines is absolutely critical to vaccine acceptance by medical providers, opinion makers, and ultimately individual patients and the public-at-large. Transparency is particularly important when public anxiety is high, product development and clinical trials have been expedited, political pressure has been exerted by public officials, there is global competition in vaccine development, and emergency use permission is granted short of full regulatory approval. It also certainly hasn’t helped that even stringent regulatory authorities in the U.S., U.K., and Europe have disagreed on what vaccines to approve and conditions and populations of approved use.” As a result, adds Baker, ”transparency about dossier submissions, the evidence submitted, independent and supplementary review by expert committees, and the detailed assessments of the regulator is vitally important. “This should include transparency around known adverse effects, post-approval pharmacovigilance, efficacy with respect to new variants, and on-going studies and time-lines for full regulatory approval,” he says. EMA Not the Only Regulatory Agency Subjected To Pressures Former US President Donald Trump at a White House Coronavirus Taskforce briefing – he used the presidential podium to exert pressure on the FDA for more rapid approval of COVID-19 vaccines. The EMA experience can be contrasted with the US Food and Drug Administration review process of the same vaccines – which was subjected to even more overt and intense political pressure from former US President Donald Trump. Those pressures included Trump’s own tweets and statements, as well as backroom approaches from White House emissaries and Trump’s political appointments in the US Centers for Disease Control, the White House COVID task force and the FDA. “Fortunately, the scientists and leadership at the FDA resisted these pressures, assured that there would be independent expert input, and reviewed the evidence with care and precision,” said Baker. “These internal forces at the FDA were helped by vaccine developers who also made it clear that they wanted there to be rigorous, independent review at the FDA.” Baker also notes the “unprecedented transparency with respect to many aspects of the [FDA] approval process,” including not only the portfolio submissions but also live video coverage of the entire FDA review deliberation. At the same time even across the Atlantic, “advocates are still pressing for even more transparency about company submissions, including underlying clinical trial data and confidential manufacturing information, and about FDA assessments,” Baker observes. Going forward, such transparency may be all the more important to both protect regulatory authorities from undue political interference – as well as building public confidence in the process – and thus in the vaccines that they approve. Ultimately, FDA transparency may also have helped build public confidence in the FDA approval process – and even stave off hackers’ attacks such as those seen in Europe. _________________________ Priti Patnaik is the founding editor of the Geneva Health Files, an independent global health reporting initiative based in Switzerland. Lucien Hordijk is a contributing reporter for the Investigative Desk, a non-profit investigative journalism group that is based in Amsterdam. Ludovica Jona (Italy), Lise Barnéoud (France), and Hristio Boytchev (Germany) also contributed to this article. This article is part of the series #BehindThePledge, a cross border investigation into the money trail of pandemic-related drug and vaccine development and rollout. This is the first publication in English-language media about the EMA leaks. Earlier versions of the story have been published by the team in media in France, The Netherlands, Italy & Germany. The project has received grants from Journalismfund and IJ4EU. Image Credits: BioNTech, Twitter, Pfizer, US Centers for Disease Control, Pfizer, White House/D. Myles Cullen. Global Citizen Launches ‘Recover Better Together’ Campaign – Guinea Launches Ebola Vaccinations – Nigeria & Zambia Studies Show High SARS-CoV2 Infections 23/02/2021 Kerry Cullinan Global Citizen CEO Hugh Evans launches 5-point global recovery campaign Vaccinating all of Africa’s health workers would need half a percent of all the doses that the G-7 countries have purchased, according to Global Citizen CEO Hugh Evans. On Tuesday, Global Citizen launched a five-point ‘Recover Better Together’ plan for the world, aimed at getting millions of citizens behind ending COVID-19 for all, ending the hunger crisis, resuming learning for children, fully protecting the planet, and advancing equity for all. “First we must focus on achieving sufficient worldwide vaccine coverage to break the chain of transmission, including, for the poorest nations,” Evans told a media briefing convened jointly with the World Health Organization, and addressed by world leaders including European Commission president Ursula von der Leyen, US Special Envoy in Climate John Kerry and South African president Cyril Ramaphosa. In his address, Ramaphosa applauded French president Macron who has called on rich countries to donate 5% of their vaccines to needy countries. “Another important step is to enable the transfer of medical technology for the duration of the pandemic. This will allow us to increase the production of COVID-19 vaccines and other medical products, lower prices, and improve distribution so that these vaccines and medical supplies reach all corners of the world,” said Ramaphosa. Guinea Starts Ebola Vaccination Drive – Nigerian and Zambian Studies Show High Levels of SARS-CoV2 Infection Healthworkers during the 2017 Ebola outbreak in the DRC. Guinea started Ebola vaccinations on Tuesday of people at high risk in Gouecke, a rural community in N’Zerekore prefecture where the first cases were detected on 14 February – the first cases since 2016. “All people who have come into contact with a confirmed Ebola patient are given the vaccine, as well as frontline and health workers. The launch started with the vaccination of health workers,” according to a media release from WHO’s Africa region. “The last time Guinea faced an Ebola outbreak, vaccines were still being developed,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “With the experience and expertise it has built up, combined with safe and effective vaccines, Guinea has the tools and the know-how to respond to this outbreak. WHO is proud to support the government to engage and empower communities, to protect health and other frontline workers, to save lives and provide high-quality care.” The WHO sent 11 000 doses of the rVSV-ZEBOV Ebola vaccine from its headquarters in Geneva, while a further 8500 doses are being procured from Merck, the vaccine’s producer in the US, “The speed with which Guinea has managed to start up vaccination efforts is remarkable and is largely thanks to the enormous contribution its experts have made to the recent Ebola outbreaks in the DRC,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “Africans supporting fellow Africans to respond to one of the most dangerous diseases on the planet is a testament to the emergency response capacity we have built over the years on the continent.” Implementing an Ebola vaccination strategy is a complex procedure as the vaccines need to be maintained at a temperature of minus 80 degrees centigrade. Guinea has developed ultra-cold chain capacity with vaccine carriers, which can keep the vaccine doses in sub-zero temperatures for up to a week. There are eight cases (four confirmed and four probable) and five people have died so far. Guinea’s neighbours are on high alert, particularly Liberia and Cote d’Ivoire which are close to the border with N’Zerekore, Guinea’s second-largest city. Meanwhile, a second person died of Ebola last week in the Democratic Republic of the Congo’s North Kivu province. Ebola, a haemorrhagic fever, is transmitted from wild animals and spreads in the humans through direct contact with the blood, and bodily fluids of infected people, and contaminated surfaces and materials. Nigeria’s First SARS-CoV-2 Seroprevalence Study Finds Almost 25% of Lagos Residents Had Antibodies Lagos Almost a quarter of Nigerians living in Lagos may have been infected with SARS-CoV2, according to the results of a seroprevalence study released on Monday by the Nigeria Centre for Disease Control (NCDC) and Nigeria Institute for Medical Research (NIMR) The household seroprevalence survey was conducted in Lagos, Enugu, Nasarawa and Gombe States in September and October last year and involved blood samples from over 10,000 people. SARS-CoV-2 antibodies were found in 23% of people sampled in Lagos and Enugu States, 19% in Nasarawa State, and 9% in Gombe State. “These rates of infection are higher than those reported through the national surveillance system and reveal that the spread of infection in the states surveyed is wider than is obvious from surveillance activities,” according to a statement by the NCDC and NIMR. The survey also showed that men had higher infection rates than women (21% of men and 17% of women in Nasarawa), and urban areas had higher infection rates than rural areas (28% of urban residents and 18% of rural residents in Enugu). The survey is currently being expanded to more states in the North-West and South geopolitical zones which were not included in the initial round of surveys. Zambia Post-Mortems Find High Level of SARS-CoV2, Minimal Testing Post-mortem surveillance of 364 Zambians who died between June and September last year detected SARS-CoV2 in 70 (19%), according to a study published in the BMJ last week. PCR tests were administered on people at the University Teaching Hospital morgue in the capital of Lusaka within 48 hours of death. Fifty of the 70 with COVID-19 had died in their communities without ever having been tested for the virus. Only five of the 19 who died in hospital had been tested. Seven children were part of the study and only one had been tested before death. The most common co-morbidities among those who died of the virus were tuberculosis (31%), hypertension (27%), HIV/AIDS (23%), alcoholism (17%), and diabetes (13%). Image Credits: WHO, Wikipedia. ‘Rapid Response Platforms’ Enabled COVID-19 Vaccine Development, Says Fauci 23/02/2021 Madeleine Hoecklin The Epidemic and Pandemic Preparedness and Response panel at the GVIRF event on Monday. Rapid response platforms, particularly the messenger RNA (mRNA) platform, have changed the landscape of vaccine development, enabling the rapid response to the COVID-19 pandemic, said Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) on Monday. Fauci, speaking at the opening of the Global Vaccine and Immunization Research Forum (GVIRF), co-organized by WHO, the Bill & Melinda Gates Foundation, and the NIAID, highlighted the innovations in vaccinology that made the speedy development of COVID-19 vaccines possible. “There are a number of new technologies that have now really dominated our approach to COVID-19. For example, there’s genetic immunisation using RNA and DNA vaccines,” said Fauci. “We are well aware now of the successes, for example, of the mRNA vaccines.” Rapid response platforms are systems that can be adapted against different pathogens. In the case of mRNA vaccines, these have been developed over a number of years to address influenza, Zika and rabies and have shown a high level of efficacy against SARS-CoV2. The Pfizer/ BioNTech and Moderna SARS-CoV2 vaccines have both had over 95% efficacy against symptomatic COVID-19 and nearly 100% efficacy against severe disease. “I think it’s fair to say that rapid response platforms have been a revolution in vaccinology over 2020 with COVID-19,” said Melanie Saville, Director of Vaccine Research and Development at the Coalition for Epidemic Preparedness Innovations (CEPI). “These can be further developed and prepared for future outbreaks, epidemics, and pandemics.” Barney Graham, deputy director of the Vaccine Research Center at NIAID, added that, over the past 12 years in particular, “new technologies have improved our ability to both prepare for and respond to emerging threats, like structural biology protein engineering and rapid platform manufacturing.” Prototype Pathogen Approach Both Graham and Fauci described the prototype pathogen approach to pandemic preparedness vaccine research used at the NIAID. This refers to studying pathogens of a particular group to build on prior experiences and use strategies to inform vaccine design for related viruses. In developing vaccines for SARS-CoV2, structure-based vaccine designs from Middle East Respiratory Syndrome (MERS-CoV), which is in the family of coronaviruses, were used and “enabled us to rapidly get a successful vaccine, particularly with mRNA [technology],” said Fauci. With the technological advances and the unprecedented R&D work conducted over the past year with COVID-19, “I think we’ve probably moved forward a decade…with COVID-19 vaccines being developed in only 300 days, whereas usually, they would take multiple years, if not decades,” said Saville. The timeline of the mRNA COVID-19 vaccine development. “One thing to point out [is] the speed with which we went from appreciating the new virus, in this case SARS-CoV2, on January 10 of 2020, to starting a phase one trial, about 65 days later, a phase 3 trial both with Moderna and with Pfizer, on 27 July and now having both vaccines already being administered here in the United States and elsewhere. [This is] the fastest in the history of vaccinology from the identification of a particular pathogen to the actual administration of a vaccine,” said Fauci. Challenges with mRNA Platforms While mRNA technology has had great advances, there is still a lot that is unknown about this type of vaccine, including what type of RNA to use and what long-term immune response durability may be. The continued development of the rapid response platforms is needed to make progress on COVID-19 and future epidemics and pandemics. “In all cases, the more robust the platform, in terms of what safety data you have from the platform, what type of immune profile, and importantly, the manufacturing process – which is often really the rate-limiting factor, [the better it is to]…get them as fine-tuned as possible,” said Saville. The manufacturing the Pfizer/BioNTech and Moderna vaccines is limited and is largely centered in Europe and North America. A map of the manufacturing sites for mRNA COVID-19 vaccines globally. “What we need to really look at in the medium and longer-term [is]…how can that manufacturing footprint be much more amenable with regional manufacturing capacity,” said Saville. “Looking at manufacturing innovation…that could be amenable to the low- and middle-income countries [is] something that really needs to be followed.” Innovations in Manufacturing While numerous accomplishments have emerged from the COVID-19 pandemic, several shortcomings, particularly in vaccine development and manufacturing, have occurred. “There’s no question that COVID has demonstrated the potential of vaccine development and R&D, but it has also exposed some pretty major gaps in the system and [has shown] what happens when a disease strikes the entire world at the same time,” said Selwyn. These gaps include the limitedd supply of vaccines secured for low- and middle-income countries; high-income countries pre-ordering large amounts of vaccines for themselves; the reduction in production capacity for other diseases, which may increase the risk of outbreaks; and the dependency on tech transfers. “In COVID, there were multiple companies who had quite limited experience with vaccine manufacturing and bringing vaccines through licensure, [who were] planning for upwards of 10 tech transfers in a single year,” said Casey Selwyn, senior officer in Vaccine Development and Global Health COVID-19 Response at the Gates Foundation, at a workshop that followed the opening session. Normally a company may undertake one transfer a year. The Innovations in Vaccine Manufacturing workshop at the GVIRF session on Monday. “To maximize global supply, we need to have innovative ways to ease and encourage tech transfer…A tech transfer requires time, it requires resources and sharing of know-how, not just intellectual property,” Selwyn added. The most efficient way to scale up vaccine production and supply over the long term is to build “ever-warm” vaccine facilities that are multi-platform and multi-purpose with a trained workforce, so that the facilities can be prepared when an outbreak occurs, proposed Selwyn. Another recommendation for innovating global manufacturing was to implement a hub and spoke distribution model, which would create a centralized network where products are received in central locations before being sent directly to their destinations. According to Selwyn, this could ease the pressure of tech transfers and establish a better geographical reach, creating a more flexible, accessible and cost effective system. Alternatively, increasing standardization of manufacturing protocols and regulatory requirements – which could include the labeling of products, serialization, and design of protocols – could also improve speed, flexibility, and cost-efficiency. “Probably one of the most important sets of innovations, sets of lessons and sets of actions for the future is really continuing to pursue uniformity and harmonization, especially for a set of diseases and pathogens that require rapid response,” said Anant Shah, New Product Lead for Global Vaccines for COVID-19 and Ebola at Merck. “We have to pursue uniformity, flexibility and efficiency if we want to continue ensuring global equitable access,” said Shah. Image Credits: NBC, GVIRF. Global Health Diplomacy In The COVID-19 Era – Can Failure Usher In A New Era of Success? 22/02/2021 Svĕt Lustig Vijay More than a year into the world’s largest global health emergency, health diplomats have fought hard to ensure that every country across the globe secures access to lifesaving coronavirus health products, including vaccines, treatments, and diagnostics. That has not happened yet, given that 80% of countries that are now rolling out vaccines are either high-income or upper middle-income countries. Export bans on essential health products in 80 countries, ranging from personal protective equipment to ventilators, have not helped either. And in the absence of clear global guidance, up to 130 countries have imposed an uneven patchwork of travel restrictions in an attempt to keep more contagious variants at bay – mostly to no avail. A panel of some two dozen leading diplomats and health policy experts from WHO, government, academia and media pondered the current state of affairs, at the Global Health Centre’s (GHC) launch of a new Guide to Global Health Diplomacy, authored by GHC founder Ilona Kickbusch along with a former Hungerian Health Minister, Haik Nikogosian, former head of the Framework Convention on Tobacco Control, Mihály Kökény; and a preface from WHO’s Director General Dr Tedros Adhanom Ghebreyesus. The guide, co-sponsored by the Swiss Confederation, offers a compass to navigate the complexity of global health diplomacy through “practical insights” and “sound wisdom”, said Norway’s leader of the labor party Jonas Gahr Stør at the launch event on Thursday. Norway’s Labour Party leader, Jonas Gahr Støre The event featured some of the bright stars in the world’s global health constellation, including former WHO DG Margaret Chan; Trudi Makhaya, economic advisor to South Africa’s President Cyril Ramaphonsa, Suhasini Haidar, editor of India’s The Hindu Newspaper, Juan Jorge Gómez Camacho, Mexico’s Ambassador to Canada, and Swiss Federal Councillor Alain Berset. The event, moderated by Kickbusch, was co- sponsored by the World Health Organization and the Swiss Federal Council. Said Kickbush: “As you can see from the subtitle of this book [better health – improved global solidarity – more equity], the three words, health, so that health moves to the centre of negotiations, solidarity, and equity – those truly are the goals of global health diplomacy.”Better health – improved global solidarity – more equity Ilona Kickbusch, Founding Director of the Graduate Institute’s Global Health Centre in Geneva. Crisis Has Shown The Failures of The Current International Health Regulations System For Pandemic Preparedness & Response Michel Kazathchkine, former Executive Director of the Global Fund and a member of the Independent Panel for Pandemic Preparedness and Response The pandemic has uncovered “many flaws” in global preparedness and response, said Michel Kazathckine, former executive director of the Global Fund to fight AIDS, Tuberculosis and Malaria, and currently serving as a member of the Independent Panel for Pandemic Preparedness and Response, mandated by the World Health Assembly in May, to explore how and why the SARS-CoV2 pandemic caught the world so badly off guard. “The international system we have established for health security did not really work as a system,” he said. “There were clear gaps in preparedness management of the response coordination.” If there is anything that diplomacy has “certainly” not achieved in the midst of the pandemic, it is “firm and binding commitments” at the international level, added the Global Health Centre’s co-director Suerie Moon. Suerie Moon, Co-Director of Global Health Centre at Geneva Graduate Institute Same Challenges Were Apparent in H5N1 Avian Flu Epidemic The challenges are not new. Some 15 years ago after the eruption of the H5N1 Avian Influenza epidemic, Indonesia protested the fact that after low- and middle-income Asian countries had shared samples of the emergent pathogen with research networks around the world, rich countries then bought up most of the vaccines thus produced – leaving other countries vulnerable. In 2021, the continued lack of clear and binding agreements to ensure equitable access to health products during health emergencies remains largely unresolved, Moon said. “We’ve known this for quite some time, but actually we have very weak, frankly, quite non-existent rules and agreements at the international level to make sure that countries get access to vaccines, so this is not a surprise,” she said. “This is not something that is new to the global health community, but it’s something that we have not yet managed to address.” While some global frameworks do exist to allow LMICs to gain emergency access to lifesaving health products – such as the pre-existing donor-financed vaccine pool for 92 LMICs managed by Gavi, The Vaccine Alliance, or tools like the WTO’s TRIPS agreement (Trade-Related Aspects of Intellectual Property Rights) – the global south still struggles to take advantage of available IP flexibilities, partially due to fear of retaliation from stronger nations and big pharma. And recent negotiations over a South African and Indian proposal for a more far-reaching TRIPS waiver have “not been easy” either, noted Trudi Makhaya, who is economic advisor to South Africa’s President Cyril Ramaphonsa. Trudi Makhaya, Economic Advisor to South Africa’s President Cyril Ramaphonsa. Another alternative, the WHO-backed voluntary licensing pool, has also failed to garner pharma support for now. Still, there is a growing appreciation that technology transfer and the development of more local health product manufacturing capacity is crucial for low- and middle-income countries going forward, said Makhaya. Notably, new World Trade Organization Director General Dr Ngozi Okonjo-Iweala has talked about a “third way” that would encourage big pharma to sign more voluntary deals with countries for local production – without impinging on intellectual property rights. However, Makhaya remains wary: “There is an appreciation that there’s got to be technology transfer [to LMICs], there’s got to be local manufacturing and that current other alternative arrangements to do that, in the absence of the TRIPS [waiver], are going to be very difficult,” she said. Economy Among the Myriad Of Global Health Challenges But access to vaccines is only one of a myriad challenges facing low- and middle-income countries in the pandemic response. Makhaya also talked about the economic response to COVID : while some “important” ideas have been floated by the international community to bolster fragile economies – such as special IMF drawing rights for low-income countries – fiscal measures have remained stunted in poorer nations, in comparison to advanced countries that have pumped up to 20% of their GDP into local economies for temporary relief to businesses and the unemployed, she said. “There have been significant calls that there should be resources at the global level that should be injected [into emerging economies],” said Makhaya. “ A key example was special drawing rights at the IMF…[but] it hasn’t found much expression.” “We have a situation where amongst advanced countries’ central banks there’s cooperation, but none has been extended to many other developing countries.” Added Juan Jorge Gómez Camacho, Mexico’s Ambassador to Canada: “Health is not just about health itself,” he said.“Health means prosperity, or the lack of. Health means economic growth, or the lack of. “Health means wealth or poverty. Health is everything. In other words, health criss-crosses all the spectrum of human activity – socially, politically, economically.” Some Successes: COVAX is Unprecedented Dr Tedros Adhanom Ghebreyesus speaking at Thursday Global Health Centre event Even so, some successes have been apparent since the pandemic struck. If the global health community has achieved anything, it is the WHO co-sponsored COVAX global vaccine facility, which has successfully brought together 190 countries “out of thin air” in the aim to provide more equitable distribution of coronavirus vaccines around the world, said Moon. “The access to COVID-19 tools accelerator is health diplomacy in action,” added Dr. Tedros. “It is an unprecedented collaboration between countries, international agencies, the private sector, and other partners to ensure vaccines, diagnostics and therapeutics are shared equitably as global public goods. Vaccine equity is a litmus test for solidarity and global health diplomacy.” Just last Friday, G7 leaders committed an additional $4.3 billion to the ACT Accelerator initiative, which includes COVAX, as well as parallel efforts for tests and treatments and health systems strengthening. That brings the total commitment to ACT for 2021 to $10.3 billion – although global health leaders say that another $22.9 billion is still needed for all arms of the initiative. Local Manufacturing Of New Vaccines Scaling up generic manufacture of COVID-19 vaccines could help expand supply and stimulate local economies Meanwhile, some vaccine-makers have made strides in advancing more local production of their vaccines around the world. Russia’s Sputnik V vaccine, for instance, which showed impressive results in the publication of recent Phase 3 results in The Lancet, is already being produced in India, South Korea, Brazil, China. And production is set to begin in Kazakhstan and Belarus, among other countries like Turkey and Iran – although Sputnik has yet to receive formal regulatory approval from a western regulatory agency or the World Health Organization. India’s Serum Institute is manufacturing a local version of the Oxford/AstraZeneca, recently approved by the European Medicines Agency. The vaccine, locally branded as Covishield, is set to play a big part in advancing the access agenda through the COVAX facility as well as through bilateral deals. Over the past two weeks, India has exported 23 million doses of the locally-produced “Covishield” vaccine to low- and middle-income countries, said National Editor for The Hindu media outlet Suhasini Haidar, who also spoke at the panel event. Still, despite the big ambition for COVAX to distribute more than 2 billion vaccines by the end of 2021, it is a rather sobering fact that COVAX-supplied countries will only be able to vaccinate 3% of their population over the first half of this year, said Moon, adding, “frankly, we need to aim far, far, higher than that.” Meanwhile, countries like Canada have already ordered five times more vaccines than they need, and the EU has ordered twice as many vaccine doses than it needs. That has opened a debate about vaccine sharing of surplus stocks by rich countries to poorer ones – an exchange which WHO would like to encourage through the COVAX facility instead of through uneven bilateral deals and donations. Global Solutions Are Important – But Regional Solutions Also Required India’s prime minister Narendra Modi as he recently announced a South East Asia regional initiative. Finally, while global frameworks are crucial in the pandemic response, countries shouldn’t wait for Geneva to take action, added other panelists. Notably, the African continent has come together in unprecedented ways through initiatives like the African Response Fund, the African Medical Supplies Platform, or the African Vaccine Acquisition Task Force, among others, said Makhaya. “Instead of looking at the world as one large area of cooperation, perhaps [we need smaller] building blocks, much more about the regions and then come to some kind of success,” added Haidar. “If we only look at the solutions as an all-or-nothing huge global system, I think we’re going to close off,” added Moon. “It’s a very complex multipolar ecosystem with lots of different solutions being figured out by different actors who are not waiting for the answers to come from Geneva.” Indeed, as this event was happening, other new regional initiatives were also taking shape – including Europe’s announcement of an emergency biodefense plan and a SouthEast Asia regional initiative for pandemic preparedness and medical emergencies mooted by Indian Prime Minister Narendra Modi. This, however, does not mean “we don’t need Geneva”, said Moon. “We absolutely need global frameworks and global agreements, but when we think about how have countries figured out how to solve their problems, it has not always been through massive global agreements and so I think we have to think creatively about how does the entire ecosystem work, including what needs to truly be global versus [regional].” One of the newer global frameworks that is now gaining steam is a “Pandemic Treaty”proposed by DG Tedros at the World Health Assembly. The treaty aims to garner stronger political commitment towards pandemic preparedness and response, noted the WHOs regional director for the EMRO region Jaouad Mahjour, also appearing at the panel debate. But until such initiatives are put into force, it “isn’t difficult” to guess who will emerge as a winner in the pandemic response, warned Kazathckine. “Health is a political choice that can and must transcend politics,” Dr Tedros said at the Thursday event. “That’s why this book is so important to build the health diplomacy capacity of both diplomats and health experts around the world.” But as Moon reminded the panel: “At the end of the day, the big challenge will not be what needs to be done, but actually how to do it. “And this is the work of diplomats – just how to implement, and how to navigate the politics… reminds us that the work of diplomats is really just beginning and that there’s a huge agenda ahead of us.” Other Key Points By Panelists “Sharing expertise and information should be at the heart of global health diplomacy. Global collaboration is key to a more equal and sustainable world that benefits all of us” said @JosepBorrellF during the launch of our Guide to Global Health Diplomacy. @EU_Commission pic.twitter.com/CBGyb2MOAx — Global Health Centre (@GVAGrad_GHC) February 18, 2021 Juan Jorge Gómez Camacho, Ambassador of Mexico to Canada.“The only way we can address this pandemic is by moving all together. We cannot address [the pandemic] country by country. It is self-defeating not only collectively [but also] individually as a country, if we focus on us instead of focusing on working together. For a diplomat, to understand in this case it is not my own interest versus everybody else’s interests. In fact, everybody else’s interest is in my best interest. Joseph Borrell Fontelles, High Representative of the EU for Foreign Affairs and Security Policy Vice-President of the European Commission -“Sharing expertise and information should be at the heard of global health diplomay.” Dr Tedros, WHO Director General “If we have learned anything, this past year, it’s that none of us can go it alone. We can only thrive when we work together across institutions across borders,” he said. “That’s why it’s truly a pleasure to join you for the launch of the guide to global health diplomacy.” Margaret Chan, former WHO Director General “Without diplomacy, we cannot begin to negotiate,” she said.“And we cannot begin to [advance] the important policy decisions that impact the health and well being of the world’s population.” Alain Berset, Federal Councillor of Switzerland “The value of global health diplomacy has probably never been more apparent as it is today,” he said. “In this crisis, we need skilled diplomacy to find good solutions.” Michel Kazathchkine, member of the Independent Panel for Pandemic Preparedness and Response “The question for us today…is not whether 2020 has been the year of global health diplomacy, but what has global health diplomacy achieved during the crisis, and where has it failed, and looking forward, which are the challenges.” "The value of global health diplomacy has never been more apparent as it is today. In this pandemic, the international community needs to come together in solidarity. We need skilled diplomacy to find good solutions to global challenges." @alain_berset @BAG_OFSP_UFSP @BAG_INT pic.twitter.com/R0s5F2ASAp — Global Health Centre (@GVAGrad_GHC) February 18, 2021 Global Health Diplomacy Book – Co Published with the WHO and the Swiss Federal Council The new book, published in collaboration with the WHO and the Swiss Federal Council, will be translated into Chinese and Portuguese, among other languages, said Kickbush. Given that health is negotiated across all sectors, the new guide is relevant to a range of stakeholders, including the media, civil society, academia, as well as ministries across various sectors, emphasized the Global Health Centre’s co-director Suerie Moon. “The book makes it quite clear that you don’t need to be a health specialist and you don’t need to be a former diplomat, and in fact some of the most important global diplomats are economic advisors or are coming from media or coming from civil society and academia and foundations and not necessarily from the traditional ranks of diplomacy. “If there’s one lesson we’ve really seen over the past year from COVID it’s that diplomacy is not only the responsibility of ministries of health, but trade, science, technology, intellectual property, travel, tourism, finance…Every single one of these ministries in government needs to be mobilized to negotiate solutions.” Read the Global Health Centre’s new guide here https://www.graduateinstitute.ch/GHD-Guide Image Credits: NBC, European Health Forum Gastein, IHEID, Twitter: @WHOAFRO. EU Cannot Sue AstraZeneca – Germany Commits to Sharing Doses 22/02/2021 Madeleine Hoecklin & Kerry Cullinan Threats from the European Commission to sue AstraZeneca over the delay in deliveries of COVID-19 vaccines hold no weight, according to the EU’s contract with the pharma company in which the right to sue was waived. Following the drugmaker’s announcement in late January of a 60% shortfall in vaccine deliveries for the first quarter after its manufacturing plants in Europe hit a number of snags, furious EU officials examined possible legal avenues to resolve the issue. The release of the full contract by RAI, an Italian broadcaster, makes public several key elements that were redacted from a version previously published by the European Commission. In particular it reveals that the Commission is unable to sue for issues with the storage, transport, and administration of vaccines, including delays in the delivery of vaccines. The exception to the restrictions on the right to legal action is AstraZeneca’s “wilful misconduct or failure to comply with EU regulatory requirements…including manufacture.” While the EU’s hands are tied in terms of filing a lawsuit, there are other pathways open, including suspending payments to AstraZeneca. The initial funding for the doses promised to the EU totals €336 million, of which the Commission already paid two-thirds. The remaining €112 million is supposed to be paid within 20 days of receiving the first installment of doses, however, with the lack of evidence of progress towards manufacturing the doses, “the Commission will have no obligation to pay the second installment and may seek to recover the first installment or a portion of it,” states the contract. It appears that AstraZeneca overestimated its manufacturing capacity and supply to the EU, setting a goal of delivering 300 million doses by the end of 2021, with 30 million doses by the end of 2020, 40 million in January, 30 million in February, 20 million in March, 80 million in April, 40 million in May, and 60 million in June. The company agreed to use its “best reasonable effort” to manufacture the initial doses ordered by the EU and to build its manufacturing capacity. AstraZeneca recently announced that it can deliver 41 million doses by the end of March with its “best reasonable effort.” That estimate is 20 million fewer doses than initially predicted, meaning the drugmaker is over two months behind schedule. Germany Commits to Sharing Vaccine Doses WHO’s Tedros and Germany’s President Frank-Walter Steinmeier address the media. German President Frank-Walter Steinmeier committed his country to sharing some of the vaccines it has ordered with low-income countries at a joint press conference with World Health Organization Director General Dr Tedros Adhanom Ghebreyesus, on Monday. However, Steinmeier said how this would be done and how many vaccines would be shared was still under discussion. Last Friday, Germany announced that it would be contributing an additional €1.5 billion in funding for the multilateral response to the pandemic, including the ACT Accelerator, at the G7 leaders’ meeting last week. Steinmeier also used the briefing to restate Germany’s opposition to the proposal of a waiver on patent protection for COVID-19 related products, as mandated by the Agreement on Trade-Related Aspects of Intellectual Property Rights, known as the TRIPS waiver. “The interest of public institutions and private companies have to be kept alive to invest in research and the development of drugs medicines and vaccines,” said Steinmeier. “So I don’t think the proposal some have made that we have waiver for patents or licensing would be the right approach.” The TRIPS waiver, currently being discussed by the World Trade Organization, has wide support including from the WHO, but it is floundering because of opposition from wealthy countries with powerful pharmaceutical industries, like Germany, the US and the UK. While Tedros welcomed Germany’s financial contribution, he pointed out that while many wealthy countries claimed to support the global vaccine access facility, COVAX, they were still trying to do bilateral deals with manufacturers for more vaccine doses “without stopping to ask whether this was undermining COVAX”. “This pandemic is really unprecedented, and we have to do everything to defeat this common enemy including waivers on intellectual property to increase production,” said Tedros. He added that the WHO was engaging directly with manufacturers and encouraging pharmaceutical companies to “turn over their facilities to produce other companies’ vaccines as Sanofi has done for the BioNTech vaccine”, and issue non-exclusive licences to enable other manufacturers to produce their vaccines. G-7 Commitments Of US$4.3 Billion Not Enough – Rich Countries Need To Stop COVID Vaccine Hoarding to Open Access Bottleneck, Says WHO Director General 22/02/2021 Kerry Cullinan Dr Tedros Adhanom Ghebreyesus, WHO Director General, at the press briefing on Friday. Despite Friday’s commitment by G-7 countries to donate another US$ 4.3 billion to a global COVID vaccine campaign, World Health Organization Director General, Dr Tedros Adhanom Ghebreyesus has accused high-income nations of still undermining equitable vaccine rollout by “doing deals” with manufacturers that deplete supplies available to the COVAX global vaccine facility. Speaking at the WHO’s biweekly media briefing, Tedros thanked the G-7 and the European Union for the new donations – but stressed that money was not enough: “If there are no vaccines to buy, money is irrelevant. Currently, some high-income countries are entering contracts with vaccine manufacturers that undermine the deals that COVAX has in place and reduce the number of doses COVAX can buy,” said Dr Tedros. “Unless we end the pandemic everywhere, we will not end it anywhere. To achieve this, we need more funding. We need countries to share doses immediately. We need manufacturers to prioritise contracts with COVAX. And we also need a significant increase in the production of vaccines.” HIV Provides Global Precedent, Says Anthony Fauci The HIV pandemic provides a “precedent” for how to get life-saving medicines to those who could not afford them – while allowing pharma companies to “maintain a considerable amount of profit”, said Anthony Fauci, US President Joe Biden’s chief scientific advisor and a guest at the WHO briefing. During the early days of the HIV pandemic, there was a lot of discussion about whether expanding the generic manufacture of new HIV antiretroviral drugs would “interfere with the appropriate profit that companies that made major investments in the development of [antiretroviral] drugs”, Fauci recalled. But through various platforms, including the US-sponsored President’s Emergency Plan for AIDS Relief (PEPFAR) as well as the new Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria, life-saving generic drugs reached millions of people and “did not have a deleterious effect on the companies who continued to do well financially and continue to make investments in research”. Even so, the pathway to those breakthroughs was painstaking, observed WHO’s Assistant Director-General for Drug Access, Mariângela Simão, observing that “too many people died unnecessarily” as rich and poor countries battled over access to HIV medicines. Mechanisms such as the Medicines Patent Pool, created to expand generic drug manufacturing in collaboration with the innovative pharma industry have provided “a proven platform to ensure that both voluntary licensing and technology transfer to increase access to medicines for HIV,TB and malaria”, said Simão. Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines But so far, the MPP precedents hasn’t been harnessed to the COVID-19 vaccine roll-out. She lamented: “Why can we not use the platform that WHO has in place, like COVID Technology Access Pool (C -TAP), to make COVID-19 technology accessible and manage intellectual property needs. “Intellectual property is not the endpoint. The endpoint is increasing manufacturing capacity and making sure good quality, efficacious and safe vaccines reach the developing countries,” Simão added. COVAX Sets Up ‘No-Fault’ Compensation Fund Earlier in the day COVAX announced that the WHO had reached an agreement with a global third party insurance provider, ESIS Inc, to administer a no-fault vaccine injury compensation programme for the 92 low- and middle-income countries and economies eligible for donor support to their vaccine campaigns. “As the first and only vaccine injury compensation mechanism operating on an international scale, the programme will offer eligible individuals in AMC-eligible countries and economies a fast, fair, robust and transparent process to receive compensation for rare, but serious adverse events associated with COVAX-distributed vaccines until 30 June 2022,” according to the global vaccine alliance, GAVI, which administers COVAX. By providing a no-fault lump-sum compensation in full and final settlement of any claims, COVAX aims to “significantly reduce the need for recourse to the law courts, a potentially lengthy and costly process”. ESIS, which is part of the Chubb group, will not charge any fees to applicants. “The No-Fault Compensation fund is a massive boost for COVAX’s goal of equitable global access to vaccines: by providing a robust, transparent and independent mechanism to settle serious adverse events it helps those in countries who might have such effects, manufacturers to roll out vaccines to countries faster, and is a key benefit for lower-income governments procuring vaccines through the Gavi COVAX AMC,” said GAVI CEO Seth Berkley. The COVAX no-fault compensation programme will come into operation via a web portal (www.covaxclaims.com) by 31 March, and people will be able to apply for compensation even if they were given a COVAX-distributed vaccine before this date. The programme is financed initially through a levy charged on all doses of COVID-19 vaccines distributed through the COVAX Facility to the AMC eligible economies until 30 June 2022. All vaccines procured or distributed through the COVAX Facility will have received prior regulatory approval from a strict national authority and/or a WHO emergency use authorization to confirm their safety and efficacy. But, as with all medicines, even vaccines that are approved for general use may, in rare cases, cause serious adverse reactions. No Need for People With Allergies to Avoid Vaccination in Fear of Anaphylactic Shock Dr Soumya Swaminathan, WHO Chief Scientist. On a more technical level of the risks of anaphylactic reactions associated with the Pfizer/ BioNTech and Moderna vaccines, Fauci said that these have been very rare events – and are most likely linked to the polyethylene glycol in the vaccine preparation. “There are 4 to 5 per million anaphylactic reactions for the Pfizer vaccine and between 2 and 3 per million to the Moderna, so it’s an unusual, rare interaction,” said Fauci. While people with known anaphylactic reactions may be advised to take special precautions, or in some cases not to be vaccinated with the mRNA vaccines, there is no reason for people with a general history of allergic reactions, to avoid vaccination, he added. Nancy Messonier, of the US Centers for Disease Control and Prevention who is leading the US Centers for Disease Control vaccine effort, told the media briefing that people who have had a history of anaphylaxis were being asked to stay at the health facility for 30 minutes after vaccination “because all the cases in US have occurred within that 30 minutes timeframe”. WHO’s Chief Scientist, Soumya Swaminathan, stressed that “every country has a system in place to do safety monitoring” and this has been coordinated by the WHO. “So far, over 200 million vaccine doses have gone into people around the world and there have been no alarming safety signals, but we will continue to monitor and update, if anything changes,” said Swaminathan. Image Credits: WHO. India Moots Regional Pandemic Platform with 10 Neighbours 22/02/2021 Menaka Rao After donating over 6 million Covid vaccines to more than 13 countries, the Indian government suggested the creation of a regional pandemic platform for preparedness and medical emergencies with its 10 neighbouring countries. At a meeting with health officials, Indian Prime Minister Narendra Modi proposed creating “a special visa scheme” for doctors and nurses to enable swift travel during health emergencies,coordinated air ambulances, a regional platform for “collating, compiling and studying data about the effectiveness of Covid-19 vaccines” and a network for “promoting technology-assisted epidemiology for preventing future pandemics.” India has reported more 11 million COVID-19 cases and over 156,000 deaths. Although cases have been declining since September last year and had considerably reduced by January, there has been an increase of about 31% in the past week, mostly in the Western state of Maharashtra. “Through our openness and determination, we have managed to achieve one of the lowest fatality rates in the world,” said Modi. “This deserves to be applauded. Today, the hopes of our region and the world are focused on rapid deployment of vaccines. In this too, we must maintain the same cooperative and collaborative spirit.” Modi was referring to the Indian government’s “Vaccine Maitri” (meaning vaccine friendship) initiative, through which the Indian government has donated more than 6.27 million doses of COVID-19 vaccines to more than 13 countries, including neighbours Bangladesh, Afghanistan, Bhutan, Myanmar and countries such as Oman, Barbados and El Salvador. It also commercially exported 10.5 million doses of vaccines to 8 countries. Modi was addressing a workshop on COVID-19 management attended by health leaders, experts and officials of Afghanistan, Bangladesh, Bhutan, Maldives, Mauritius, Nepal, Pakistan, Seychelles, Sri Lanka and India. Evoking the “spirit of collaboration” among these countries, Modi said that India and these countries have a lot in common and should share their successful health policies and schemes. “We share so many common challenges – climate change, natural disasters, poverty, illiteracy, and social and gender imbalances. But we also share the power of centuries old cultural and people-to-people linkages. If we focus on all that unites us, our region can overcome not only the present pandemic, but our other challenges too,” he said. Variants May be Associated With Surge in COVID Cases In the last few days, the Maharashtra state government reported a sudden burst of cases in the Vidarbha region, closer to Central India. The genome sequencing of a few cases in Amravati district showed “unique mutations” including E484Q, which is similar to a mutation (E484K) found in South African and Brazilian variants, according to a Times of India report. Maharashtra and Kerala account for more than 74% of the cases in the country while Chhattisgarh and Madhya Pradesh are also seeing a rise. This is in contrast to the steady downward trend of the pandemic in India since last September last year. The country is reporting an average of 12,000 cases a day, as compared to more 90,000 cases in a day in September. Experts have attributed the overall fall in COVID-19 positive cases over the past few months to herd immunity caused by widespread infection, especially in cities such as Mumbai, Pune, and Delhi which saw the largest outbreaks in the country. A recent round of sero-surveillance in Delhi between January 15 to January 23 among 28,000 people found that 56% of those surveyed had antibodies against COVID-19. “Those infected with Covid will only protect themselves but also protect others. Half the population will not transmit to others. Besides, the susceptible population is reduced by 50%,” explained Dr Sanjay Rai, from Delhi’s All India Institute of Medical Sciences. Citing a recently published study in the New England Journal of Medicine, Rai said that those who are infected are protected from disease for at least six months. The study which was conducted with more than 12,000 health workers in the UK, showed that presence of antibodies was associated with a substantially reduced risk of reinfection in six months. More than 9 million people have been at least given one dose of the vaccine. “India has a young population. About 50% of the population is under 25 years, and 65% of the population under 35 years. There could be a very large fraction of the population then which had asymptomatic infections and were not tested. They would also offer some protection to the population,” said Dr Shahid Jameel, a virologist with Ashoka University, Delhi. However, a nation-wide survey showed only one out of 5 people have been exposed to the virus. “The message is that a large proportion of the population remains vulnerable,” said Dr. Balram Bhargava, who heads Indian Council of Medical Research, that helmed the national-wide sero-survey. Meanwhile, there is some evidence that people who have already had COVID-19 can become reinfected with variants. Image Credits: https://dashboard.cowin.gov.in/. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Some Countries Ease Lockdowns, But Others Battle New COVID-19 Surges 23/02/2021 Raisa Santos & Kerry Cullinan Frankfurt, Germany The United Kingdom, Switzerland, Israel and Turkey are cautiously reopening businesses and relaxing limits on gatherings and travel as COVID-19 cases declined both globally and within these countries. However, parts of France, the Czech Republic, and Sweden are preparing for harder lockdown measures as their cases surge in contrast to worldwide trends. As of 23 February, there were 2,530,101 new cases in the past week. The COVID-19 Epidemiological Update reported a 16% global decline in cases, with over 500,000 fewer cases than the beginning of the month. Five out of six WHO regions were showing double-digit percentage declines in new cases, with only the Eastern Mediterranean Region showing a 7% rise. Europe and the Americas continue to see the greatest drops in absolute numbers of cases while the number of new deaths has also declined in all regions. UK & Switzerland Outline Roadmaps to Relax Restrictions Lockdown “Green” border roads between Switzerland and Germany Switzerland will relax some restrictions from 1 March, allowing museums, shops, and zoos to open at limited capacity. Private outdoor events with up to 15 people will also be permitted. A second phase of reopening should commence on 1 April. On Monday, UK Prime Minister Boris Johnson announced the government’s roadmap to ease restrictions in England, which will be guided at all stages by data as opposed to set dates. Step 1 of the roadmap will begin in March with a return to in-person education in schools and colleges. Most outdoor attractions and settings, as well as non-essential retail, which includes zoos, pubs, restaurants, gyms, and retail stores, will stay closed for at least another month. Step 4, which will see a wider opening of a number of businesses, is expected no later than 21 June. The United Kingdom had implemented a national lockdown in response to the rising cases that resulted from the B.1.1.7 variant, and has even extended the lockdown in Northern Ireland, to 1 April. London, UK: Camden High Street in lockdown Together with an ongoing vaccine campaign, these measures appear to be working, with case rates declining across all age groups and regions, in the most recent weekly surveillance report published. “Our efforts are working as case rates, hospitalisation rates and deaths are slowly falling,” said Dr Yvonne Doyle, Medical Director at Public Health England. Doyle still expressed concern about the new infection numbers, which were still higher than the cases at the end of September. “This could increase very quickly if we do not follow the current measures. Although it is difficult, we must continue to stay home and protect lives.” The UK roadmap for reopening outlines four steps: continued successful vaccine deployment, evidence that demonstrates vaccines are sufficient in reducing hospitalizations and deaths in those vaccinated, reduction in infection rates that prevent a surge in hospitalizations, and assessment of the risks not to be fundamentally changed by the new emerging variants of concern. There will be a minimum of five weeks between each step: four weeks for the data to reflect changes in restrictions; followed by seven days’ notice of the restrictions to be eased. Istanbul, Turkey Turkey also plans to start a gradual normalization process in March, with measures to be lifted “on a provincial basis”. The country’s 81 provinces will be categorized based on risk levels – from very high to low – and progress in vaccinations to determine whether they are ready for normalization. This new process for normalization comes after the Turkish Health Ministry started announcing an average of weekly cases for provinces last week. This data will be used to determine whether restrictions are lifted. Israel Re-opens For Business – Except During Holiday & At Airport Meanwhile, the Israeli government began to reopen hotels, shopping centers, and even cultural events on 21 February after its government approved the second and third phases of the exit plan from lockdown as new COVID cases continued to decline, particularly among people over 60, most of whom have been immunized. Infections rates and serious cases in Israel have declined sharply after more than 80% of people over the age of 60 either were vaccinated or recovered from COVID-19. The campaign has since opened to everyone over the age of 16. However, airports and land borders will be closed for 14 more days, and the country’s borders closed until 6 March. Only 200 people a day are allowed to board “rescue flights”, and this has left thousands of Israeli citizens stranded around the world. Restrictions on mass gatherings have also been relaxed to 20 people outdoors and 10 people indoors, instead of 10 and 5 respectively. At the same time, it was likely that the government would declare a curfew over the upcoming Purim weekend, a holiday traditionally observed by raucous celebrations commemorating the biblical story of the rescue of Persian Jews by the Queen Esther. Coinciding with the relaxation measures, a Green Pass system was put into place to grant Israelis who have had two vaccine doses automatic access to gyms, studios, cultural and sports events, fairs and hotels. Those without the pass have to show proof of a recent COVID test. Children under 16, who can’t be immunized, may still be admitted to some venues, like hotels, along with their immunized parents. Palestine Vaccination Campaign to Begin, Calls on Israel to Reserve More Vaccines for Palestinians Nabi Moussa, Occupied West Bank Palestinians in Gaza were also reportedly due to get their first jabs as another 20,000 vaccines donated by the United Arab Emirates arrived Sunday in the barricaded strip from Egypt via the Rafah crossing. Israel allowed the transfer of 2,000 vaccine doses into the Strip last week. In the Occupied West Bank, vaccine campaigns by the Palestinian Authority with Russia’s Sputnik V vaccine were only just beginning – although West Bank Palestinian infection rates have been comparatively lower than those in Israel, even after the latter had immunized over 50% of its 9.3 million citizens with at least a first dose. A World Bank report on Monday called on Israel to share more of its vaccines with the PA, saying: “While Israel has been leading the world in terms of per capita vaccinations, no one has been vaccinated in the Palestinian territories yet, and the Israeli MoH has not formulated an allocation strategy to support the territories, beyond providing 5,000 vaccines for Palestinian doctors. Humanitarian organizations in both Israel and West Bank and Gaza have called for Israel to reserve a higher amount of vaccines for the Palestinian territories. Given the challenges for the Palestinian Authority to procure vaccines, the statement calls for operational and financial support from Israel to PA.” The Economic Monitoring report further stated: “In order to ensure there is an effective vaccination campaign, Palestinian and Israeli authorities should coordinate in the financing, purchase and distribution of safe and effective COVID-19 vaccines,” noting that the Palestinian Authority faces a US$ 30 million shortfall in vaccine funding, even after support from the WHO co-sponsored COVAX facility. Germany Considers Reopening Even if Cases are Rising Angela Merkel, Chancellor of Germany. Germany’s Chancellor Angela Merkel has also proposed a plan to ease that country’s lockdown which has been in place since November. Merkel reportedly told her Christian Democrat (CDU) party that lockdown measures could be eased in several stages, combined with increased coronavirus testing. The stages would focus on personal contacts (how many people a person meets); schools, sports, restaurants, cafes, and cultural events. However, talk of easing restrictions in Germany belies the upward trend of infections in the country. The Robert Koch Institute reported 4,369 new COVID-19 cases as well as 62 associated deaths. There are major concerns of the COVID-19 variants pushing up numbers. Frankfurt, Germany: Masks required on cycle path France, Sweden, and the Czech Republic – Tougher Lockdowns Paris, France: A woman serves a hot dog in front of a restaurant in the Latin Quarter. French bars and restaurants can no longer accommodate consumers because of the measures taken to combat the COVID-19 pandemic. Some restaurants remain open and serve drinks and take-out meals. While other countries will soon enjoy relaxed restrictions, there have been increases in Nice in France, the Czech Republic, and Sweden. Nice reported 740 new cases per week per 100,000 residents, triple the national average. France has applied a localized lockdown over the next two weekends from Théoule-sur-Mer to Menton, and Nice. French Health Minister Olivier Veran said that measures could include a stricter form of the curfew imposed nationwide in France or a weekend lockdown in the city. “Consultations will be conducted over the weekend to take additional measures to stem the epidemic, ranging from a reinforced curfew to local lockdown at weekends,” Véran said. The Czech Republic is also experiencing a rise, with 11, 233 cases reported on Tuesday, an increase of 7,100 in a single day. Test positivity rate also increased to 40.6%, the highest since 9 January. The Czech Ministry of Health has mandated that masks must be worn in places with larger concentrations of people, especially shops, public transportation, and hospitals, effective Thursday. The Ministry has also submitted to the government a law on emergency measures in an effort to curb the resurgence of COVID-19 in the country, including restrictions on services, a ban on mass events, and the restriction of public transport. “The purpose of the proposed law is to legally enshrine the measures that we issue as a crisis in accordance with the crisis law as part of the COVID-19 epidemic. Thanks to this, it is possible to issue measures for which we have so far needed an emergency, ” explained the Minister of Health Jan Blatný. Uppsala, Sweden: People social distancing Meanwhile, Sweden is preparing the strictest restrictions yet, in an effort to curb a resurgence in COVID-19 cases as the variant first detected in the UK spreads rapidly. “The British variant is increasing very fast. This variant will with fairly high probability be the dominant one within a few weeks or a month… We have a package [of national measures] being readied that will be presented tomorrow,” said Chief Epidemiologist Anders Tegnell at a news conference. Concerns about a possible third wave of the pandemic have been growing since the number of new infections have risen and the new variants have spread. The Swedish government has laid the ground for potential lockdown measures to be tougher than previously measures enacted earlier in the pandemic. The list of businesses that will face mandatory closure in Sweden include shops, hair salons, gyms, and restaurants. The country has also closed its borders to Denmark and Norway. Negative COVID-19 tests are now required for entry into Sweden. Declines Also Seen in United States and India New York City, United States: Outdoor dining during pandemic While declines in serious cases in Israel and the UK may be attributed to vaccines, it remains unclear why numbers are declining globally as some countries battle their second, third, and fourth waves of COVID-19. For the United States, the scale-up of vaccination and the shift in seasons are driving down cases, according to the Institute for Health Metrics and Evaluation (IHME) during a briefing last week. However, variants including the more infectious B.1.1.7 which first emerged in the UK in November 2019, have been detected in the US which could drive transmission. Epidemiologists in India have also questioned the declining cases, pointing to low rates of testing and habitual underreporting of causes of death, particularly in rural India. However, Prime Minister Narendra Modi is hoping that the vaccination drive that began in January will spur wider recovery. Though vaccine uptake remains slower than officials hoped, as of 18 February, more than 98 million vaccine doses have been administered in India. “I don’t think anyone really thinks that without vaccines and a vaccination program being widely available that we can go back to whatever is full normalcy,” said Sireesha Yadlapalli, a Hyderabad-based senior director at the United States Pharmacopeia, a scientific nonprofit organization. “Hopefully this is the slowdown and there’s no second wave.” Bangalore, India: Empty streets during lockdown in early 2020. Despite a nationwide declide, there has been a rise in cases seen in the Indian state of Maharashtra, which has ordered new restrictions on people’s movement and imposed night time curfews. Mumbai, Maharashtra’s capital and India’s financial hub, also banned religious, social, and political gatherings. The state has reported nearly 7,000 new cases on Sunday, a steep rise from 2,000 daily cases earlier this month. The Indian Ministry of Health and Family Welfare has stated that the surge in COVID cases in the state cannot be attributed to strains N440K and E484Q, which have been detected in other countries. WHO Warns Against Complacency Dr Michael Ryan, Health Emergencies Executive Director While some of the declines, such as those in England, Scotland and Israel, may be attributed to massive vaccine campaigns – in other regions, where vaccination is only just getting under way, global health officials have had few explanations for the dip in cases. “We’re certainly not out of the woods yet,” said Health Emergencies Executive Director Dr Mike Ryan at a WHO press conference in Geneva last Thursday. “The virus still has a lot of energy. You’re also dealing with urban settings, many people still living in areas that are overcrowded, multi-generation, multi-family homes. It is very difficult to break chains of transmission in a complex society. Some countries are coming down that hill more quickly than others.” WHO technical lead on COVID-19 Dr Maria van Kerkhove stressed: “We cannot let ourselves get into a situation where the virus can resurge again. Remember what we need to continue to do to drive it down and get cases down into single digits. “We just need to stay the course, hold on to what is working consistently deliberately as we roll out vaccines and make sure that vaccinations start in all countries,” said Van Kerkhove. Ryan also cautioned that, although the global COVID-19 cases are now at their lowest since last October, this could be the result of the natural patterns of the virus. “I do think a good portion of that has been done to the huge efforts made by communities. There have been very stringent lockdowns and stay-at-home orders and other things, but also serum prevalence is rising,” said Ryan. “We need to understand what is driving those transmission dynamics. Is it natural seasonality and wave-like pattern of the disease? Are we building up a level of immunity in the population that’s preventing the disease from finding the next case? Are our control measures having an impact on that?’ asked Ryan. “I think as we move into [northern hemisphere] springtime, we need to drive towards higher levels of vaccinations, getting an equitable distribution of that vaccine, getting rid of the deaths and the hospitalizations and the suffering, but [also] continuing to drive the case numbers down.” Image Credits: Twitter, 7C0/Flickr, Falk Lademann/Flickr, Marc Barrot/Flickr, Sergey Yeliseev/Flickr, Health Policy Watch , David King/Flickr, Ben Hartschuh, 7C0/Flickr, Flickr: IMF Photo/Cyril Marcilhacy. The European Medicines Agency’s COVID-19 Vaccine Leaks: Hacks, Regulatory Pressures And Manufacturing Concerns 23/02/2021 Priti Patnaik & Lucien Hordijk European Medicines Agency headquarters, Amsterdam, The Netherlands EXCLUSIVE – A series of recent leaks of emails and documents surrounding the EMA’s approval of the first COVID-19 vaccine by Pfizer/BioNTech highlight the intense political pressures regulatory agencies are under during the pandemic – as well as an oft-forgotten aspect of vaccine approvals – the quality control of vaccines during the leap from clinical trials to large-scale commercial production. Priti Patnaik & Lucien Hordijk explore. Cyber leaks, public health, geopolitics, vaccine nationalism and political pressure come together in this heady story about the complex challenges that the world’s strongest regulatory agencies are facing as they review and approve new COVID-19 vaccines, developed at unprecedented speed. When a series of emails and documents hacked from the European Medical Agency (EMA) in December 2020 surfaced in early 2021 on the dark web, they revealed a cautionary tale about how even one of the world’s strongest regulatory agencies may be subjected to intense political pressures in their review of COVID-19 vaccines – even as they try to play by the book in their reviews. The hacked documents also shed light on an oft-ignored aspect of vaccine review and approval beyond safety and efficacy – that is quality-assurance of production processes as new vaccine products make the leap from clinical trials to large-scale production. Shortages Led to a Blame Game Ursula von der Leyen, President of the European Commission, speaking at the World Economic Forum in late January – shortly after EMA approval of the first COVID-19 vaccines. And the regulatory approvals did not, ultimately usher in a smooth vaccine rollout. Rather, vaccine shortages have plagued most of Europe on the back of unanticipated production glitches, leading to a political blame game at the very top of the European Commission, (EC). This, in turn, prompted the EU to adopt new rules on export restrictions that have been widely criticised. This story has four parts: what the leaked documents show; how authorities responded to the leaks; the potential motivations for the breaches by hackers seeking to undermine confidence in the vaccines; and what lessons can be learned from the EMA breaches. Part I: The Language of Political Pressure On January 13th 2021 internal emails and documents from the EMA showed up on two hacker forums: Raidforums, an English language marketplace for database breaches and leaks; and Rutor a Russian marketplace on “the dark web”. The dark web is home to encrypted online content not indexed by search engines. These documents, dating from mid- to late November 2020, amounted to nearly 900 pages reports and memos, which included some 20 different email exchanges between EMA officials. They concern the review by EMA’s top management of the Pfizer / BioNTech vaccine in the lead up to its approval. The EMA first reported the cyberattack on December 9th, 2020. The leaks illustrate two important aspects of the regulatory review process: That the EMA was put under intense political pressure by the European Commission to hasten the regulatory process of the first vaccine approvals – particularly those of Pfizer/BioNtech and Moderna; During the Pfizer/BioNTech regulatory process, the EMA had concerns related to the consistency of vaccine quality during the commercial production. Significantly, Pfizer addressed these EMA concerns before the vaccine was approved. But the episode illustrates why such issues would better be shared transparently as part of the regulatory review process, experts say [keeping in mind that US Food and Drug Administration review meetings are even aired publicly online]. As Dr Barbara Mintzes, Associate Professor, The University of Sydney Charles Perkins Centre and School of Pharmacy, and an expert on the interface between clinical research and regulatory decision-making, observed: “I wonder why these issues with production quality were only made public via leaked documents that had become available on the dark web. Why were they not under open and public discussion? These types of exchanges should not be secret.” Leaks Suggest EMA Was Under Pressure to Hasten Vaccine Approvals The cold chain storage for the Pfizer/BioNTech vaccine at Pfizer’s warehouse in Kalamazoo, Michigan. Speedier US FDA and British vaccine approvals added to the pressure on the EMA process. The chain of leaked emails reveals that the EMA was operating under intense political pressure, exerted from the very top of the European Commission (EC), to speed up approvals for COVID-19 vaccines. Without rapid EMA approval of the Pfizer vaccine and others Brussels feared it could not keep its promise to deliver on vaccines for all EU citizens simultaneously and by the end of 2020. Already on 19 November, 2020, Commission President Ursula von der Leyen had publicly announced that both BioNtech/Pfizer and Moderna vaccines could be approved by the EMA by the end of the year. EMA members were uncomfortable with the political promises being made, as reflected in a series of internal emails between the EMA officials from November 12, 19 and 20, 2020, which were among those that came to light in January 2021. And at the same time the pressures to adhere to the EC schedule were immense. While an EU directive allows member states to temporarily use unauthorized drugs in emergencies, the Commission wanted to avoid a situation where countries would begin issuing emergency permits for vaccines at national level, helter skelter. Speedier approvals by other regulatory authorities including UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration also added to the pressure on the EMA. Even so, the email series reflects both the challenges as well as concerns of EMA officials about ensuring adherence to a strict regulatory process, while keeping to Von der Leyen’s ambitious schedule for the approval of the Pfizer and Moderna vaccines. EMA Officials Had Concerns About Commission’s Ambitious Schedule Vials of the Pfizer-BioNTech COVID-19 vaccine. Within EMA expert ranks there was widespread concern that politically-driven deadlines should not compromise the technical review – particularly resolution of the manufacturing quality-assurance issues that also emerged as concerns in the same period: “What is new in my view is that she [Von der Leyen] clearly identifies the 2 vaccines that could be approved before the end of the year. There are still issues with both so it needs to be seen if all this can be sorted out in time, whilst not compromising the robustness of the review”, writes one EMA official in an email on 20 November, 2020 . An email dated November 19, 2020 recounted a telephone conversation between EMA officials and a European Union commissioner. Relates the EMA official to another colleague: “Atmosphere was rather tense….at times even a bit unpleasant.” The official notes that it “provides a hint on what EMA may expect if the expectations are not being met, irrespective if such expectations are realistic or not”. The EMA official goes on to suggest that an interval of even several weeks between an authorisation granted by the FDA & the UK’s Medicines and Healthcare products Regulatory Agency (MHRA); and the EMA will not be acceptable to the European Commission. It would lead to significant “the political fall-out,” the EMA official warned. “We have to be ready for the worst-case scenario,” writes the same EMA official in the email dated November 19, 2020”We will be overwhelmed on all fronts and in the middle of a storm. Whose support can we then rely on?” . According to yet another email dated November 22, the EMA official warned Commission staff: “We are speeding up everything as much as possible, but we also have to make sure that our scientific review is as robust as possible.” EMA and European Commission Deny Political Interference Stefan De Keersmaecker, spokesperson for health, food safety and transport, at the European Commission press briefing 15, January 2021. Asked for comment on the political pressures, an EMA spokesperson replied to us on January 15, 2021 saying: “Despite this urgency (to make vaccines available), there has always been consensus across the EU not to compromise the high-quality standards and to base any recommendation on the strength of the scientific evidence on a vaccine’s safety, quality and efficacy, and nothing else.” The European Commission likewise denied any political interference in the regulatory approval process: “The Commission is fully committed to only authorising vaccines that are deemed safe and effective by its independent scientific agency,” Stefan De Keersmaecker, spokesperson for health, food safety and transport, told us in reply to an inquiry. Only an hour after responding to the queries of our investigative team – which were the first to address this aspect of the email leaks, European Commission authorities hastily convened a press conference on the issue. At the press briefing, Keersmaecker, said that the leaked documents had been “manipulated”: “The EMA has just published its public statement on the cyberattacks of which they are a victim and they have stressed, it is important that you are all aware of that, that some of the correspondence have been manipulated by the perpetrators prior to the publication in a way that could undermine trust in vaccines. I am saying this just to draw your attention that some of the documents that are out there seem to have been manipulated by perpetrators, and therefore have to be considered with utmost care.” PART II: Vaccine Production Quality Assurance Pfizer’s COVID-19 vaccine during the manufacturing process. The EMA’s concerns about quality assurance of the mass production of the Pfizer/BioNtech vaccine (brand name Comirnaty) was a key technical issue to emerge in the regulatory review, as illuminated by the series of leaked EMA emails from November 2020. Here, the regulator’s concerns focused mostly on the Pfizer/BioNtech vaccine candidate, which was the very first vaccine in the EMA regulatory approval pipeline. At the time when the issue arose in November, 2020, some production factories were yet to be inspected, and the regulator was awaiting additional data from Pfizer. The key concern centered around differences in the quality of the vaccine batches produced for clinical trials and batches for commercial production noted by the EMA review experts. According to the leaked documents, the concerns arose over differences in the levels of “mRNA integrity” – an indicator of the purity of the active vaccine drug substance. While the vaccines used in the clinical trials had between 69% – 81% intact mRNA, initial samples of the batches that were destined to be used in large scale manufacturing showed only 59% intact mRNA on average, with some batches as low as 51%. This concerned the EMA – both in terms of safety as well as efficacy of the vaccine doses. According to an email between EMA officials on 23 November, 2020, the EMA stated the following: “…The potential implications of this RNA integrity loss in commercial batches compared to clinical ones in terms of both safety and efficacy are to be defined. “Whether or not the observed compatibility issues could be a blocking point will depend on the relevance of these observations to safety and efficacy and the company will be requested to fully justify the lower %RNA integrity (and other differences noted) “Point for discussion will be whether the comparability issues can be solved only by quality data (additional functional / in vitro biological data + available non-clinical) or that further clinical data (bridging studies are / will be performed) will be needed. It is difficult to make any projections on this.” Ultimately, however, those concerns were resolved to the satisfaction of EMA reviewers, the document leaks also show. Pfizer offered to make manufacturing modifications to ensure that mRNA integrity levels in the commercial production process would remain consistent to those of the clinical trials. The email exchanges refer to manufacturing adjustments ensuring mRNA integrity levels remained at around 75% – although the documents don’t explain how those modifications were made. EMA Responses to Questions About Quality Assurance Review Along with the EMA replieas, a European Commission media briefing on 15 January, 2021, also addressed the email leaks On 15 January, in response to our queries about the quality assurance review of production processes, the EMA said the follow-up data it had received from Pfizer showed “modified forms of mRNA at somewhat higher levels in the batches manufactured with the commercial process as compared to material used in clinical trials.” The EMA clarified to us that such modified mRNA forms were not determined to be a safety risk, particularly in light of the low overall dose of mRNA involved – just 30 micrograms of active ingredient (30 μg): “The amount of any such proteins, is expected to be too low to elicit an immune response of biological relevance.” stated the EMA response. As a result, the risks of any adverse immunological events occurring in reaction to any modified mRNA forms was deemed to be low. Indeed, considering the low dose of mRNA (30 μg), impurities are not considered a safety issue based on general toxicological principles, the EMA said. In their response to our queries, the EMA also acknowledged that the leaked emails reflected the discussions that took place. A spokesperson from the EMA said, “The company was able to address these issues and supply the required information and data to allow EMA to move towards a positive recommendation for this vaccine.” Pfizer, for its part, did not respond to our inquiries on how the company addressed concerns the EMA had raised in November 2020. In a statement in mid-January, the company said: “As the European Medicine Agency’s investigation [of the cyberattack] is ongoing, we defer to them on any updates.” How do mRNA vaccines work? Description of Pfizer’s use of mRNA technology to develop COVID-19 vaccines. Coronaviruses are made up of a single-stranded RNA protein, bounded by protein and wrapped in an envelope of lipid molecules The SARS-CoV-2 virus uses the spike proteins covering its surface to bind to ACE2 receptors found in the lung and other organs. It then fuses with the membrane of the host cell and releases its genetic material. Once the virus has overtaken the cell, it hijacks the cell’s internal machinery to make proteins that help it replicate. Most COVID-19 vaccines have targeted the distinctive spike proteins of the SARS-CoV-2 virus – used by the virus to pry its way into the body’s cells. Typically, vaccines involve injecting a weakened, inactivated or genetically modified form of the pathogen into the body to trigger immune response. However, mRNA vaccines involve the use of messenger Ribonucleic Acid (mRNA) to carry “instructions” for manufacturing a spike protein into the body. That, in turn, triggers the immune response. As described in a Health Policy Watch interview with Moderna’s Chief Medical Officer Tal Zaks from November 2020: “mRNA is a transient copy of the instructions in our genes that instructs the cell’s ribosomes to make protein. ….An mRNA vaccine is not a virus, [or even a weakened virus]. It only gives the cells transit instructions to make that one piece of virus that we want to educate the immune system to recognize. It’s essentially an instruction code. I inject it into the muscle. It gets distributed to the lymph nodes where the immune system works. The messenger RNA encodes for the spike protein and our cells start to make this spike protein. “Now the immune system sees a new protein it’s never seen before. And it goes, ‘Oh, hold on a second. This looks like a foreign threat. …let me go block it.’ And so the immune system starts to generate antibodies and T cells that recognize that spike protein. It focuses the attention of the immune system, just on that one protein.” Independent Expert Confirms – No Vaccine Efficacy or Safety Issue We also interviewed Steve Pascolo, a researcher at the University Hospital of Zurich, an expert on mRNA vaccines, regarding potential impacts of lower mRNA integrity levels on either safety or efficacy of the Pfizer/BioNTech vaccine. Pascolo, also a co-founder of CureVac who left the company in 2006, said that he did not see serious issues of safety or efficacy arising: “In the early trials of BioNTech, they had immune responses with just one microgram of RNA.” (the approved mRNA vaccine has 30 micrograms of RNA per dose), said Pascolo, also author of a recent paper Synthetic Messenger RNA-Based Vaccines: from Scorn to Hype. And what about safety? Could a lower mRNA “integrity” level could impact the vaccine’s safety? Was it possible that the presence of “truncated” mRNA proteins in the vaccine’s active ingredient – other than the exact target mRNA protein – could also have unwanted immune impacts? Said Pascolo: “There is no safety implication of having a shorter mRNA transcript in the vaccine. In fact a shorter transcript will probably not be translated (it misses the functionality important ends) and if it would, may result in production of shorter proteins that may even participate in the overall immune response.” PART III – EMA Says Emails Were Manipulated by Hackers To Sow Vaccine Mistrust When our team published its first story on the leaked documents in Business Insider Germany (on January 15, 2021), an EMA spokesperson said that the agency “would not verify” the authenticity of the leaked documents because they have been stolen by hackers and placed on the dark web. Later on that same day, an EMA press statement acknowledged that the “unlawfully accessed documents.. Included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines.”The 15 January statement added that “Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.” Ten days later, on 25 January, the EMA issued another statement on the cyberattack that had led to the email leaks, with more details on how the series of email leaks had been manipulated by hackers – to create mistrust around the vaccines themselves. “Whilst individual emails are authentic, data from different users were selected and aggregated, screenshots from multiple folders and mailboxes have been created and additional titles were added by the perpetrators in a way which could undermine trust in vaccines”, said the EMA press statement issued on January 25. Analysts Suggest EMA Emails Were Hacked by State Entity Undoubtedly, the way these documents appeared on the dark web, played into the hands of sensationalism muddying the regulatory reviews. The leaked documents from the EMA were named “BIG DATA SCAM of Pfizer’s vaccines” and “Astonishing fraud Evil Pfizer!!” Jean-Michel Doan, an open-source analyst who specialises in cybercrime at Sekoia, an IT security company in France, said, it is likely that the attack was caused by hackers affiliated to a state entity. “This kind of hacking tactic with data theft followed by data leaks has already been practiced by Russian agents (Guccifer 2.0/ Democratic National Convention leaks and World Anti-Doping Agency leaks).” Cyberattacks focusing on undermining confidence around brands of the Covid vaccine have also been undertaken by hacking groups affiliated with China, North Korea, and Iran and Russia, he added. The team also spoke with Mirko Gatto, CEO of Yarix, an Italian company that works in IT security, on whether anti-vaxxers could have orchestrated such an attack. Gatto said, “All is possible, but if anti-vaxers want to damage someone they go in other places, for example on Twitter. They use open source intelligence (OSINT) sources. They want to communicate as much as possible and [the] black market is not a place for this kind of strategy.” Part IV; Balancing Regulatory Processes, Political Pressures & Right To Know Clearly, the leaks reveal the kinds of political pressures that have been faced by even the world’s most stringent regulatory agencies in the pandemic era. They underline the penultimate importance that politicians need to attach to restraint – in order to maintain public confidence in regulatory processes – and the vaccines they produce. Even so, it appears the EU drug regulator adhered to its due diligence process. The EMA issued the Pfizer-BioNTech’s vaccine a conditional marketing authorization on December 21, 2020- a full three weeks after the UK (December 5th) and two weeks after the US FDA actions (December 11th) – suggesting that the EM indeed took time to resolve questions about safety, efficacy and manufacturing quality assurance. . Still, the leaks provide a cautionary tale about the pressures that regulatory authorities may face – with implications for other national regulatory agencies as well as the World Health Organization – which has its own emergency use listing process. If one of the strictest regulators in the world is subjected to such pressures, it is likely the pressures on other authorities may be even more intense. Transparency of Dossier Submissions Professor Brook Baker, Northeastern University, School of Law The other lesson learned may be one about the importance of transparent regulatory reviews. If the exchanges between the EMA and Pfizer about aspects of quality assurance of production processes had been a transparent matter of record – it might have removed the sting of some of the leaked emails – which ostensibly sought to undermine vaccine confidence. Observes Brook Baker, professor of law at Northeastern University in Boston told Health Policy Watch, “Transparency by regulatory authorities and WHO prequalification with respect to COVID-19 vaccines is absolutely critical to vaccine acceptance by medical providers, opinion makers, and ultimately individual patients and the public-at-large. Transparency is particularly important when public anxiety is high, product development and clinical trials have been expedited, political pressure has been exerted by public officials, there is global competition in vaccine development, and emergency use permission is granted short of full regulatory approval. It also certainly hasn’t helped that even stringent regulatory authorities in the U.S., U.K., and Europe have disagreed on what vaccines to approve and conditions and populations of approved use.” As a result, adds Baker, ”transparency about dossier submissions, the evidence submitted, independent and supplementary review by expert committees, and the detailed assessments of the regulator is vitally important. “This should include transparency around known adverse effects, post-approval pharmacovigilance, efficacy with respect to new variants, and on-going studies and time-lines for full regulatory approval,” he says. EMA Not the Only Regulatory Agency Subjected To Pressures Former US President Donald Trump at a White House Coronavirus Taskforce briefing – he used the presidential podium to exert pressure on the FDA for more rapid approval of COVID-19 vaccines. The EMA experience can be contrasted with the US Food and Drug Administration review process of the same vaccines – which was subjected to even more overt and intense political pressure from former US President Donald Trump. Those pressures included Trump’s own tweets and statements, as well as backroom approaches from White House emissaries and Trump’s political appointments in the US Centers for Disease Control, the White House COVID task force and the FDA. “Fortunately, the scientists and leadership at the FDA resisted these pressures, assured that there would be independent expert input, and reviewed the evidence with care and precision,” said Baker. “These internal forces at the FDA were helped by vaccine developers who also made it clear that they wanted there to be rigorous, independent review at the FDA.” Baker also notes the “unprecedented transparency with respect to many aspects of the [FDA] approval process,” including not only the portfolio submissions but also live video coverage of the entire FDA review deliberation. At the same time even across the Atlantic, “advocates are still pressing for even more transparency about company submissions, including underlying clinical trial data and confidential manufacturing information, and about FDA assessments,” Baker observes. Going forward, such transparency may be all the more important to both protect regulatory authorities from undue political interference – as well as building public confidence in the process – and thus in the vaccines that they approve. Ultimately, FDA transparency may also have helped build public confidence in the FDA approval process – and even stave off hackers’ attacks such as those seen in Europe. _________________________ Priti Patnaik is the founding editor of the Geneva Health Files, an independent global health reporting initiative based in Switzerland. Lucien Hordijk is a contributing reporter for the Investigative Desk, a non-profit investigative journalism group that is based in Amsterdam. Ludovica Jona (Italy), Lise Barnéoud (France), and Hristio Boytchev (Germany) also contributed to this article. This article is part of the series #BehindThePledge, a cross border investigation into the money trail of pandemic-related drug and vaccine development and rollout. This is the first publication in English-language media about the EMA leaks. Earlier versions of the story have been published by the team in media in France, The Netherlands, Italy & Germany. The project has received grants from Journalismfund and IJ4EU. Image Credits: BioNTech, Twitter, Pfizer, US Centers for Disease Control, Pfizer, White House/D. Myles Cullen. Global Citizen Launches ‘Recover Better Together’ Campaign – Guinea Launches Ebola Vaccinations – Nigeria & Zambia Studies Show High SARS-CoV2 Infections 23/02/2021 Kerry Cullinan Global Citizen CEO Hugh Evans launches 5-point global recovery campaign Vaccinating all of Africa’s health workers would need half a percent of all the doses that the G-7 countries have purchased, according to Global Citizen CEO Hugh Evans. On Tuesday, Global Citizen launched a five-point ‘Recover Better Together’ plan for the world, aimed at getting millions of citizens behind ending COVID-19 for all, ending the hunger crisis, resuming learning for children, fully protecting the planet, and advancing equity for all. “First we must focus on achieving sufficient worldwide vaccine coverage to break the chain of transmission, including, for the poorest nations,” Evans told a media briefing convened jointly with the World Health Organization, and addressed by world leaders including European Commission president Ursula von der Leyen, US Special Envoy in Climate John Kerry and South African president Cyril Ramaphosa. In his address, Ramaphosa applauded French president Macron who has called on rich countries to donate 5% of their vaccines to needy countries. “Another important step is to enable the transfer of medical technology for the duration of the pandemic. This will allow us to increase the production of COVID-19 vaccines and other medical products, lower prices, and improve distribution so that these vaccines and medical supplies reach all corners of the world,” said Ramaphosa. Guinea Starts Ebola Vaccination Drive – Nigerian and Zambian Studies Show High Levels of SARS-CoV2 Infection Healthworkers during the 2017 Ebola outbreak in the DRC. Guinea started Ebola vaccinations on Tuesday of people at high risk in Gouecke, a rural community in N’Zerekore prefecture where the first cases were detected on 14 February – the first cases since 2016. “All people who have come into contact with a confirmed Ebola patient are given the vaccine, as well as frontline and health workers. The launch started with the vaccination of health workers,” according to a media release from WHO’s Africa region. “The last time Guinea faced an Ebola outbreak, vaccines were still being developed,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “With the experience and expertise it has built up, combined with safe and effective vaccines, Guinea has the tools and the know-how to respond to this outbreak. WHO is proud to support the government to engage and empower communities, to protect health and other frontline workers, to save lives and provide high-quality care.” The WHO sent 11 000 doses of the rVSV-ZEBOV Ebola vaccine from its headquarters in Geneva, while a further 8500 doses are being procured from Merck, the vaccine’s producer in the US, “The speed with which Guinea has managed to start up vaccination efforts is remarkable and is largely thanks to the enormous contribution its experts have made to the recent Ebola outbreaks in the DRC,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “Africans supporting fellow Africans to respond to one of the most dangerous diseases on the planet is a testament to the emergency response capacity we have built over the years on the continent.” Implementing an Ebola vaccination strategy is a complex procedure as the vaccines need to be maintained at a temperature of minus 80 degrees centigrade. Guinea has developed ultra-cold chain capacity with vaccine carriers, which can keep the vaccine doses in sub-zero temperatures for up to a week. There are eight cases (four confirmed and four probable) and five people have died so far. Guinea’s neighbours are on high alert, particularly Liberia and Cote d’Ivoire which are close to the border with N’Zerekore, Guinea’s second-largest city. Meanwhile, a second person died of Ebola last week in the Democratic Republic of the Congo’s North Kivu province. Ebola, a haemorrhagic fever, is transmitted from wild animals and spreads in the humans through direct contact with the blood, and bodily fluids of infected people, and contaminated surfaces and materials. Nigeria’s First SARS-CoV-2 Seroprevalence Study Finds Almost 25% of Lagos Residents Had Antibodies Lagos Almost a quarter of Nigerians living in Lagos may have been infected with SARS-CoV2, according to the results of a seroprevalence study released on Monday by the Nigeria Centre for Disease Control (NCDC) and Nigeria Institute for Medical Research (NIMR) The household seroprevalence survey was conducted in Lagos, Enugu, Nasarawa and Gombe States in September and October last year and involved blood samples from over 10,000 people. SARS-CoV-2 antibodies were found in 23% of people sampled in Lagos and Enugu States, 19% in Nasarawa State, and 9% in Gombe State. “These rates of infection are higher than those reported through the national surveillance system and reveal that the spread of infection in the states surveyed is wider than is obvious from surveillance activities,” according to a statement by the NCDC and NIMR. The survey also showed that men had higher infection rates than women (21% of men and 17% of women in Nasarawa), and urban areas had higher infection rates than rural areas (28% of urban residents and 18% of rural residents in Enugu). The survey is currently being expanded to more states in the North-West and South geopolitical zones which were not included in the initial round of surveys. Zambia Post-Mortems Find High Level of SARS-CoV2, Minimal Testing Post-mortem surveillance of 364 Zambians who died between June and September last year detected SARS-CoV2 in 70 (19%), according to a study published in the BMJ last week. PCR tests were administered on people at the University Teaching Hospital morgue in the capital of Lusaka within 48 hours of death. Fifty of the 70 with COVID-19 had died in their communities without ever having been tested for the virus. Only five of the 19 who died in hospital had been tested. Seven children were part of the study and only one had been tested before death. The most common co-morbidities among those who died of the virus were tuberculosis (31%), hypertension (27%), HIV/AIDS (23%), alcoholism (17%), and diabetes (13%). Image Credits: WHO, Wikipedia. ‘Rapid Response Platforms’ Enabled COVID-19 Vaccine Development, Says Fauci 23/02/2021 Madeleine Hoecklin The Epidemic and Pandemic Preparedness and Response panel at the GVIRF event on Monday. Rapid response platforms, particularly the messenger RNA (mRNA) platform, have changed the landscape of vaccine development, enabling the rapid response to the COVID-19 pandemic, said Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) on Monday. Fauci, speaking at the opening of the Global Vaccine and Immunization Research Forum (GVIRF), co-organized by WHO, the Bill & Melinda Gates Foundation, and the NIAID, highlighted the innovations in vaccinology that made the speedy development of COVID-19 vaccines possible. “There are a number of new technologies that have now really dominated our approach to COVID-19. For example, there’s genetic immunisation using RNA and DNA vaccines,” said Fauci. “We are well aware now of the successes, for example, of the mRNA vaccines.” Rapid response platforms are systems that can be adapted against different pathogens. In the case of mRNA vaccines, these have been developed over a number of years to address influenza, Zika and rabies and have shown a high level of efficacy against SARS-CoV2. The Pfizer/ BioNTech and Moderna SARS-CoV2 vaccines have both had over 95% efficacy against symptomatic COVID-19 and nearly 100% efficacy against severe disease. “I think it’s fair to say that rapid response platforms have been a revolution in vaccinology over 2020 with COVID-19,” said Melanie Saville, Director of Vaccine Research and Development at the Coalition for Epidemic Preparedness Innovations (CEPI). “These can be further developed and prepared for future outbreaks, epidemics, and pandemics.” Barney Graham, deputy director of the Vaccine Research Center at NIAID, added that, over the past 12 years in particular, “new technologies have improved our ability to both prepare for and respond to emerging threats, like structural biology protein engineering and rapid platform manufacturing.” Prototype Pathogen Approach Both Graham and Fauci described the prototype pathogen approach to pandemic preparedness vaccine research used at the NIAID. This refers to studying pathogens of a particular group to build on prior experiences and use strategies to inform vaccine design for related viruses. In developing vaccines for SARS-CoV2, structure-based vaccine designs from Middle East Respiratory Syndrome (MERS-CoV), which is in the family of coronaviruses, were used and “enabled us to rapidly get a successful vaccine, particularly with mRNA [technology],” said Fauci. With the technological advances and the unprecedented R&D work conducted over the past year with COVID-19, “I think we’ve probably moved forward a decade…with COVID-19 vaccines being developed in only 300 days, whereas usually, they would take multiple years, if not decades,” said Saville. The timeline of the mRNA COVID-19 vaccine development. “One thing to point out [is] the speed with which we went from appreciating the new virus, in this case SARS-CoV2, on January 10 of 2020, to starting a phase one trial, about 65 days later, a phase 3 trial both with Moderna and with Pfizer, on 27 July and now having both vaccines already being administered here in the United States and elsewhere. [This is] the fastest in the history of vaccinology from the identification of a particular pathogen to the actual administration of a vaccine,” said Fauci. Challenges with mRNA Platforms While mRNA technology has had great advances, there is still a lot that is unknown about this type of vaccine, including what type of RNA to use and what long-term immune response durability may be. The continued development of the rapid response platforms is needed to make progress on COVID-19 and future epidemics and pandemics. “In all cases, the more robust the platform, in terms of what safety data you have from the platform, what type of immune profile, and importantly, the manufacturing process – which is often really the rate-limiting factor, [the better it is to]…get them as fine-tuned as possible,” said Saville. The manufacturing the Pfizer/BioNTech and Moderna vaccines is limited and is largely centered in Europe and North America. A map of the manufacturing sites for mRNA COVID-19 vaccines globally. “What we need to really look at in the medium and longer-term [is]…how can that manufacturing footprint be much more amenable with regional manufacturing capacity,” said Saville. “Looking at manufacturing innovation…that could be amenable to the low- and middle-income countries [is] something that really needs to be followed.” Innovations in Manufacturing While numerous accomplishments have emerged from the COVID-19 pandemic, several shortcomings, particularly in vaccine development and manufacturing, have occurred. “There’s no question that COVID has demonstrated the potential of vaccine development and R&D, but it has also exposed some pretty major gaps in the system and [has shown] what happens when a disease strikes the entire world at the same time,” said Selwyn. These gaps include the limitedd supply of vaccines secured for low- and middle-income countries; high-income countries pre-ordering large amounts of vaccines for themselves; the reduction in production capacity for other diseases, which may increase the risk of outbreaks; and the dependency on tech transfers. “In COVID, there were multiple companies who had quite limited experience with vaccine manufacturing and bringing vaccines through licensure, [who were] planning for upwards of 10 tech transfers in a single year,” said Casey Selwyn, senior officer in Vaccine Development and Global Health COVID-19 Response at the Gates Foundation, at a workshop that followed the opening session. Normally a company may undertake one transfer a year. The Innovations in Vaccine Manufacturing workshop at the GVIRF session on Monday. “To maximize global supply, we need to have innovative ways to ease and encourage tech transfer…A tech transfer requires time, it requires resources and sharing of know-how, not just intellectual property,” Selwyn added. The most efficient way to scale up vaccine production and supply over the long term is to build “ever-warm” vaccine facilities that are multi-platform and multi-purpose with a trained workforce, so that the facilities can be prepared when an outbreak occurs, proposed Selwyn. Another recommendation for innovating global manufacturing was to implement a hub and spoke distribution model, which would create a centralized network where products are received in central locations before being sent directly to their destinations. According to Selwyn, this could ease the pressure of tech transfers and establish a better geographical reach, creating a more flexible, accessible and cost effective system. Alternatively, increasing standardization of manufacturing protocols and regulatory requirements – which could include the labeling of products, serialization, and design of protocols – could also improve speed, flexibility, and cost-efficiency. “Probably one of the most important sets of innovations, sets of lessons and sets of actions for the future is really continuing to pursue uniformity and harmonization, especially for a set of diseases and pathogens that require rapid response,” said Anant Shah, New Product Lead for Global Vaccines for COVID-19 and Ebola at Merck. “We have to pursue uniformity, flexibility and efficiency if we want to continue ensuring global equitable access,” said Shah. Image Credits: NBC, GVIRF. Global Health Diplomacy In The COVID-19 Era – Can Failure Usher In A New Era of Success? 22/02/2021 Svĕt Lustig Vijay More than a year into the world’s largest global health emergency, health diplomats have fought hard to ensure that every country across the globe secures access to lifesaving coronavirus health products, including vaccines, treatments, and diagnostics. That has not happened yet, given that 80% of countries that are now rolling out vaccines are either high-income or upper middle-income countries. Export bans on essential health products in 80 countries, ranging from personal protective equipment to ventilators, have not helped either. And in the absence of clear global guidance, up to 130 countries have imposed an uneven patchwork of travel restrictions in an attempt to keep more contagious variants at bay – mostly to no avail. A panel of some two dozen leading diplomats and health policy experts from WHO, government, academia and media pondered the current state of affairs, at the Global Health Centre’s (GHC) launch of a new Guide to Global Health Diplomacy, authored by GHC founder Ilona Kickbusch along with a former Hungerian Health Minister, Haik Nikogosian, former head of the Framework Convention on Tobacco Control, Mihály Kökény; and a preface from WHO’s Director General Dr Tedros Adhanom Ghebreyesus. The guide, co-sponsored by the Swiss Confederation, offers a compass to navigate the complexity of global health diplomacy through “practical insights” and “sound wisdom”, said Norway’s leader of the labor party Jonas Gahr Stør at the launch event on Thursday. Norway’s Labour Party leader, Jonas Gahr Støre The event featured some of the bright stars in the world’s global health constellation, including former WHO DG Margaret Chan; Trudi Makhaya, economic advisor to South Africa’s President Cyril Ramaphonsa, Suhasini Haidar, editor of India’s The Hindu Newspaper, Juan Jorge Gómez Camacho, Mexico’s Ambassador to Canada, and Swiss Federal Councillor Alain Berset. The event, moderated by Kickbusch, was co- sponsored by the World Health Organization and the Swiss Federal Council. Said Kickbush: “As you can see from the subtitle of this book [better health – improved global solidarity – more equity], the three words, health, so that health moves to the centre of negotiations, solidarity, and equity – those truly are the goals of global health diplomacy.”Better health – improved global solidarity – more equity Ilona Kickbusch, Founding Director of the Graduate Institute’s Global Health Centre in Geneva. Crisis Has Shown The Failures of The Current International Health Regulations System For Pandemic Preparedness & Response Michel Kazathchkine, former Executive Director of the Global Fund and a member of the Independent Panel for Pandemic Preparedness and Response The pandemic has uncovered “many flaws” in global preparedness and response, said Michel Kazathckine, former executive director of the Global Fund to fight AIDS, Tuberculosis and Malaria, and currently serving as a member of the Independent Panel for Pandemic Preparedness and Response, mandated by the World Health Assembly in May, to explore how and why the SARS-CoV2 pandemic caught the world so badly off guard. “The international system we have established for health security did not really work as a system,” he said. “There were clear gaps in preparedness management of the response coordination.” If there is anything that diplomacy has “certainly” not achieved in the midst of the pandemic, it is “firm and binding commitments” at the international level, added the Global Health Centre’s co-director Suerie Moon. Suerie Moon, Co-Director of Global Health Centre at Geneva Graduate Institute Same Challenges Were Apparent in H5N1 Avian Flu Epidemic The challenges are not new. Some 15 years ago after the eruption of the H5N1 Avian Influenza epidemic, Indonesia protested the fact that after low- and middle-income Asian countries had shared samples of the emergent pathogen with research networks around the world, rich countries then bought up most of the vaccines thus produced – leaving other countries vulnerable. In 2021, the continued lack of clear and binding agreements to ensure equitable access to health products during health emergencies remains largely unresolved, Moon said. “We’ve known this for quite some time, but actually we have very weak, frankly, quite non-existent rules and agreements at the international level to make sure that countries get access to vaccines, so this is not a surprise,” she said. “This is not something that is new to the global health community, but it’s something that we have not yet managed to address.” While some global frameworks do exist to allow LMICs to gain emergency access to lifesaving health products – such as the pre-existing donor-financed vaccine pool for 92 LMICs managed by Gavi, The Vaccine Alliance, or tools like the WTO’s TRIPS agreement (Trade-Related Aspects of Intellectual Property Rights) – the global south still struggles to take advantage of available IP flexibilities, partially due to fear of retaliation from stronger nations and big pharma. And recent negotiations over a South African and Indian proposal for a more far-reaching TRIPS waiver have “not been easy” either, noted Trudi Makhaya, who is economic advisor to South Africa’s President Cyril Ramaphonsa. Trudi Makhaya, Economic Advisor to South Africa’s President Cyril Ramaphonsa. Another alternative, the WHO-backed voluntary licensing pool, has also failed to garner pharma support for now. Still, there is a growing appreciation that technology transfer and the development of more local health product manufacturing capacity is crucial for low- and middle-income countries going forward, said Makhaya. Notably, new World Trade Organization Director General Dr Ngozi Okonjo-Iweala has talked about a “third way” that would encourage big pharma to sign more voluntary deals with countries for local production – without impinging on intellectual property rights. However, Makhaya remains wary: “There is an appreciation that there’s got to be technology transfer [to LMICs], there’s got to be local manufacturing and that current other alternative arrangements to do that, in the absence of the TRIPS [waiver], are going to be very difficult,” she said. Economy Among the Myriad Of Global Health Challenges But access to vaccines is only one of a myriad challenges facing low- and middle-income countries in the pandemic response. Makhaya also talked about the economic response to COVID : while some “important” ideas have been floated by the international community to bolster fragile economies – such as special IMF drawing rights for low-income countries – fiscal measures have remained stunted in poorer nations, in comparison to advanced countries that have pumped up to 20% of their GDP into local economies for temporary relief to businesses and the unemployed, she said. “There have been significant calls that there should be resources at the global level that should be injected [into emerging economies],” said Makhaya. “ A key example was special drawing rights at the IMF…[but] it hasn’t found much expression.” “We have a situation where amongst advanced countries’ central banks there’s cooperation, but none has been extended to many other developing countries.” Added Juan Jorge Gómez Camacho, Mexico’s Ambassador to Canada: “Health is not just about health itself,” he said.“Health means prosperity, or the lack of. Health means economic growth, or the lack of. “Health means wealth or poverty. Health is everything. In other words, health criss-crosses all the spectrum of human activity – socially, politically, economically.” Some Successes: COVAX is Unprecedented Dr Tedros Adhanom Ghebreyesus speaking at Thursday Global Health Centre event Even so, some successes have been apparent since the pandemic struck. If the global health community has achieved anything, it is the WHO co-sponsored COVAX global vaccine facility, which has successfully brought together 190 countries “out of thin air” in the aim to provide more equitable distribution of coronavirus vaccines around the world, said Moon. “The access to COVID-19 tools accelerator is health diplomacy in action,” added Dr. Tedros. “It is an unprecedented collaboration between countries, international agencies, the private sector, and other partners to ensure vaccines, diagnostics and therapeutics are shared equitably as global public goods. Vaccine equity is a litmus test for solidarity and global health diplomacy.” Just last Friday, G7 leaders committed an additional $4.3 billion to the ACT Accelerator initiative, which includes COVAX, as well as parallel efforts for tests and treatments and health systems strengthening. That brings the total commitment to ACT for 2021 to $10.3 billion – although global health leaders say that another $22.9 billion is still needed for all arms of the initiative. Local Manufacturing Of New Vaccines Scaling up generic manufacture of COVID-19 vaccines could help expand supply and stimulate local economies Meanwhile, some vaccine-makers have made strides in advancing more local production of their vaccines around the world. Russia’s Sputnik V vaccine, for instance, which showed impressive results in the publication of recent Phase 3 results in The Lancet, is already being produced in India, South Korea, Brazil, China. And production is set to begin in Kazakhstan and Belarus, among other countries like Turkey and Iran – although Sputnik has yet to receive formal regulatory approval from a western regulatory agency or the World Health Organization. India’s Serum Institute is manufacturing a local version of the Oxford/AstraZeneca, recently approved by the European Medicines Agency. The vaccine, locally branded as Covishield, is set to play a big part in advancing the access agenda through the COVAX facility as well as through bilateral deals. Over the past two weeks, India has exported 23 million doses of the locally-produced “Covishield” vaccine to low- and middle-income countries, said National Editor for The Hindu media outlet Suhasini Haidar, who also spoke at the panel event. Still, despite the big ambition for COVAX to distribute more than 2 billion vaccines by the end of 2021, it is a rather sobering fact that COVAX-supplied countries will only be able to vaccinate 3% of their population over the first half of this year, said Moon, adding, “frankly, we need to aim far, far, higher than that.” Meanwhile, countries like Canada have already ordered five times more vaccines than they need, and the EU has ordered twice as many vaccine doses than it needs. That has opened a debate about vaccine sharing of surplus stocks by rich countries to poorer ones – an exchange which WHO would like to encourage through the COVAX facility instead of through uneven bilateral deals and donations. Global Solutions Are Important – But Regional Solutions Also Required India’s prime minister Narendra Modi as he recently announced a South East Asia regional initiative. Finally, while global frameworks are crucial in the pandemic response, countries shouldn’t wait for Geneva to take action, added other panelists. Notably, the African continent has come together in unprecedented ways through initiatives like the African Response Fund, the African Medical Supplies Platform, or the African Vaccine Acquisition Task Force, among others, said Makhaya. “Instead of looking at the world as one large area of cooperation, perhaps [we need smaller] building blocks, much more about the regions and then come to some kind of success,” added Haidar. “If we only look at the solutions as an all-or-nothing huge global system, I think we’re going to close off,” added Moon. “It’s a very complex multipolar ecosystem with lots of different solutions being figured out by different actors who are not waiting for the answers to come from Geneva.” Indeed, as this event was happening, other new regional initiatives were also taking shape – including Europe’s announcement of an emergency biodefense plan and a SouthEast Asia regional initiative for pandemic preparedness and medical emergencies mooted by Indian Prime Minister Narendra Modi. This, however, does not mean “we don’t need Geneva”, said Moon. “We absolutely need global frameworks and global agreements, but when we think about how have countries figured out how to solve their problems, it has not always been through massive global agreements and so I think we have to think creatively about how does the entire ecosystem work, including what needs to truly be global versus [regional].” One of the newer global frameworks that is now gaining steam is a “Pandemic Treaty”proposed by DG Tedros at the World Health Assembly. The treaty aims to garner stronger political commitment towards pandemic preparedness and response, noted the WHOs regional director for the EMRO region Jaouad Mahjour, also appearing at the panel debate. But until such initiatives are put into force, it “isn’t difficult” to guess who will emerge as a winner in the pandemic response, warned Kazathckine. “Health is a political choice that can and must transcend politics,” Dr Tedros said at the Thursday event. “That’s why this book is so important to build the health diplomacy capacity of both diplomats and health experts around the world.” But as Moon reminded the panel: “At the end of the day, the big challenge will not be what needs to be done, but actually how to do it. “And this is the work of diplomats – just how to implement, and how to navigate the politics… reminds us that the work of diplomats is really just beginning and that there’s a huge agenda ahead of us.” Other Key Points By Panelists “Sharing expertise and information should be at the heart of global health diplomacy. Global collaboration is key to a more equal and sustainable world that benefits all of us” said @JosepBorrellF during the launch of our Guide to Global Health Diplomacy. @EU_Commission pic.twitter.com/CBGyb2MOAx — Global Health Centre (@GVAGrad_GHC) February 18, 2021 Juan Jorge Gómez Camacho, Ambassador of Mexico to Canada.“The only way we can address this pandemic is by moving all together. We cannot address [the pandemic] country by country. It is self-defeating not only collectively [but also] individually as a country, if we focus on us instead of focusing on working together. For a diplomat, to understand in this case it is not my own interest versus everybody else’s interests. In fact, everybody else’s interest is in my best interest. Joseph Borrell Fontelles, High Representative of the EU for Foreign Affairs and Security Policy Vice-President of the European Commission -“Sharing expertise and information should be at the heard of global health diplomay.” Dr Tedros, WHO Director General “If we have learned anything, this past year, it’s that none of us can go it alone. We can only thrive when we work together across institutions across borders,” he said. “That’s why it’s truly a pleasure to join you for the launch of the guide to global health diplomacy.” Margaret Chan, former WHO Director General “Without diplomacy, we cannot begin to negotiate,” she said.“And we cannot begin to [advance] the important policy decisions that impact the health and well being of the world’s population.” Alain Berset, Federal Councillor of Switzerland “The value of global health diplomacy has probably never been more apparent as it is today,” he said. “In this crisis, we need skilled diplomacy to find good solutions.” Michel Kazathchkine, member of the Independent Panel for Pandemic Preparedness and Response “The question for us today…is not whether 2020 has been the year of global health diplomacy, but what has global health diplomacy achieved during the crisis, and where has it failed, and looking forward, which are the challenges.” "The value of global health diplomacy has never been more apparent as it is today. In this pandemic, the international community needs to come together in solidarity. We need skilled diplomacy to find good solutions to global challenges." @alain_berset @BAG_OFSP_UFSP @BAG_INT pic.twitter.com/R0s5F2ASAp — Global Health Centre (@GVAGrad_GHC) February 18, 2021 Global Health Diplomacy Book – Co Published with the WHO and the Swiss Federal Council The new book, published in collaboration with the WHO and the Swiss Federal Council, will be translated into Chinese and Portuguese, among other languages, said Kickbush. Given that health is negotiated across all sectors, the new guide is relevant to a range of stakeholders, including the media, civil society, academia, as well as ministries across various sectors, emphasized the Global Health Centre’s co-director Suerie Moon. “The book makes it quite clear that you don’t need to be a health specialist and you don’t need to be a former diplomat, and in fact some of the most important global diplomats are economic advisors or are coming from media or coming from civil society and academia and foundations and not necessarily from the traditional ranks of diplomacy. “If there’s one lesson we’ve really seen over the past year from COVID it’s that diplomacy is not only the responsibility of ministries of health, but trade, science, technology, intellectual property, travel, tourism, finance…Every single one of these ministries in government needs to be mobilized to negotiate solutions.” Read the Global Health Centre’s new guide here https://www.graduateinstitute.ch/GHD-Guide Image Credits: NBC, European Health Forum Gastein, IHEID, Twitter: @WHOAFRO. EU Cannot Sue AstraZeneca – Germany Commits to Sharing Doses 22/02/2021 Madeleine Hoecklin & Kerry Cullinan Threats from the European Commission to sue AstraZeneca over the delay in deliveries of COVID-19 vaccines hold no weight, according to the EU’s contract with the pharma company in which the right to sue was waived. Following the drugmaker’s announcement in late January of a 60% shortfall in vaccine deliveries for the first quarter after its manufacturing plants in Europe hit a number of snags, furious EU officials examined possible legal avenues to resolve the issue. The release of the full contract by RAI, an Italian broadcaster, makes public several key elements that were redacted from a version previously published by the European Commission. In particular it reveals that the Commission is unable to sue for issues with the storage, transport, and administration of vaccines, including delays in the delivery of vaccines. The exception to the restrictions on the right to legal action is AstraZeneca’s “wilful misconduct or failure to comply with EU regulatory requirements…including manufacture.” While the EU’s hands are tied in terms of filing a lawsuit, there are other pathways open, including suspending payments to AstraZeneca. The initial funding for the doses promised to the EU totals €336 million, of which the Commission already paid two-thirds. The remaining €112 million is supposed to be paid within 20 days of receiving the first installment of doses, however, with the lack of evidence of progress towards manufacturing the doses, “the Commission will have no obligation to pay the second installment and may seek to recover the first installment or a portion of it,” states the contract. It appears that AstraZeneca overestimated its manufacturing capacity and supply to the EU, setting a goal of delivering 300 million doses by the end of 2021, with 30 million doses by the end of 2020, 40 million in January, 30 million in February, 20 million in March, 80 million in April, 40 million in May, and 60 million in June. The company agreed to use its “best reasonable effort” to manufacture the initial doses ordered by the EU and to build its manufacturing capacity. AstraZeneca recently announced that it can deliver 41 million doses by the end of March with its “best reasonable effort.” That estimate is 20 million fewer doses than initially predicted, meaning the drugmaker is over two months behind schedule. Germany Commits to Sharing Vaccine Doses WHO’s Tedros and Germany’s President Frank-Walter Steinmeier address the media. German President Frank-Walter Steinmeier committed his country to sharing some of the vaccines it has ordered with low-income countries at a joint press conference with World Health Organization Director General Dr Tedros Adhanom Ghebreyesus, on Monday. However, Steinmeier said how this would be done and how many vaccines would be shared was still under discussion. Last Friday, Germany announced that it would be contributing an additional €1.5 billion in funding for the multilateral response to the pandemic, including the ACT Accelerator, at the G7 leaders’ meeting last week. Steinmeier also used the briefing to restate Germany’s opposition to the proposal of a waiver on patent protection for COVID-19 related products, as mandated by the Agreement on Trade-Related Aspects of Intellectual Property Rights, known as the TRIPS waiver. “The interest of public institutions and private companies have to be kept alive to invest in research and the development of drugs medicines and vaccines,” said Steinmeier. “So I don’t think the proposal some have made that we have waiver for patents or licensing would be the right approach.” The TRIPS waiver, currently being discussed by the World Trade Organization, has wide support including from the WHO, but it is floundering because of opposition from wealthy countries with powerful pharmaceutical industries, like Germany, the US and the UK. While Tedros welcomed Germany’s financial contribution, he pointed out that while many wealthy countries claimed to support the global vaccine access facility, COVAX, they were still trying to do bilateral deals with manufacturers for more vaccine doses “without stopping to ask whether this was undermining COVAX”. “This pandemic is really unprecedented, and we have to do everything to defeat this common enemy including waivers on intellectual property to increase production,” said Tedros. He added that the WHO was engaging directly with manufacturers and encouraging pharmaceutical companies to “turn over their facilities to produce other companies’ vaccines as Sanofi has done for the BioNTech vaccine”, and issue non-exclusive licences to enable other manufacturers to produce their vaccines. G-7 Commitments Of US$4.3 Billion Not Enough – Rich Countries Need To Stop COVID Vaccine Hoarding to Open Access Bottleneck, Says WHO Director General 22/02/2021 Kerry Cullinan Dr Tedros Adhanom Ghebreyesus, WHO Director General, at the press briefing on Friday. Despite Friday’s commitment by G-7 countries to donate another US$ 4.3 billion to a global COVID vaccine campaign, World Health Organization Director General, Dr Tedros Adhanom Ghebreyesus has accused high-income nations of still undermining equitable vaccine rollout by “doing deals” with manufacturers that deplete supplies available to the COVAX global vaccine facility. Speaking at the WHO’s biweekly media briefing, Tedros thanked the G-7 and the European Union for the new donations – but stressed that money was not enough: “If there are no vaccines to buy, money is irrelevant. Currently, some high-income countries are entering contracts with vaccine manufacturers that undermine the deals that COVAX has in place and reduce the number of doses COVAX can buy,” said Dr Tedros. “Unless we end the pandemic everywhere, we will not end it anywhere. To achieve this, we need more funding. We need countries to share doses immediately. We need manufacturers to prioritise contracts with COVAX. And we also need a significant increase in the production of vaccines.” HIV Provides Global Precedent, Says Anthony Fauci The HIV pandemic provides a “precedent” for how to get life-saving medicines to those who could not afford them – while allowing pharma companies to “maintain a considerable amount of profit”, said Anthony Fauci, US President Joe Biden’s chief scientific advisor and a guest at the WHO briefing. During the early days of the HIV pandemic, there was a lot of discussion about whether expanding the generic manufacture of new HIV antiretroviral drugs would “interfere with the appropriate profit that companies that made major investments in the development of [antiretroviral] drugs”, Fauci recalled. But through various platforms, including the US-sponsored President’s Emergency Plan for AIDS Relief (PEPFAR) as well as the new Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria, life-saving generic drugs reached millions of people and “did not have a deleterious effect on the companies who continued to do well financially and continue to make investments in research”. Even so, the pathway to those breakthroughs was painstaking, observed WHO’s Assistant Director-General for Drug Access, Mariângela Simão, observing that “too many people died unnecessarily” as rich and poor countries battled over access to HIV medicines. Mechanisms such as the Medicines Patent Pool, created to expand generic drug manufacturing in collaboration with the innovative pharma industry have provided “a proven platform to ensure that both voluntary licensing and technology transfer to increase access to medicines for HIV,TB and malaria”, said Simão. Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines But so far, the MPP precedents hasn’t been harnessed to the COVID-19 vaccine roll-out. She lamented: “Why can we not use the platform that WHO has in place, like COVID Technology Access Pool (C -TAP), to make COVID-19 technology accessible and manage intellectual property needs. “Intellectual property is not the endpoint. The endpoint is increasing manufacturing capacity and making sure good quality, efficacious and safe vaccines reach the developing countries,” Simão added. COVAX Sets Up ‘No-Fault’ Compensation Fund Earlier in the day COVAX announced that the WHO had reached an agreement with a global third party insurance provider, ESIS Inc, to administer a no-fault vaccine injury compensation programme for the 92 low- and middle-income countries and economies eligible for donor support to their vaccine campaigns. “As the first and only vaccine injury compensation mechanism operating on an international scale, the programme will offer eligible individuals in AMC-eligible countries and economies a fast, fair, robust and transparent process to receive compensation for rare, but serious adverse events associated with COVAX-distributed vaccines until 30 June 2022,” according to the global vaccine alliance, GAVI, which administers COVAX. By providing a no-fault lump-sum compensation in full and final settlement of any claims, COVAX aims to “significantly reduce the need for recourse to the law courts, a potentially lengthy and costly process”. ESIS, which is part of the Chubb group, will not charge any fees to applicants. “The No-Fault Compensation fund is a massive boost for COVAX’s goal of equitable global access to vaccines: by providing a robust, transparent and independent mechanism to settle serious adverse events it helps those in countries who might have such effects, manufacturers to roll out vaccines to countries faster, and is a key benefit for lower-income governments procuring vaccines through the Gavi COVAX AMC,” said GAVI CEO Seth Berkley. The COVAX no-fault compensation programme will come into operation via a web portal (www.covaxclaims.com) by 31 March, and people will be able to apply for compensation even if they were given a COVAX-distributed vaccine before this date. The programme is financed initially through a levy charged on all doses of COVID-19 vaccines distributed through the COVAX Facility to the AMC eligible economies until 30 June 2022. All vaccines procured or distributed through the COVAX Facility will have received prior regulatory approval from a strict national authority and/or a WHO emergency use authorization to confirm their safety and efficacy. But, as with all medicines, even vaccines that are approved for general use may, in rare cases, cause serious adverse reactions. No Need for People With Allergies to Avoid Vaccination in Fear of Anaphylactic Shock Dr Soumya Swaminathan, WHO Chief Scientist. On a more technical level of the risks of anaphylactic reactions associated with the Pfizer/ BioNTech and Moderna vaccines, Fauci said that these have been very rare events – and are most likely linked to the polyethylene glycol in the vaccine preparation. “There are 4 to 5 per million anaphylactic reactions for the Pfizer vaccine and between 2 and 3 per million to the Moderna, so it’s an unusual, rare interaction,” said Fauci. While people with known anaphylactic reactions may be advised to take special precautions, or in some cases not to be vaccinated with the mRNA vaccines, there is no reason for people with a general history of allergic reactions, to avoid vaccination, he added. Nancy Messonier, of the US Centers for Disease Control and Prevention who is leading the US Centers for Disease Control vaccine effort, told the media briefing that people who have had a history of anaphylaxis were being asked to stay at the health facility for 30 minutes after vaccination “because all the cases in US have occurred within that 30 minutes timeframe”. WHO’s Chief Scientist, Soumya Swaminathan, stressed that “every country has a system in place to do safety monitoring” and this has been coordinated by the WHO. “So far, over 200 million vaccine doses have gone into people around the world and there have been no alarming safety signals, but we will continue to monitor and update, if anything changes,” said Swaminathan. Image Credits: WHO. India Moots Regional Pandemic Platform with 10 Neighbours 22/02/2021 Menaka Rao After donating over 6 million Covid vaccines to more than 13 countries, the Indian government suggested the creation of a regional pandemic platform for preparedness and medical emergencies with its 10 neighbouring countries. At a meeting with health officials, Indian Prime Minister Narendra Modi proposed creating “a special visa scheme” for doctors and nurses to enable swift travel during health emergencies,coordinated air ambulances, a regional platform for “collating, compiling and studying data about the effectiveness of Covid-19 vaccines” and a network for “promoting technology-assisted epidemiology for preventing future pandemics.” India has reported more 11 million COVID-19 cases and over 156,000 deaths. Although cases have been declining since September last year and had considerably reduced by January, there has been an increase of about 31% in the past week, mostly in the Western state of Maharashtra. “Through our openness and determination, we have managed to achieve one of the lowest fatality rates in the world,” said Modi. “This deserves to be applauded. Today, the hopes of our region and the world are focused on rapid deployment of vaccines. In this too, we must maintain the same cooperative and collaborative spirit.” Modi was referring to the Indian government’s “Vaccine Maitri” (meaning vaccine friendship) initiative, through which the Indian government has donated more than 6.27 million doses of COVID-19 vaccines to more than 13 countries, including neighbours Bangladesh, Afghanistan, Bhutan, Myanmar and countries such as Oman, Barbados and El Salvador. It also commercially exported 10.5 million doses of vaccines to 8 countries. Modi was addressing a workshop on COVID-19 management attended by health leaders, experts and officials of Afghanistan, Bangladesh, Bhutan, Maldives, Mauritius, Nepal, Pakistan, Seychelles, Sri Lanka and India. Evoking the “spirit of collaboration” among these countries, Modi said that India and these countries have a lot in common and should share their successful health policies and schemes. “We share so many common challenges – climate change, natural disasters, poverty, illiteracy, and social and gender imbalances. But we also share the power of centuries old cultural and people-to-people linkages. If we focus on all that unites us, our region can overcome not only the present pandemic, but our other challenges too,” he said. Variants May be Associated With Surge in COVID Cases In the last few days, the Maharashtra state government reported a sudden burst of cases in the Vidarbha region, closer to Central India. The genome sequencing of a few cases in Amravati district showed “unique mutations” including E484Q, which is similar to a mutation (E484K) found in South African and Brazilian variants, according to a Times of India report. Maharashtra and Kerala account for more than 74% of the cases in the country while Chhattisgarh and Madhya Pradesh are also seeing a rise. This is in contrast to the steady downward trend of the pandemic in India since last September last year. The country is reporting an average of 12,000 cases a day, as compared to more 90,000 cases in a day in September. Experts have attributed the overall fall in COVID-19 positive cases over the past few months to herd immunity caused by widespread infection, especially in cities such as Mumbai, Pune, and Delhi which saw the largest outbreaks in the country. A recent round of sero-surveillance in Delhi between January 15 to January 23 among 28,000 people found that 56% of those surveyed had antibodies against COVID-19. “Those infected with Covid will only protect themselves but also protect others. Half the population will not transmit to others. Besides, the susceptible population is reduced by 50%,” explained Dr Sanjay Rai, from Delhi’s All India Institute of Medical Sciences. Citing a recently published study in the New England Journal of Medicine, Rai said that those who are infected are protected from disease for at least six months. The study which was conducted with more than 12,000 health workers in the UK, showed that presence of antibodies was associated with a substantially reduced risk of reinfection in six months. More than 9 million people have been at least given one dose of the vaccine. “India has a young population. About 50% of the population is under 25 years, and 65% of the population under 35 years. There could be a very large fraction of the population then which had asymptomatic infections and were not tested. They would also offer some protection to the population,” said Dr Shahid Jameel, a virologist with Ashoka University, Delhi. However, a nation-wide survey showed only one out of 5 people have been exposed to the virus. “The message is that a large proportion of the population remains vulnerable,” said Dr. Balram Bhargava, who heads Indian Council of Medical Research, that helmed the national-wide sero-survey. Meanwhile, there is some evidence that people who have already had COVID-19 can become reinfected with variants. Image Credits: https://dashboard.cowin.gov.in/. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
The European Medicines Agency’s COVID-19 Vaccine Leaks: Hacks, Regulatory Pressures And Manufacturing Concerns 23/02/2021 Priti Patnaik & Lucien Hordijk European Medicines Agency headquarters, Amsterdam, The Netherlands EXCLUSIVE – A series of recent leaks of emails and documents surrounding the EMA’s approval of the first COVID-19 vaccine by Pfizer/BioNTech highlight the intense political pressures regulatory agencies are under during the pandemic – as well as an oft-forgotten aspect of vaccine approvals – the quality control of vaccines during the leap from clinical trials to large-scale commercial production. Priti Patnaik & Lucien Hordijk explore. Cyber leaks, public health, geopolitics, vaccine nationalism and political pressure come together in this heady story about the complex challenges that the world’s strongest regulatory agencies are facing as they review and approve new COVID-19 vaccines, developed at unprecedented speed. When a series of emails and documents hacked from the European Medical Agency (EMA) in December 2020 surfaced in early 2021 on the dark web, they revealed a cautionary tale about how even one of the world’s strongest regulatory agencies may be subjected to intense political pressures in their review of COVID-19 vaccines – even as they try to play by the book in their reviews. The hacked documents also shed light on an oft-ignored aspect of vaccine review and approval beyond safety and efficacy – that is quality-assurance of production processes as new vaccine products make the leap from clinical trials to large-scale production. Shortages Led to a Blame Game Ursula von der Leyen, President of the European Commission, speaking at the World Economic Forum in late January – shortly after EMA approval of the first COVID-19 vaccines. And the regulatory approvals did not, ultimately usher in a smooth vaccine rollout. Rather, vaccine shortages have plagued most of Europe on the back of unanticipated production glitches, leading to a political blame game at the very top of the European Commission, (EC). This, in turn, prompted the EU to adopt new rules on export restrictions that have been widely criticised. This story has four parts: what the leaked documents show; how authorities responded to the leaks; the potential motivations for the breaches by hackers seeking to undermine confidence in the vaccines; and what lessons can be learned from the EMA breaches. Part I: The Language of Political Pressure On January 13th 2021 internal emails and documents from the EMA showed up on two hacker forums: Raidforums, an English language marketplace for database breaches and leaks; and Rutor a Russian marketplace on “the dark web”. The dark web is home to encrypted online content not indexed by search engines. These documents, dating from mid- to late November 2020, amounted to nearly 900 pages reports and memos, which included some 20 different email exchanges between EMA officials. They concern the review by EMA’s top management of the Pfizer / BioNTech vaccine in the lead up to its approval. The EMA first reported the cyberattack on December 9th, 2020. The leaks illustrate two important aspects of the regulatory review process: That the EMA was put under intense political pressure by the European Commission to hasten the regulatory process of the first vaccine approvals – particularly those of Pfizer/BioNtech and Moderna; During the Pfizer/BioNTech regulatory process, the EMA had concerns related to the consistency of vaccine quality during the commercial production. Significantly, Pfizer addressed these EMA concerns before the vaccine was approved. But the episode illustrates why such issues would better be shared transparently as part of the regulatory review process, experts say [keeping in mind that US Food and Drug Administration review meetings are even aired publicly online]. As Dr Barbara Mintzes, Associate Professor, The University of Sydney Charles Perkins Centre and School of Pharmacy, and an expert on the interface between clinical research and regulatory decision-making, observed: “I wonder why these issues with production quality were only made public via leaked documents that had become available on the dark web. Why were they not under open and public discussion? These types of exchanges should not be secret.” Leaks Suggest EMA Was Under Pressure to Hasten Vaccine Approvals The cold chain storage for the Pfizer/BioNTech vaccine at Pfizer’s warehouse in Kalamazoo, Michigan. Speedier US FDA and British vaccine approvals added to the pressure on the EMA process. The chain of leaked emails reveals that the EMA was operating under intense political pressure, exerted from the very top of the European Commission (EC), to speed up approvals for COVID-19 vaccines. Without rapid EMA approval of the Pfizer vaccine and others Brussels feared it could not keep its promise to deliver on vaccines for all EU citizens simultaneously and by the end of 2020. Already on 19 November, 2020, Commission President Ursula von der Leyen had publicly announced that both BioNtech/Pfizer and Moderna vaccines could be approved by the EMA by the end of the year. EMA members were uncomfortable with the political promises being made, as reflected in a series of internal emails between the EMA officials from November 12, 19 and 20, 2020, which were among those that came to light in January 2021. And at the same time the pressures to adhere to the EC schedule were immense. While an EU directive allows member states to temporarily use unauthorized drugs in emergencies, the Commission wanted to avoid a situation where countries would begin issuing emergency permits for vaccines at national level, helter skelter. Speedier approvals by other regulatory authorities including UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration also added to the pressure on the EMA. Even so, the email series reflects both the challenges as well as concerns of EMA officials about ensuring adherence to a strict regulatory process, while keeping to Von der Leyen’s ambitious schedule for the approval of the Pfizer and Moderna vaccines. EMA Officials Had Concerns About Commission’s Ambitious Schedule Vials of the Pfizer-BioNTech COVID-19 vaccine. Within EMA expert ranks there was widespread concern that politically-driven deadlines should not compromise the technical review – particularly resolution of the manufacturing quality-assurance issues that also emerged as concerns in the same period: “What is new in my view is that she [Von der Leyen] clearly identifies the 2 vaccines that could be approved before the end of the year. There are still issues with both so it needs to be seen if all this can be sorted out in time, whilst not compromising the robustness of the review”, writes one EMA official in an email on 20 November, 2020 . An email dated November 19, 2020 recounted a telephone conversation between EMA officials and a European Union commissioner. Relates the EMA official to another colleague: “Atmosphere was rather tense….at times even a bit unpleasant.” The official notes that it “provides a hint on what EMA may expect if the expectations are not being met, irrespective if such expectations are realistic or not”. The EMA official goes on to suggest that an interval of even several weeks between an authorisation granted by the FDA & the UK’s Medicines and Healthcare products Regulatory Agency (MHRA); and the EMA will not be acceptable to the European Commission. It would lead to significant “the political fall-out,” the EMA official warned. “We have to be ready for the worst-case scenario,” writes the same EMA official in the email dated November 19, 2020”We will be overwhelmed on all fronts and in the middle of a storm. Whose support can we then rely on?” . According to yet another email dated November 22, the EMA official warned Commission staff: “We are speeding up everything as much as possible, but we also have to make sure that our scientific review is as robust as possible.” EMA and European Commission Deny Political Interference Stefan De Keersmaecker, spokesperson for health, food safety and transport, at the European Commission press briefing 15, January 2021. Asked for comment on the political pressures, an EMA spokesperson replied to us on January 15, 2021 saying: “Despite this urgency (to make vaccines available), there has always been consensus across the EU not to compromise the high-quality standards and to base any recommendation on the strength of the scientific evidence on a vaccine’s safety, quality and efficacy, and nothing else.” The European Commission likewise denied any political interference in the regulatory approval process: “The Commission is fully committed to only authorising vaccines that are deemed safe and effective by its independent scientific agency,” Stefan De Keersmaecker, spokesperson for health, food safety and transport, told us in reply to an inquiry. Only an hour after responding to the queries of our investigative team – which were the first to address this aspect of the email leaks, European Commission authorities hastily convened a press conference on the issue. At the press briefing, Keersmaecker, said that the leaked documents had been “manipulated”: “The EMA has just published its public statement on the cyberattacks of which they are a victim and they have stressed, it is important that you are all aware of that, that some of the correspondence have been manipulated by the perpetrators prior to the publication in a way that could undermine trust in vaccines. I am saying this just to draw your attention that some of the documents that are out there seem to have been manipulated by perpetrators, and therefore have to be considered with utmost care.” PART II: Vaccine Production Quality Assurance Pfizer’s COVID-19 vaccine during the manufacturing process. The EMA’s concerns about quality assurance of the mass production of the Pfizer/BioNtech vaccine (brand name Comirnaty) was a key technical issue to emerge in the regulatory review, as illuminated by the series of leaked EMA emails from November 2020. Here, the regulator’s concerns focused mostly on the Pfizer/BioNtech vaccine candidate, which was the very first vaccine in the EMA regulatory approval pipeline. At the time when the issue arose in November, 2020, some production factories were yet to be inspected, and the regulator was awaiting additional data from Pfizer. The key concern centered around differences in the quality of the vaccine batches produced for clinical trials and batches for commercial production noted by the EMA review experts. According to the leaked documents, the concerns arose over differences in the levels of “mRNA integrity” – an indicator of the purity of the active vaccine drug substance. While the vaccines used in the clinical trials had between 69% – 81% intact mRNA, initial samples of the batches that were destined to be used in large scale manufacturing showed only 59% intact mRNA on average, with some batches as low as 51%. This concerned the EMA – both in terms of safety as well as efficacy of the vaccine doses. According to an email between EMA officials on 23 November, 2020, the EMA stated the following: “…The potential implications of this RNA integrity loss in commercial batches compared to clinical ones in terms of both safety and efficacy are to be defined. “Whether or not the observed compatibility issues could be a blocking point will depend on the relevance of these observations to safety and efficacy and the company will be requested to fully justify the lower %RNA integrity (and other differences noted) “Point for discussion will be whether the comparability issues can be solved only by quality data (additional functional / in vitro biological data + available non-clinical) or that further clinical data (bridging studies are / will be performed) will be needed. It is difficult to make any projections on this.” Ultimately, however, those concerns were resolved to the satisfaction of EMA reviewers, the document leaks also show. Pfizer offered to make manufacturing modifications to ensure that mRNA integrity levels in the commercial production process would remain consistent to those of the clinical trials. The email exchanges refer to manufacturing adjustments ensuring mRNA integrity levels remained at around 75% – although the documents don’t explain how those modifications were made. EMA Responses to Questions About Quality Assurance Review Along with the EMA replieas, a European Commission media briefing on 15 January, 2021, also addressed the email leaks On 15 January, in response to our queries about the quality assurance review of production processes, the EMA said the follow-up data it had received from Pfizer showed “modified forms of mRNA at somewhat higher levels in the batches manufactured with the commercial process as compared to material used in clinical trials.” The EMA clarified to us that such modified mRNA forms were not determined to be a safety risk, particularly in light of the low overall dose of mRNA involved – just 30 micrograms of active ingredient (30 μg): “The amount of any such proteins, is expected to be too low to elicit an immune response of biological relevance.” stated the EMA response. As a result, the risks of any adverse immunological events occurring in reaction to any modified mRNA forms was deemed to be low. Indeed, considering the low dose of mRNA (30 μg), impurities are not considered a safety issue based on general toxicological principles, the EMA said. In their response to our queries, the EMA also acknowledged that the leaked emails reflected the discussions that took place. A spokesperson from the EMA said, “The company was able to address these issues and supply the required information and data to allow EMA to move towards a positive recommendation for this vaccine.” Pfizer, for its part, did not respond to our inquiries on how the company addressed concerns the EMA had raised in November 2020. In a statement in mid-January, the company said: “As the European Medicine Agency’s investigation [of the cyberattack] is ongoing, we defer to them on any updates.” How do mRNA vaccines work? Description of Pfizer’s use of mRNA technology to develop COVID-19 vaccines. Coronaviruses are made up of a single-stranded RNA protein, bounded by protein and wrapped in an envelope of lipid molecules The SARS-CoV-2 virus uses the spike proteins covering its surface to bind to ACE2 receptors found in the lung and other organs. It then fuses with the membrane of the host cell and releases its genetic material. Once the virus has overtaken the cell, it hijacks the cell’s internal machinery to make proteins that help it replicate. Most COVID-19 vaccines have targeted the distinctive spike proteins of the SARS-CoV-2 virus – used by the virus to pry its way into the body’s cells. Typically, vaccines involve injecting a weakened, inactivated or genetically modified form of the pathogen into the body to trigger immune response. However, mRNA vaccines involve the use of messenger Ribonucleic Acid (mRNA) to carry “instructions” for manufacturing a spike protein into the body. That, in turn, triggers the immune response. As described in a Health Policy Watch interview with Moderna’s Chief Medical Officer Tal Zaks from November 2020: “mRNA is a transient copy of the instructions in our genes that instructs the cell’s ribosomes to make protein. ….An mRNA vaccine is not a virus, [or even a weakened virus]. It only gives the cells transit instructions to make that one piece of virus that we want to educate the immune system to recognize. It’s essentially an instruction code. I inject it into the muscle. It gets distributed to the lymph nodes where the immune system works. The messenger RNA encodes for the spike protein and our cells start to make this spike protein. “Now the immune system sees a new protein it’s never seen before. And it goes, ‘Oh, hold on a second. This looks like a foreign threat. …let me go block it.’ And so the immune system starts to generate antibodies and T cells that recognize that spike protein. It focuses the attention of the immune system, just on that one protein.” Independent Expert Confirms – No Vaccine Efficacy or Safety Issue We also interviewed Steve Pascolo, a researcher at the University Hospital of Zurich, an expert on mRNA vaccines, regarding potential impacts of lower mRNA integrity levels on either safety or efficacy of the Pfizer/BioNTech vaccine. Pascolo, also a co-founder of CureVac who left the company in 2006, said that he did not see serious issues of safety or efficacy arising: “In the early trials of BioNTech, they had immune responses with just one microgram of RNA.” (the approved mRNA vaccine has 30 micrograms of RNA per dose), said Pascolo, also author of a recent paper Synthetic Messenger RNA-Based Vaccines: from Scorn to Hype. And what about safety? Could a lower mRNA “integrity” level could impact the vaccine’s safety? Was it possible that the presence of “truncated” mRNA proteins in the vaccine’s active ingredient – other than the exact target mRNA protein – could also have unwanted immune impacts? Said Pascolo: “There is no safety implication of having a shorter mRNA transcript in the vaccine. In fact a shorter transcript will probably not be translated (it misses the functionality important ends) and if it would, may result in production of shorter proteins that may even participate in the overall immune response.” PART III – EMA Says Emails Were Manipulated by Hackers To Sow Vaccine Mistrust When our team published its first story on the leaked documents in Business Insider Germany (on January 15, 2021), an EMA spokesperson said that the agency “would not verify” the authenticity of the leaked documents because they have been stolen by hackers and placed on the dark web. Later on that same day, an EMA press statement acknowledged that the “unlawfully accessed documents.. Included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines.”The 15 January statement added that “Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.” Ten days later, on 25 January, the EMA issued another statement on the cyberattack that had led to the email leaks, with more details on how the series of email leaks had been manipulated by hackers – to create mistrust around the vaccines themselves. “Whilst individual emails are authentic, data from different users were selected and aggregated, screenshots from multiple folders and mailboxes have been created and additional titles were added by the perpetrators in a way which could undermine trust in vaccines”, said the EMA press statement issued on January 25. Analysts Suggest EMA Emails Were Hacked by State Entity Undoubtedly, the way these documents appeared on the dark web, played into the hands of sensationalism muddying the regulatory reviews. The leaked documents from the EMA were named “BIG DATA SCAM of Pfizer’s vaccines” and “Astonishing fraud Evil Pfizer!!” Jean-Michel Doan, an open-source analyst who specialises in cybercrime at Sekoia, an IT security company in France, said, it is likely that the attack was caused by hackers affiliated to a state entity. “This kind of hacking tactic with data theft followed by data leaks has already been practiced by Russian agents (Guccifer 2.0/ Democratic National Convention leaks and World Anti-Doping Agency leaks).” Cyberattacks focusing on undermining confidence around brands of the Covid vaccine have also been undertaken by hacking groups affiliated with China, North Korea, and Iran and Russia, he added. The team also spoke with Mirko Gatto, CEO of Yarix, an Italian company that works in IT security, on whether anti-vaxxers could have orchestrated such an attack. Gatto said, “All is possible, but if anti-vaxers want to damage someone they go in other places, for example on Twitter. They use open source intelligence (OSINT) sources. They want to communicate as much as possible and [the] black market is not a place for this kind of strategy.” Part IV; Balancing Regulatory Processes, Political Pressures & Right To Know Clearly, the leaks reveal the kinds of political pressures that have been faced by even the world’s most stringent regulatory agencies in the pandemic era. They underline the penultimate importance that politicians need to attach to restraint – in order to maintain public confidence in regulatory processes – and the vaccines they produce. Even so, it appears the EU drug regulator adhered to its due diligence process. The EMA issued the Pfizer-BioNTech’s vaccine a conditional marketing authorization on December 21, 2020- a full three weeks after the UK (December 5th) and two weeks after the US FDA actions (December 11th) – suggesting that the EM indeed took time to resolve questions about safety, efficacy and manufacturing quality assurance. . Still, the leaks provide a cautionary tale about the pressures that regulatory authorities may face – with implications for other national regulatory agencies as well as the World Health Organization – which has its own emergency use listing process. If one of the strictest regulators in the world is subjected to such pressures, it is likely the pressures on other authorities may be even more intense. Transparency of Dossier Submissions Professor Brook Baker, Northeastern University, School of Law The other lesson learned may be one about the importance of transparent regulatory reviews. If the exchanges between the EMA and Pfizer about aspects of quality assurance of production processes had been a transparent matter of record – it might have removed the sting of some of the leaked emails – which ostensibly sought to undermine vaccine confidence. Observes Brook Baker, professor of law at Northeastern University in Boston told Health Policy Watch, “Transparency by regulatory authorities and WHO prequalification with respect to COVID-19 vaccines is absolutely critical to vaccine acceptance by medical providers, opinion makers, and ultimately individual patients and the public-at-large. Transparency is particularly important when public anxiety is high, product development and clinical trials have been expedited, political pressure has been exerted by public officials, there is global competition in vaccine development, and emergency use permission is granted short of full regulatory approval. It also certainly hasn’t helped that even stringent regulatory authorities in the U.S., U.K., and Europe have disagreed on what vaccines to approve and conditions and populations of approved use.” As a result, adds Baker, ”transparency about dossier submissions, the evidence submitted, independent and supplementary review by expert committees, and the detailed assessments of the regulator is vitally important. “This should include transparency around known adverse effects, post-approval pharmacovigilance, efficacy with respect to new variants, and on-going studies and time-lines for full regulatory approval,” he says. EMA Not the Only Regulatory Agency Subjected To Pressures Former US President Donald Trump at a White House Coronavirus Taskforce briefing – he used the presidential podium to exert pressure on the FDA for more rapid approval of COVID-19 vaccines. The EMA experience can be contrasted with the US Food and Drug Administration review process of the same vaccines – which was subjected to even more overt and intense political pressure from former US President Donald Trump. Those pressures included Trump’s own tweets and statements, as well as backroom approaches from White House emissaries and Trump’s political appointments in the US Centers for Disease Control, the White House COVID task force and the FDA. “Fortunately, the scientists and leadership at the FDA resisted these pressures, assured that there would be independent expert input, and reviewed the evidence with care and precision,” said Baker. “These internal forces at the FDA were helped by vaccine developers who also made it clear that they wanted there to be rigorous, independent review at the FDA.” Baker also notes the “unprecedented transparency with respect to many aspects of the [FDA] approval process,” including not only the portfolio submissions but also live video coverage of the entire FDA review deliberation. At the same time even across the Atlantic, “advocates are still pressing for even more transparency about company submissions, including underlying clinical trial data and confidential manufacturing information, and about FDA assessments,” Baker observes. Going forward, such transparency may be all the more important to both protect regulatory authorities from undue political interference – as well as building public confidence in the process – and thus in the vaccines that they approve. Ultimately, FDA transparency may also have helped build public confidence in the FDA approval process – and even stave off hackers’ attacks such as those seen in Europe. _________________________ Priti Patnaik is the founding editor of the Geneva Health Files, an independent global health reporting initiative based in Switzerland. Lucien Hordijk is a contributing reporter for the Investigative Desk, a non-profit investigative journalism group that is based in Amsterdam. Ludovica Jona (Italy), Lise Barnéoud (France), and Hristio Boytchev (Germany) also contributed to this article. This article is part of the series #BehindThePledge, a cross border investigation into the money trail of pandemic-related drug and vaccine development and rollout. This is the first publication in English-language media about the EMA leaks. Earlier versions of the story have been published by the team in media in France, The Netherlands, Italy & Germany. The project has received grants from Journalismfund and IJ4EU. Image Credits: BioNTech, Twitter, Pfizer, US Centers for Disease Control, Pfizer, White House/D. Myles Cullen. Global Citizen Launches ‘Recover Better Together’ Campaign – Guinea Launches Ebola Vaccinations – Nigeria & Zambia Studies Show High SARS-CoV2 Infections 23/02/2021 Kerry Cullinan Global Citizen CEO Hugh Evans launches 5-point global recovery campaign Vaccinating all of Africa’s health workers would need half a percent of all the doses that the G-7 countries have purchased, according to Global Citizen CEO Hugh Evans. On Tuesday, Global Citizen launched a five-point ‘Recover Better Together’ plan for the world, aimed at getting millions of citizens behind ending COVID-19 for all, ending the hunger crisis, resuming learning for children, fully protecting the planet, and advancing equity for all. “First we must focus on achieving sufficient worldwide vaccine coverage to break the chain of transmission, including, for the poorest nations,” Evans told a media briefing convened jointly with the World Health Organization, and addressed by world leaders including European Commission president Ursula von der Leyen, US Special Envoy in Climate John Kerry and South African president Cyril Ramaphosa. In his address, Ramaphosa applauded French president Macron who has called on rich countries to donate 5% of their vaccines to needy countries. “Another important step is to enable the transfer of medical technology for the duration of the pandemic. This will allow us to increase the production of COVID-19 vaccines and other medical products, lower prices, and improve distribution so that these vaccines and medical supplies reach all corners of the world,” said Ramaphosa. Guinea Starts Ebola Vaccination Drive – Nigerian and Zambian Studies Show High Levels of SARS-CoV2 Infection Healthworkers during the 2017 Ebola outbreak in the DRC. Guinea started Ebola vaccinations on Tuesday of people at high risk in Gouecke, a rural community in N’Zerekore prefecture where the first cases were detected on 14 February – the first cases since 2016. “All people who have come into contact with a confirmed Ebola patient are given the vaccine, as well as frontline and health workers. The launch started with the vaccination of health workers,” according to a media release from WHO’s Africa region. “The last time Guinea faced an Ebola outbreak, vaccines were still being developed,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “With the experience and expertise it has built up, combined with safe and effective vaccines, Guinea has the tools and the know-how to respond to this outbreak. WHO is proud to support the government to engage and empower communities, to protect health and other frontline workers, to save lives and provide high-quality care.” The WHO sent 11 000 doses of the rVSV-ZEBOV Ebola vaccine from its headquarters in Geneva, while a further 8500 doses are being procured from Merck, the vaccine’s producer in the US, “The speed with which Guinea has managed to start up vaccination efforts is remarkable and is largely thanks to the enormous contribution its experts have made to the recent Ebola outbreaks in the DRC,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “Africans supporting fellow Africans to respond to one of the most dangerous diseases on the planet is a testament to the emergency response capacity we have built over the years on the continent.” Implementing an Ebola vaccination strategy is a complex procedure as the vaccines need to be maintained at a temperature of minus 80 degrees centigrade. Guinea has developed ultra-cold chain capacity with vaccine carriers, which can keep the vaccine doses in sub-zero temperatures for up to a week. There are eight cases (four confirmed and four probable) and five people have died so far. Guinea’s neighbours are on high alert, particularly Liberia and Cote d’Ivoire which are close to the border with N’Zerekore, Guinea’s second-largest city. Meanwhile, a second person died of Ebola last week in the Democratic Republic of the Congo’s North Kivu province. Ebola, a haemorrhagic fever, is transmitted from wild animals and spreads in the humans through direct contact with the blood, and bodily fluids of infected people, and contaminated surfaces and materials. Nigeria’s First SARS-CoV-2 Seroprevalence Study Finds Almost 25% of Lagos Residents Had Antibodies Lagos Almost a quarter of Nigerians living in Lagos may have been infected with SARS-CoV2, according to the results of a seroprevalence study released on Monday by the Nigeria Centre for Disease Control (NCDC) and Nigeria Institute for Medical Research (NIMR) The household seroprevalence survey was conducted in Lagos, Enugu, Nasarawa and Gombe States in September and October last year and involved blood samples from over 10,000 people. SARS-CoV-2 antibodies were found in 23% of people sampled in Lagos and Enugu States, 19% in Nasarawa State, and 9% in Gombe State. “These rates of infection are higher than those reported through the national surveillance system and reveal that the spread of infection in the states surveyed is wider than is obvious from surveillance activities,” according to a statement by the NCDC and NIMR. The survey also showed that men had higher infection rates than women (21% of men and 17% of women in Nasarawa), and urban areas had higher infection rates than rural areas (28% of urban residents and 18% of rural residents in Enugu). The survey is currently being expanded to more states in the North-West and South geopolitical zones which were not included in the initial round of surveys. Zambia Post-Mortems Find High Level of SARS-CoV2, Minimal Testing Post-mortem surveillance of 364 Zambians who died between June and September last year detected SARS-CoV2 in 70 (19%), according to a study published in the BMJ last week. PCR tests were administered on people at the University Teaching Hospital morgue in the capital of Lusaka within 48 hours of death. Fifty of the 70 with COVID-19 had died in their communities without ever having been tested for the virus. Only five of the 19 who died in hospital had been tested. Seven children were part of the study and only one had been tested before death. The most common co-morbidities among those who died of the virus were tuberculosis (31%), hypertension (27%), HIV/AIDS (23%), alcoholism (17%), and diabetes (13%). Image Credits: WHO, Wikipedia. ‘Rapid Response Platforms’ Enabled COVID-19 Vaccine Development, Says Fauci 23/02/2021 Madeleine Hoecklin The Epidemic and Pandemic Preparedness and Response panel at the GVIRF event on Monday. Rapid response platforms, particularly the messenger RNA (mRNA) platform, have changed the landscape of vaccine development, enabling the rapid response to the COVID-19 pandemic, said Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) on Monday. Fauci, speaking at the opening of the Global Vaccine and Immunization Research Forum (GVIRF), co-organized by WHO, the Bill & Melinda Gates Foundation, and the NIAID, highlighted the innovations in vaccinology that made the speedy development of COVID-19 vaccines possible. “There are a number of new technologies that have now really dominated our approach to COVID-19. For example, there’s genetic immunisation using RNA and DNA vaccines,” said Fauci. “We are well aware now of the successes, for example, of the mRNA vaccines.” Rapid response platforms are systems that can be adapted against different pathogens. In the case of mRNA vaccines, these have been developed over a number of years to address influenza, Zika and rabies and have shown a high level of efficacy against SARS-CoV2. The Pfizer/ BioNTech and Moderna SARS-CoV2 vaccines have both had over 95% efficacy against symptomatic COVID-19 and nearly 100% efficacy against severe disease. “I think it’s fair to say that rapid response platforms have been a revolution in vaccinology over 2020 with COVID-19,” said Melanie Saville, Director of Vaccine Research and Development at the Coalition for Epidemic Preparedness Innovations (CEPI). “These can be further developed and prepared for future outbreaks, epidemics, and pandemics.” Barney Graham, deputy director of the Vaccine Research Center at NIAID, added that, over the past 12 years in particular, “new technologies have improved our ability to both prepare for and respond to emerging threats, like structural biology protein engineering and rapid platform manufacturing.” Prototype Pathogen Approach Both Graham and Fauci described the prototype pathogen approach to pandemic preparedness vaccine research used at the NIAID. This refers to studying pathogens of a particular group to build on prior experiences and use strategies to inform vaccine design for related viruses. In developing vaccines for SARS-CoV2, structure-based vaccine designs from Middle East Respiratory Syndrome (MERS-CoV), which is in the family of coronaviruses, were used and “enabled us to rapidly get a successful vaccine, particularly with mRNA [technology],” said Fauci. With the technological advances and the unprecedented R&D work conducted over the past year with COVID-19, “I think we’ve probably moved forward a decade…with COVID-19 vaccines being developed in only 300 days, whereas usually, they would take multiple years, if not decades,” said Saville. The timeline of the mRNA COVID-19 vaccine development. “One thing to point out [is] the speed with which we went from appreciating the new virus, in this case SARS-CoV2, on January 10 of 2020, to starting a phase one trial, about 65 days later, a phase 3 trial both with Moderna and with Pfizer, on 27 July and now having both vaccines already being administered here in the United States and elsewhere. [This is] the fastest in the history of vaccinology from the identification of a particular pathogen to the actual administration of a vaccine,” said Fauci. Challenges with mRNA Platforms While mRNA technology has had great advances, there is still a lot that is unknown about this type of vaccine, including what type of RNA to use and what long-term immune response durability may be. The continued development of the rapid response platforms is needed to make progress on COVID-19 and future epidemics and pandemics. “In all cases, the more robust the platform, in terms of what safety data you have from the platform, what type of immune profile, and importantly, the manufacturing process – which is often really the rate-limiting factor, [the better it is to]…get them as fine-tuned as possible,” said Saville. The manufacturing the Pfizer/BioNTech and Moderna vaccines is limited and is largely centered in Europe and North America. A map of the manufacturing sites for mRNA COVID-19 vaccines globally. “What we need to really look at in the medium and longer-term [is]…how can that manufacturing footprint be much more amenable with regional manufacturing capacity,” said Saville. “Looking at manufacturing innovation…that could be amenable to the low- and middle-income countries [is] something that really needs to be followed.” Innovations in Manufacturing While numerous accomplishments have emerged from the COVID-19 pandemic, several shortcomings, particularly in vaccine development and manufacturing, have occurred. “There’s no question that COVID has demonstrated the potential of vaccine development and R&D, but it has also exposed some pretty major gaps in the system and [has shown] what happens when a disease strikes the entire world at the same time,” said Selwyn. These gaps include the limitedd supply of vaccines secured for low- and middle-income countries; high-income countries pre-ordering large amounts of vaccines for themselves; the reduction in production capacity for other diseases, which may increase the risk of outbreaks; and the dependency on tech transfers. “In COVID, there were multiple companies who had quite limited experience with vaccine manufacturing and bringing vaccines through licensure, [who were] planning for upwards of 10 tech transfers in a single year,” said Casey Selwyn, senior officer in Vaccine Development and Global Health COVID-19 Response at the Gates Foundation, at a workshop that followed the opening session. Normally a company may undertake one transfer a year. The Innovations in Vaccine Manufacturing workshop at the GVIRF session on Monday. “To maximize global supply, we need to have innovative ways to ease and encourage tech transfer…A tech transfer requires time, it requires resources and sharing of know-how, not just intellectual property,” Selwyn added. The most efficient way to scale up vaccine production and supply over the long term is to build “ever-warm” vaccine facilities that are multi-platform and multi-purpose with a trained workforce, so that the facilities can be prepared when an outbreak occurs, proposed Selwyn. Another recommendation for innovating global manufacturing was to implement a hub and spoke distribution model, which would create a centralized network where products are received in central locations before being sent directly to their destinations. According to Selwyn, this could ease the pressure of tech transfers and establish a better geographical reach, creating a more flexible, accessible and cost effective system. Alternatively, increasing standardization of manufacturing protocols and regulatory requirements – which could include the labeling of products, serialization, and design of protocols – could also improve speed, flexibility, and cost-efficiency. “Probably one of the most important sets of innovations, sets of lessons and sets of actions for the future is really continuing to pursue uniformity and harmonization, especially for a set of diseases and pathogens that require rapid response,” said Anant Shah, New Product Lead for Global Vaccines for COVID-19 and Ebola at Merck. “We have to pursue uniformity, flexibility and efficiency if we want to continue ensuring global equitable access,” said Shah. Image Credits: NBC, GVIRF. Global Health Diplomacy In The COVID-19 Era – Can Failure Usher In A New Era of Success? 22/02/2021 Svĕt Lustig Vijay More than a year into the world’s largest global health emergency, health diplomats have fought hard to ensure that every country across the globe secures access to lifesaving coronavirus health products, including vaccines, treatments, and diagnostics. That has not happened yet, given that 80% of countries that are now rolling out vaccines are either high-income or upper middle-income countries. Export bans on essential health products in 80 countries, ranging from personal protective equipment to ventilators, have not helped either. And in the absence of clear global guidance, up to 130 countries have imposed an uneven patchwork of travel restrictions in an attempt to keep more contagious variants at bay – mostly to no avail. A panel of some two dozen leading diplomats and health policy experts from WHO, government, academia and media pondered the current state of affairs, at the Global Health Centre’s (GHC) launch of a new Guide to Global Health Diplomacy, authored by GHC founder Ilona Kickbusch along with a former Hungerian Health Minister, Haik Nikogosian, former head of the Framework Convention on Tobacco Control, Mihály Kökény; and a preface from WHO’s Director General Dr Tedros Adhanom Ghebreyesus. The guide, co-sponsored by the Swiss Confederation, offers a compass to navigate the complexity of global health diplomacy through “practical insights” and “sound wisdom”, said Norway’s leader of the labor party Jonas Gahr Stør at the launch event on Thursday. Norway’s Labour Party leader, Jonas Gahr Støre The event featured some of the bright stars in the world’s global health constellation, including former WHO DG Margaret Chan; Trudi Makhaya, economic advisor to South Africa’s President Cyril Ramaphonsa, Suhasini Haidar, editor of India’s The Hindu Newspaper, Juan Jorge Gómez Camacho, Mexico’s Ambassador to Canada, and Swiss Federal Councillor Alain Berset. The event, moderated by Kickbusch, was co- sponsored by the World Health Organization and the Swiss Federal Council. Said Kickbush: “As you can see from the subtitle of this book [better health – improved global solidarity – more equity], the three words, health, so that health moves to the centre of negotiations, solidarity, and equity – those truly are the goals of global health diplomacy.”Better health – improved global solidarity – more equity Ilona Kickbusch, Founding Director of the Graduate Institute’s Global Health Centre in Geneva. Crisis Has Shown The Failures of The Current International Health Regulations System For Pandemic Preparedness & Response Michel Kazathchkine, former Executive Director of the Global Fund and a member of the Independent Panel for Pandemic Preparedness and Response The pandemic has uncovered “many flaws” in global preparedness and response, said Michel Kazathckine, former executive director of the Global Fund to fight AIDS, Tuberculosis and Malaria, and currently serving as a member of the Independent Panel for Pandemic Preparedness and Response, mandated by the World Health Assembly in May, to explore how and why the SARS-CoV2 pandemic caught the world so badly off guard. “The international system we have established for health security did not really work as a system,” he said. “There were clear gaps in preparedness management of the response coordination.” If there is anything that diplomacy has “certainly” not achieved in the midst of the pandemic, it is “firm and binding commitments” at the international level, added the Global Health Centre’s co-director Suerie Moon. Suerie Moon, Co-Director of Global Health Centre at Geneva Graduate Institute Same Challenges Were Apparent in H5N1 Avian Flu Epidemic The challenges are not new. Some 15 years ago after the eruption of the H5N1 Avian Influenza epidemic, Indonesia protested the fact that after low- and middle-income Asian countries had shared samples of the emergent pathogen with research networks around the world, rich countries then bought up most of the vaccines thus produced – leaving other countries vulnerable. In 2021, the continued lack of clear and binding agreements to ensure equitable access to health products during health emergencies remains largely unresolved, Moon said. “We’ve known this for quite some time, but actually we have very weak, frankly, quite non-existent rules and agreements at the international level to make sure that countries get access to vaccines, so this is not a surprise,” she said. “This is not something that is new to the global health community, but it’s something that we have not yet managed to address.” While some global frameworks do exist to allow LMICs to gain emergency access to lifesaving health products – such as the pre-existing donor-financed vaccine pool for 92 LMICs managed by Gavi, The Vaccine Alliance, or tools like the WTO’s TRIPS agreement (Trade-Related Aspects of Intellectual Property Rights) – the global south still struggles to take advantage of available IP flexibilities, partially due to fear of retaliation from stronger nations and big pharma. And recent negotiations over a South African and Indian proposal for a more far-reaching TRIPS waiver have “not been easy” either, noted Trudi Makhaya, who is economic advisor to South Africa’s President Cyril Ramaphonsa. Trudi Makhaya, Economic Advisor to South Africa’s President Cyril Ramaphonsa. Another alternative, the WHO-backed voluntary licensing pool, has also failed to garner pharma support for now. Still, there is a growing appreciation that technology transfer and the development of more local health product manufacturing capacity is crucial for low- and middle-income countries going forward, said Makhaya. Notably, new World Trade Organization Director General Dr Ngozi Okonjo-Iweala has talked about a “third way” that would encourage big pharma to sign more voluntary deals with countries for local production – without impinging on intellectual property rights. However, Makhaya remains wary: “There is an appreciation that there’s got to be technology transfer [to LMICs], there’s got to be local manufacturing and that current other alternative arrangements to do that, in the absence of the TRIPS [waiver], are going to be very difficult,” she said. Economy Among the Myriad Of Global Health Challenges But access to vaccines is only one of a myriad challenges facing low- and middle-income countries in the pandemic response. Makhaya also talked about the economic response to COVID : while some “important” ideas have been floated by the international community to bolster fragile economies – such as special IMF drawing rights for low-income countries – fiscal measures have remained stunted in poorer nations, in comparison to advanced countries that have pumped up to 20% of their GDP into local economies for temporary relief to businesses and the unemployed, she said. “There have been significant calls that there should be resources at the global level that should be injected [into emerging economies],” said Makhaya. “ A key example was special drawing rights at the IMF…[but] it hasn’t found much expression.” “We have a situation where amongst advanced countries’ central banks there’s cooperation, but none has been extended to many other developing countries.” Added Juan Jorge Gómez Camacho, Mexico’s Ambassador to Canada: “Health is not just about health itself,” he said.“Health means prosperity, or the lack of. Health means economic growth, or the lack of. “Health means wealth or poverty. Health is everything. In other words, health criss-crosses all the spectrum of human activity – socially, politically, economically.” Some Successes: COVAX is Unprecedented Dr Tedros Adhanom Ghebreyesus speaking at Thursday Global Health Centre event Even so, some successes have been apparent since the pandemic struck. If the global health community has achieved anything, it is the WHO co-sponsored COVAX global vaccine facility, which has successfully brought together 190 countries “out of thin air” in the aim to provide more equitable distribution of coronavirus vaccines around the world, said Moon. “The access to COVID-19 tools accelerator is health diplomacy in action,” added Dr. Tedros. “It is an unprecedented collaboration between countries, international agencies, the private sector, and other partners to ensure vaccines, diagnostics and therapeutics are shared equitably as global public goods. Vaccine equity is a litmus test for solidarity and global health diplomacy.” Just last Friday, G7 leaders committed an additional $4.3 billion to the ACT Accelerator initiative, which includes COVAX, as well as parallel efforts for tests and treatments and health systems strengthening. That brings the total commitment to ACT for 2021 to $10.3 billion – although global health leaders say that another $22.9 billion is still needed for all arms of the initiative. Local Manufacturing Of New Vaccines Scaling up generic manufacture of COVID-19 vaccines could help expand supply and stimulate local economies Meanwhile, some vaccine-makers have made strides in advancing more local production of their vaccines around the world. Russia’s Sputnik V vaccine, for instance, which showed impressive results in the publication of recent Phase 3 results in The Lancet, is already being produced in India, South Korea, Brazil, China. And production is set to begin in Kazakhstan and Belarus, among other countries like Turkey and Iran – although Sputnik has yet to receive formal regulatory approval from a western regulatory agency or the World Health Organization. India’s Serum Institute is manufacturing a local version of the Oxford/AstraZeneca, recently approved by the European Medicines Agency. The vaccine, locally branded as Covishield, is set to play a big part in advancing the access agenda through the COVAX facility as well as through bilateral deals. Over the past two weeks, India has exported 23 million doses of the locally-produced “Covishield” vaccine to low- and middle-income countries, said National Editor for The Hindu media outlet Suhasini Haidar, who also spoke at the panel event. Still, despite the big ambition for COVAX to distribute more than 2 billion vaccines by the end of 2021, it is a rather sobering fact that COVAX-supplied countries will only be able to vaccinate 3% of their population over the first half of this year, said Moon, adding, “frankly, we need to aim far, far, higher than that.” Meanwhile, countries like Canada have already ordered five times more vaccines than they need, and the EU has ordered twice as many vaccine doses than it needs. That has opened a debate about vaccine sharing of surplus stocks by rich countries to poorer ones – an exchange which WHO would like to encourage through the COVAX facility instead of through uneven bilateral deals and donations. Global Solutions Are Important – But Regional Solutions Also Required India’s prime minister Narendra Modi as he recently announced a South East Asia regional initiative. Finally, while global frameworks are crucial in the pandemic response, countries shouldn’t wait for Geneva to take action, added other panelists. Notably, the African continent has come together in unprecedented ways through initiatives like the African Response Fund, the African Medical Supplies Platform, or the African Vaccine Acquisition Task Force, among others, said Makhaya. “Instead of looking at the world as one large area of cooperation, perhaps [we need smaller] building blocks, much more about the regions and then come to some kind of success,” added Haidar. “If we only look at the solutions as an all-or-nothing huge global system, I think we’re going to close off,” added Moon. “It’s a very complex multipolar ecosystem with lots of different solutions being figured out by different actors who are not waiting for the answers to come from Geneva.” Indeed, as this event was happening, other new regional initiatives were also taking shape – including Europe’s announcement of an emergency biodefense plan and a SouthEast Asia regional initiative for pandemic preparedness and medical emergencies mooted by Indian Prime Minister Narendra Modi. This, however, does not mean “we don’t need Geneva”, said Moon. “We absolutely need global frameworks and global agreements, but when we think about how have countries figured out how to solve their problems, it has not always been through massive global agreements and so I think we have to think creatively about how does the entire ecosystem work, including what needs to truly be global versus [regional].” One of the newer global frameworks that is now gaining steam is a “Pandemic Treaty”proposed by DG Tedros at the World Health Assembly. The treaty aims to garner stronger political commitment towards pandemic preparedness and response, noted the WHOs regional director for the EMRO region Jaouad Mahjour, also appearing at the panel debate. But until such initiatives are put into force, it “isn’t difficult” to guess who will emerge as a winner in the pandemic response, warned Kazathckine. “Health is a political choice that can and must transcend politics,” Dr Tedros said at the Thursday event. “That’s why this book is so important to build the health diplomacy capacity of both diplomats and health experts around the world.” But as Moon reminded the panel: “At the end of the day, the big challenge will not be what needs to be done, but actually how to do it. “And this is the work of diplomats – just how to implement, and how to navigate the politics… reminds us that the work of diplomats is really just beginning and that there’s a huge agenda ahead of us.” Other Key Points By Panelists “Sharing expertise and information should be at the heart of global health diplomacy. Global collaboration is key to a more equal and sustainable world that benefits all of us” said @JosepBorrellF during the launch of our Guide to Global Health Diplomacy. @EU_Commission pic.twitter.com/CBGyb2MOAx — Global Health Centre (@GVAGrad_GHC) February 18, 2021 Juan Jorge Gómez Camacho, Ambassador of Mexico to Canada.“The only way we can address this pandemic is by moving all together. We cannot address [the pandemic] country by country. It is self-defeating not only collectively [but also] individually as a country, if we focus on us instead of focusing on working together. For a diplomat, to understand in this case it is not my own interest versus everybody else’s interests. In fact, everybody else’s interest is in my best interest. Joseph Borrell Fontelles, High Representative of the EU for Foreign Affairs and Security Policy Vice-President of the European Commission -“Sharing expertise and information should be at the heard of global health diplomay.” Dr Tedros, WHO Director General “If we have learned anything, this past year, it’s that none of us can go it alone. We can only thrive when we work together across institutions across borders,” he said. “That’s why it’s truly a pleasure to join you for the launch of the guide to global health diplomacy.” Margaret Chan, former WHO Director General “Without diplomacy, we cannot begin to negotiate,” she said.“And we cannot begin to [advance] the important policy decisions that impact the health and well being of the world’s population.” Alain Berset, Federal Councillor of Switzerland “The value of global health diplomacy has probably never been more apparent as it is today,” he said. “In this crisis, we need skilled diplomacy to find good solutions.” Michel Kazathchkine, member of the Independent Panel for Pandemic Preparedness and Response “The question for us today…is not whether 2020 has been the year of global health diplomacy, but what has global health diplomacy achieved during the crisis, and where has it failed, and looking forward, which are the challenges.” "The value of global health diplomacy has never been more apparent as it is today. In this pandemic, the international community needs to come together in solidarity. We need skilled diplomacy to find good solutions to global challenges." @alain_berset @BAG_OFSP_UFSP @BAG_INT pic.twitter.com/R0s5F2ASAp — Global Health Centre (@GVAGrad_GHC) February 18, 2021 Global Health Diplomacy Book – Co Published with the WHO and the Swiss Federal Council The new book, published in collaboration with the WHO and the Swiss Federal Council, will be translated into Chinese and Portuguese, among other languages, said Kickbush. Given that health is negotiated across all sectors, the new guide is relevant to a range of stakeholders, including the media, civil society, academia, as well as ministries across various sectors, emphasized the Global Health Centre’s co-director Suerie Moon. “The book makes it quite clear that you don’t need to be a health specialist and you don’t need to be a former diplomat, and in fact some of the most important global diplomats are economic advisors or are coming from media or coming from civil society and academia and foundations and not necessarily from the traditional ranks of diplomacy. “If there’s one lesson we’ve really seen over the past year from COVID it’s that diplomacy is not only the responsibility of ministries of health, but trade, science, technology, intellectual property, travel, tourism, finance…Every single one of these ministries in government needs to be mobilized to negotiate solutions.” Read the Global Health Centre’s new guide here https://www.graduateinstitute.ch/GHD-Guide Image Credits: NBC, European Health Forum Gastein, IHEID, Twitter: @WHOAFRO. EU Cannot Sue AstraZeneca – Germany Commits to Sharing Doses 22/02/2021 Madeleine Hoecklin & Kerry Cullinan Threats from the European Commission to sue AstraZeneca over the delay in deliveries of COVID-19 vaccines hold no weight, according to the EU’s contract with the pharma company in which the right to sue was waived. Following the drugmaker’s announcement in late January of a 60% shortfall in vaccine deliveries for the first quarter after its manufacturing plants in Europe hit a number of snags, furious EU officials examined possible legal avenues to resolve the issue. The release of the full contract by RAI, an Italian broadcaster, makes public several key elements that were redacted from a version previously published by the European Commission. In particular it reveals that the Commission is unable to sue for issues with the storage, transport, and administration of vaccines, including delays in the delivery of vaccines. The exception to the restrictions on the right to legal action is AstraZeneca’s “wilful misconduct or failure to comply with EU regulatory requirements…including manufacture.” While the EU’s hands are tied in terms of filing a lawsuit, there are other pathways open, including suspending payments to AstraZeneca. The initial funding for the doses promised to the EU totals €336 million, of which the Commission already paid two-thirds. The remaining €112 million is supposed to be paid within 20 days of receiving the first installment of doses, however, with the lack of evidence of progress towards manufacturing the doses, “the Commission will have no obligation to pay the second installment and may seek to recover the first installment or a portion of it,” states the contract. It appears that AstraZeneca overestimated its manufacturing capacity and supply to the EU, setting a goal of delivering 300 million doses by the end of 2021, with 30 million doses by the end of 2020, 40 million in January, 30 million in February, 20 million in March, 80 million in April, 40 million in May, and 60 million in June. The company agreed to use its “best reasonable effort” to manufacture the initial doses ordered by the EU and to build its manufacturing capacity. AstraZeneca recently announced that it can deliver 41 million doses by the end of March with its “best reasonable effort.” That estimate is 20 million fewer doses than initially predicted, meaning the drugmaker is over two months behind schedule. Germany Commits to Sharing Vaccine Doses WHO’s Tedros and Germany’s President Frank-Walter Steinmeier address the media. German President Frank-Walter Steinmeier committed his country to sharing some of the vaccines it has ordered with low-income countries at a joint press conference with World Health Organization Director General Dr Tedros Adhanom Ghebreyesus, on Monday. However, Steinmeier said how this would be done and how many vaccines would be shared was still under discussion. Last Friday, Germany announced that it would be contributing an additional €1.5 billion in funding for the multilateral response to the pandemic, including the ACT Accelerator, at the G7 leaders’ meeting last week. Steinmeier also used the briefing to restate Germany’s opposition to the proposal of a waiver on patent protection for COVID-19 related products, as mandated by the Agreement on Trade-Related Aspects of Intellectual Property Rights, known as the TRIPS waiver. “The interest of public institutions and private companies have to be kept alive to invest in research and the development of drugs medicines and vaccines,” said Steinmeier. “So I don’t think the proposal some have made that we have waiver for patents or licensing would be the right approach.” The TRIPS waiver, currently being discussed by the World Trade Organization, has wide support including from the WHO, but it is floundering because of opposition from wealthy countries with powerful pharmaceutical industries, like Germany, the US and the UK. While Tedros welcomed Germany’s financial contribution, he pointed out that while many wealthy countries claimed to support the global vaccine access facility, COVAX, they were still trying to do bilateral deals with manufacturers for more vaccine doses “without stopping to ask whether this was undermining COVAX”. “This pandemic is really unprecedented, and we have to do everything to defeat this common enemy including waivers on intellectual property to increase production,” said Tedros. He added that the WHO was engaging directly with manufacturers and encouraging pharmaceutical companies to “turn over their facilities to produce other companies’ vaccines as Sanofi has done for the BioNTech vaccine”, and issue non-exclusive licences to enable other manufacturers to produce their vaccines. G-7 Commitments Of US$4.3 Billion Not Enough – Rich Countries Need To Stop COVID Vaccine Hoarding to Open Access Bottleneck, Says WHO Director General 22/02/2021 Kerry Cullinan Dr Tedros Adhanom Ghebreyesus, WHO Director General, at the press briefing on Friday. Despite Friday’s commitment by G-7 countries to donate another US$ 4.3 billion to a global COVID vaccine campaign, World Health Organization Director General, Dr Tedros Adhanom Ghebreyesus has accused high-income nations of still undermining equitable vaccine rollout by “doing deals” with manufacturers that deplete supplies available to the COVAX global vaccine facility. Speaking at the WHO’s biweekly media briefing, Tedros thanked the G-7 and the European Union for the new donations – but stressed that money was not enough: “If there are no vaccines to buy, money is irrelevant. Currently, some high-income countries are entering contracts with vaccine manufacturers that undermine the deals that COVAX has in place and reduce the number of doses COVAX can buy,” said Dr Tedros. “Unless we end the pandemic everywhere, we will not end it anywhere. To achieve this, we need more funding. We need countries to share doses immediately. We need manufacturers to prioritise contracts with COVAX. And we also need a significant increase in the production of vaccines.” HIV Provides Global Precedent, Says Anthony Fauci The HIV pandemic provides a “precedent” for how to get life-saving medicines to those who could not afford them – while allowing pharma companies to “maintain a considerable amount of profit”, said Anthony Fauci, US President Joe Biden’s chief scientific advisor and a guest at the WHO briefing. During the early days of the HIV pandemic, there was a lot of discussion about whether expanding the generic manufacture of new HIV antiretroviral drugs would “interfere with the appropriate profit that companies that made major investments in the development of [antiretroviral] drugs”, Fauci recalled. But through various platforms, including the US-sponsored President’s Emergency Plan for AIDS Relief (PEPFAR) as well as the new Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria, life-saving generic drugs reached millions of people and “did not have a deleterious effect on the companies who continued to do well financially and continue to make investments in research”. Even so, the pathway to those breakthroughs was painstaking, observed WHO’s Assistant Director-General for Drug Access, Mariângela Simão, observing that “too many people died unnecessarily” as rich and poor countries battled over access to HIV medicines. Mechanisms such as the Medicines Patent Pool, created to expand generic drug manufacturing in collaboration with the innovative pharma industry have provided “a proven platform to ensure that both voluntary licensing and technology transfer to increase access to medicines for HIV,TB and malaria”, said Simão. Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines But so far, the MPP precedents hasn’t been harnessed to the COVID-19 vaccine roll-out. She lamented: “Why can we not use the platform that WHO has in place, like COVID Technology Access Pool (C -TAP), to make COVID-19 technology accessible and manage intellectual property needs. “Intellectual property is not the endpoint. The endpoint is increasing manufacturing capacity and making sure good quality, efficacious and safe vaccines reach the developing countries,” Simão added. COVAX Sets Up ‘No-Fault’ Compensation Fund Earlier in the day COVAX announced that the WHO had reached an agreement with a global third party insurance provider, ESIS Inc, to administer a no-fault vaccine injury compensation programme for the 92 low- and middle-income countries and economies eligible for donor support to their vaccine campaigns. “As the first and only vaccine injury compensation mechanism operating on an international scale, the programme will offer eligible individuals in AMC-eligible countries and economies a fast, fair, robust and transparent process to receive compensation for rare, but serious adverse events associated with COVAX-distributed vaccines until 30 June 2022,” according to the global vaccine alliance, GAVI, which administers COVAX. By providing a no-fault lump-sum compensation in full and final settlement of any claims, COVAX aims to “significantly reduce the need for recourse to the law courts, a potentially lengthy and costly process”. ESIS, which is part of the Chubb group, will not charge any fees to applicants. “The No-Fault Compensation fund is a massive boost for COVAX’s goal of equitable global access to vaccines: by providing a robust, transparent and independent mechanism to settle serious adverse events it helps those in countries who might have such effects, manufacturers to roll out vaccines to countries faster, and is a key benefit for lower-income governments procuring vaccines through the Gavi COVAX AMC,” said GAVI CEO Seth Berkley. The COVAX no-fault compensation programme will come into operation via a web portal (www.covaxclaims.com) by 31 March, and people will be able to apply for compensation even if they were given a COVAX-distributed vaccine before this date. The programme is financed initially through a levy charged on all doses of COVID-19 vaccines distributed through the COVAX Facility to the AMC eligible economies until 30 June 2022. All vaccines procured or distributed through the COVAX Facility will have received prior regulatory approval from a strict national authority and/or a WHO emergency use authorization to confirm their safety and efficacy. But, as with all medicines, even vaccines that are approved for general use may, in rare cases, cause serious adverse reactions. No Need for People With Allergies to Avoid Vaccination in Fear of Anaphylactic Shock Dr Soumya Swaminathan, WHO Chief Scientist. On a more technical level of the risks of anaphylactic reactions associated with the Pfizer/ BioNTech and Moderna vaccines, Fauci said that these have been very rare events – and are most likely linked to the polyethylene glycol in the vaccine preparation. “There are 4 to 5 per million anaphylactic reactions for the Pfizer vaccine and between 2 and 3 per million to the Moderna, so it’s an unusual, rare interaction,” said Fauci. While people with known anaphylactic reactions may be advised to take special precautions, or in some cases not to be vaccinated with the mRNA vaccines, there is no reason for people with a general history of allergic reactions, to avoid vaccination, he added. Nancy Messonier, of the US Centers for Disease Control and Prevention who is leading the US Centers for Disease Control vaccine effort, told the media briefing that people who have had a history of anaphylaxis were being asked to stay at the health facility for 30 minutes after vaccination “because all the cases in US have occurred within that 30 minutes timeframe”. WHO’s Chief Scientist, Soumya Swaminathan, stressed that “every country has a system in place to do safety monitoring” and this has been coordinated by the WHO. “So far, over 200 million vaccine doses have gone into people around the world and there have been no alarming safety signals, but we will continue to monitor and update, if anything changes,” said Swaminathan. Image Credits: WHO. India Moots Regional Pandemic Platform with 10 Neighbours 22/02/2021 Menaka Rao After donating over 6 million Covid vaccines to more than 13 countries, the Indian government suggested the creation of a regional pandemic platform for preparedness and medical emergencies with its 10 neighbouring countries. At a meeting with health officials, Indian Prime Minister Narendra Modi proposed creating “a special visa scheme” for doctors and nurses to enable swift travel during health emergencies,coordinated air ambulances, a regional platform for “collating, compiling and studying data about the effectiveness of Covid-19 vaccines” and a network for “promoting technology-assisted epidemiology for preventing future pandemics.” India has reported more 11 million COVID-19 cases and over 156,000 deaths. Although cases have been declining since September last year and had considerably reduced by January, there has been an increase of about 31% in the past week, mostly in the Western state of Maharashtra. “Through our openness and determination, we have managed to achieve one of the lowest fatality rates in the world,” said Modi. “This deserves to be applauded. Today, the hopes of our region and the world are focused on rapid deployment of vaccines. In this too, we must maintain the same cooperative and collaborative spirit.” Modi was referring to the Indian government’s “Vaccine Maitri” (meaning vaccine friendship) initiative, through which the Indian government has donated more than 6.27 million doses of COVID-19 vaccines to more than 13 countries, including neighbours Bangladesh, Afghanistan, Bhutan, Myanmar and countries such as Oman, Barbados and El Salvador. It also commercially exported 10.5 million doses of vaccines to 8 countries. Modi was addressing a workshop on COVID-19 management attended by health leaders, experts and officials of Afghanistan, Bangladesh, Bhutan, Maldives, Mauritius, Nepal, Pakistan, Seychelles, Sri Lanka and India. Evoking the “spirit of collaboration” among these countries, Modi said that India and these countries have a lot in common and should share their successful health policies and schemes. “We share so many common challenges – climate change, natural disasters, poverty, illiteracy, and social and gender imbalances. But we also share the power of centuries old cultural and people-to-people linkages. If we focus on all that unites us, our region can overcome not only the present pandemic, but our other challenges too,” he said. Variants May be Associated With Surge in COVID Cases In the last few days, the Maharashtra state government reported a sudden burst of cases in the Vidarbha region, closer to Central India. The genome sequencing of a few cases in Amravati district showed “unique mutations” including E484Q, which is similar to a mutation (E484K) found in South African and Brazilian variants, according to a Times of India report. Maharashtra and Kerala account for more than 74% of the cases in the country while Chhattisgarh and Madhya Pradesh are also seeing a rise. This is in contrast to the steady downward trend of the pandemic in India since last September last year. The country is reporting an average of 12,000 cases a day, as compared to more 90,000 cases in a day in September. Experts have attributed the overall fall in COVID-19 positive cases over the past few months to herd immunity caused by widespread infection, especially in cities such as Mumbai, Pune, and Delhi which saw the largest outbreaks in the country. A recent round of sero-surveillance in Delhi between January 15 to January 23 among 28,000 people found that 56% of those surveyed had antibodies against COVID-19. “Those infected with Covid will only protect themselves but also protect others. Half the population will not transmit to others. Besides, the susceptible population is reduced by 50%,” explained Dr Sanjay Rai, from Delhi’s All India Institute of Medical Sciences. Citing a recently published study in the New England Journal of Medicine, Rai said that those who are infected are protected from disease for at least six months. The study which was conducted with more than 12,000 health workers in the UK, showed that presence of antibodies was associated with a substantially reduced risk of reinfection in six months. More than 9 million people have been at least given one dose of the vaccine. “India has a young population. About 50% of the population is under 25 years, and 65% of the population under 35 years. There could be a very large fraction of the population then which had asymptomatic infections and were not tested. They would also offer some protection to the population,” said Dr Shahid Jameel, a virologist with Ashoka University, Delhi. However, a nation-wide survey showed only one out of 5 people have been exposed to the virus. “The message is that a large proportion of the population remains vulnerable,” said Dr. Balram Bhargava, who heads Indian Council of Medical Research, that helmed the national-wide sero-survey. Meanwhile, there is some evidence that people who have already had COVID-19 can become reinfected with variants. Image Credits: https://dashboard.cowin.gov.in/. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Global Citizen Launches ‘Recover Better Together’ Campaign – Guinea Launches Ebola Vaccinations – Nigeria & Zambia Studies Show High SARS-CoV2 Infections 23/02/2021 Kerry Cullinan Global Citizen CEO Hugh Evans launches 5-point global recovery campaign Vaccinating all of Africa’s health workers would need half a percent of all the doses that the G-7 countries have purchased, according to Global Citizen CEO Hugh Evans. On Tuesday, Global Citizen launched a five-point ‘Recover Better Together’ plan for the world, aimed at getting millions of citizens behind ending COVID-19 for all, ending the hunger crisis, resuming learning for children, fully protecting the planet, and advancing equity for all. “First we must focus on achieving sufficient worldwide vaccine coverage to break the chain of transmission, including, for the poorest nations,” Evans told a media briefing convened jointly with the World Health Organization, and addressed by world leaders including European Commission president Ursula von der Leyen, US Special Envoy in Climate John Kerry and South African president Cyril Ramaphosa. In his address, Ramaphosa applauded French president Macron who has called on rich countries to donate 5% of their vaccines to needy countries. “Another important step is to enable the transfer of medical technology for the duration of the pandemic. This will allow us to increase the production of COVID-19 vaccines and other medical products, lower prices, and improve distribution so that these vaccines and medical supplies reach all corners of the world,” said Ramaphosa. Guinea Starts Ebola Vaccination Drive – Nigerian and Zambian Studies Show High Levels of SARS-CoV2 Infection Healthworkers during the 2017 Ebola outbreak in the DRC. Guinea started Ebola vaccinations on Tuesday of people at high risk in Gouecke, a rural community in N’Zerekore prefecture where the first cases were detected on 14 February – the first cases since 2016. “All people who have come into contact with a confirmed Ebola patient are given the vaccine, as well as frontline and health workers. The launch started with the vaccination of health workers,” according to a media release from WHO’s Africa region. “The last time Guinea faced an Ebola outbreak, vaccines were still being developed,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “With the experience and expertise it has built up, combined with safe and effective vaccines, Guinea has the tools and the know-how to respond to this outbreak. WHO is proud to support the government to engage and empower communities, to protect health and other frontline workers, to save lives and provide high-quality care.” The WHO sent 11 000 doses of the rVSV-ZEBOV Ebola vaccine from its headquarters in Geneva, while a further 8500 doses are being procured from Merck, the vaccine’s producer in the US, “The speed with which Guinea has managed to start up vaccination efforts is remarkable and is largely thanks to the enormous contribution its experts have made to the recent Ebola outbreaks in the DRC,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “Africans supporting fellow Africans to respond to one of the most dangerous diseases on the planet is a testament to the emergency response capacity we have built over the years on the continent.” Implementing an Ebola vaccination strategy is a complex procedure as the vaccines need to be maintained at a temperature of minus 80 degrees centigrade. Guinea has developed ultra-cold chain capacity with vaccine carriers, which can keep the vaccine doses in sub-zero temperatures for up to a week. There are eight cases (four confirmed and four probable) and five people have died so far. Guinea’s neighbours are on high alert, particularly Liberia and Cote d’Ivoire which are close to the border with N’Zerekore, Guinea’s second-largest city. Meanwhile, a second person died of Ebola last week in the Democratic Republic of the Congo’s North Kivu province. Ebola, a haemorrhagic fever, is transmitted from wild animals and spreads in the humans through direct contact with the blood, and bodily fluids of infected people, and contaminated surfaces and materials. Nigeria’s First SARS-CoV-2 Seroprevalence Study Finds Almost 25% of Lagos Residents Had Antibodies Lagos Almost a quarter of Nigerians living in Lagos may have been infected with SARS-CoV2, according to the results of a seroprevalence study released on Monday by the Nigeria Centre for Disease Control (NCDC) and Nigeria Institute for Medical Research (NIMR) The household seroprevalence survey was conducted in Lagos, Enugu, Nasarawa and Gombe States in September and October last year and involved blood samples from over 10,000 people. SARS-CoV-2 antibodies were found in 23% of people sampled in Lagos and Enugu States, 19% in Nasarawa State, and 9% in Gombe State. “These rates of infection are higher than those reported through the national surveillance system and reveal that the spread of infection in the states surveyed is wider than is obvious from surveillance activities,” according to a statement by the NCDC and NIMR. The survey also showed that men had higher infection rates than women (21% of men and 17% of women in Nasarawa), and urban areas had higher infection rates than rural areas (28% of urban residents and 18% of rural residents in Enugu). The survey is currently being expanded to more states in the North-West and South geopolitical zones which were not included in the initial round of surveys. Zambia Post-Mortems Find High Level of SARS-CoV2, Minimal Testing Post-mortem surveillance of 364 Zambians who died between June and September last year detected SARS-CoV2 in 70 (19%), according to a study published in the BMJ last week. PCR tests were administered on people at the University Teaching Hospital morgue in the capital of Lusaka within 48 hours of death. Fifty of the 70 with COVID-19 had died in their communities without ever having been tested for the virus. Only five of the 19 who died in hospital had been tested. Seven children were part of the study and only one had been tested before death. The most common co-morbidities among those who died of the virus were tuberculosis (31%), hypertension (27%), HIV/AIDS (23%), alcoholism (17%), and diabetes (13%). Image Credits: WHO, Wikipedia. ‘Rapid Response Platforms’ Enabled COVID-19 Vaccine Development, Says Fauci 23/02/2021 Madeleine Hoecklin The Epidemic and Pandemic Preparedness and Response panel at the GVIRF event on Monday. Rapid response platforms, particularly the messenger RNA (mRNA) platform, have changed the landscape of vaccine development, enabling the rapid response to the COVID-19 pandemic, said Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) on Monday. Fauci, speaking at the opening of the Global Vaccine and Immunization Research Forum (GVIRF), co-organized by WHO, the Bill & Melinda Gates Foundation, and the NIAID, highlighted the innovations in vaccinology that made the speedy development of COVID-19 vaccines possible. “There are a number of new technologies that have now really dominated our approach to COVID-19. For example, there’s genetic immunisation using RNA and DNA vaccines,” said Fauci. “We are well aware now of the successes, for example, of the mRNA vaccines.” Rapid response platforms are systems that can be adapted against different pathogens. In the case of mRNA vaccines, these have been developed over a number of years to address influenza, Zika and rabies and have shown a high level of efficacy against SARS-CoV2. The Pfizer/ BioNTech and Moderna SARS-CoV2 vaccines have both had over 95% efficacy against symptomatic COVID-19 and nearly 100% efficacy against severe disease. “I think it’s fair to say that rapid response platforms have been a revolution in vaccinology over 2020 with COVID-19,” said Melanie Saville, Director of Vaccine Research and Development at the Coalition for Epidemic Preparedness Innovations (CEPI). “These can be further developed and prepared for future outbreaks, epidemics, and pandemics.” Barney Graham, deputy director of the Vaccine Research Center at NIAID, added that, over the past 12 years in particular, “new technologies have improved our ability to both prepare for and respond to emerging threats, like structural biology protein engineering and rapid platform manufacturing.” Prototype Pathogen Approach Both Graham and Fauci described the prototype pathogen approach to pandemic preparedness vaccine research used at the NIAID. This refers to studying pathogens of a particular group to build on prior experiences and use strategies to inform vaccine design for related viruses. In developing vaccines for SARS-CoV2, structure-based vaccine designs from Middle East Respiratory Syndrome (MERS-CoV), which is in the family of coronaviruses, were used and “enabled us to rapidly get a successful vaccine, particularly with mRNA [technology],” said Fauci. With the technological advances and the unprecedented R&D work conducted over the past year with COVID-19, “I think we’ve probably moved forward a decade…with COVID-19 vaccines being developed in only 300 days, whereas usually, they would take multiple years, if not decades,” said Saville. The timeline of the mRNA COVID-19 vaccine development. “One thing to point out [is] the speed with which we went from appreciating the new virus, in this case SARS-CoV2, on January 10 of 2020, to starting a phase one trial, about 65 days later, a phase 3 trial both with Moderna and with Pfizer, on 27 July and now having both vaccines already being administered here in the United States and elsewhere. [This is] the fastest in the history of vaccinology from the identification of a particular pathogen to the actual administration of a vaccine,” said Fauci. Challenges with mRNA Platforms While mRNA technology has had great advances, there is still a lot that is unknown about this type of vaccine, including what type of RNA to use and what long-term immune response durability may be. The continued development of the rapid response platforms is needed to make progress on COVID-19 and future epidemics and pandemics. “In all cases, the more robust the platform, in terms of what safety data you have from the platform, what type of immune profile, and importantly, the manufacturing process – which is often really the rate-limiting factor, [the better it is to]…get them as fine-tuned as possible,” said Saville. The manufacturing the Pfizer/BioNTech and Moderna vaccines is limited and is largely centered in Europe and North America. A map of the manufacturing sites for mRNA COVID-19 vaccines globally. “What we need to really look at in the medium and longer-term [is]…how can that manufacturing footprint be much more amenable with regional manufacturing capacity,” said Saville. “Looking at manufacturing innovation…that could be amenable to the low- and middle-income countries [is] something that really needs to be followed.” Innovations in Manufacturing While numerous accomplishments have emerged from the COVID-19 pandemic, several shortcomings, particularly in vaccine development and manufacturing, have occurred. “There’s no question that COVID has demonstrated the potential of vaccine development and R&D, but it has also exposed some pretty major gaps in the system and [has shown] what happens when a disease strikes the entire world at the same time,” said Selwyn. These gaps include the limitedd supply of vaccines secured for low- and middle-income countries; high-income countries pre-ordering large amounts of vaccines for themselves; the reduction in production capacity for other diseases, which may increase the risk of outbreaks; and the dependency on tech transfers. “In COVID, there were multiple companies who had quite limited experience with vaccine manufacturing and bringing vaccines through licensure, [who were] planning for upwards of 10 tech transfers in a single year,” said Casey Selwyn, senior officer in Vaccine Development and Global Health COVID-19 Response at the Gates Foundation, at a workshop that followed the opening session. Normally a company may undertake one transfer a year. The Innovations in Vaccine Manufacturing workshop at the GVIRF session on Monday. “To maximize global supply, we need to have innovative ways to ease and encourage tech transfer…A tech transfer requires time, it requires resources and sharing of know-how, not just intellectual property,” Selwyn added. The most efficient way to scale up vaccine production and supply over the long term is to build “ever-warm” vaccine facilities that are multi-platform and multi-purpose with a trained workforce, so that the facilities can be prepared when an outbreak occurs, proposed Selwyn. Another recommendation for innovating global manufacturing was to implement a hub and spoke distribution model, which would create a centralized network where products are received in central locations before being sent directly to their destinations. According to Selwyn, this could ease the pressure of tech transfers and establish a better geographical reach, creating a more flexible, accessible and cost effective system. Alternatively, increasing standardization of manufacturing protocols and regulatory requirements – which could include the labeling of products, serialization, and design of protocols – could also improve speed, flexibility, and cost-efficiency. “Probably one of the most important sets of innovations, sets of lessons and sets of actions for the future is really continuing to pursue uniformity and harmonization, especially for a set of diseases and pathogens that require rapid response,” said Anant Shah, New Product Lead for Global Vaccines for COVID-19 and Ebola at Merck. “We have to pursue uniformity, flexibility and efficiency if we want to continue ensuring global equitable access,” said Shah. Image Credits: NBC, GVIRF. Global Health Diplomacy In The COVID-19 Era – Can Failure Usher In A New Era of Success? 22/02/2021 Svĕt Lustig Vijay More than a year into the world’s largest global health emergency, health diplomats have fought hard to ensure that every country across the globe secures access to lifesaving coronavirus health products, including vaccines, treatments, and diagnostics. That has not happened yet, given that 80% of countries that are now rolling out vaccines are either high-income or upper middle-income countries. Export bans on essential health products in 80 countries, ranging from personal protective equipment to ventilators, have not helped either. And in the absence of clear global guidance, up to 130 countries have imposed an uneven patchwork of travel restrictions in an attempt to keep more contagious variants at bay – mostly to no avail. A panel of some two dozen leading diplomats and health policy experts from WHO, government, academia and media pondered the current state of affairs, at the Global Health Centre’s (GHC) launch of a new Guide to Global Health Diplomacy, authored by GHC founder Ilona Kickbusch along with a former Hungerian Health Minister, Haik Nikogosian, former head of the Framework Convention on Tobacco Control, Mihály Kökény; and a preface from WHO’s Director General Dr Tedros Adhanom Ghebreyesus. The guide, co-sponsored by the Swiss Confederation, offers a compass to navigate the complexity of global health diplomacy through “practical insights” and “sound wisdom”, said Norway’s leader of the labor party Jonas Gahr Stør at the launch event on Thursday. Norway’s Labour Party leader, Jonas Gahr Støre The event featured some of the bright stars in the world’s global health constellation, including former WHO DG Margaret Chan; Trudi Makhaya, economic advisor to South Africa’s President Cyril Ramaphonsa, Suhasini Haidar, editor of India’s The Hindu Newspaper, Juan Jorge Gómez Camacho, Mexico’s Ambassador to Canada, and Swiss Federal Councillor Alain Berset. The event, moderated by Kickbusch, was co- sponsored by the World Health Organization and the Swiss Federal Council. Said Kickbush: “As you can see from the subtitle of this book [better health – improved global solidarity – more equity], the three words, health, so that health moves to the centre of negotiations, solidarity, and equity – those truly are the goals of global health diplomacy.”Better health – improved global solidarity – more equity Ilona Kickbusch, Founding Director of the Graduate Institute’s Global Health Centre in Geneva. Crisis Has Shown The Failures of The Current International Health Regulations System For Pandemic Preparedness & Response Michel Kazathchkine, former Executive Director of the Global Fund and a member of the Independent Panel for Pandemic Preparedness and Response The pandemic has uncovered “many flaws” in global preparedness and response, said Michel Kazathckine, former executive director of the Global Fund to fight AIDS, Tuberculosis and Malaria, and currently serving as a member of the Independent Panel for Pandemic Preparedness and Response, mandated by the World Health Assembly in May, to explore how and why the SARS-CoV2 pandemic caught the world so badly off guard. “The international system we have established for health security did not really work as a system,” he said. “There were clear gaps in preparedness management of the response coordination.” If there is anything that diplomacy has “certainly” not achieved in the midst of the pandemic, it is “firm and binding commitments” at the international level, added the Global Health Centre’s co-director Suerie Moon. Suerie Moon, Co-Director of Global Health Centre at Geneva Graduate Institute Same Challenges Were Apparent in H5N1 Avian Flu Epidemic The challenges are not new. Some 15 years ago after the eruption of the H5N1 Avian Influenza epidemic, Indonesia protested the fact that after low- and middle-income Asian countries had shared samples of the emergent pathogen with research networks around the world, rich countries then bought up most of the vaccines thus produced – leaving other countries vulnerable. In 2021, the continued lack of clear and binding agreements to ensure equitable access to health products during health emergencies remains largely unresolved, Moon said. “We’ve known this for quite some time, but actually we have very weak, frankly, quite non-existent rules and agreements at the international level to make sure that countries get access to vaccines, so this is not a surprise,” she said. “This is not something that is new to the global health community, but it’s something that we have not yet managed to address.” While some global frameworks do exist to allow LMICs to gain emergency access to lifesaving health products – such as the pre-existing donor-financed vaccine pool for 92 LMICs managed by Gavi, The Vaccine Alliance, or tools like the WTO’s TRIPS agreement (Trade-Related Aspects of Intellectual Property Rights) – the global south still struggles to take advantage of available IP flexibilities, partially due to fear of retaliation from stronger nations and big pharma. And recent negotiations over a South African and Indian proposal for a more far-reaching TRIPS waiver have “not been easy” either, noted Trudi Makhaya, who is economic advisor to South Africa’s President Cyril Ramaphonsa. Trudi Makhaya, Economic Advisor to South Africa’s President Cyril Ramaphonsa. Another alternative, the WHO-backed voluntary licensing pool, has also failed to garner pharma support for now. Still, there is a growing appreciation that technology transfer and the development of more local health product manufacturing capacity is crucial for low- and middle-income countries going forward, said Makhaya. Notably, new World Trade Organization Director General Dr Ngozi Okonjo-Iweala has talked about a “third way” that would encourage big pharma to sign more voluntary deals with countries for local production – without impinging on intellectual property rights. However, Makhaya remains wary: “There is an appreciation that there’s got to be technology transfer [to LMICs], there’s got to be local manufacturing and that current other alternative arrangements to do that, in the absence of the TRIPS [waiver], are going to be very difficult,” she said. Economy Among the Myriad Of Global Health Challenges But access to vaccines is only one of a myriad challenges facing low- and middle-income countries in the pandemic response. Makhaya also talked about the economic response to COVID : while some “important” ideas have been floated by the international community to bolster fragile economies – such as special IMF drawing rights for low-income countries – fiscal measures have remained stunted in poorer nations, in comparison to advanced countries that have pumped up to 20% of their GDP into local economies for temporary relief to businesses and the unemployed, she said. “There have been significant calls that there should be resources at the global level that should be injected [into emerging economies],” said Makhaya. “ A key example was special drawing rights at the IMF…[but] it hasn’t found much expression.” “We have a situation where amongst advanced countries’ central banks there’s cooperation, but none has been extended to many other developing countries.” Added Juan Jorge Gómez Camacho, Mexico’s Ambassador to Canada: “Health is not just about health itself,” he said.“Health means prosperity, or the lack of. Health means economic growth, or the lack of. “Health means wealth or poverty. Health is everything. In other words, health criss-crosses all the spectrum of human activity – socially, politically, economically.” Some Successes: COVAX is Unprecedented Dr Tedros Adhanom Ghebreyesus speaking at Thursday Global Health Centre event Even so, some successes have been apparent since the pandemic struck. If the global health community has achieved anything, it is the WHO co-sponsored COVAX global vaccine facility, which has successfully brought together 190 countries “out of thin air” in the aim to provide more equitable distribution of coronavirus vaccines around the world, said Moon. “The access to COVID-19 tools accelerator is health diplomacy in action,” added Dr. Tedros. “It is an unprecedented collaboration between countries, international agencies, the private sector, and other partners to ensure vaccines, diagnostics and therapeutics are shared equitably as global public goods. Vaccine equity is a litmus test for solidarity and global health diplomacy.” Just last Friday, G7 leaders committed an additional $4.3 billion to the ACT Accelerator initiative, which includes COVAX, as well as parallel efforts for tests and treatments and health systems strengthening. That brings the total commitment to ACT for 2021 to $10.3 billion – although global health leaders say that another $22.9 billion is still needed for all arms of the initiative. Local Manufacturing Of New Vaccines Scaling up generic manufacture of COVID-19 vaccines could help expand supply and stimulate local economies Meanwhile, some vaccine-makers have made strides in advancing more local production of their vaccines around the world. Russia’s Sputnik V vaccine, for instance, which showed impressive results in the publication of recent Phase 3 results in The Lancet, is already being produced in India, South Korea, Brazil, China. And production is set to begin in Kazakhstan and Belarus, among other countries like Turkey and Iran – although Sputnik has yet to receive formal regulatory approval from a western regulatory agency or the World Health Organization. India’s Serum Institute is manufacturing a local version of the Oxford/AstraZeneca, recently approved by the European Medicines Agency. The vaccine, locally branded as Covishield, is set to play a big part in advancing the access agenda through the COVAX facility as well as through bilateral deals. Over the past two weeks, India has exported 23 million doses of the locally-produced “Covishield” vaccine to low- and middle-income countries, said National Editor for The Hindu media outlet Suhasini Haidar, who also spoke at the panel event. Still, despite the big ambition for COVAX to distribute more than 2 billion vaccines by the end of 2021, it is a rather sobering fact that COVAX-supplied countries will only be able to vaccinate 3% of their population over the first half of this year, said Moon, adding, “frankly, we need to aim far, far, higher than that.” Meanwhile, countries like Canada have already ordered five times more vaccines than they need, and the EU has ordered twice as many vaccine doses than it needs. That has opened a debate about vaccine sharing of surplus stocks by rich countries to poorer ones – an exchange which WHO would like to encourage through the COVAX facility instead of through uneven bilateral deals and donations. Global Solutions Are Important – But Regional Solutions Also Required India’s prime minister Narendra Modi as he recently announced a South East Asia regional initiative. Finally, while global frameworks are crucial in the pandemic response, countries shouldn’t wait for Geneva to take action, added other panelists. Notably, the African continent has come together in unprecedented ways through initiatives like the African Response Fund, the African Medical Supplies Platform, or the African Vaccine Acquisition Task Force, among others, said Makhaya. “Instead of looking at the world as one large area of cooperation, perhaps [we need smaller] building blocks, much more about the regions and then come to some kind of success,” added Haidar. “If we only look at the solutions as an all-or-nothing huge global system, I think we’re going to close off,” added Moon. “It’s a very complex multipolar ecosystem with lots of different solutions being figured out by different actors who are not waiting for the answers to come from Geneva.” Indeed, as this event was happening, other new regional initiatives were also taking shape – including Europe’s announcement of an emergency biodefense plan and a SouthEast Asia regional initiative for pandemic preparedness and medical emergencies mooted by Indian Prime Minister Narendra Modi. This, however, does not mean “we don’t need Geneva”, said Moon. “We absolutely need global frameworks and global agreements, but when we think about how have countries figured out how to solve their problems, it has not always been through massive global agreements and so I think we have to think creatively about how does the entire ecosystem work, including what needs to truly be global versus [regional].” One of the newer global frameworks that is now gaining steam is a “Pandemic Treaty”proposed by DG Tedros at the World Health Assembly. The treaty aims to garner stronger political commitment towards pandemic preparedness and response, noted the WHOs regional director for the EMRO region Jaouad Mahjour, also appearing at the panel debate. But until such initiatives are put into force, it “isn’t difficult” to guess who will emerge as a winner in the pandemic response, warned Kazathckine. “Health is a political choice that can and must transcend politics,” Dr Tedros said at the Thursday event. “That’s why this book is so important to build the health diplomacy capacity of both diplomats and health experts around the world.” But as Moon reminded the panel: “At the end of the day, the big challenge will not be what needs to be done, but actually how to do it. “And this is the work of diplomats – just how to implement, and how to navigate the politics… reminds us that the work of diplomats is really just beginning and that there’s a huge agenda ahead of us.” Other Key Points By Panelists “Sharing expertise and information should be at the heart of global health diplomacy. Global collaboration is key to a more equal and sustainable world that benefits all of us” said @JosepBorrellF during the launch of our Guide to Global Health Diplomacy. @EU_Commission pic.twitter.com/CBGyb2MOAx — Global Health Centre (@GVAGrad_GHC) February 18, 2021 Juan Jorge Gómez Camacho, Ambassador of Mexico to Canada.“The only way we can address this pandemic is by moving all together. We cannot address [the pandemic] country by country. It is self-defeating not only collectively [but also] individually as a country, if we focus on us instead of focusing on working together. For a diplomat, to understand in this case it is not my own interest versus everybody else’s interests. In fact, everybody else’s interest is in my best interest. Joseph Borrell Fontelles, High Representative of the EU for Foreign Affairs and Security Policy Vice-President of the European Commission -“Sharing expertise and information should be at the heard of global health diplomay.” Dr Tedros, WHO Director General “If we have learned anything, this past year, it’s that none of us can go it alone. We can only thrive when we work together across institutions across borders,” he said. “That’s why it’s truly a pleasure to join you for the launch of the guide to global health diplomacy.” Margaret Chan, former WHO Director General “Without diplomacy, we cannot begin to negotiate,” she said.“And we cannot begin to [advance] the important policy decisions that impact the health and well being of the world’s population.” Alain Berset, Federal Councillor of Switzerland “The value of global health diplomacy has probably never been more apparent as it is today,” he said. “In this crisis, we need skilled diplomacy to find good solutions.” Michel Kazathchkine, member of the Independent Panel for Pandemic Preparedness and Response “The question for us today…is not whether 2020 has been the year of global health diplomacy, but what has global health diplomacy achieved during the crisis, and where has it failed, and looking forward, which are the challenges.” "The value of global health diplomacy has never been more apparent as it is today. In this pandemic, the international community needs to come together in solidarity. We need skilled diplomacy to find good solutions to global challenges." @alain_berset @BAG_OFSP_UFSP @BAG_INT pic.twitter.com/R0s5F2ASAp — Global Health Centre (@GVAGrad_GHC) February 18, 2021 Global Health Diplomacy Book – Co Published with the WHO and the Swiss Federal Council The new book, published in collaboration with the WHO and the Swiss Federal Council, will be translated into Chinese and Portuguese, among other languages, said Kickbush. Given that health is negotiated across all sectors, the new guide is relevant to a range of stakeholders, including the media, civil society, academia, as well as ministries across various sectors, emphasized the Global Health Centre’s co-director Suerie Moon. “The book makes it quite clear that you don’t need to be a health specialist and you don’t need to be a former diplomat, and in fact some of the most important global diplomats are economic advisors or are coming from media or coming from civil society and academia and foundations and not necessarily from the traditional ranks of diplomacy. “If there’s one lesson we’ve really seen over the past year from COVID it’s that diplomacy is not only the responsibility of ministries of health, but trade, science, technology, intellectual property, travel, tourism, finance…Every single one of these ministries in government needs to be mobilized to negotiate solutions.” Read the Global Health Centre’s new guide here https://www.graduateinstitute.ch/GHD-Guide Image Credits: NBC, European Health Forum Gastein, IHEID, Twitter: @WHOAFRO. EU Cannot Sue AstraZeneca – Germany Commits to Sharing Doses 22/02/2021 Madeleine Hoecklin & Kerry Cullinan Threats from the European Commission to sue AstraZeneca over the delay in deliveries of COVID-19 vaccines hold no weight, according to the EU’s contract with the pharma company in which the right to sue was waived. Following the drugmaker’s announcement in late January of a 60% shortfall in vaccine deliveries for the first quarter after its manufacturing plants in Europe hit a number of snags, furious EU officials examined possible legal avenues to resolve the issue. The release of the full contract by RAI, an Italian broadcaster, makes public several key elements that were redacted from a version previously published by the European Commission. In particular it reveals that the Commission is unable to sue for issues with the storage, transport, and administration of vaccines, including delays in the delivery of vaccines. The exception to the restrictions on the right to legal action is AstraZeneca’s “wilful misconduct or failure to comply with EU regulatory requirements…including manufacture.” While the EU’s hands are tied in terms of filing a lawsuit, there are other pathways open, including suspending payments to AstraZeneca. The initial funding for the doses promised to the EU totals €336 million, of which the Commission already paid two-thirds. The remaining €112 million is supposed to be paid within 20 days of receiving the first installment of doses, however, with the lack of evidence of progress towards manufacturing the doses, “the Commission will have no obligation to pay the second installment and may seek to recover the first installment or a portion of it,” states the contract. It appears that AstraZeneca overestimated its manufacturing capacity and supply to the EU, setting a goal of delivering 300 million doses by the end of 2021, with 30 million doses by the end of 2020, 40 million in January, 30 million in February, 20 million in March, 80 million in April, 40 million in May, and 60 million in June. The company agreed to use its “best reasonable effort” to manufacture the initial doses ordered by the EU and to build its manufacturing capacity. AstraZeneca recently announced that it can deliver 41 million doses by the end of March with its “best reasonable effort.” That estimate is 20 million fewer doses than initially predicted, meaning the drugmaker is over two months behind schedule. Germany Commits to Sharing Vaccine Doses WHO’s Tedros and Germany’s President Frank-Walter Steinmeier address the media. German President Frank-Walter Steinmeier committed his country to sharing some of the vaccines it has ordered with low-income countries at a joint press conference with World Health Organization Director General Dr Tedros Adhanom Ghebreyesus, on Monday. However, Steinmeier said how this would be done and how many vaccines would be shared was still under discussion. Last Friday, Germany announced that it would be contributing an additional €1.5 billion in funding for the multilateral response to the pandemic, including the ACT Accelerator, at the G7 leaders’ meeting last week. Steinmeier also used the briefing to restate Germany’s opposition to the proposal of a waiver on patent protection for COVID-19 related products, as mandated by the Agreement on Trade-Related Aspects of Intellectual Property Rights, known as the TRIPS waiver. “The interest of public institutions and private companies have to be kept alive to invest in research and the development of drugs medicines and vaccines,” said Steinmeier. “So I don’t think the proposal some have made that we have waiver for patents or licensing would be the right approach.” The TRIPS waiver, currently being discussed by the World Trade Organization, has wide support including from the WHO, but it is floundering because of opposition from wealthy countries with powerful pharmaceutical industries, like Germany, the US and the UK. While Tedros welcomed Germany’s financial contribution, he pointed out that while many wealthy countries claimed to support the global vaccine access facility, COVAX, they were still trying to do bilateral deals with manufacturers for more vaccine doses “without stopping to ask whether this was undermining COVAX”. “This pandemic is really unprecedented, and we have to do everything to defeat this common enemy including waivers on intellectual property to increase production,” said Tedros. He added that the WHO was engaging directly with manufacturers and encouraging pharmaceutical companies to “turn over their facilities to produce other companies’ vaccines as Sanofi has done for the BioNTech vaccine”, and issue non-exclusive licences to enable other manufacturers to produce their vaccines. G-7 Commitments Of US$4.3 Billion Not Enough – Rich Countries Need To Stop COVID Vaccine Hoarding to Open Access Bottleneck, Says WHO Director General 22/02/2021 Kerry Cullinan Dr Tedros Adhanom Ghebreyesus, WHO Director General, at the press briefing on Friday. Despite Friday’s commitment by G-7 countries to donate another US$ 4.3 billion to a global COVID vaccine campaign, World Health Organization Director General, Dr Tedros Adhanom Ghebreyesus has accused high-income nations of still undermining equitable vaccine rollout by “doing deals” with manufacturers that deplete supplies available to the COVAX global vaccine facility. Speaking at the WHO’s biweekly media briefing, Tedros thanked the G-7 and the European Union for the new donations – but stressed that money was not enough: “If there are no vaccines to buy, money is irrelevant. Currently, some high-income countries are entering contracts with vaccine manufacturers that undermine the deals that COVAX has in place and reduce the number of doses COVAX can buy,” said Dr Tedros. “Unless we end the pandemic everywhere, we will not end it anywhere. To achieve this, we need more funding. We need countries to share doses immediately. We need manufacturers to prioritise contracts with COVAX. And we also need a significant increase in the production of vaccines.” HIV Provides Global Precedent, Says Anthony Fauci The HIV pandemic provides a “precedent” for how to get life-saving medicines to those who could not afford them – while allowing pharma companies to “maintain a considerable amount of profit”, said Anthony Fauci, US President Joe Biden’s chief scientific advisor and a guest at the WHO briefing. During the early days of the HIV pandemic, there was a lot of discussion about whether expanding the generic manufacture of new HIV antiretroviral drugs would “interfere with the appropriate profit that companies that made major investments in the development of [antiretroviral] drugs”, Fauci recalled. But through various platforms, including the US-sponsored President’s Emergency Plan for AIDS Relief (PEPFAR) as well as the new Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria, life-saving generic drugs reached millions of people and “did not have a deleterious effect on the companies who continued to do well financially and continue to make investments in research”. Even so, the pathway to those breakthroughs was painstaking, observed WHO’s Assistant Director-General for Drug Access, Mariângela Simão, observing that “too many people died unnecessarily” as rich and poor countries battled over access to HIV medicines. Mechanisms such as the Medicines Patent Pool, created to expand generic drug manufacturing in collaboration with the innovative pharma industry have provided “a proven platform to ensure that both voluntary licensing and technology transfer to increase access to medicines for HIV,TB and malaria”, said Simão. Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines But so far, the MPP precedents hasn’t been harnessed to the COVID-19 vaccine roll-out. She lamented: “Why can we not use the platform that WHO has in place, like COVID Technology Access Pool (C -TAP), to make COVID-19 technology accessible and manage intellectual property needs. “Intellectual property is not the endpoint. The endpoint is increasing manufacturing capacity and making sure good quality, efficacious and safe vaccines reach the developing countries,” Simão added. COVAX Sets Up ‘No-Fault’ Compensation Fund Earlier in the day COVAX announced that the WHO had reached an agreement with a global third party insurance provider, ESIS Inc, to administer a no-fault vaccine injury compensation programme for the 92 low- and middle-income countries and economies eligible for donor support to their vaccine campaigns. “As the first and only vaccine injury compensation mechanism operating on an international scale, the programme will offer eligible individuals in AMC-eligible countries and economies a fast, fair, robust and transparent process to receive compensation for rare, but serious adverse events associated with COVAX-distributed vaccines until 30 June 2022,” according to the global vaccine alliance, GAVI, which administers COVAX. By providing a no-fault lump-sum compensation in full and final settlement of any claims, COVAX aims to “significantly reduce the need for recourse to the law courts, a potentially lengthy and costly process”. ESIS, which is part of the Chubb group, will not charge any fees to applicants. “The No-Fault Compensation fund is a massive boost for COVAX’s goal of equitable global access to vaccines: by providing a robust, transparent and independent mechanism to settle serious adverse events it helps those in countries who might have such effects, manufacturers to roll out vaccines to countries faster, and is a key benefit for lower-income governments procuring vaccines through the Gavi COVAX AMC,” said GAVI CEO Seth Berkley. The COVAX no-fault compensation programme will come into operation via a web portal (www.covaxclaims.com) by 31 March, and people will be able to apply for compensation even if they were given a COVAX-distributed vaccine before this date. The programme is financed initially through a levy charged on all doses of COVID-19 vaccines distributed through the COVAX Facility to the AMC eligible economies until 30 June 2022. All vaccines procured or distributed through the COVAX Facility will have received prior regulatory approval from a strict national authority and/or a WHO emergency use authorization to confirm their safety and efficacy. But, as with all medicines, even vaccines that are approved for general use may, in rare cases, cause serious adverse reactions. No Need for People With Allergies to Avoid Vaccination in Fear of Anaphylactic Shock Dr Soumya Swaminathan, WHO Chief Scientist. On a more technical level of the risks of anaphylactic reactions associated with the Pfizer/ BioNTech and Moderna vaccines, Fauci said that these have been very rare events – and are most likely linked to the polyethylene glycol in the vaccine preparation. “There are 4 to 5 per million anaphylactic reactions for the Pfizer vaccine and between 2 and 3 per million to the Moderna, so it’s an unusual, rare interaction,” said Fauci. While people with known anaphylactic reactions may be advised to take special precautions, or in some cases not to be vaccinated with the mRNA vaccines, there is no reason for people with a general history of allergic reactions, to avoid vaccination, he added. Nancy Messonier, of the US Centers for Disease Control and Prevention who is leading the US Centers for Disease Control vaccine effort, told the media briefing that people who have had a history of anaphylaxis were being asked to stay at the health facility for 30 minutes after vaccination “because all the cases in US have occurred within that 30 minutes timeframe”. WHO’s Chief Scientist, Soumya Swaminathan, stressed that “every country has a system in place to do safety monitoring” and this has been coordinated by the WHO. “So far, over 200 million vaccine doses have gone into people around the world and there have been no alarming safety signals, but we will continue to monitor and update, if anything changes,” said Swaminathan. Image Credits: WHO. India Moots Regional Pandemic Platform with 10 Neighbours 22/02/2021 Menaka Rao After donating over 6 million Covid vaccines to more than 13 countries, the Indian government suggested the creation of a regional pandemic platform for preparedness and medical emergencies with its 10 neighbouring countries. At a meeting with health officials, Indian Prime Minister Narendra Modi proposed creating “a special visa scheme” for doctors and nurses to enable swift travel during health emergencies,coordinated air ambulances, a regional platform for “collating, compiling and studying data about the effectiveness of Covid-19 vaccines” and a network for “promoting technology-assisted epidemiology for preventing future pandemics.” India has reported more 11 million COVID-19 cases and over 156,000 deaths. Although cases have been declining since September last year and had considerably reduced by January, there has been an increase of about 31% in the past week, mostly in the Western state of Maharashtra. “Through our openness and determination, we have managed to achieve one of the lowest fatality rates in the world,” said Modi. “This deserves to be applauded. Today, the hopes of our region and the world are focused on rapid deployment of vaccines. In this too, we must maintain the same cooperative and collaborative spirit.” Modi was referring to the Indian government’s “Vaccine Maitri” (meaning vaccine friendship) initiative, through which the Indian government has donated more than 6.27 million doses of COVID-19 vaccines to more than 13 countries, including neighbours Bangladesh, Afghanistan, Bhutan, Myanmar and countries such as Oman, Barbados and El Salvador. It also commercially exported 10.5 million doses of vaccines to 8 countries. Modi was addressing a workshop on COVID-19 management attended by health leaders, experts and officials of Afghanistan, Bangladesh, Bhutan, Maldives, Mauritius, Nepal, Pakistan, Seychelles, Sri Lanka and India. Evoking the “spirit of collaboration” among these countries, Modi said that India and these countries have a lot in common and should share their successful health policies and schemes. “We share so many common challenges – climate change, natural disasters, poverty, illiteracy, and social and gender imbalances. But we also share the power of centuries old cultural and people-to-people linkages. If we focus on all that unites us, our region can overcome not only the present pandemic, but our other challenges too,” he said. Variants May be Associated With Surge in COVID Cases In the last few days, the Maharashtra state government reported a sudden burst of cases in the Vidarbha region, closer to Central India. The genome sequencing of a few cases in Amravati district showed “unique mutations” including E484Q, which is similar to a mutation (E484K) found in South African and Brazilian variants, according to a Times of India report. Maharashtra and Kerala account for more than 74% of the cases in the country while Chhattisgarh and Madhya Pradesh are also seeing a rise. This is in contrast to the steady downward trend of the pandemic in India since last September last year. The country is reporting an average of 12,000 cases a day, as compared to more 90,000 cases in a day in September. Experts have attributed the overall fall in COVID-19 positive cases over the past few months to herd immunity caused by widespread infection, especially in cities such as Mumbai, Pune, and Delhi which saw the largest outbreaks in the country. A recent round of sero-surveillance in Delhi between January 15 to January 23 among 28,000 people found that 56% of those surveyed had antibodies against COVID-19. “Those infected with Covid will only protect themselves but also protect others. Half the population will not transmit to others. Besides, the susceptible population is reduced by 50%,” explained Dr Sanjay Rai, from Delhi’s All India Institute of Medical Sciences. Citing a recently published study in the New England Journal of Medicine, Rai said that those who are infected are protected from disease for at least six months. The study which was conducted with more than 12,000 health workers in the UK, showed that presence of antibodies was associated with a substantially reduced risk of reinfection in six months. More than 9 million people have been at least given one dose of the vaccine. “India has a young population. About 50% of the population is under 25 years, and 65% of the population under 35 years. There could be a very large fraction of the population then which had asymptomatic infections and were not tested. They would also offer some protection to the population,” said Dr Shahid Jameel, a virologist with Ashoka University, Delhi. However, a nation-wide survey showed only one out of 5 people have been exposed to the virus. “The message is that a large proportion of the population remains vulnerable,” said Dr. Balram Bhargava, who heads Indian Council of Medical Research, that helmed the national-wide sero-survey. Meanwhile, there is some evidence that people who have already had COVID-19 can become reinfected with variants. Image Credits: https://dashboard.cowin.gov.in/. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
‘Rapid Response Platforms’ Enabled COVID-19 Vaccine Development, Says Fauci 23/02/2021 Madeleine Hoecklin The Epidemic and Pandemic Preparedness and Response panel at the GVIRF event on Monday. Rapid response platforms, particularly the messenger RNA (mRNA) platform, have changed the landscape of vaccine development, enabling the rapid response to the COVID-19 pandemic, said Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) on Monday. Fauci, speaking at the opening of the Global Vaccine and Immunization Research Forum (GVIRF), co-organized by WHO, the Bill & Melinda Gates Foundation, and the NIAID, highlighted the innovations in vaccinology that made the speedy development of COVID-19 vaccines possible. “There are a number of new technologies that have now really dominated our approach to COVID-19. For example, there’s genetic immunisation using RNA and DNA vaccines,” said Fauci. “We are well aware now of the successes, for example, of the mRNA vaccines.” Rapid response platforms are systems that can be adapted against different pathogens. In the case of mRNA vaccines, these have been developed over a number of years to address influenza, Zika and rabies and have shown a high level of efficacy against SARS-CoV2. The Pfizer/ BioNTech and Moderna SARS-CoV2 vaccines have both had over 95% efficacy against symptomatic COVID-19 and nearly 100% efficacy against severe disease. “I think it’s fair to say that rapid response platforms have been a revolution in vaccinology over 2020 with COVID-19,” said Melanie Saville, Director of Vaccine Research and Development at the Coalition for Epidemic Preparedness Innovations (CEPI). “These can be further developed and prepared for future outbreaks, epidemics, and pandemics.” Barney Graham, deputy director of the Vaccine Research Center at NIAID, added that, over the past 12 years in particular, “new technologies have improved our ability to both prepare for and respond to emerging threats, like structural biology protein engineering and rapid platform manufacturing.” Prototype Pathogen Approach Both Graham and Fauci described the prototype pathogen approach to pandemic preparedness vaccine research used at the NIAID. This refers to studying pathogens of a particular group to build on prior experiences and use strategies to inform vaccine design for related viruses. In developing vaccines for SARS-CoV2, structure-based vaccine designs from Middle East Respiratory Syndrome (MERS-CoV), which is in the family of coronaviruses, were used and “enabled us to rapidly get a successful vaccine, particularly with mRNA [technology],” said Fauci. With the technological advances and the unprecedented R&D work conducted over the past year with COVID-19, “I think we’ve probably moved forward a decade…with COVID-19 vaccines being developed in only 300 days, whereas usually, they would take multiple years, if not decades,” said Saville. The timeline of the mRNA COVID-19 vaccine development. “One thing to point out [is] the speed with which we went from appreciating the new virus, in this case SARS-CoV2, on January 10 of 2020, to starting a phase one trial, about 65 days later, a phase 3 trial both with Moderna and with Pfizer, on 27 July and now having both vaccines already being administered here in the United States and elsewhere. [This is] the fastest in the history of vaccinology from the identification of a particular pathogen to the actual administration of a vaccine,” said Fauci. Challenges with mRNA Platforms While mRNA technology has had great advances, there is still a lot that is unknown about this type of vaccine, including what type of RNA to use and what long-term immune response durability may be. The continued development of the rapid response platforms is needed to make progress on COVID-19 and future epidemics and pandemics. “In all cases, the more robust the platform, in terms of what safety data you have from the platform, what type of immune profile, and importantly, the manufacturing process – which is often really the rate-limiting factor, [the better it is to]…get them as fine-tuned as possible,” said Saville. The manufacturing the Pfizer/BioNTech and Moderna vaccines is limited and is largely centered in Europe and North America. A map of the manufacturing sites for mRNA COVID-19 vaccines globally. “What we need to really look at in the medium and longer-term [is]…how can that manufacturing footprint be much more amenable with regional manufacturing capacity,” said Saville. “Looking at manufacturing innovation…that could be amenable to the low- and middle-income countries [is] something that really needs to be followed.” Innovations in Manufacturing While numerous accomplishments have emerged from the COVID-19 pandemic, several shortcomings, particularly in vaccine development and manufacturing, have occurred. “There’s no question that COVID has demonstrated the potential of vaccine development and R&D, but it has also exposed some pretty major gaps in the system and [has shown] what happens when a disease strikes the entire world at the same time,” said Selwyn. These gaps include the limitedd supply of vaccines secured for low- and middle-income countries; high-income countries pre-ordering large amounts of vaccines for themselves; the reduction in production capacity for other diseases, which may increase the risk of outbreaks; and the dependency on tech transfers. “In COVID, there were multiple companies who had quite limited experience with vaccine manufacturing and bringing vaccines through licensure, [who were] planning for upwards of 10 tech transfers in a single year,” said Casey Selwyn, senior officer in Vaccine Development and Global Health COVID-19 Response at the Gates Foundation, at a workshop that followed the opening session. Normally a company may undertake one transfer a year. The Innovations in Vaccine Manufacturing workshop at the GVIRF session on Monday. “To maximize global supply, we need to have innovative ways to ease and encourage tech transfer…A tech transfer requires time, it requires resources and sharing of know-how, not just intellectual property,” Selwyn added. The most efficient way to scale up vaccine production and supply over the long term is to build “ever-warm” vaccine facilities that are multi-platform and multi-purpose with a trained workforce, so that the facilities can be prepared when an outbreak occurs, proposed Selwyn. Another recommendation for innovating global manufacturing was to implement a hub and spoke distribution model, which would create a centralized network where products are received in central locations before being sent directly to their destinations. According to Selwyn, this could ease the pressure of tech transfers and establish a better geographical reach, creating a more flexible, accessible and cost effective system. Alternatively, increasing standardization of manufacturing protocols and regulatory requirements – which could include the labeling of products, serialization, and design of protocols – could also improve speed, flexibility, and cost-efficiency. “Probably one of the most important sets of innovations, sets of lessons and sets of actions for the future is really continuing to pursue uniformity and harmonization, especially for a set of diseases and pathogens that require rapid response,” said Anant Shah, New Product Lead for Global Vaccines for COVID-19 and Ebola at Merck. “We have to pursue uniformity, flexibility and efficiency if we want to continue ensuring global equitable access,” said Shah. Image Credits: NBC, GVIRF. Global Health Diplomacy In The COVID-19 Era – Can Failure Usher In A New Era of Success? 22/02/2021 Svĕt Lustig Vijay More than a year into the world’s largest global health emergency, health diplomats have fought hard to ensure that every country across the globe secures access to lifesaving coronavirus health products, including vaccines, treatments, and diagnostics. That has not happened yet, given that 80% of countries that are now rolling out vaccines are either high-income or upper middle-income countries. Export bans on essential health products in 80 countries, ranging from personal protective equipment to ventilators, have not helped either. And in the absence of clear global guidance, up to 130 countries have imposed an uneven patchwork of travel restrictions in an attempt to keep more contagious variants at bay – mostly to no avail. A panel of some two dozen leading diplomats and health policy experts from WHO, government, academia and media pondered the current state of affairs, at the Global Health Centre’s (GHC) launch of a new Guide to Global Health Diplomacy, authored by GHC founder Ilona Kickbusch along with a former Hungerian Health Minister, Haik Nikogosian, former head of the Framework Convention on Tobacco Control, Mihály Kökény; and a preface from WHO’s Director General Dr Tedros Adhanom Ghebreyesus. The guide, co-sponsored by the Swiss Confederation, offers a compass to navigate the complexity of global health diplomacy through “practical insights” and “sound wisdom”, said Norway’s leader of the labor party Jonas Gahr Stør at the launch event on Thursday. Norway’s Labour Party leader, Jonas Gahr Støre The event featured some of the bright stars in the world’s global health constellation, including former WHO DG Margaret Chan; Trudi Makhaya, economic advisor to South Africa’s President Cyril Ramaphonsa, Suhasini Haidar, editor of India’s The Hindu Newspaper, Juan Jorge Gómez Camacho, Mexico’s Ambassador to Canada, and Swiss Federal Councillor Alain Berset. The event, moderated by Kickbusch, was co- sponsored by the World Health Organization and the Swiss Federal Council. Said Kickbush: “As you can see from the subtitle of this book [better health – improved global solidarity – more equity], the three words, health, so that health moves to the centre of negotiations, solidarity, and equity – those truly are the goals of global health diplomacy.”Better health – improved global solidarity – more equity Ilona Kickbusch, Founding Director of the Graduate Institute’s Global Health Centre in Geneva. Crisis Has Shown The Failures of The Current International Health Regulations System For Pandemic Preparedness & Response Michel Kazathchkine, former Executive Director of the Global Fund and a member of the Independent Panel for Pandemic Preparedness and Response The pandemic has uncovered “many flaws” in global preparedness and response, said Michel Kazathckine, former executive director of the Global Fund to fight AIDS, Tuberculosis and Malaria, and currently serving as a member of the Independent Panel for Pandemic Preparedness and Response, mandated by the World Health Assembly in May, to explore how and why the SARS-CoV2 pandemic caught the world so badly off guard. “The international system we have established for health security did not really work as a system,” he said. “There were clear gaps in preparedness management of the response coordination.” If there is anything that diplomacy has “certainly” not achieved in the midst of the pandemic, it is “firm and binding commitments” at the international level, added the Global Health Centre’s co-director Suerie Moon. Suerie Moon, Co-Director of Global Health Centre at Geneva Graduate Institute Same Challenges Were Apparent in H5N1 Avian Flu Epidemic The challenges are not new. Some 15 years ago after the eruption of the H5N1 Avian Influenza epidemic, Indonesia protested the fact that after low- and middle-income Asian countries had shared samples of the emergent pathogen with research networks around the world, rich countries then bought up most of the vaccines thus produced – leaving other countries vulnerable. In 2021, the continued lack of clear and binding agreements to ensure equitable access to health products during health emergencies remains largely unresolved, Moon said. “We’ve known this for quite some time, but actually we have very weak, frankly, quite non-existent rules and agreements at the international level to make sure that countries get access to vaccines, so this is not a surprise,” she said. “This is not something that is new to the global health community, but it’s something that we have not yet managed to address.” While some global frameworks do exist to allow LMICs to gain emergency access to lifesaving health products – such as the pre-existing donor-financed vaccine pool for 92 LMICs managed by Gavi, The Vaccine Alliance, or tools like the WTO’s TRIPS agreement (Trade-Related Aspects of Intellectual Property Rights) – the global south still struggles to take advantage of available IP flexibilities, partially due to fear of retaliation from stronger nations and big pharma. And recent negotiations over a South African and Indian proposal for a more far-reaching TRIPS waiver have “not been easy” either, noted Trudi Makhaya, who is economic advisor to South Africa’s President Cyril Ramaphonsa. Trudi Makhaya, Economic Advisor to South Africa’s President Cyril Ramaphonsa. Another alternative, the WHO-backed voluntary licensing pool, has also failed to garner pharma support for now. Still, there is a growing appreciation that technology transfer and the development of more local health product manufacturing capacity is crucial for low- and middle-income countries going forward, said Makhaya. Notably, new World Trade Organization Director General Dr Ngozi Okonjo-Iweala has talked about a “third way” that would encourage big pharma to sign more voluntary deals with countries for local production – without impinging on intellectual property rights. However, Makhaya remains wary: “There is an appreciation that there’s got to be technology transfer [to LMICs], there’s got to be local manufacturing and that current other alternative arrangements to do that, in the absence of the TRIPS [waiver], are going to be very difficult,” she said. Economy Among the Myriad Of Global Health Challenges But access to vaccines is only one of a myriad challenges facing low- and middle-income countries in the pandemic response. Makhaya also talked about the economic response to COVID : while some “important” ideas have been floated by the international community to bolster fragile economies – such as special IMF drawing rights for low-income countries – fiscal measures have remained stunted in poorer nations, in comparison to advanced countries that have pumped up to 20% of their GDP into local economies for temporary relief to businesses and the unemployed, she said. “There have been significant calls that there should be resources at the global level that should be injected [into emerging economies],” said Makhaya. “ A key example was special drawing rights at the IMF…[but] it hasn’t found much expression.” “We have a situation where amongst advanced countries’ central banks there’s cooperation, but none has been extended to many other developing countries.” Added Juan Jorge Gómez Camacho, Mexico’s Ambassador to Canada: “Health is not just about health itself,” he said.“Health means prosperity, or the lack of. Health means economic growth, or the lack of. “Health means wealth or poverty. Health is everything. In other words, health criss-crosses all the spectrum of human activity – socially, politically, economically.” Some Successes: COVAX is Unprecedented Dr Tedros Adhanom Ghebreyesus speaking at Thursday Global Health Centre event Even so, some successes have been apparent since the pandemic struck. If the global health community has achieved anything, it is the WHO co-sponsored COVAX global vaccine facility, which has successfully brought together 190 countries “out of thin air” in the aim to provide more equitable distribution of coronavirus vaccines around the world, said Moon. “The access to COVID-19 tools accelerator is health diplomacy in action,” added Dr. Tedros. “It is an unprecedented collaboration between countries, international agencies, the private sector, and other partners to ensure vaccines, diagnostics and therapeutics are shared equitably as global public goods. Vaccine equity is a litmus test for solidarity and global health diplomacy.” Just last Friday, G7 leaders committed an additional $4.3 billion to the ACT Accelerator initiative, which includes COVAX, as well as parallel efforts for tests and treatments and health systems strengthening. That brings the total commitment to ACT for 2021 to $10.3 billion – although global health leaders say that another $22.9 billion is still needed for all arms of the initiative. Local Manufacturing Of New Vaccines Scaling up generic manufacture of COVID-19 vaccines could help expand supply and stimulate local economies Meanwhile, some vaccine-makers have made strides in advancing more local production of their vaccines around the world. Russia’s Sputnik V vaccine, for instance, which showed impressive results in the publication of recent Phase 3 results in The Lancet, is already being produced in India, South Korea, Brazil, China. And production is set to begin in Kazakhstan and Belarus, among other countries like Turkey and Iran – although Sputnik has yet to receive formal regulatory approval from a western regulatory agency or the World Health Organization. India’s Serum Institute is manufacturing a local version of the Oxford/AstraZeneca, recently approved by the European Medicines Agency. The vaccine, locally branded as Covishield, is set to play a big part in advancing the access agenda through the COVAX facility as well as through bilateral deals. Over the past two weeks, India has exported 23 million doses of the locally-produced “Covishield” vaccine to low- and middle-income countries, said National Editor for The Hindu media outlet Suhasini Haidar, who also spoke at the panel event. Still, despite the big ambition for COVAX to distribute more than 2 billion vaccines by the end of 2021, it is a rather sobering fact that COVAX-supplied countries will only be able to vaccinate 3% of their population over the first half of this year, said Moon, adding, “frankly, we need to aim far, far, higher than that.” Meanwhile, countries like Canada have already ordered five times more vaccines than they need, and the EU has ordered twice as many vaccine doses than it needs. That has opened a debate about vaccine sharing of surplus stocks by rich countries to poorer ones – an exchange which WHO would like to encourage through the COVAX facility instead of through uneven bilateral deals and donations. Global Solutions Are Important – But Regional Solutions Also Required India’s prime minister Narendra Modi as he recently announced a South East Asia regional initiative. Finally, while global frameworks are crucial in the pandemic response, countries shouldn’t wait for Geneva to take action, added other panelists. Notably, the African continent has come together in unprecedented ways through initiatives like the African Response Fund, the African Medical Supplies Platform, or the African Vaccine Acquisition Task Force, among others, said Makhaya. “Instead of looking at the world as one large area of cooperation, perhaps [we need smaller] building blocks, much more about the regions and then come to some kind of success,” added Haidar. “If we only look at the solutions as an all-or-nothing huge global system, I think we’re going to close off,” added Moon. “It’s a very complex multipolar ecosystem with lots of different solutions being figured out by different actors who are not waiting for the answers to come from Geneva.” Indeed, as this event was happening, other new regional initiatives were also taking shape – including Europe’s announcement of an emergency biodefense plan and a SouthEast Asia regional initiative for pandemic preparedness and medical emergencies mooted by Indian Prime Minister Narendra Modi. This, however, does not mean “we don’t need Geneva”, said Moon. “We absolutely need global frameworks and global agreements, but when we think about how have countries figured out how to solve their problems, it has not always been through massive global agreements and so I think we have to think creatively about how does the entire ecosystem work, including what needs to truly be global versus [regional].” One of the newer global frameworks that is now gaining steam is a “Pandemic Treaty”proposed by DG Tedros at the World Health Assembly. The treaty aims to garner stronger political commitment towards pandemic preparedness and response, noted the WHOs regional director for the EMRO region Jaouad Mahjour, also appearing at the panel debate. But until such initiatives are put into force, it “isn’t difficult” to guess who will emerge as a winner in the pandemic response, warned Kazathckine. “Health is a political choice that can and must transcend politics,” Dr Tedros said at the Thursday event. “That’s why this book is so important to build the health diplomacy capacity of both diplomats and health experts around the world.” But as Moon reminded the panel: “At the end of the day, the big challenge will not be what needs to be done, but actually how to do it. “And this is the work of diplomats – just how to implement, and how to navigate the politics… reminds us that the work of diplomats is really just beginning and that there’s a huge agenda ahead of us.” Other Key Points By Panelists “Sharing expertise and information should be at the heart of global health diplomacy. Global collaboration is key to a more equal and sustainable world that benefits all of us” said @JosepBorrellF during the launch of our Guide to Global Health Diplomacy. @EU_Commission pic.twitter.com/CBGyb2MOAx — Global Health Centre (@GVAGrad_GHC) February 18, 2021 Juan Jorge Gómez Camacho, Ambassador of Mexico to Canada.“The only way we can address this pandemic is by moving all together. We cannot address [the pandemic] country by country. It is self-defeating not only collectively [but also] individually as a country, if we focus on us instead of focusing on working together. For a diplomat, to understand in this case it is not my own interest versus everybody else’s interests. In fact, everybody else’s interest is in my best interest. Joseph Borrell Fontelles, High Representative of the EU for Foreign Affairs and Security Policy Vice-President of the European Commission -“Sharing expertise and information should be at the heard of global health diplomay.” Dr Tedros, WHO Director General “If we have learned anything, this past year, it’s that none of us can go it alone. We can only thrive when we work together across institutions across borders,” he said. “That’s why it’s truly a pleasure to join you for the launch of the guide to global health diplomacy.” Margaret Chan, former WHO Director General “Without diplomacy, we cannot begin to negotiate,” she said.“And we cannot begin to [advance] the important policy decisions that impact the health and well being of the world’s population.” Alain Berset, Federal Councillor of Switzerland “The value of global health diplomacy has probably never been more apparent as it is today,” he said. “In this crisis, we need skilled diplomacy to find good solutions.” Michel Kazathchkine, member of the Independent Panel for Pandemic Preparedness and Response “The question for us today…is not whether 2020 has been the year of global health diplomacy, but what has global health diplomacy achieved during the crisis, and where has it failed, and looking forward, which are the challenges.” "The value of global health diplomacy has never been more apparent as it is today. In this pandemic, the international community needs to come together in solidarity. We need skilled diplomacy to find good solutions to global challenges." @alain_berset @BAG_OFSP_UFSP @BAG_INT pic.twitter.com/R0s5F2ASAp — Global Health Centre (@GVAGrad_GHC) February 18, 2021 Global Health Diplomacy Book – Co Published with the WHO and the Swiss Federal Council The new book, published in collaboration with the WHO and the Swiss Federal Council, will be translated into Chinese and Portuguese, among other languages, said Kickbush. Given that health is negotiated across all sectors, the new guide is relevant to a range of stakeholders, including the media, civil society, academia, as well as ministries across various sectors, emphasized the Global Health Centre’s co-director Suerie Moon. “The book makes it quite clear that you don’t need to be a health specialist and you don’t need to be a former diplomat, and in fact some of the most important global diplomats are economic advisors or are coming from media or coming from civil society and academia and foundations and not necessarily from the traditional ranks of diplomacy. “If there’s one lesson we’ve really seen over the past year from COVID it’s that diplomacy is not only the responsibility of ministries of health, but trade, science, technology, intellectual property, travel, tourism, finance…Every single one of these ministries in government needs to be mobilized to negotiate solutions.” Read the Global Health Centre’s new guide here https://www.graduateinstitute.ch/GHD-Guide Image Credits: NBC, European Health Forum Gastein, IHEID, Twitter: @WHOAFRO. EU Cannot Sue AstraZeneca – Germany Commits to Sharing Doses 22/02/2021 Madeleine Hoecklin & Kerry Cullinan Threats from the European Commission to sue AstraZeneca over the delay in deliveries of COVID-19 vaccines hold no weight, according to the EU’s contract with the pharma company in which the right to sue was waived. Following the drugmaker’s announcement in late January of a 60% shortfall in vaccine deliveries for the first quarter after its manufacturing plants in Europe hit a number of snags, furious EU officials examined possible legal avenues to resolve the issue. The release of the full contract by RAI, an Italian broadcaster, makes public several key elements that were redacted from a version previously published by the European Commission. In particular it reveals that the Commission is unable to sue for issues with the storage, transport, and administration of vaccines, including delays in the delivery of vaccines. The exception to the restrictions on the right to legal action is AstraZeneca’s “wilful misconduct or failure to comply with EU regulatory requirements…including manufacture.” While the EU’s hands are tied in terms of filing a lawsuit, there are other pathways open, including suspending payments to AstraZeneca. The initial funding for the doses promised to the EU totals €336 million, of which the Commission already paid two-thirds. The remaining €112 million is supposed to be paid within 20 days of receiving the first installment of doses, however, with the lack of evidence of progress towards manufacturing the doses, “the Commission will have no obligation to pay the second installment and may seek to recover the first installment or a portion of it,” states the contract. It appears that AstraZeneca overestimated its manufacturing capacity and supply to the EU, setting a goal of delivering 300 million doses by the end of 2021, with 30 million doses by the end of 2020, 40 million in January, 30 million in February, 20 million in March, 80 million in April, 40 million in May, and 60 million in June. The company agreed to use its “best reasonable effort” to manufacture the initial doses ordered by the EU and to build its manufacturing capacity. AstraZeneca recently announced that it can deliver 41 million doses by the end of March with its “best reasonable effort.” That estimate is 20 million fewer doses than initially predicted, meaning the drugmaker is over two months behind schedule. Germany Commits to Sharing Vaccine Doses WHO’s Tedros and Germany’s President Frank-Walter Steinmeier address the media. German President Frank-Walter Steinmeier committed his country to sharing some of the vaccines it has ordered with low-income countries at a joint press conference with World Health Organization Director General Dr Tedros Adhanom Ghebreyesus, on Monday. However, Steinmeier said how this would be done and how many vaccines would be shared was still under discussion. Last Friday, Germany announced that it would be contributing an additional €1.5 billion in funding for the multilateral response to the pandemic, including the ACT Accelerator, at the G7 leaders’ meeting last week. Steinmeier also used the briefing to restate Germany’s opposition to the proposal of a waiver on patent protection for COVID-19 related products, as mandated by the Agreement on Trade-Related Aspects of Intellectual Property Rights, known as the TRIPS waiver. “The interest of public institutions and private companies have to be kept alive to invest in research and the development of drugs medicines and vaccines,” said Steinmeier. “So I don’t think the proposal some have made that we have waiver for patents or licensing would be the right approach.” The TRIPS waiver, currently being discussed by the World Trade Organization, has wide support including from the WHO, but it is floundering because of opposition from wealthy countries with powerful pharmaceutical industries, like Germany, the US and the UK. While Tedros welcomed Germany’s financial contribution, he pointed out that while many wealthy countries claimed to support the global vaccine access facility, COVAX, they were still trying to do bilateral deals with manufacturers for more vaccine doses “without stopping to ask whether this was undermining COVAX”. “This pandemic is really unprecedented, and we have to do everything to defeat this common enemy including waivers on intellectual property to increase production,” said Tedros. He added that the WHO was engaging directly with manufacturers and encouraging pharmaceutical companies to “turn over their facilities to produce other companies’ vaccines as Sanofi has done for the BioNTech vaccine”, and issue non-exclusive licences to enable other manufacturers to produce their vaccines. G-7 Commitments Of US$4.3 Billion Not Enough – Rich Countries Need To Stop COVID Vaccine Hoarding to Open Access Bottleneck, Says WHO Director General 22/02/2021 Kerry Cullinan Dr Tedros Adhanom Ghebreyesus, WHO Director General, at the press briefing on Friday. Despite Friday’s commitment by G-7 countries to donate another US$ 4.3 billion to a global COVID vaccine campaign, World Health Organization Director General, Dr Tedros Adhanom Ghebreyesus has accused high-income nations of still undermining equitable vaccine rollout by “doing deals” with manufacturers that deplete supplies available to the COVAX global vaccine facility. Speaking at the WHO’s biweekly media briefing, Tedros thanked the G-7 and the European Union for the new donations – but stressed that money was not enough: “If there are no vaccines to buy, money is irrelevant. Currently, some high-income countries are entering contracts with vaccine manufacturers that undermine the deals that COVAX has in place and reduce the number of doses COVAX can buy,” said Dr Tedros. “Unless we end the pandemic everywhere, we will not end it anywhere. To achieve this, we need more funding. We need countries to share doses immediately. We need manufacturers to prioritise contracts with COVAX. And we also need a significant increase in the production of vaccines.” HIV Provides Global Precedent, Says Anthony Fauci The HIV pandemic provides a “precedent” for how to get life-saving medicines to those who could not afford them – while allowing pharma companies to “maintain a considerable amount of profit”, said Anthony Fauci, US President Joe Biden’s chief scientific advisor and a guest at the WHO briefing. During the early days of the HIV pandemic, there was a lot of discussion about whether expanding the generic manufacture of new HIV antiretroviral drugs would “interfere with the appropriate profit that companies that made major investments in the development of [antiretroviral] drugs”, Fauci recalled. But through various platforms, including the US-sponsored President’s Emergency Plan for AIDS Relief (PEPFAR) as well as the new Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria, life-saving generic drugs reached millions of people and “did not have a deleterious effect on the companies who continued to do well financially and continue to make investments in research”. Even so, the pathway to those breakthroughs was painstaking, observed WHO’s Assistant Director-General for Drug Access, Mariângela Simão, observing that “too many people died unnecessarily” as rich and poor countries battled over access to HIV medicines. Mechanisms such as the Medicines Patent Pool, created to expand generic drug manufacturing in collaboration with the innovative pharma industry have provided “a proven platform to ensure that both voluntary licensing and technology transfer to increase access to medicines for HIV,TB and malaria”, said Simão. Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines But so far, the MPP precedents hasn’t been harnessed to the COVID-19 vaccine roll-out. She lamented: “Why can we not use the platform that WHO has in place, like COVID Technology Access Pool (C -TAP), to make COVID-19 technology accessible and manage intellectual property needs. “Intellectual property is not the endpoint. The endpoint is increasing manufacturing capacity and making sure good quality, efficacious and safe vaccines reach the developing countries,” Simão added. COVAX Sets Up ‘No-Fault’ Compensation Fund Earlier in the day COVAX announced that the WHO had reached an agreement with a global third party insurance provider, ESIS Inc, to administer a no-fault vaccine injury compensation programme for the 92 low- and middle-income countries and economies eligible for donor support to their vaccine campaigns. “As the first and only vaccine injury compensation mechanism operating on an international scale, the programme will offer eligible individuals in AMC-eligible countries and economies a fast, fair, robust and transparent process to receive compensation for rare, but serious adverse events associated with COVAX-distributed vaccines until 30 June 2022,” according to the global vaccine alliance, GAVI, which administers COVAX. By providing a no-fault lump-sum compensation in full and final settlement of any claims, COVAX aims to “significantly reduce the need for recourse to the law courts, a potentially lengthy and costly process”. ESIS, which is part of the Chubb group, will not charge any fees to applicants. “The No-Fault Compensation fund is a massive boost for COVAX’s goal of equitable global access to vaccines: by providing a robust, transparent and independent mechanism to settle serious adverse events it helps those in countries who might have such effects, manufacturers to roll out vaccines to countries faster, and is a key benefit for lower-income governments procuring vaccines through the Gavi COVAX AMC,” said GAVI CEO Seth Berkley. The COVAX no-fault compensation programme will come into operation via a web portal (www.covaxclaims.com) by 31 March, and people will be able to apply for compensation even if they were given a COVAX-distributed vaccine before this date. The programme is financed initially through a levy charged on all doses of COVID-19 vaccines distributed through the COVAX Facility to the AMC eligible economies until 30 June 2022. All vaccines procured or distributed through the COVAX Facility will have received prior regulatory approval from a strict national authority and/or a WHO emergency use authorization to confirm their safety and efficacy. But, as with all medicines, even vaccines that are approved for general use may, in rare cases, cause serious adverse reactions. No Need for People With Allergies to Avoid Vaccination in Fear of Anaphylactic Shock Dr Soumya Swaminathan, WHO Chief Scientist. On a more technical level of the risks of anaphylactic reactions associated with the Pfizer/ BioNTech and Moderna vaccines, Fauci said that these have been very rare events – and are most likely linked to the polyethylene glycol in the vaccine preparation. “There are 4 to 5 per million anaphylactic reactions for the Pfizer vaccine and between 2 and 3 per million to the Moderna, so it’s an unusual, rare interaction,” said Fauci. While people with known anaphylactic reactions may be advised to take special precautions, or in some cases not to be vaccinated with the mRNA vaccines, there is no reason for people with a general history of allergic reactions, to avoid vaccination, he added. Nancy Messonier, of the US Centers for Disease Control and Prevention who is leading the US Centers for Disease Control vaccine effort, told the media briefing that people who have had a history of anaphylaxis were being asked to stay at the health facility for 30 minutes after vaccination “because all the cases in US have occurred within that 30 minutes timeframe”. WHO’s Chief Scientist, Soumya Swaminathan, stressed that “every country has a system in place to do safety monitoring” and this has been coordinated by the WHO. “So far, over 200 million vaccine doses have gone into people around the world and there have been no alarming safety signals, but we will continue to monitor and update, if anything changes,” said Swaminathan. Image Credits: WHO. India Moots Regional Pandemic Platform with 10 Neighbours 22/02/2021 Menaka Rao After donating over 6 million Covid vaccines to more than 13 countries, the Indian government suggested the creation of a regional pandemic platform for preparedness and medical emergencies with its 10 neighbouring countries. At a meeting with health officials, Indian Prime Minister Narendra Modi proposed creating “a special visa scheme” for doctors and nurses to enable swift travel during health emergencies,coordinated air ambulances, a regional platform for “collating, compiling and studying data about the effectiveness of Covid-19 vaccines” and a network for “promoting technology-assisted epidemiology for preventing future pandemics.” India has reported more 11 million COVID-19 cases and over 156,000 deaths. Although cases have been declining since September last year and had considerably reduced by January, there has been an increase of about 31% in the past week, mostly in the Western state of Maharashtra. “Through our openness and determination, we have managed to achieve one of the lowest fatality rates in the world,” said Modi. “This deserves to be applauded. Today, the hopes of our region and the world are focused on rapid deployment of vaccines. In this too, we must maintain the same cooperative and collaborative spirit.” Modi was referring to the Indian government’s “Vaccine Maitri” (meaning vaccine friendship) initiative, through which the Indian government has donated more than 6.27 million doses of COVID-19 vaccines to more than 13 countries, including neighbours Bangladesh, Afghanistan, Bhutan, Myanmar and countries such as Oman, Barbados and El Salvador. It also commercially exported 10.5 million doses of vaccines to 8 countries. Modi was addressing a workshop on COVID-19 management attended by health leaders, experts and officials of Afghanistan, Bangladesh, Bhutan, Maldives, Mauritius, Nepal, Pakistan, Seychelles, Sri Lanka and India. Evoking the “spirit of collaboration” among these countries, Modi said that India and these countries have a lot in common and should share their successful health policies and schemes. “We share so many common challenges – climate change, natural disasters, poverty, illiteracy, and social and gender imbalances. But we also share the power of centuries old cultural and people-to-people linkages. If we focus on all that unites us, our region can overcome not only the present pandemic, but our other challenges too,” he said. Variants May be Associated With Surge in COVID Cases In the last few days, the Maharashtra state government reported a sudden burst of cases in the Vidarbha region, closer to Central India. The genome sequencing of a few cases in Amravati district showed “unique mutations” including E484Q, which is similar to a mutation (E484K) found in South African and Brazilian variants, according to a Times of India report. Maharashtra and Kerala account for more than 74% of the cases in the country while Chhattisgarh and Madhya Pradesh are also seeing a rise. This is in contrast to the steady downward trend of the pandemic in India since last September last year. The country is reporting an average of 12,000 cases a day, as compared to more 90,000 cases in a day in September. Experts have attributed the overall fall in COVID-19 positive cases over the past few months to herd immunity caused by widespread infection, especially in cities such as Mumbai, Pune, and Delhi which saw the largest outbreaks in the country. A recent round of sero-surveillance in Delhi between January 15 to January 23 among 28,000 people found that 56% of those surveyed had antibodies against COVID-19. “Those infected with Covid will only protect themselves but also protect others. Half the population will not transmit to others. Besides, the susceptible population is reduced by 50%,” explained Dr Sanjay Rai, from Delhi’s All India Institute of Medical Sciences. Citing a recently published study in the New England Journal of Medicine, Rai said that those who are infected are protected from disease for at least six months. The study which was conducted with more than 12,000 health workers in the UK, showed that presence of antibodies was associated with a substantially reduced risk of reinfection in six months. More than 9 million people have been at least given one dose of the vaccine. “India has a young population. About 50% of the population is under 25 years, and 65% of the population under 35 years. There could be a very large fraction of the population then which had asymptomatic infections and were not tested. They would also offer some protection to the population,” said Dr Shahid Jameel, a virologist with Ashoka University, Delhi. However, a nation-wide survey showed only one out of 5 people have been exposed to the virus. “The message is that a large proportion of the population remains vulnerable,” said Dr. Balram Bhargava, who heads Indian Council of Medical Research, that helmed the national-wide sero-survey. Meanwhile, there is some evidence that people who have already had COVID-19 can become reinfected with variants. Image Credits: https://dashboard.cowin.gov.in/. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Global Health Diplomacy In The COVID-19 Era – Can Failure Usher In A New Era of Success? 22/02/2021 Svĕt Lustig Vijay More than a year into the world’s largest global health emergency, health diplomats have fought hard to ensure that every country across the globe secures access to lifesaving coronavirus health products, including vaccines, treatments, and diagnostics. That has not happened yet, given that 80% of countries that are now rolling out vaccines are either high-income or upper middle-income countries. Export bans on essential health products in 80 countries, ranging from personal protective equipment to ventilators, have not helped either. And in the absence of clear global guidance, up to 130 countries have imposed an uneven patchwork of travel restrictions in an attempt to keep more contagious variants at bay – mostly to no avail. A panel of some two dozen leading diplomats and health policy experts from WHO, government, academia and media pondered the current state of affairs, at the Global Health Centre’s (GHC) launch of a new Guide to Global Health Diplomacy, authored by GHC founder Ilona Kickbusch along with a former Hungerian Health Minister, Haik Nikogosian, former head of the Framework Convention on Tobacco Control, Mihály Kökény; and a preface from WHO’s Director General Dr Tedros Adhanom Ghebreyesus. The guide, co-sponsored by the Swiss Confederation, offers a compass to navigate the complexity of global health diplomacy through “practical insights” and “sound wisdom”, said Norway’s leader of the labor party Jonas Gahr Stør at the launch event on Thursday. Norway’s Labour Party leader, Jonas Gahr Støre The event featured some of the bright stars in the world’s global health constellation, including former WHO DG Margaret Chan; Trudi Makhaya, economic advisor to South Africa’s President Cyril Ramaphonsa, Suhasini Haidar, editor of India’s The Hindu Newspaper, Juan Jorge Gómez Camacho, Mexico’s Ambassador to Canada, and Swiss Federal Councillor Alain Berset. The event, moderated by Kickbusch, was co- sponsored by the World Health Organization and the Swiss Federal Council. Said Kickbush: “As you can see from the subtitle of this book [better health – improved global solidarity – more equity], the three words, health, so that health moves to the centre of negotiations, solidarity, and equity – those truly are the goals of global health diplomacy.”Better health – improved global solidarity – more equity Ilona Kickbusch, Founding Director of the Graduate Institute’s Global Health Centre in Geneva. Crisis Has Shown The Failures of The Current International Health Regulations System For Pandemic Preparedness & Response Michel Kazathchkine, former Executive Director of the Global Fund and a member of the Independent Panel for Pandemic Preparedness and Response The pandemic has uncovered “many flaws” in global preparedness and response, said Michel Kazathckine, former executive director of the Global Fund to fight AIDS, Tuberculosis and Malaria, and currently serving as a member of the Independent Panel for Pandemic Preparedness and Response, mandated by the World Health Assembly in May, to explore how and why the SARS-CoV2 pandemic caught the world so badly off guard. “The international system we have established for health security did not really work as a system,” he said. “There were clear gaps in preparedness management of the response coordination.” If there is anything that diplomacy has “certainly” not achieved in the midst of the pandemic, it is “firm and binding commitments” at the international level, added the Global Health Centre’s co-director Suerie Moon. Suerie Moon, Co-Director of Global Health Centre at Geneva Graduate Institute Same Challenges Were Apparent in H5N1 Avian Flu Epidemic The challenges are not new. Some 15 years ago after the eruption of the H5N1 Avian Influenza epidemic, Indonesia protested the fact that after low- and middle-income Asian countries had shared samples of the emergent pathogen with research networks around the world, rich countries then bought up most of the vaccines thus produced – leaving other countries vulnerable. In 2021, the continued lack of clear and binding agreements to ensure equitable access to health products during health emergencies remains largely unresolved, Moon said. “We’ve known this for quite some time, but actually we have very weak, frankly, quite non-existent rules and agreements at the international level to make sure that countries get access to vaccines, so this is not a surprise,” she said. “This is not something that is new to the global health community, but it’s something that we have not yet managed to address.” While some global frameworks do exist to allow LMICs to gain emergency access to lifesaving health products – such as the pre-existing donor-financed vaccine pool for 92 LMICs managed by Gavi, The Vaccine Alliance, or tools like the WTO’s TRIPS agreement (Trade-Related Aspects of Intellectual Property Rights) – the global south still struggles to take advantage of available IP flexibilities, partially due to fear of retaliation from stronger nations and big pharma. And recent negotiations over a South African and Indian proposal for a more far-reaching TRIPS waiver have “not been easy” either, noted Trudi Makhaya, who is economic advisor to South Africa’s President Cyril Ramaphonsa. Trudi Makhaya, Economic Advisor to South Africa’s President Cyril Ramaphonsa. Another alternative, the WHO-backed voluntary licensing pool, has also failed to garner pharma support for now. Still, there is a growing appreciation that technology transfer and the development of more local health product manufacturing capacity is crucial for low- and middle-income countries going forward, said Makhaya. Notably, new World Trade Organization Director General Dr Ngozi Okonjo-Iweala has talked about a “third way” that would encourage big pharma to sign more voluntary deals with countries for local production – without impinging on intellectual property rights. However, Makhaya remains wary: “There is an appreciation that there’s got to be technology transfer [to LMICs], there’s got to be local manufacturing and that current other alternative arrangements to do that, in the absence of the TRIPS [waiver], are going to be very difficult,” she said. Economy Among the Myriad Of Global Health Challenges But access to vaccines is only one of a myriad challenges facing low- and middle-income countries in the pandemic response. Makhaya also talked about the economic response to COVID : while some “important” ideas have been floated by the international community to bolster fragile economies – such as special IMF drawing rights for low-income countries – fiscal measures have remained stunted in poorer nations, in comparison to advanced countries that have pumped up to 20% of their GDP into local economies for temporary relief to businesses and the unemployed, she said. “There have been significant calls that there should be resources at the global level that should be injected [into emerging economies],” said Makhaya. “ A key example was special drawing rights at the IMF…[but] it hasn’t found much expression.” “We have a situation where amongst advanced countries’ central banks there’s cooperation, but none has been extended to many other developing countries.” Added Juan Jorge Gómez Camacho, Mexico’s Ambassador to Canada: “Health is not just about health itself,” he said.“Health means prosperity, or the lack of. Health means economic growth, or the lack of. “Health means wealth or poverty. Health is everything. In other words, health criss-crosses all the spectrum of human activity – socially, politically, economically.” Some Successes: COVAX is Unprecedented Dr Tedros Adhanom Ghebreyesus speaking at Thursday Global Health Centre event Even so, some successes have been apparent since the pandemic struck. If the global health community has achieved anything, it is the WHO co-sponsored COVAX global vaccine facility, which has successfully brought together 190 countries “out of thin air” in the aim to provide more equitable distribution of coronavirus vaccines around the world, said Moon. “The access to COVID-19 tools accelerator is health diplomacy in action,” added Dr. Tedros. “It is an unprecedented collaboration between countries, international agencies, the private sector, and other partners to ensure vaccines, diagnostics and therapeutics are shared equitably as global public goods. Vaccine equity is a litmus test for solidarity and global health diplomacy.” Just last Friday, G7 leaders committed an additional $4.3 billion to the ACT Accelerator initiative, which includes COVAX, as well as parallel efforts for tests and treatments and health systems strengthening. That brings the total commitment to ACT for 2021 to $10.3 billion – although global health leaders say that another $22.9 billion is still needed for all arms of the initiative. Local Manufacturing Of New Vaccines Scaling up generic manufacture of COVID-19 vaccines could help expand supply and stimulate local economies Meanwhile, some vaccine-makers have made strides in advancing more local production of their vaccines around the world. Russia’s Sputnik V vaccine, for instance, which showed impressive results in the publication of recent Phase 3 results in The Lancet, is already being produced in India, South Korea, Brazil, China. And production is set to begin in Kazakhstan and Belarus, among other countries like Turkey and Iran – although Sputnik has yet to receive formal regulatory approval from a western regulatory agency or the World Health Organization. India’s Serum Institute is manufacturing a local version of the Oxford/AstraZeneca, recently approved by the European Medicines Agency. The vaccine, locally branded as Covishield, is set to play a big part in advancing the access agenda through the COVAX facility as well as through bilateral deals. Over the past two weeks, India has exported 23 million doses of the locally-produced “Covishield” vaccine to low- and middle-income countries, said National Editor for The Hindu media outlet Suhasini Haidar, who also spoke at the panel event. Still, despite the big ambition for COVAX to distribute more than 2 billion vaccines by the end of 2021, it is a rather sobering fact that COVAX-supplied countries will only be able to vaccinate 3% of their population over the first half of this year, said Moon, adding, “frankly, we need to aim far, far, higher than that.” Meanwhile, countries like Canada have already ordered five times more vaccines than they need, and the EU has ordered twice as many vaccine doses than it needs. That has opened a debate about vaccine sharing of surplus stocks by rich countries to poorer ones – an exchange which WHO would like to encourage through the COVAX facility instead of through uneven bilateral deals and donations. Global Solutions Are Important – But Regional Solutions Also Required India’s prime minister Narendra Modi as he recently announced a South East Asia regional initiative. Finally, while global frameworks are crucial in the pandemic response, countries shouldn’t wait for Geneva to take action, added other panelists. Notably, the African continent has come together in unprecedented ways through initiatives like the African Response Fund, the African Medical Supplies Platform, or the African Vaccine Acquisition Task Force, among others, said Makhaya. “Instead of looking at the world as one large area of cooperation, perhaps [we need smaller] building blocks, much more about the regions and then come to some kind of success,” added Haidar. “If we only look at the solutions as an all-or-nothing huge global system, I think we’re going to close off,” added Moon. “It’s a very complex multipolar ecosystem with lots of different solutions being figured out by different actors who are not waiting for the answers to come from Geneva.” Indeed, as this event was happening, other new regional initiatives were also taking shape – including Europe’s announcement of an emergency biodefense plan and a SouthEast Asia regional initiative for pandemic preparedness and medical emergencies mooted by Indian Prime Minister Narendra Modi. This, however, does not mean “we don’t need Geneva”, said Moon. “We absolutely need global frameworks and global agreements, but when we think about how have countries figured out how to solve their problems, it has not always been through massive global agreements and so I think we have to think creatively about how does the entire ecosystem work, including what needs to truly be global versus [regional].” One of the newer global frameworks that is now gaining steam is a “Pandemic Treaty”proposed by DG Tedros at the World Health Assembly. The treaty aims to garner stronger political commitment towards pandemic preparedness and response, noted the WHOs regional director for the EMRO region Jaouad Mahjour, also appearing at the panel debate. But until such initiatives are put into force, it “isn’t difficult” to guess who will emerge as a winner in the pandemic response, warned Kazathckine. “Health is a political choice that can and must transcend politics,” Dr Tedros said at the Thursday event. “That’s why this book is so important to build the health diplomacy capacity of both diplomats and health experts around the world.” But as Moon reminded the panel: “At the end of the day, the big challenge will not be what needs to be done, but actually how to do it. “And this is the work of diplomats – just how to implement, and how to navigate the politics… reminds us that the work of diplomats is really just beginning and that there’s a huge agenda ahead of us.” Other Key Points By Panelists “Sharing expertise and information should be at the heart of global health diplomacy. Global collaboration is key to a more equal and sustainable world that benefits all of us” said @JosepBorrellF during the launch of our Guide to Global Health Diplomacy. @EU_Commission pic.twitter.com/CBGyb2MOAx — Global Health Centre (@GVAGrad_GHC) February 18, 2021 Juan Jorge Gómez Camacho, Ambassador of Mexico to Canada.“The only way we can address this pandemic is by moving all together. We cannot address [the pandemic] country by country. It is self-defeating not only collectively [but also] individually as a country, if we focus on us instead of focusing on working together. For a diplomat, to understand in this case it is not my own interest versus everybody else’s interests. In fact, everybody else’s interest is in my best interest. Joseph Borrell Fontelles, High Representative of the EU for Foreign Affairs and Security Policy Vice-President of the European Commission -“Sharing expertise and information should be at the heard of global health diplomay.” Dr Tedros, WHO Director General “If we have learned anything, this past year, it’s that none of us can go it alone. We can only thrive when we work together across institutions across borders,” he said. “That’s why it’s truly a pleasure to join you for the launch of the guide to global health diplomacy.” Margaret Chan, former WHO Director General “Without diplomacy, we cannot begin to negotiate,” she said.“And we cannot begin to [advance] the important policy decisions that impact the health and well being of the world’s population.” Alain Berset, Federal Councillor of Switzerland “The value of global health diplomacy has probably never been more apparent as it is today,” he said. “In this crisis, we need skilled diplomacy to find good solutions.” Michel Kazathchkine, member of the Independent Panel for Pandemic Preparedness and Response “The question for us today…is not whether 2020 has been the year of global health diplomacy, but what has global health diplomacy achieved during the crisis, and where has it failed, and looking forward, which are the challenges.” "The value of global health diplomacy has never been more apparent as it is today. In this pandemic, the international community needs to come together in solidarity. We need skilled diplomacy to find good solutions to global challenges." @alain_berset @BAG_OFSP_UFSP @BAG_INT pic.twitter.com/R0s5F2ASAp — Global Health Centre (@GVAGrad_GHC) February 18, 2021 Global Health Diplomacy Book – Co Published with the WHO and the Swiss Federal Council The new book, published in collaboration with the WHO and the Swiss Federal Council, will be translated into Chinese and Portuguese, among other languages, said Kickbush. Given that health is negotiated across all sectors, the new guide is relevant to a range of stakeholders, including the media, civil society, academia, as well as ministries across various sectors, emphasized the Global Health Centre’s co-director Suerie Moon. “The book makes it quite clear that you don’t need to be a health specialist and you don’t need to be a former diplomat, and in fact some of the most important global diplomats are economic advisors or are coming from media or coming from civil society and academia and foundations and not necessarily from the traditional ranks of diplomacy. “If there’s one lesson we’ve really seen over the past year from COVID it’s that diplomacy is not only the responsibility of ministries of health, but trade, science, technology, intellectual property, travel, tourism, finance…Every single one of these ministries in government needs to be mobilized to negotiate solutions.” Read the Global Health Centre’s new guide here https://www.graduateinstitute.ch/GHD-Guide Image Credits: NBC, European Health Forum Gastein, IHEID, Twitter: @WHOAFRO. EU Cannot Sue AstraZeneca – Germany Commits to Sharing Doses 22/02/2021 Madeleine Hoecklin & Kerry Cullinan Threats from the European Commission to sue AstraZeneca over the delay in deliveries of COVID-19 vaccines hold no weight, according to the EU’s contract with the pharma company in which the right to sue was waived. Following the drugmaker’s announcement in late January of a 60% shortfall in vaccine deliveries for the first quarter after its manufacturing plants in Europe hit a number of snags, furious EU officials examined possible legal avenues to resolve the issue. The release of the full contract by RAI, an Italian broadcaster, makes public several key elements that were redacted from a version previously published by the European Commission. In particular it reveals that the Commission is unable to sue for issues with the storage, transport, and administration of vaccines, including delays in the delivery of vaccines. The exception to the restrictions on the right to legal action is AstraZeneca’s “wilful misconduct or failure to comply with EU regulatory requirements…including manufacture.” While the EU’s hands are tied in terms of filing a lawsuit, there are other pathways open, including suspending payments to AstraZeneca. The initial funding for the doses promised to the EU totals €336 million, of which the Commission already paid two-thirds. The remaining €112 million is supposed to be paid within 20 days of receiving the first installment of doses, however, with the lack of evidence of progress towards manufacturing the doses, “the Commission will have no obligation to pay the second installment and may seek to recover the first installment or a portion of it,” states the contract. It appears that AstraZeneca overestimated its manufacturing capacity and supply to the EU, setting a goal of delivering 300 million doses by the end of 2021, with 30 million doses by the end of 2020, 40 million in January, 30 million in February, 20 million in March, 80 million in April, 40 million in May, and 60 million in June. The company agreed to use its “best reasonable effort” to manufacture the initial doses ordered by the EU and to build its manufacturing capacity. AstraZeneca recently announced that it can deliver 41 million doses by the end of March with its “best reasonable effort.” That estimate is 20 million fewer doses than initially predicted, meaning the drugmaker is over two months behind schedule. Germany Commits to Sharing Vaccine Doses WHO’s Tedros and Germany’s President Frank-Walter Steinmeier address the media. German President Frank-Walter Steinmeier committed his country to sharing some of the vaccines it has ordered with low-income countries at a joint press conference with World Health Organization Director General Dr Tedros Adhanom Ghebreyesus, on Monday. However, Steinmeier said how this would be done and how many vaccines would be shared was still under discussion. Last Friday, Germany announced that it would be contributing an additional €1.5 billion in funding for the multilateral response to the pandemic, including the ACT Accelerator, at the G7 leaders’ meeting last week. Steinmeier also used the briefing to restate Germany’s opposition to the proposal of a waiver on patent protection for COVID-19 related products, as mandated by the Agreement on Trade-Related Aspects of Intellectual Property Rights, known as the TRIPS waiver. “The interest of public institutions and private companies have to be kept alive to invest in research and the development of drugs medicines and vaccines,” said Steinmeier. “So I don’t think the proposal some have made that we have waiver for patents or licensing would be the right approach.” The TRIPS waiver, currently being discussed by the World Trade Organization, has wide support including from the WHO, but it is floundering because of opposition from wealthy countries with powerful pharmaceutical industries, like Germany, the US and the UK. While Tedros welcomed Germany’s financial contribution, he pointed out that while many wealthy countries claimed to support the global vaccine access facility, COVAX, they were still trying to do bilateral deals with manufacturers for more vaccine doses “without stopping to ask whether this was undermining COVAX”. “This pandemic is really unprecedented, and we have to do everything to defeat this common enemy including waivers on intellectual property to increase production,” said Tedros. He added that the WHO was engaging directly with manufacturers and encouraging pharmaceutical companies to “turn over their facilities to produce other companies’ vaccines as Sanofi has done for the BioNTech vaccine”, and issue non-exclusive licences to enable other manufacturers to produce their vaccines. G-7 Commitments Of US$4.3 Billion Not Enough – Rich Countries Need To Stop COVID Vaccine Hoarding to Open Access Bottleneck, Says WHO Director General 22/02/2021 Kerry Cullinan Dr Tedros Adhanom Ghebreyesus, WHO Director General, at the press briefing on Friday. Despite Friday’s commitment by G-7 countries to donate another US$ 4.3 billion to a global COVID vaccine campaign, World Health Organization Director General, Dr Tedros Adhanom Ghebreyesus has accused high-income nations of still undermining equitable vaccine rollout by “doing deals” with manufacturers that deplete supplies available to the COVAX global vaccine facility. Speaking at the WHO’s biweekly media briefing, Tedros thanked the G-7 and the European Union for the new donations – but stressed that money was not enough: “If there are no vaccines to buy, money is irrelevant. Currently, some high-income countries are entering contracts with vaccine manufacturers that undermine the deals that COVAX has in place and reduce the number of doses COVAX can buy,” said Dr Tedros. “Unless we end the pandemic everywhere, we will not end it anywhere. To achieve this, we need more funding. We need countries to share doses immediately. We need manufacturers to prioritise contracts with COVAX. And we also need a significant increase in the production of vaccines.” HIV Provides Global Precedent, Says Anthony Fauci The HIV pandemic provides a “precedent” for how to get life-saving medicines to those who could not afford them – while allowing pharma companies to “maintain a considerable amount of profit”, said Anthony Fauci, US President Joe Biden’s chief scientific advisor and a guest at the WHO briefing. During the early days of the HIV pandemic, there was a lot of discussion about whether expanding the generic manufacture of new HIV antiretroviral drugs would “interfere with the appropriate profit that companies that made major investments in the development of [antiretroviral] drugs”, Fauci recalled. But through various platforms, including the US-sponsored President’s Emergency Plan for AIDS Relief (PEPFAR) as well as the new Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria, life-saving generic drugs reached millions of people and “did not have a deleterious effect on the companies who continued to do well financially and continue to make investments in research”. Even so, the pathway to those breakthroughs was painstaking, observed WHO’s Assistant Director-General for Drug Access, Mariângela Simão, observing that “too many people died unnecessarily” as rich and poor countries battled over access to HIV medicines. Mechanisms such as the Medicines Patent Pool, created to expand generic drug manufacturing in collaboration with the innovative pharma industry have provided “a proven platform to ensure that both voluntary licensing and technology transfer to increase access to medicines for HIV,TB and malaria”, said Simão. Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines But so far, the MPP precedents hasn’t been harnessed to the COVID-19 vaccine roll-out. She lamented: “Why can we not use the platform that WHO has in place, like COVID Technology Access Pool (C -TAP), to make COVID-19 technology accessible and manage intellectual property needs. “Intellectual property is not the endpoint. The endpoint is increasing manufacturing capacity and making sure good quality, efficacious and safe vaccines reach the developing countries,” Simão added. COVAX Sets Up ‘No-Fault’ Compensation Fund Earlier in the day COVAX announced that the WHO had reached an agreement with a global third party insurance provider, ESIS Inc, to administer a no-fault vaccine injury compensation programme for the 92 low- and middle-income countries and economies eligible for donor support to their vaccine campaigns. “As the first and only vaccine injury compensation mechanism operating on an international scale, the programme will offer eligible individuals in AMC-eligible countries and economies a fast, fair, robust and transparent process to receive compensation for rare, but serious adverse events associated with COVAX-distributed vaccines until 30 June 2022,” according to the global vaccine alliance, GAVI, which administers COVAX. By providing a no-fault lump-sum compensation in full and final settlement of any claims, COVAX aims to “significantly reduce the need for recourse to the law courts, a potentially lengthy and costly process”. ESIS, which is part of the Chubb group, will not charge any fees to applicants. “The No-Fault Compensation fund is a massive boost for COVAX’s goal of equitable global access to vaccines: by providing a robust, transparent and independent mechanism to settle serious adverse events it helps those in countries who might have such effects, manufacturers to roll out vaccines to countries faster, and is a key benefit for lower-income governments procuring vaccines through the Gavi COVAX AMC,” said GAVI CEO Seth Berkley. The COVAX no-fault compensation programme will come into operation via a web portal (www.covaxclaims.com) by 31 March, and people will be able to apply for compensation even if they were given a COVAX-distributed vaccine before this date. The programme is financed initially through a levy charged on all doses of COVID-19 vaccines distributed through the COVAX Facility to the AMC eligible economies until 30 June 2022. All vaccines procured or distributed through the COVAX Facility will have received prior regulatory approval from a strict national authority and/or a WHO emergency use authorization to confirm their safety and efficacy. But, as with all medicines, even vaccines that are approved for general use may, in rare cases, cause serious adverse reactions. No Need for People With Allergies to Avoid Vaccination in Fear of Anaphylactic Shock Dr Soumya Swaminathan, WHO Chief Scientist. On a more technical level of the risks of anaphylactic reactions associated with the Pfizer/ BioNTech and Moderna vaccines, Fauci said that these have been very rare events – and are most likely linked to the polyethylene glycol in the vaccine preparation. “There are 4 to 5 per million anaphylactic reactions for the Pfizer vaccine and between 2 and 3 per million to the Moderna, so it’s an unusual, rare interaction,” said Fauci. While people with known anaphylactic reactions may be advised to take special precautions, or in some cases not to be vaccinated with the mRNA vaccines, there is no reason for people with a general history of allergic reactions, to avoid vaccination, he added. Nancy Messonier, of the US Centers for Disease Control and Prevention who is leading the US Centers for Disease Control vaccine effort, told the media briefing that people who have had a history of anaphylaxis were being asked to stay at the health facility for 30 minutes after vaccination “because all the cases in US have occurred within that 30 minutes timeframe”. WHO’s Chief Scientist, Soumya Swaminathan, stressed that “every country has a system in place to do safety monitoring” and this has been coordinated by the WHO. “So far, over 200 million vaccine doses have gone into people around the world and there have been no alarming safety signals, but we will continue to monitor and update, if anything changes,” said Swaminathan. Image Credits: WHO. India Moots Regional Pandemic Platform with 10 Neighbours 22/02/2021 Menaka Rao After donating over 6 million Covid vaccines to more than 13 countries, the Indian government suggested the creation of a regional pandemic platform for preparedness and medical emergencies with its 10 neighbouring countries. At a meeting with health officials, Indian Prime Minister Narendra Modi proposed creating “a special visa scheme” for doctors and nurses to enable swift travel during health emergencies,coordinated air ambulances, a regional platform for “collating, compiling and studying data about the effectiveness of Covid-19 vaccines” and a network for “promoting technology-assisted epidemiology for preventing future pandemics.” India has reported more 11 million COVID-19 cases and over 156,000 deaths. Although cases have been declining since September last year and had considerably reduced by January, there has been an increase of about 31% in the past week, mostly in the Western state of Maharashtra. “Through our openness and determination, we have managed to achieve one of the lowest fatality rates in the world,” said Modi. “This deserves to be applauded. Today, the hopes of our region and the world are focused on rapid deployment of vaccines. In this too, we must maintain the same cooperative and collaborative spirit.” Modi was referring to the Indian government’s “Vaccine Maitri” (meaning vaccine friendship) initiative, through which the Indian government has donated more than 6.27 million doses of COVID-19 vaccines to more than 13 countries, including neighbours Bangladesh, Afghanistan, Bhutan, Myanmar and countries such as Oman, Barbados and El Salvador. It also commercially exported 10.5 million doses of vaccines to 8 countries. Modi was addressing a workshop on COVID-19 management attended by health leaders, experts and officials of Afghanistan, Bangladesh, Bhutan, Maldives, Mauritius, Nepal, Pakistan, Seychelles, Sri Lanka and India. Evoking the “spirit of collaboration” among these countries, Modi said that India and these countries have a lot in common and should share their successful health policies and schemes. “We share so many common challenges – climate change, natural disasters, poverty, illiteracy, and social and gender imbalances. But we also share the power of centuries old cultural and people-to-people linkages. If we focus on all that unites us, our region can overcome not only the present pandemic, but our other challenges too,” he said. Variants May be Associated With Surge in COVID Cases In the last few days, the Maharashtra state government reported a sudden burst of cases in the Vidarbha region, closer to Central India. The genome sequencing of a few cases in Amravati district showed “unique mutations” including E484Q, which is similar to a mutation (E484K) found in South African and Brazilian variants, according to a Times of India report. Maharashtra and Kerala account for more than 74% of the cases in the country while Chhattisgarh and Madhya Pradesh are also seeing a rise. This is in contrast to the steady downward trend of the pandemic in India since last September last year. The country is reporting an average of 12,000 cases a day, as compared to more 90,000 cases in a day in September. Experts have attributed the overall fall in COVID-19 positive cases over the past few months to herd immunity caused by widespread infection, especially in cities such as Mumbai, Pune, and Delhi which saw the largest outbreaks in the country. A recent round of sero-surveillance in Delhi between January 15 to January 23 among 28,000 people found that 56% of those surveyed had antibodies against COVID-19. “Those infected with Covid will only protect themselves but also protect others. Half the population will not transmit to others. Besides, the susceptible population is reduced by 50%,” explained Dr Sanjay Rai, from Delhi’s All India Institute of Medical Sciences. Citing a recently published study in the New England Journal of Medicine, Rai said that those who are infected are protected from disease for at least six months. The study which was conducted with more than 12,000 health workers in the UK, showed that presence of antibodies was associated with a substantially reduced risk of reinfection in six months. More than 9 million people have been at least given one dose of the vaccine. “India has a young population. About 50% of the population is under 25 years, and 65% of the population under 35 years. There could be a very large fraction of the population then which had asymptomatic infections and were not tested. They would also offer some protection to the population,” said Dr Shahid Jameel, a virologist with Ashoka University, Delhi. However, a nation-wide survey showed only one out of 5 people have been exposed to the virus. “The message is that a large proportion of the population remains vulnerable,” said Dr. Balram Bhargava, who heads Indian Council of Medical Research, that helmed the national-wide sero-survey. Meanwhile, there is some evidence that people who have already had COVID-19 can become reinfected with variants. Image Credits: https://dashboard.cowin.gov.in/. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
EU Cannot Sue AstraZeneca – Germany Commits to Sharing Doses 22/02/2021 Madeleine Hoecklin & Kerry Cullinan Threats from the European Commission to sue AstraZeneca over the delay in deliveries of COVID-19 vaccines hold no weight, according to the EU’s contract with the pharma company in which the right to sue was waived. Following the drugmaker’s announcement in late January of a 60% shortfall in vaccine deliveries for the first quarter after its manufacturing plants in Europe hit a number of snags, furious EU officials examined possible legal avenues to resolve the issue. The release of the full contract by RAI, an Italian broadcaster, makes public several key elements that were redacted from a version previously published by the European Commission. In particular it reveals that the Commission is unable to sue for issues with the storage, transport, and administration of vaccines, including delays in the delivery of vaccines. The exception to the restrictions on the right to legal action is AstraZeneca’s “wilful misconduct or failure to comply with EU regulatory requirements…including manufacture.” While the EU’s hands are tied in terms of filing a lawsuit, there are other pathways open, including suspending payments to AstraZeneca. The initial funding for the doses promised to the EU totals €336 million, of which the Commission already paid two-thirds. The remaining €112 million is supposed to be paid within 20 days of receiving the first installment of doses, however, with the lack of evidence of progress towards manufacturing the doses, “the Commission will have no obligation to pay the second installment and may seek to recover the first installment or a portion of it,” states the contract. It appears that AstraZeneca overestimated its manufacturing capacity and supply to the EU, setting a goal of delivering 300 million doses by the end of 2021, with 30 million doses by the end of 2020, 40 million in January, 30 million in February, 20 million in March, 80 million in April, 40 million in May, and 60 million in June. The company agreed to use its “best reasonable effort” to manufacture the initial doses ordered by the EU and to build its manufacturing capacity. AstraZeneca recently announced that it can deliver 41 million doses by the end of March with its “best reasonable effort.” That estimate is 20 million fewer doses than initially predicted, meaning the drugmaker is over two months behind schedule. Germany Commits to Sharing Vaccine Doses WHO’s Tedros and Germany’s President Frank-Walter Steinmeier address the media. German President Frank-Walter Steinmeier committed his country to sharing some of the vaccines it has ordered with low-income countries at a joint press conference with World Health Organization Director General Dr Tedros Adhanom Ghebreyesus, on Monday. However, Steinmeier said how this would be done and how many vaccines would be shared was still under discussion. Last Friday, Germany announced that it would be contributing an additional €1.5 billion in funding for the multilateral response to the pandemic, including the ACT Accelerator, at the G7 leaders’ meeting last week. Steinmeier also used the briefing to restate Germany’s opposition to the proposal of a waiver on patent protection for COVID-19 related products, as mandated by the Agreement on Trade-Related Aspects of Intellectual Property Rights, known as the TRIPS waiver. “The interest of public institutions and private companies have to be kept alive to invest in research and the development of drugs medicines and vaccines,” said Steinmeier. “So I don’t think the proposal some have made that we have waiver for patents or licensing would be the right approach.” The TRIPS waiver, currently being discussed by the World Trade Organization, has wide support including from the WHO, but it is floundering because of opposition from wealthy countries with powerful pharmaceutical industries, like Germany, the US and the UK. While Tedros welcomed Germany’s financial contribution, he pointed out that while many wealthy countries claimed to support the global vaccine access facility, COVAX, they were still trying to do bilateral deals with manufacturers for more vaccine doses “without stopping to ask whether this was undermining COVAX”. “This pandemic is really unprecedented, and we have to do everything to defeat this common enemy including waivers on intellectual property to increase production,” said Tedros. He added that the WHO was engaging directly with manufacturers and encouraging pharmaceutical companies to “turn over their facilities to produce other companies’ vaccines as Sanofi has done for the BioNTech vaccine”, and issue non-exclusive licences to enable other manufacturers to produce their vaccines. G-7 Commitments Of US$4.3 Billion Not Enough – Rich Countries Need To Stop COVID Vaccine Hoarding to Open Access Bottleneck, Says WHO Director General 22/02/2021 Kerry Cullinan Dr Tedros Adhanom Ghebreyesus, WHO Director General, at the press briefing on Friday. Despite Friday’s commitment by G-7 countries to donate another US$ 4.3 billion to a global COVID vaccine campaign, World Health Organization Director General, Dr Tedros Adhanom Ghebreyesus has accused high-income nations of still undermining equitable vaccine rollout by “doing deals” with manufacturers that deplete supplies available to the COVAX global vaccine facility. Speaking at the WHO’s biweekly media briefing, Tedros thanked the G-7 and the European Union for the new donations – but stressed that money was not enough: “If there are no vaccines to buy, money is irrelevant. Currently, some high-income countries are entering contracts with vaccine manufacturers that undermine the deals that COVAX has in place and reduce the number of doses COVAX can buy,” said Dr Tedros. “Unless we end the pandemic everywhere, we will not end it anywhere. To achieve this, we need more funding. We need countries to share doses immediately. We need manufacturers to prioritise contracts with COVAX. And we also need a significant increase in the production of vaccines.” HIV Provides Global Precedent, Says Anthony Fauci The HIV pandemic provides a “precedent” for how to get life-saving medicines to those who could not afford them – while allowing pharma companies to “maintain a considerable amount of profit”, said Anthony Fauci, US President Joe Biden’s chief scientific advisor and a guest at the WHO briefing. During the early days of the HIV pandemic, there was a lot of discussion about whether expanding the generic manufacture of new HIV antiretroviral drugs would “interfere with the appropriate profit that companies that made major investments in the development of [antiretroviral] drugs”, Fauci recalled. But through various platforms, including the US-sponsored President’s Emergency Plan for AIDS Relief (PEPFAR) as well as the new Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria, life-saving generic drugs reached millions of people and “did not have a deleterious effect on the companies who continued to do well financially and continue to make investments in research”. Even so, the pathway to those breakthroughs was painstaking, observed WHO’s Assistant Director-General for Drug Access, Mariângela Simão, observing that “too many people died unnecessarily” as rich and poor countries battled over access to HIV medicines. Mechanisms such as the Medicines Patent Pool, created to expand generic drug manufacturing in collaboration with the innovative pharma industry have provided “a proven platform to ensure that both voluntary licensing and technology transfer to increase access to medicines for HIV,TB and malaria”, said Simão. Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines But so far, the MPP precedents hasn’t been harnessed to the COVID-19 vaccine roll-out. She lamented: “Why can we not use the platform that WHO has in place, like COVID Technology Access Pool (C -TAP), to make COVID-19 technology accessible and manage intellectual property needs. “Intellectual property is not the endpoint. The endpoint is increasing manufacturing capacity and making sure good quality, efficacious and safe vaccines reach the developing countries,” Simão added. COVAX Sets Up ‘No-Fault’ Compensation Fund Earlier in the day COVAX announced that the WHO had reached an agreement with a global third party insurance provider, ESIS Inc, to administer a no-fault vaccine injury compensation programme for the 92 low- and middle-income countries and economies eligible for donor support to their vaccine campaigns. “As the first and only vaccine injury compensation mechanism operating on an international scale, the programme will offer eligible individuals in AMC-eligible countries and economies a fast, fair, robust and transparent process to receive compensation for rare, but serious adverse events associated with COVAX-distributed vaccines until 30 June 2022,” according to the global vaccine alliance, GAVI, which administers COVAX. By providing a no-fault lump-sum compensation in full and final settlement of any claims, COVAX aims to “significantly reduce the need for recourse to the law courts, a potentially lengthy and costly process”. ESIS, which is part of the Chubb group, will not charge any fees to applicants. “The No-Fault Compensation fund is a massive boost for COVAX’s goal of equitable global access to vaccines: by providing a robust, transparent and independent mechanism to settle serious adverse events it helps those in countries who might have such effects, manufacturers to roll out vaccines to countries faster, and is a key benefit for lower-income governments procuring vaccines through the Gavi COVAX AMC,” said GAVI CEO Seth Berkley. The COVAX no-fault compensation programme will come into operation via a web portal (www.covaxclaims.com) by 31 March, and people will be able to apply for compensation even if they were given a COVAX-distributed vaccine before this date. The programme is financed initially through a levy charged on all doses of COVID-19 vaccines distributed through the COVAX Facility to the AMC eligible economies until 30 June 2022. All vaccines procured or distributed through the COVAX Facility will have received prior regulatory approval from a strict national authority and/or a WHO emergency use authorization to confirm their safety and efficacy. But, as with all medicines, even vaccines that are approved for general use may, in rare cases, cause serious adverse reactions. No Need for People With Allergies to Avoid Vaccination in Fear of Anaphylactic Shock Dr Soumya Swaminathan, WHO Chief Scientist. On a more technical level of the risks of anaphylactic reactions associated with the Pfizer/ BioNTech and Moderna vaccines, Fauci said that these have been very rare events – and are most likely linked to the polyethylene glycol in the vaccine preparation. “There are 4 to 5 per million anaphylactic reactions for the Pfizer vaccine and between 2 and 3 per million to the Moderna, so it’s an unusual, rare interaction,” said Fauci. While people with known anaphylactic reactions may be advised to take special precautions, or in some cases not to be vaccinated with the mRNA vaccines, there is no reason for people with a general history of allergic reactions, to avoid vaccination, he added. Nancy Messonier, of the US Centers for Disease Control and Prevention who is leading the US Centers for Disease Control vaccine effort, told the media briefing that people who have had a history of anaphylaxis were being asked to stay at the health facility for 30 minutes after vaccination “because all the cases in US have occurred within that 30 minutes timeframe”. WHO’s Chief Scientist, Soumya Swaminathan, stressed that “every country has a system in place to do safety monitoring” and this has been coordinated by the WHO. “So far, over 200 million vaccine doses have gone into people around the world and there have been no alarming safety signals, but we will continue to monitor and update, if anything changes,” said Swaminathan. Image Credits: WHO. India Moots Regional Pandemic Platform with 10 Neighbours 22/02/2021 Menaka Rao After donating over 6 million Covid vaccines to more than 13 countries, the Indian government suggested the creation of a regional pandemic platform for preparedness and medical emergencies with its 10 neighbouring countries. At a meeting with health officials, Indian Prime Minister Narendra Modi proposed creating “a special visa scheme” for doctors and nurses to enable swift travel during health emergencies,coordinated air ambulances, a regional platform for “collating, compiling and studying data about the effectiveness of Covid-19 vaccines” and a network for “promoting technology-assisted epidemiology for preventing future pandemics.” India has reported more 11 million COVID-19 cases and over 156,000 deaths. Although cases have been declining since September last year and had considerably reduced by January, there has been an increase of about 31% in the past week, mostly in the Western state of Maharashtra. “Through our openness and determination, we have managed to achieve one of the lowest fatality rates in the world,” said Modi. “This deserves to be applauded. Today, the hopes of our region and the world are focused on rapid deployment of vaccines. In this too, we must maintain the same cooperative and collaborative spirit.” Modi was referring to the Indian government’s “Vaccine Maitri” (meaning vaccine friendship) initiative, through which the Indian government has donated more than 6.27 million doses of COVID-19 vaccines to more than 13 countries, including neighbours Bangladesh, Afghanistan, Bhutan, Myanmar and countries such as Oman, Barbados and El Salvador. It also commercially exported 10.5 million doses of vaccines to 8 countries. Modi was addressing a workshop on COVID-19 management attended by health leaders, experts and officials of Afghanistan, Bangladesh, Bhutan, Maldives, Mauritius, Nepal, Pakistan, Seychelles, Sri Lanka and India. Evoking the “spirit of collaboration” among these countries, Modi said that India and these countries have a lot in common and should share their successful health policies and schemes. “We share so many common challenges – climate change, natural disasters, poverty, illiteracy, and social and gender imbalances. But we also share the power of centuries old cultural and people-to-people linkages. If we focus on all that unites us, our region can overcome not only the present pandemic, but our other challenges too,” he said. Variants May be Associated With Surge in COVID Cases In the last few days, the Maharashtra state government reported a sudden burst of cases in the Vidarbha region, closer to Central India. The genome sequencing of a few cases in Amravati district showed “unique mutations” including E484Q, which is similar to a mutation (E484K) found in South African and Brazilian variants, according to a Times of India report. Maharashtra and Kerala account for more than 74% of the cases in the country while Chhattisgarh and Madhya Pradesh are also seeing a rise. This is in contrast to the steady downward trend of the pandemic in India since last September last year. The country is reporting an average of 12,000 cases a day, as compared to more 90,000 cases in a day in September. Experts have attributed the overall fall in COVID-19 positive cases over the past few months to herd immunity caused by widespread infection, especially in cities such as Mumbai, Pune, and Delhi which saw the largest outbreaks in the country. A recent round of sero-surveillance in Delhi between January 15 to January 23 among 28,000 people found that 56% of those surveyed had antibodies against COVID-19. “Those infected with Covid will only protect themselves but also protect others. Half the population will not transmit to others. Besides, the susceptible population is reduced by 50%,” explained Dr Sanjay Rai, from Delhi’s All India Institute of Medical Sciences. Citing a recently published study in the New England Journal of Medicine, Rai said that those who are infected are protected from disease for at least six months. The study which was conducted with more than 12,000 health workers in the UK, showed that presence of antibodies was associated with a substantially reduced risk of reinfection in six months. More than 9 million people have been at least given one dose of the vaccine. “India has a young population. About 50% of the population is under 25 years, and 65% of the population under 35 years. There could be a very large fraction of the population then which had asymptomatic infections and were not tested. They would also offer some protection to the population,” said Dr Shahid Jameel, a virologist with Ashoka University, Delhi. However, a nation-wide survey showed only one out of 5 people have been exposed to the virus. “The message is that a large proportion of the population remains vulnerable,” said Dr. Balram Bhargava, who heads Indian Council of Medical Research, that helmed the national-wide sero-survey. Meanwhile, there is some evidence that people who have already had COVID-19 can become reinfected with variants. Image Credits: https://dashboard.cowin.gov.in/. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
G-7 Commitments Of US$4.3 Billion Not Enough – Rich Countries Need To Stop COVID Vaccine Hoarding to Open Access Bottleneck, Says WHO Director General 22/02/2021 Kerry Cullinan Dr Tedros Adhanom Ghebreyesus, WHO Director General, at the press briefing on Friday. Despite Friday’s commitment by G-7 countries to donate another US$ 4.3 billion to a global COVID vaccine campaign, World Health Organization Director General, Dr Tedros Adhanom Ghebreyesus has accused high-income nations of still undermining equitable vaccine rollout by “doing deals” with manufacturers that deplete supplies available to the COVAX global vaccine facility. Speaking at the WHO’s biweekly media briefing, Tedros thanked the G-7 and the European Union for the new donations – but stressed that money was not enough: “If there are no vaccines to buy, money is irrelevant. Currently, some high-income countries are entering contracts with vaccine manufacturers that undermine the deals that COVAX has in place and reduce the number of doses COVAX can buy,” said Dr Tedros. “Unless we end the pandemic everywhere, we will not end it anywhere. To achieve this, we need more funding. We need countries to share doses immediately. We need manufacturers to prioritise contracts with COVAX. And we also need a significant increase in the production of vaccines.” HIV Provides Global Precedent, Says Anthony Fauci The HIV pandemic provides a “precedent” for how to get life-saving medicines to those who could not afford them – while allowing pharma companies to “maintain a considerable amount of profit”, said Anthony Fauci, US President Joe Biden’s chief scientific advisor and a guest at the WHO briefing. During the early days of the HIV pandemic, there was a lot of discussion about whether expanding the generic manufacture of new HIV antiretroviral drugs would “interfere with the appropriate profit that companies that made major investments in the development of [antiretroviral] drugs”, Fauci recalled. But through various platforms, including the US-sponsored President’s Emergency Plan for AIDS Relief (PEPFAR) as well as the new Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria, life-saving generic drugs reached millions of people and “did not have a deleterious effect on the companies who continued to do well financially and continue to make investments in research”. Even so, the pathway to those breakthroughs was painstaking, observed WHO’s Assistant Director-General for Drug Access, Mariângela Simão, observing that “too many people died unnecessarily” as rich and poor countries battled over access to HIV medicines. Mechanisms such as the Medicines Patent Pool, created to expand generic drug manufacturing in collaboration with the innovative pharma industry have provided “a proven platform to ensure that both voluntary licensing and technology transfer to increase access to medicines for HIV,TB and malaria”, said Simão. Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines But so far, the MPP precedents hasn’t been harnessed to the COVID-19 vaccine roll-out. She lamented: “Why can we not use the platform that WHO has in place, like COVID Technology Access Pool (C -TAP), to make COVID-19 technology accessible and manage intellectual property needs. “Intellectual property is not the endpoint. The endpoint is increasing manufacturing capacity and making sure good quality, efficacious and safe vaccines reach the developing countries,” Simão added. COVAX Sets Up ‘No-Fault’ Compensation Fund Earlier in the day COVAX announced that the WHO had reached an agreement with a global third party insurance provider, ESIS Inc, to administer a no-fault vaccine injury compensation programme for the 92 low- and middle-income countries and economies eligible for donor support to their vaccine campaigns. “As the first and only vaccine injury compensation mechanism operating on an international scale, the programme will offer eligible individuals in AMC-eligible countries and economies a fast, fair, robust and transparent process to receive compensation for rare, but serious adverse events associated with COVAX-distributed vaccines until 30 June 2022,” according to the global vaccine alliance, GAVI, which administers COVAX. By providing a no-fault lump-sum compensation in full and final settlement of any claims, COVAX aims to “significantly reduce the need for recourse to the law courts, a potentially lengthy and costly process”. ESIS, which is part of the Chubb group, will not charge any fees to applicants. “The No-Fault Compensation fund is a massive boost for COVAX’s goal of equitable global access to vaccines: by providing a robust, transparent and independent mechanism to settle serious adverse events it helps those in countries who might have such effects, manufacturers to roll out vaccines to countries faster, and is a key benefit for lower-income governments procuring vaccines through the Gavi COVAX AMC,” said GAVI CEO Seth Berkley. The COVAX no-fault compensation programme will come into operation via a web portal (www.covaxclaims.com) by 31 March, and people will be able to apply for compensation even if they were given a COVAX-distributed vaccine before this date. The programme is financed initially through a levy charged on all doses of COVID-19 vaccines distributed through the COVAX Facility to the AMC eligible economies until 30 June 2022. All vaccines procured or distributed through the COVAX Facility will have received prior regulatory approval from a strict national authority and/or a WHO emergency use authorization to confirm their safety and efficacy. But, as with all medicines, even vaccines that are approved for general use may, in rare cases, cause serious adverse reactions. No Need for People With Allergies to Avoid Vaccination in Fear of Anaphylactic Shock Dr Soumya Swaminathan, WHO Chief Scientist. On a more technical level of the risks of anaphylactic reactions associated with the Pfizer/ BioNTech and Moderna vaccines, Fauci said that these have been very rare events – and are most likely linked to the polyethylene glycol in the vaccine preparation. “There are 4 to 5 per million anaphylactic reactions for the Pfizer vaccine and between 2 and 3 per million to the Moderna, so it’s an unusual, rare interaction,” said Fauci. While people with known anaphylactic reactions may be advised to take special precautions, or in some cases not to be vaccinated with the mRNA vaccines, there is no reason for people with a general history of allergic reactions, to avoid vaccination, he added. Nancy Messonier, of the US Centers for Disease Control and Prevention who is leading the US Centers for Disease Control vaccine effort, told the media briefing that people who have had a history of anaphylaxis were being asked to stay at the health facility for 30 minutes after vaccination “because all the cases in US have occurred within that 30 minutes timeframe”. WHO’s Chief Scientist, Soumya Swaminathan, stressed that “every country has a system in place to do safety monitoring” and this has been coordinated by the WHO. “So far, over 200 million vaccine doses have gone into people around the world and there have been no alarming safety signals, but we will continue to monitor and update, if anything changes,” said Swaminathan. Image Credits: WHO. India Moots Regional Pandemic Platform with 10 Neighbours 22/02/2021 Menaka Rao After donating over 6 million Covid vaccines to more than 13 countries, the Indian government suggested the creation of a regional pandemic platform for preparedness and medical emergencies with its 10 neighbouring countries. At a meeting with health officials, Indian Prime Minister Narendra Modi proposed creating “a special visa scheme” for doctors and nurses to enable swift travel during health emergencies,coordinated air ambulances, a regional platform for “collating, compiling and studying data about the effectiveness of Covid-19 vaccines” and a network for “promoting technology-assisted epidemiology for preventing future pandemics.” India has reported more 11 million COVID-19 cases and over 156,000 deaths. Although cases have been declining since September last year and had considerably reduced by January, there has been an increase of about 31% in the past week, mostly in the Western state of Maharashtra. “Through our openness and determination, we have managed to achieve one of the lowest fatality rates in the world,” said Modi. “This deserves to be applauded. Today, the hopes of our region and the world are focused on rapid deployment of vaccines. In this too, we must maintain the same cooperative and collaborative spirit.” Modi was referring to the Indian government’s “Vaccine Maitri” (meaning vaccine friendship) initiative, through which the Indian government has donated more than 6.27 million doses of COVID-19 vaccines to more than 13 countries, including neighbours Bangladesh, Afghanistan, Bhutan, Myanmar and countries such as Oman, Barbados and El Salvador. It also commercially exported 10.5 million doses of vaccines to 8 countries. Modi was addressing a workshop on COVID-19 management attended by health leaders, experts and officials of Afghanistan, Bangladesh, Bhutan, Maldives, Mauritius, Nepal, Pakistan, Seychelles, Sri Lanka and India. Evoking the “spirit of collaboration” among these countries, Modi said that India and these countries have a lot in common and should share their successful health policies and schemes. “We share so many common challenges – climate change, natural disasters, poverty, illiteracy, and social and gender imbalances. But we also share the power of centuries old cultural and people-to-people linkages. If we focus on all that unites us, our region can overcome not only the present pandemic, but our other challenges too,” he said. Variants May be Associated With Surge in COVID Cases In the last few days, the Maharashtra state government reported a sudden burst of cases in the Vidarbha region, closer to Central India. The genome sequencing of a few cases in Amravati district showed “unique mutations” including E484Q, which is similar to a mutation (E484K) found in South African and Brazilian variants, according to a Times of India report. Maharashtra and Kerala account for more than 74% of the cases in the country while Chhattisgarh and Madhya Pradesh are also seeing a rise. This is in contrast to the steady downward trend of the pandemic in India since last September last year. The country is reporting an average of 12,000 cases a day, as compared to more 90,000 cases in a day in September. Experts have attributed the overall fall in COVID-19 positive cases over the past few months to herd immunity caused by widespread infection, especially in cities such as Mumbai, Pune, and Delhi which saw the largest outbreaks in the country. A recent round of sero-surveillance in Delhi between January 15 to January 23 among 28,000 people found that 56% of those surveyed had antibodies against COVID-19. “Those infected with Covid will only protect themselves but also protect others. Half the population will not transmit to others. Besides, the susceptible population is reduced by 50%,” explained Dr Sanjay Rai, from Delhi’s All India Institute of Medical Sciences. Citing a recently published study in the New England Journal of Medicine, Rai said that those who are infected are protected from disease for at least six months. The study which was conducted with more than 12,000 health workers in the UK, showed that presence of antibodies was associated with a substantially reduced risk of reinfection in six months. More than 9 million people have been at least given one dose of the vaccine. “India has a young population. About 50% of the population is under 25 years, and 65% of the population under 35 years. There could be a very large fraction of the population then which had asymptomatic infections and were not tested. They would also offer some protection to the population,” said Dr Shahid Jameel, a virologist with Ashoka University, Delhi. However, a nation-wide survey showed only one out of 5 people have been exposed to the virus. “The message is that a large proportion of the population remains vulnerable,” said Dr. Balram Bhargava, who heads Indian Council of Medical Research, that helmed the national-wide sero-survey. Meanwhile, there is some evidence that people who have already had COVID-19 can become reinfected with variants. Image Credits: https://dashboard.cowin.gov.in/. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy
India Moots Regional Pandemic Platform with 10 Neighbours 22/02/2021 Menaka Rao After donating over 6 million Covid vaccines to more than 13 countries, the Indian government suggested the creation of a regional pandemic platform for preparedness and medical emergencies with its 10 neighbouring countries. At a meeting with health officials, Indian Prime Minister Narendra Modi proposed creating “a special visa scheme” for doctors and nurses to enable swift travel during health emergencies,coordinated air ambulances, a regional platform for “collating, compiling and studying data about the effectiveness of Covid-19 vaccines” and a network for “promoting technology-assisted epidemiology for preventing future pandemics.” India has reported more 11 million COVID-19 cases and over 156,000 deaths. Although cases have been declining since September last year and had considerably reduced by January, there has been an increase of about 31% in the past week, mostly in the Western state of Maharashtra. “Through our openness and determination, we have managed to achieve one of the lowest fatality rates in the world,” said Modi. “This deserves to be applauded. Today, the hopes of our region and the world are focused on rapid deployment of vaccines. In this too, we must maintain the same cooperative and collaborative spirit.” Modi was referring to the Indian government’s “Vaccine Maitri” (meaning vaccine friendship) initiative, through which the Indian government has donated more than 6.27 million doses of COVID-19 vaccines to more than 13 countries, including neighbours Bangladesh, Afghanistan, Bhutan, Myanmar and countries such as Oman, Barbados and El Salvador. It also commercially exported 10.5 million doses of vaccines to 8 countries. Modi was addressing a workshop on COVID-19 management attended by health leaders, experts and officials of Afghanistan, Bangladesh, Bhutan, Maldives, Mauritius, Nepal, Pakistan, Seychelles, Sri Lanka and India. Evoking the “spirit of collaboration” among these countries, Modi said that India and these countries have a lot in common and should share their successful health policies and schemes. “We share so many common challenges – climate change, natural disasters, poverty, illiteracy, and social and gender imbalances. But we also share the power of centuries old cultural and people-to-people linkages. If we focus on all that unites us, our region can overcome not only the present pandemic, but our other challenges too,” he said. Variants May be Associated With Surge in COVID Cases In the last few days, the Maharashtra state government reported a sudden burst of cases in the Vidarbha region, closer to Central India. The genome sequencing of a few cases in Amravati district showed “unique mutations” including E484Q, which is similar to a mutation (E484K) found in South African and Brazilian variants, according to a Times of India report. Maharashtra and Kerala account for more than 74% of the cases in the country while Chhattisgarh and Madhya Pradesh are also seeing a rise. This is in contrast to the steady downward trend of the pandemic in India since last September last year. The country is reporting an average of 12,000 cases a day, as compared to more 90,000 cases in a day in September. Experts have attributed the overall fall in COVID-19 positive cases over the past few months to herd immunity caused by widespread infection, especially in cities such as Mumbai, Pune, and Delhi which saw the largest outbreaks in the country. A recent round of sero-surveillance in Delhi between January 15 to January 23 among 28,000 people found that 56% of those surveyed had antibodies against COVID-19. “Those infected with Covid will only protect themselves but also protect others. Half the population will not transmit to others. Besides, the susceptible population is reduced by 50%,” explained Dr Sanjay Rai, from Delhi’s All India Institute of Medical Sciences. Citing a recently published study in the New England Journal of Medicine, Rai said that those who are infected are protected from disease for at least six months. The study which was conducted with more than 12,000 health workers in the UK, showed that presence of antibodies was associated with a substantially reduced risk of reinfection in six months. More than 9 million people have been at least given one dose of the vaccine. “India has a young population. About 50% of the population is under 25 years, and 65% of the population under 35 years. There could be a very large fraction of the population then which had asymptomatic infections and were not tested. They would also offer some protection to the population,” said Dr Shahid Jameel, a virologist with Ashoka University, Delhi. However, a nation-wide survey showed only one out of 5 people have been exposed to the virus. “The message is that a large proportion of the population remains vulnerable,” said Dr. Balram Bhargava, who heads Indian Council of Medical Research, that helmed the national-wide sero-survey. Meanwhile, there is some evidence that people who have already had COVID-19 can become reinfected with variants. Image Credits: https://dashboard.cowin.gov.in/. Posts navigation Older postsNewer posts