One Year Later: COVID-19 Versus WHO And The World – Successes, Failures & Hopes 30/01/2021 Elaine Ruth Fletcher Shoppers in Wuhan, China, post-COVID-19 lockdown “A strange virus is circulating in Wuhan, China,” said my grad school intern, Grace Ren, just back from a visit to her mother in Shanghai in early January, 2020. Somewhere in between the brief respite of New Year’s and a hurried fondue alongside frigid Lake Leman in early February during WHO’s first and last in-person meeting of 2020 – a pandemic crept into the world through the doors of fashionable Milan, Madrid and New York City – and then onto Geneva, Rio, Cape Town, and Delhi. Grace’s warning in that first week of the new year, when most people in Europe are still concentrating on their holidays, coincided with WHO issuing its first formal alert on 5 January about a mysterious pneumonia-like disease. “Where is Wuhan?” I asked, feeling ignorant already. I soon learnt that Wuhan is a city of 10 million people, home to China’s steel industry and a major international base for auto manufacturing. We wouldn’t know until later. But this was to be the first time rich countries would be hit first and hardest by such a virus in over 100 years. Beginning with Italy, but soon followed by France, Spain, the United Kingdom, and the United States – health systems in rich countries struggled to care for a surge of desperately ill people – foreshadowing what poorer countries, like South Africa and Brazil, would soon undergo as well. One year later, new variants of that virus are on a new onward march. Are we better armed today? One Year Later Exactly one year after WHO declared a Public Health Emergency of International Concern on 30 January 2020, many of those same rich countries are struggling yet again with dangerously high mortality rates and overloaded health systems. New and potentially more infectious virus variants have emerged in places as far flung as the United Kingdom, South Africa, Brazil and Japan. And that is despite the remarkable progress made in new vaccines and therapeutic tools for the disease that WHO named COVID-19. Some 100 million people have become ill and over 2 million have died. Many of the world’s poorest countries have escaped with comparatively fewer COVID cases and lower mortality. But these countries may still suffer more “collateral damage” in terms of health as well as economically, over the long term, according to recent studies. And as those countries wait for access to vaccines, they face tough, every day choices about how to keep case rates low with curfews and lockdowns, while ensuring peoples’ everyday survival. Against that landscape, here is a rundown of some of the key issues WHO and the global community faced in the pandemic’s early days; ironically some of the same issues loom again as variants proliferate. Person-to-Person Transmission Top WHO officials present initial findings on the emerging coronavirus to international journalists crowded into WHO’s “SHOC” room in early February 2020. A few weeks later, briefings would all move online. In January and February of last year, journalists – myself included – regularly crowded into the WHO’s strategic health operations centre, or “SHOC” room as it’s better known, used for briefings on the most important WHO statements and decision-making moments. The room is a small airless space measuring only about 5×5 metres. WHO had just declared the coronavirus “public health emergency of international concern”. As we gathered there in the week of the WHO’s executive board meeting (3-8 February), as well as for several weeks after, I wondered: was WHO headquarters virus-immune? Initially, Chinese and WHO officials downplayed the risks of person-to-person transmission of the virus. The unspoken hope was this new coronavirus might behave like a foodborne virus – tied mostly at first to workers at the Wuhan Seafood market where wild animals from around the country were housed in crowded conditions, prior to their on-site slaughter and sale – for use in traditional medicines and food platters. Or, perhaps this new coronavirus would behave like its SARS circa 2003 predecessor – transmissible at close range, but less deadly. It was an underestimation of the initial signals about virus spread, thanks partly to an “alert system that seems to have come from an earlier analogue era”, that led to WHO delays in its international health emergency declaration for a full month after the first reports of the virus were made, stated an independent panel co-led by New Zealand’s ex-prime minister Helen Clark, and Liberia’s former president, Ellen Johnson Sirleaf, in an interim report to WHO published last week. Former Liberian President Ellen Johnson Sirleaf, co-chair, of the Independent Panel’s review of the COVID19 pandemic response, at a media briefing on 19 January. However, there were worrisome signs from the start. Among the very first cluster of early infections reported in Wuhan were household members of people working at the city’s seafood market – who had not shopped there themselves. This already suggested the virus was transmissible among people living in close proximity. Then, on 13 January, the first case outside of Wuhan was reported by Thailand’s Ministry of Health, in a person who had been in Wuhan, but not the market, followed by other similar cases in Thailand and Japan. These were widely reported in the press, as evidence that human transmission was occurring. Even so, it was only on 19 January that the WHO finally acknowledged that there was “limited” evidence of human-to-human transmission of the virus, just three days before an official Chinese announcement. Was the WHO’s caution and delay due to an excessive WHO subservience to official Chinese views – or a lack of means to quickly gather all the expert evidence? Preliminary investigations conducted by the Chinese authorities have found no clear evidence of human-to-human transmission of the novel #coronavirus (2019-nCoV) identified in #Wuhan, #China🇨🇳. pic.twitter.com/Fnl5P877VG — World Health Organization (WHO) (@WHO) January 14, 2020 China Controls the SARS-CoV2 Narrative Zhang Yongzhen, the Chinese virologist who first released the full sequence of the novel coronavirus in early January, 2020, is one expert who said that his early January warnings about human-to-human transmission went unheeded, in a recent New York Times interview: “At that time, I made four findings about the virus. One, it was like SARS. Two, it was a new coronavirus. Most important, the virus was transmitted through the respiratory tract. I also thought it was more infectious than the flu virus… Even then, I thought it must be able to spread from humans to humans,” he said, wishing that “more experts had shared my opinion from the beginning… Whether in the United States or in China, we need to cultivate a group of critics — real scientists in the field. … Who will be the next to dare to speak the truth? You must have enough courage.” Indeed, from the beginning, while WHO was busy praising China for its fast and efficient response, the voices of scientists who issued early warnings or voiced independent views were muted. One of the most famous of the early “whistleblowers” was Li Wenliang, who noted the cluster of 7 cases tied to the Wuhan seafood market in December 2019 on a doctors’ WeChat. He was at first detained by police for spreading rumors, then released – only to die of the coronavirus himself on 7 February. Since then a string of citizen journalists and lawyers who documented the initial chain of events around the Wuhan outbreak have been silenced, arrested or ‘disappeared.‘ Li Wenliang, doctor at Central Hospital of Wuhan, was one of the 8 people detained by police for spreading “rumors” about the new viral disease – from which he died on 7 February. The Wuhan virologist, Shi Zhengli, said in late December that she would welcome a visit by the WHO team to her lab at the Wuhan Institute of Virology; her research into bat coronaviruses has given her the nickname of “bat woman” – but also led to suspicions that the virus could have escaped from her laboratory. The WHO team, which arrived in Wuhan two weeks ago after months of bureaucratic delay, and was finally seen leaving a hotel after completing a quarantine on Friday. However, behind the scenes, China has mounted a full-fledged propaganda campaign to discredit any evidence that the SARS-COV2 virus originated in China at all. That is despite the fact that SARS-CoV2 is widely believed to have emerged from the same family of coronaviruses that the Institute was investigating – which infect horseshoe bats in the Yunnan region of China, some 1800 kilomteres away. Already in 2013, there were reports of miners in the province dying of a mysterious pneumonia that was later linked to cave-dwelling bats in the area – and which harbor coronaviruses that have already been heavily researched, and which share soe 96% of the same genetic material as SARS-CoV2. The WHO team investigating the origins of the COVID-19 pandemic arriving at the Wuhan Tianhe International Airport on Thursday. While Chinese scientists themselves freely made that link in the early days of the outbreak, they were quickly muzzled as well. And now any research on that topic must be approved by a task force under the direct command of President Xi Jinping. China has begun spinning alternative conspiracy theories, meanwhile – suggesting that it could have originated in Europe or SouthEast Asia, or most recently, that the virus was even imported by the US military. Given those constraints, experts have held out little hope that the WHO independent team now visiting China to search for the origins of the virus will indeed come upon the genuine tracks of the biggest mystery of all – how the virus first reached Wuhan – via a biosafety leak, or the initially slow and silent spread of a variant strain among bats, wildlife merchats, or other intermediate animals that traders regularly trap, tansport and trade. To Travel Or Not? Border guards conduct health checks at the “Guglielmo Marconi” airport in Bologna, Italy, in late February, one of the early virus epicenters. WHO advise against travel restrictions was widely ignored,a and then discarded wholesale as the pandemic swept across early and then the world. Early on countries began to slap travel restrictions on China, then on other countries, first in Asia and later even on close neighbours as the infection spread. Canada closed its borders to the US; European Union countries, pledged to open traffic in the Schengen agreement, took the same steps. WHO staunchly opposed any travel restrictions, however, and repeated pronouncements by WHO’s director general Dr Tedros Adhanom Ghebreyesus and health emergencies executive director Mike Ryan – were widely cited by politicians and media well into the summer of 2020. WHO’s argument has been that the widespread use of travel restrictions will further inhibit countries from reporting on future pathogen outbreaks. A WHO insider admitted in a private conversation recently to me: “We also were playing from the book of Ebola – when they didn’t really help anyway, and developing countries were injured by travel restrictions.” In fact, travel restrictions failed entirely in many cases. The United States was among the first countries to limit international travel – restricting the entry of most foreign nationals who had visited China within the past 14 days, after declaring its own international health emergency on 31 January. The US restrictions, poorly framed and executed, ultimately left the virus to infiltrate via US nationals returning from China as well as travellers arriving from other countries around the world where the virus rapidly spread. On the other end of the spectrum, New Zealand initially banned flights altogether, later opening its airspace subject to strict, and consistent COVID testing and quarantine restrictions on incoming arrivals. After an initial strict lockdown and 25 deaths, the country reopened gradually. It today has no reported infections or local transmission – leaving social and mass gatherings, restaurants, schools and businesses to operating fully and normally. Life back to normal in New Zealand – which has eliminated COVID-19. But New Zealand’s success was never championed by WHO as something to imitate. “It’s part of the religion of global health: Travel and trade restrictions are bad… I’m one of the congregants,” said Lawrence O. Gostin, a professor of global health law at Georgetown University, in a recent New York Times investigation into how open skies policies helped fuel the rapid, early spread of the virus with globe-trotting skiers bringing infections from Asia to Europe and Europe to the United States. Paradoxically, it has been low- and middle-income countries, including China and many countries in Africa, that have gradually implemented a more nuanced approach – including strict COVID-19 test requirements as a prerequisite for travel – and precisely as a low-cost measure to control the introduction of cases from abroad. A trip from Geneva to the Democratic Republic of Congo, for instance, requires a COVID test 72 hours in advance of travel, followed by quarantine and another COVID test several days after arrival. Greece has been one of the European countries that has succeeded in keeping COVID cases exceptionally low during the present virus wave, possibly as a result of its COVID-testing rules. To Mask Or Not? Wuhan lining up outside a drugstore to buy masks. Already in January these were required by Chinese authorities although WHO only issued a recommendation in July. Early on, China and other Asian countries also adopted mass masking measures to combat virus transmission. This was something that WHO would resist for months – while insiders say a fierce internal debate over the issue raged – until finally making a 180 degree turn – after some 239 experts criticised the WHO stance in an open letter in a scientific journal – about the hottest form of scientific protest that you can imagine. At the core of the early – but unstated – WHO concerns was that masks were in short supply. In light of that, they should be allocated to health care professionals who needed them most urgently. As with travel, senior WHO officials were operating from the only playbooks that they knew, those designed for earlier WHO responses to the 2003 SARS pandemic, more recently, two successive Ebola epidemics in West and Central Africa in 2014 and 2018. When asked why so many Chinese were wearing masks and yet WHO was not recommending the practice – at one press briefing in February 2020, WHO’s executive director Mike Ryan called masking a “cultural practice” in Asia – essentially something that other countries didn’t need to fuss about. Dovetailing with that was a WHO message that the virus was only transmissible at very short range by humid droplets of coughs or sneezes – but not from the smaller particles also emitted in routine speech and breathing. Over and over, the public was assured by the WHO that staying a metre away from other people and hand-washing would be sufficient to stem the tide of the rising virus story. In one social media video broadcast in mid-March, a WHO expert talked about how to use public transport safely in the COVID area. Asked if masking on a bus might be a good idea if the bus was full – she responded with an alternative – just skip the crowded bus until the next one arrives. Most commuters wear masks to protect against transmission of COVID-19 on a train in Singapore in mid-February – even before it was officially required by Singaporean authorities. Yet the WHO advice to the public also seemed disingenuous – not to mention impractical. How many people dependent on public transport would have the luxury of skipping a bus to catch the next one – unless they happened to be riding the New York City subway? Meanwhile, in shops, buses and subways from Singapore to New York City, masking was rapidly taking hold. Israel mandated it universally in March. In cities from Prague to Lagos, homemade cloth masks also became popular- sparking an entire cottage industry of mask making – including ones with design sense – quietly supported by WHO’s Africa region, which said social distancing rules were impractical in many crowded African cities. For nearly three months after WHO declared COVID-19 a pandemic on 11 March, the WHO continued to resist suggestions that public masking should be recommended – even in virus hotspots or for workers like border control police or bus drivers. In early June, WHO began issuing guidance to the public on how to wear non-medical masks of fabric. The final WHO volte-face came only in July, after scientists in 32 countries called on the agency to revise its guidance to acknowledge that SARS-CoV2 virus transmission was indeed happening via tiny aerosol particles, and not just larger droplets. Soon after, the WHO embarked on a media campaign to promote masking. Covax and Other WHO Successes WHO Director General Dr Tedros Adhanom Ghebreyesus announces COVAX vaccine procurement deal with Pfizer/BioNTech for 40 million vaccine doses on Friday 22 January, 2021. COVAX, he said, is poised to begin distributing vaccines. While the corporate WHO positions on key scientific questions was overly hesitant and delayed, the WHO Director General himself was also coming under increasing fire from the United States for pandering too much to Chinese influence in WHO’s pandemic response. At the same time, the DG’s biggest weakness was also possibly his biggest strength. Resolutely refusing to take sides with either China or the USA, he constantly sought to rise above the fray – and call upon a fractured world to come together. “Solidarity, solidarity, solidarity” became his calling card phrase. “No one is safe until everyone is safe” was another one. “We are family” became another motto, after he recruited pop singer Kim Sledge, to collaborate with WHO in a a remake of her hit classic to raise funds to fight the pandemic. Emerging directly out of the solidarity message was the ambitious ACT Accelerator initiative. Launched in April 2020 to fast-track development and rollout of tests, treatments and vaccines, to countries around the world has been an ambitious centerpiece of WHO strategy. Funding gathered to date still falls far short of the US$ 28 billion WHO says is needed. And a “C-Tap patent pool” created to pool intellectual property on COVID health products has failed entirely to get off the ground- much to the ire of access advocates who published an open letter to WHO recently on how to address some of C-Tap’s shortcomings. Among the various ACT initiatives, the COVAX vaccine facility, which aims to get billions of vaccines to the world’s poorest countries is its hallmark project. The fortunes of COVAX have also been uneven, with 180 countries joining the project with small pre-procurement vaccine orders initially – only to have most rich countries seal much larger vaccine contracts directly with pharma, in a parallel universe of bilateral deals. That has left Tedros to repeatedly lament the “vaccine nationalism” that had characterized the first stages of the vaccine rollout. At the outset of the bi-annual WHO Executive Board meeting on 18 January, Dr Tedros warned darkly of a world on the “brink of catastrophe and moral failure” due to vaccine hoarding by other countries. The first 50 countries to begin vaccinating the public were primarily high or middle-income ones – and there were almost almost no low-income countries doling out jabs, he noted. Forecast of the vaccine candidate-specific supply of COVID-19 vaccines to the COVAX Facility, as of 20 January. Those looking at the glass half-full might note that in fact countries like, India, Indonesia and Brazil also have been among those early starters. South Africa hopes to start producing a Johnson & Johnson vaccine as soon as March. And the African Union on Thursday announced that it had secured a second, 400 million dose commitment of AstraZeneca vaccines for its member states from India’s Serum Institute – following on an earlier pre-order deal for 270 million doses. “”If you add 400 million doses to the 270 million doses, I think we are beginning to make very, very good progress,” Africa CDC director John Nkengasong told a press conference on Thursday. On the one hand, the AU moves are perhaps a welcome declaration of African independence from donor driven handouts – countries’ vaccine purchases can be funded by a five-year loan from the African Export-Import Bank (Afreximbank). Still, these remain ‘bilateral’ deals of one sort or another that bypass COVAX – the only framework, through which equitable distribution is being organized proportional to a country’s population, and including all of the world’s poorest states. On 22 January, however, the flagging COVAX facility received a much-needed shot in the arm. Pfizer, producer of one of the most cutting-edge COVID vaccines joined the initiative, offering 40 million vaccine doses on a no-profit basis. Adding to commitments from AstraZeneca and other companies, the facility should now be able to distribute some 2.3 billion vaccine doses in 2021, said Seth Berkley, CEO of Gavi, The Vaccine Aliance, another COVAX co-sponsor, on 22 January. That, Berkley added, should be enough to vaccinate at least 27 per cent of people in the world’s 92 poorest countries that will be dependent on donor-financed vaccine contributions. By the close of the Executive Board meeting last Tuesday, the WHO DG had thrown down a gauntlet – to his own organization, his partners in the COVAX rollout, and donors. The highest risk groups in every low-income country in the world should be reached with an initial supply of vaccines in the first 120 days of 2021. Vaccination doses administered globally, as of 29 January 2021 since 14 December 2020. Solidarity and Solidarity Trials Early on, WHO also announced its Solidarity trials platform – linking clinical trials of potential Covid remedies from around the world with systematic protocols so that results could be aggregated into a more powerful finding. By June, the research documented the efficacy of the inexpensive drug dexamethasone in treatment- while debunking the reports about hydroxychloroquine, and later remdesivir, for which WHO found no life-saving benefits. WHO’s advice would buck that of a powerful pharma company, Gilead, which had developed the drug and received US FDA approval. Other noteworthy accomplishments have included: Tests, training and PPE in Low- and MIddle-Income Countries. Early on in the pandemic WHO began rolling these out physically – as it turned out the pandemic didn’t head south, but rather west toward Europe, but these were important in preparing the way for future waves that hit Africa and the Americas harder. Millions of pieces of PPE and rapid test kits have since been distributed, while national laboratories across Africa have been trained in more sophisticated PCR testing techniques. Now, WHO is bolstering capacity in those same laboratories to identify virus variants, noted WHO’s African Regional Director Matshidiso Moeti, at a WHO African Region press briefing last week. Clinical guidance – WHO has developed dozens of pieces of guidance about the clinical management of COVID-19, from testing to intensive care treatment. Along with that, it has mounted dozens of courses for health professionals on the free WHO Academy platforms, including smartphone APPS. Media and Fake Media – Moving from the traditionally small, and often insular physical press briefings at Geneva headquarters, WHO has opened its doors virtually to the world with twice a week briefings since late February. WHO uses those meetings to talk about other topics well beyond COVID – such as TB, HIV, and gender equity – leaving the world better informed about the full set of global health issues faced in the pandemic. The formal press briefings have been complemented by Social media Q&As and short, factual videos like the Science in 5 series, and collaborations with celebrity events, like Kim Sledge’s remake of her hit classic “We are Family” to raise funds to fight the pandemic. In addition, creative new partnerships have been formed with big media entities, such as Twitter and Facebook to combat fake pandemic news and steer people to validated health information. Repeating the Same Mistakes? Wearing cloth masks to protect from COVID-19 in Nigeria in April 2020 Credit: @CRSPHCDA1 Will WHO’s cautious response to the emergence of the new COVID-19 virus variants, lead the agency to repeat some of the same mistakes made in the early days of the pandemic? The signs are worrisome. For example, WHO initially downplayed the mortality risks from the virus variant, even as research accumulates that they are indeed more dangerous. It remains to be seen if WHO will change it’s tune in the wake of expert findings from the United Kingdom, the United States and elsewhere that variants are not only more infectious, but also potentially more deadly. Related to that, countries such as Germany and Austria in Europe, as well as experts in the United States, are now recommending the public replace their cloth masks with more infection-proof “high-filtration” FFP or N95 alternatives, at least in crowded indoor spaces. In a op-ed on 26 January in The Washington Post, Joseph Allen, director of Harvard University’s T.H. Chan School of Public Health Healthy Buildings programme, argued for US adoption of what experts there are calling Hi-Fi masks: “In the scrambling for information and tools in the early days of the pandemic, it was acceptable to just say any cloth mask will do because it’s true. But we’ve learned so much since then, and we need to adjust our strategy,” Allen said. “A typical cloth mask might capture half of all respiratory aerosols that come out of our mouth when we talk, sing or just breath. A tightly woven cloth mask might get you to 60 or 70 percent, and a blue surgical mask can get you to 70 or 80 percent… while N95 masks “filter 95%.” But it remains to be seen if WHO, which was slow to take up masks in the first place, will rapidly update its own advice recommending that high-filtration masks be reserved for medical personnel only. Even though inexpensive FFP and N95 masks are now widely available in high-income countries, among WHO insiders who spoke to me, the fears remain almost the same as a year ago. Were the Organization to recommend that the public now adopt high-filtration medical masks, rather than cloth ones, more global mask supplies would be diverted to rich countries and prices would rise. And that would lead to even less access to such masks in hospitals of poorer countries and regions, where they are still in short supply. A masked airline staff person checks passengers in at the Murtala Muhammed airport in Lagos, Nigeria. COVID tests have now become a pre-requisite for boarding to many African destinations. On international travel, the global health body has yet to recommend COVID-19 tests as one of a suite of strategies for controlling international travel-related transmission. This is despite the fact that international travel is unquestionably the main vector for the spread of new variants of the disease – which could undermine vaccine efficacy. This reticence has traditionally been fuelled by fears that testing for travel would divert resources from testing other, much larger, suspect groups, one WHO insider told Health Policy Watch recently – during a time when tests were expensive and in critically short supply. There are, however, signs that the in-born WHO resistance to travel-related COVID testing may be changing after the head of Africa CDC John Nkengasong, called for a “common approach” to COVID testing last week – framing it as a fairer strategy than other travel measures – that discriminate against travelers based on their national or flight origns. “We should not be banning people because of their geographical origin, but we should be encouraging people to travel with negative tests and facilitate the testing process so that people can travel with a negative test,” Nkengasong said at an African CDC briefing on Thursday. Added Mke Ryan, Executive Director for Health Emergencies, in a WHO briefing in Geneva on the following day, “We do need coherent messaging around travel requirements.” What he didn’t say is whether WHO would provide that. Yet further on the horizon looms another thorny travel issue – that of so-called “vaccine passports” for people who have been immunized. A WHO expert committee recently said that a policy on this would be premature, in light of the small numbers of people who have been immunized so far. However, it is certainly the time when such a policy needs to be prepared – and it is not without precedent. For over 15 years countries where yellow fever is endemic have required incoming arrivals to show evidence of yellow fever vaccination – a requirement that is explicitly permitted by the WHO International Health Regulations of 2005. Cautious Hope Despite All A doctor administering the Johnson & Johnson COVID-19 vaccine candidate during phase 3 clinical trials – efficacy results for the one-dose vaccine, released Friday, were only 66% efficacy as compared to 85.6% for Novavax and over 90% for Pfizer and Moderna vaccines. Despite the setbacks seen over the past year – and the worrisome signs of variants on the rampage over the past month, a number of factors still give rise for cautious hope now. Here are a few of the reasons to be hopeful: United States move to rejoin the WHO. This cannot be understated – in light of the new challenges being faced by virus variants – which will eventually force WHO to adapt its advice yet again on all of the sensitive points raised – transmission risks, mortality estimates, masking, and travel. What’s important is that the United States Centers for Disease Control (USCDC) advice has batteries of research teams – backed by a budget that is far larger than WHO’s. The two entities have traditionally worked synergistically – alongside other global health colleagues the world over – in developing balanced guidance. Dr Anthony Fauci, Chief Medical Advisor to new US President Joe Biden addresses the WHO Executive Board Thursday, 21 January, the morning after Biden’s inauguration, when he ordered the resumption of relations with the WHO.. Quickening global response to virus variants. The emergence of variants is no surprise – what may be a surprise is that until now few threatened the root efficacy of existing tests, treatments and vaccines in the pipeline. But in laboratories of the most highly-infected and thus concerned countries – from South Africa to the UK, Brazil, Israel and the USA, sleuthing for variants is now in full swing. That will allow governments to identify them and respond more rapidly, including “booster doses” of vaccines as was suggested by Moderna this week. The variant story is also an important wake-up call to politicians and the public that vaccines are not a panacea – and that countries in fact need to continue using other means – e.g. masking and social distancing – if they want to bring mortality rates down. Along with that, WHO is moving to create a Swiss-based “biohub” to share genetic information about pathogens and variants in a faster and more efficient channels than current WHO Pandemic Influenza Preparedness (PIP) networks. Member state determination to reform WHO and pandemic alert systems. The WHO has recently spoken about a pandemic “treaty” that would strengthen the legal requirements attached to the “International Health Regulations” that currently regulate emergency response. This initiative, however, is primarily led by G-20 states and could lead to a standoff in May with China, Russia and its allies – which see stronger enforcement of global rules on pathogen risk reporting as a threat to their internal control of information flow – regime stability, and sovereignty. At the same time, with African, Latin American and South-East Asia crippled by the pandemic, many member states that often swing in the direction of China, may be reflecting on whether a stronger and faster alert system may also serve their interests. A pandemic wake-up call for climate change and biodiversity loss. For climate advocates, another faint silver lining in the pandemic cloud may be that the world is also waking up to the risks of climate change – which is also deeply intertwined with the risks of biodiversity loss, driven by a global passion for meat-rich diets and in parts of Asia and Africa, wild meat from primates, reptiles, rodents (e.g. bats), or other endangered species like mammals like the pangolin, which is widely consumed for their meat in Asia and Africa, and which can be intermediate carriers of viruses from other sources. “Whether it is pandemics like this or climate change or water access, the world is very vulnerable. There’s no opportunity for the world to go back to a nationalistic past and think you can solve all the problems. The problems are all transnational, and therefore their solutions will be, as well,” declared Jeremy Farrar, Director of the Wellcome Trust during a webinar, ‘Major challenges for global health in a post-COVID-19 world’, hosted by the Liverpool School of Tropical Medicine (LSTM). Pangolin, Manis javanica – This scaly mammal, is one of the world’s most endangered species, is hunted, trapped and traded in China, where it is prized for its meat and its scales, used in traditional medicine. It is also a reservoir for coronavirus infections, encroachment on such wildlife increases risks of new pathgen outbreaks. Vaccine rollout. Equity issues notwithstanding, the vaccine rollout is still proof of how fast science R&D can move in the real world – with political will and financing. One other big question is whether new vaccines will hold up against SARS-CoV2 variants, which are causing higher rates of infection and possibly even mortality. Reports Friday from the large Phase 3 clinical trials of Novavax and Johnson & Johnson vaccine candidates provide the best evidence, so far, that vaccines under development over the past year still pass the bar even when tested against the major variants. But vaccine efficacy was also somewhat lower when the vaccines met the virus mutations which first emerged in the United Kingdom, Brazil and, particularly, the one first identified in South Africa (B.1.351 also called 501Y.V2). Initial data from both Moderna and Pfizer, suggest something similar – although their laboratory-based studies have involved just a few blood sample tests of each variant, and are thus more difficult to analyze. Even so, most of the pharma players and vaccine experts agree: it’s likely that COVID vaccines will have to be tweaked or updated with boosters, over time, as occurs regularly for influenza shots. This underscores, once more that while vaccines are a game-changer – they need to be part of a broader strategy and will not make the virus go away on their own. The Virus is Coming; This Virus May Never Go Away Mike Ryan, Executive Director of WHO Health Emergencies Programme, warns that the virus “may never go away” at a WHO COVID-19 press briefing in May 2020 From the early days of the pandemic, WHO was clear about its warnings that this virus could reach all countries and hit them with equal ferocity. What mattered, however, was the degree of the response. Today, whatever happened in the past year, countries have to come to the hard realisation that the COVID may become just another endemic virus in our communities and “may never go away” , as WHO’s Ryan warned in May 2020. That is the pattern that Ebola and HIV, not to mention the many other diseases like measles, smallpox and influenza that likely emerged from animal sources – after humans created the fundamental pre-conditions for such leaps to occur with the domestication of livestock 9,000 years ago, and the creation of the first urban settlements. Now, as people crowd even closer together, deforestation and food consumption leads tomore intensive agriculture and more contact with wildlife, those pre-conditions are better than ever. As older groups of people are vaccinated, die or develop natural immunity, the new and more infectious SARS-CoV2 variants are also beginning to infect proportionately more young people. This is a trend already being seen in Israel – where 40 per cent of new COVID infections are now being reported among children under the age of 18 – as some 70 per cent of people over the age of 60 were vaccinated. That, too, is also part of a natural cycle that epidemic viruses may follow, historians suggest. It’s a cycle that led to the development of the current set of “childhood diseases” against which we now routinely immunise. The question remains – what lessons will countries, and WHO, will take from the first months to move forward in the new year? Updated from: Covid-19 vs WHO and the world: successes failures and hopes a year on. First published by Geneva Solutions, a news and opinion platform for International Geneva. Image Credits: José Mauquer , Nandu News, CGTN, Dipartimento Protezione Civile, Photo by mona Masoumi on Unsplash, China News Service/中国新闻网, Jade Lee , GAVI, Our World in Data, Cross River State Primary Health Care, Nigeria , Paul Adepoju/HealthPolicyWatch, Johnson & Johnson, WHO, Piekfrosch/wikipedia. Novavax’s COVID Vaccine Shows High Efficacy In Trials; J&J One-Dose Shot Less So – As Europe Feuds With AstraZeneca 29/01/2021 Madeleine Hoecklin Novavax’s vaccine candidate had a vaccine efficacy rate of 89.3%, while Johnson & Johnson’s highly anticipated single-dose COVID-19 vaccine is 66% effective in preventing moderate to severe infection. Novavax has become the first COVID-19 vaccine to show clinical efficacy against two major new SARS-CoV-2 virus variants now circulating worldwide – although the vaccine’s highest efficacy of 95.6% was against the COVID strain that had been predominant up until the end of 2020. The results of a UK-based Phase 3 clinical trial, which enrolled over 15,000 participants between 18 and 84 years of age, showed an efficacy rate of 85.6% for the Novavax vaccine against the B.1.1.7 variant first detected in the United Kingdom. Half of the COVID-19 cases in the trial were reportedly caused by the B.1.1.7 variant. The vaccine had a 60% efficacy rate against the “highly worrisome variant currently circulating in South Africa,” reported the principal investigator of the Novavax trial in South Africa, Professor Shabir Maddi. This left an average vaccine efficacy rate of 89.3% from the all arms of the trial. “[This] is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants,” said Stanley C. Erck, CEO of Novavax, in a press release. Stanley C. Erck, President and CEO of Novavax, in an interview with CNBC. Meanwhile, the United States joined over 30 other countries in reporting infections from the B.1.351 variant (also called 501Y.V2), first identified in South Africa. Novavax’s results also included an analysis of a small Phase 2b trial in South Africa with 4,400 participants, where most of the cases that occurred were caused by the B.1.351 variant. Approximately a third of participants also were previously infected with SARS-CoV-2, which suggests that prior infection may not provide full immunity against the variant. Novavax Results Are First Showing Vaccine Efficacy Against Variants In Large Populations The Novavax results are the first to show vaccine efficacy against the variants in large clinical trials – as compared to lab tests of blood samples. While the vaccine performed less impressively against the variants – the results still are reassuring insofar as they pass the 60% bar that both the World Health Organization and the US Food and Drug Administration had set as a criteria for an effective COVID vaccine. “This is positive news and, if approved by the medicines regulator, the Novavax vaccine will be a significant boost to our vaccination programme and another weapon in our arsenal to beat this awful virus,” said Matt Hancock, UK Secretary of State for Health and Social Care. Other COVID-19 vaccines have only been tested on the variants in labs. Moderna announced on Monday that there was a six fold reduction in neutralizing antibodies with the B.1.351 variant, but suspected that the response would be sufficiently protective. Data from Pfizer’s in vitro studies on certain mutations present in the variants, released on Wednesday, revealed that neutralization against the virus was lower, but “the small differences in viral neutralization observed in these studies are unlikely to lead to a significant reduction in the effectiveness of the vaccine.” Novavax plans to immediately begin clinical development of a vaccine targeting the B.1.351 variant and expects to select a candidate for a booster or a combination bivalent vaccine in the coming days. Clinical testing on the new vaccines will commence between April and June of this year. “We can expect to see, if required, new vaccines or bivalent vaccines where two different strains are joined together in one vaccine. That now can be done at pace so that we can keep up with these variants, should they prove to be difficult to prevent with the vaccine that we have at the moment,” said Professor Paul Heath, Chief Investigator of the UK Novavax trial, in an interview with BBC Radio 4. The Novavax vaccine candidate, unlike the Pfizer/BioNTech and Moderna vaccines, uses fairly traditional vaccine technology to generate antigens derived from the SARS-CoV-2 spike protein, which are then joined with an adjuvant to enhance the immune response. Similar to the Oxford/AstraZeneca vaccine, it can be stored at normal refrigeration temperatures (2-8°C), which simplifies the transport and delivery process. “NVX-CoV2373 has the potential to play an important role in solving this global public health crisis. We look forward to continue to work…to make the vaccine available as quickly as possible,” said Erck. Novavax has signed vaccine deals with Canada for 75 million doses, the UK for 60 million doses, Australia for 51 million doses, New Zealand for 10.7 million doses, and the US for 100 million doses, which Operation Warp Speed paid US$1.6 billion to secure and to fund clinical development. Vaccination doses administered globally, as of 29 January 2021 since 14 December 2020. In addition, Novavax signed a manufacturing agreement with the Serum Institute of India to produce 1 billion doses of the vaccine in 2021, increasing the global manufacturing capacity to over 2 billion annually. Johnson & Johnson’s One-Shot Vaccine Shows Efficacy – But At Lower Levels On a less promising note, Johnson & Johnson’s highly anticipated single-dose COVID-19 vaccine was only 66% effective in preventing moderate to severe infection, according to results of Phase 3 trials released by the company on Friday. But that falls well behind the 90% or more efficacy ratings that Moderna and Pfizer/BioNTech vaccines have received – as well as the results obtained by Novavax and AstraZeneca in some arms of their trials. Among its 43,700 participants in the large J&J multi-country ENSEMBLE trial, the level of protection against moderate to severe infection provided by the vaccine varied by country and region, with the US recording an efficacy rate of 72%, Latin America reporting 66%, and South Africa recording the lowest levels of efficacy at 57%. The lower levels of protection in Latin America and South Africa could be due to the spread of SARS-CoV-2 variants that are more highly transmissible during the trial. Nearly all cases of COVID-19 in the trial in South Africa were linked to the variant, the company said. However it did not provide precisely stratified results against each individual variant. The company said that the Phase 3 ENSEMBLE clinical trial also showed “protection was generally consistent across race, age groups, including adults over 60 years of age.” Some 28 days after vaccination, the vaccine candidate was 85% effective in preventing severe disease – which includes admission to an intensive care unit, respiratory failure, organ failure, or death – in all adults over the age of 18 and in all regions studied. And complete protection against COVID-19-related hospitalization and death was provided by the vaccine candidate. Moderate illness was defined as COVID-19 infection with evidence of pneumonia, abnormal blood oxygen saturation levels, deep vein thrombosis, abnormal respiratory rate, or two or more systemic symptoms of COVID-19. A doctor administering the Johnson & Johnson COVID-19 vaccine candidate during the phase 3 clinical trials. J&J Touts Results On Severe Disease – Says It Will Still File For US FDA Authorization In February The company still plans to file for Emergency Use Authorization with the US Food and Drug Administration (FDA) in early February and expects to begin deploying doses immediately following its authorization. “These topline results with a single-shot COVID-19 vaccine candidate represent a promising moment,” said Paul Stoffels, Chief Scientific Officer at Johnson & Johnson, in a press release. “Eighty-five percent efficacy in preventing severe COVID-19 disease and prevention of COVID-19-related medical interventions will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19. It also offers the hope of helping ease the huge burden placed on healthcare systems and communities.” The vaccine candidate can be stored for at least three months at temperatures of 2-8°C and can be transported using existing cold chain technologies and standard vaccine distribution channels. The logistical advantages of the Johnson & Johnson vaccine could prove instrumental in light of the increasing need to reduce transmission and the emergence of additional variants. “Changing the trajectory of the pandemic will require mass vaccination to create herd immunity, and a single-dose regimen with fast onset of protection and ease of delivery and storage provides a potential solution to reaching as many people as possible,” said Mathai Mammen, Global Head of Research and Development at Janssen Pharmaceuticals. “The ability to avoid hospitalizations and deaths would change the game in combating the pandemic.” J&J Also Signed Deal With COVAX Forecast of the vaccine candidate-specific supply of COVID-19 vaccines to the COVAX Facility, as of 20 January. Johnson & Johnson has also signed an agreement with the COVAX Facility to provide up to 500 million doses for distribution to low- and middle-income countries. Once the agreement is finalized, Gavi, the Vaccine Alliance, the organization co-leading COVAX, will be able to procure up to 200 million doses in 2021 and 300 million in 2022. Unfortunately, Johnson & Johnson is reportedly experiencing manufacturing delays and is lagging behind its previously set timeline. According to US federal government officials, the company is estimated to be two months behind schedule. The pharma company joins several others who have announced issues in vaccine production, a few of which, namely Pfizer, AstraZeneca and most recently Moderna, have delayed the delivery of doses. However, Johnson & Johnson claims to be on track to meet its contractual agreements. “The Company’s anticipated manufacturing timeline will enable it to meet its 2021 supply commitments, including those signed with governments and global organizations,” said the press release. AstraZeneca, Facing Clash with EU, Releases Vaccine Deal Meanwhile, AstraZeneca published its Advanced Purchase Agreement (APA) with the European Commission amid a feud over the delay in the delivery of COVID-19 vaccines to the region. The Advanced Purchase Agreement between AstraZeneca and the EU, signed on 27 August 2020. In the partially redacted contract, signed on 27 August, 2020, AstraZeneca committed to “use its Best Reasonable Efforts…to build capacity to manufacture 300 million doses of the vaccine…for distribution within the EU.” ‘Best Reasonable Efforts’ is defined as “the activities and degree of effort that a company of similar size with a similarly-sized infrastructure and similar resources as AstraZeneca would undertake or use in the development and manufacture of a vaccine at the relevant stage of development.” Since the UK holds its own deal directly with AstraZeneca and won’t face the same shortfall of vaccines, EU leaders have called for the delivery of doses produced in the UK to make up for the shortage. Pascal Soriot, CEO of AstraZeneca, claims that the products manufactured at the two plants in the UK are reserved for its own citizens under the vaccine deal until a sufficient number of doses have been supplied to the UK. EU officials, however, dispute this argument under article 5.4 of the contract, which states that AstraZeneca agrees to “use its Best Reasonable Efforts to manufacture the vaccine at manufacturing sites located within the EU…and may manufacture the vaccine in non-EU facilities.” According to Ursula von der Leyen, President of the European Commission, the pharmaceutical company is legally obligated to use the four manufacturing sites in Europe – two in the UK, one in Belgium, and one in the Netherlands – to fulfil its supply commitments. While the dispute remains unresolved, Spain and France have announced the temporary pause in their vaccine campaigns because of the shortage of doses. Madrid suspended inoculations on Wednesday for the next two week and Paris plans to temporarily halt its program beginning on 2 February. European Commission Establishes Authorization Mechanism for Vaccine Exports In a move to increase transparency surrounding the export of COVID-19 vaccines covered under APAs and to ensure the continuation of vaccination campaigns in the EU, the European Commission has put in place a measure requiring authorization for the export of vaccines produced in the EU. “We gave upfront funding to companies to build the necessary manufacturing capacity to produce vaccines, so deliveries can start as soon as they are authorised,” said Stella Kyriakides, Commissioner for Health and Food Safety, in a press release. “We now need transparency on where the vaccines we secured are going and ensure that they reach our citizens.” Stella Kyriakides, European Commissioner for Health and Food Safety, at a press briefing on Friday. The “time-limited and targeted system” will be in place until the end of March 2021 and will not interfere with the EU’s humanitarian aid commitments, including the delivery of vaccines to low- and middle-income countries through the COVAX Facility, according to Valdis Dombrovskis, Executive Vice-President and Commissioner for Trade of the European Commission. The authorization will be granted or denied by the EU member states where the production of COVID-19 vaccines takes place. The aim of the new measure will not be to restrict exports “any more than absolutely necessary,” but instead to ensure the critical shortages in Europe are relieved in a “targeted, transparent, proportionate, [and] temporary” manner, said the trade document published by the European Commission on Friday. AstraZeneca Vaccine Receives Approval from EU Regulator Hours earlier, the European Medicines Agency (EMA) recommended the Oxford/AstraZeneca vaccine for approval one month after the UK provided it with authorization and began the vaccine rollout. The European Commission followed suit shortly after and granted conditional marketing authorization to the vaccine on Friday, making it the third COVID-19 vaccine authorized in the EU. After much discussion about whether the vaccine rollout should include adults over the age of 55, due to the lack of data in older participants, the EMA decided to recommend the vaccine to individuals aged 18 and older. “There are not yet enough results in older participants…to provide a figure for how well the vaccine will work in this group. However, protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines…EMA’s scientific experts considered that the vaccine can be used in older adults,” said the EMA press release. Overall, the vaccine demonstrated a 60% efficacy rate in clinical trials. “With the AstraZeneca vaccine now authorized, 400 million additional doses will be available in Europe. I expect the company to deliver these doses as agreed, so that Europeans can be vaccinated as soon as possible,” said Ursula von der Leyen, President of the European Commission in a press release. We have just authorised the @AstraZeneca vaccine on the EU market following a positive assessment by @EMA_News I expect the company to deliver the 400 million doses as agreed. We will keep on doing all we can to secure vaccines for Europeans, our neighbours & partners worldwide — Ursula von der Leyen (@vonderleyen) January 29, 2021 Following news of the authorization of the Oxford/AstraZeneca vaccine in the EU, WHO officials expressed their hope to grant the vaccine emergency use listing within two weeks. The Strategic Advisory Group of Experts on Immunisation (SAGE), WHO’s vaccine advisory panel, is scheduled to meet to review the Oxford/AstraZeneca vaccine on 8 February. “We should have an emergency use listing, providing, of course, that everything goes to plan and all the data is there. We can then start receiving doses from the manufacturing sites in India and South Korea,” said Soumya Swaminathan, WHO Chief Scientist, at a press conference on Friday. The Oxford/AstraZeneca vaccine is considered one with global potential – due to its ability to be stored at refrigerator temperatures, making its storage and transportation more manageable, particularly for countries without access to ultra-cold chain storage, which is required for the Pfizer and Moderna vaccines. Status of COVID-19 vaccines in the process of receiving WHO “Emergency Use Listing” approval, as of 25 January. Image Credits: Johnson & Johnson, Johnson & Johnson, CNBC, Our World in Data, Johnson & Johnson, GAVI, European Commission, Twitter – European Commission, WHO. COVAX Will Be Able To Give Country Data On Expected COVID Vaccine Allocations Within ‘Next Day’ 29/01/2021 Kerry Cullinan The COVAX facility was launched to ensure equitable distribution of the COVID-19 vaccine. Member countries will have an idea of how many COVID vaccine doses they will receive via the World Health Organization’s COVAX Facility and when they will arrive within the next day, WHO special advisor Dr Bruce Alyward has said. These “indicative allocations” would depend on when the WHO’s regulatory review of the specific vaccines that COVAX plans to distribute is completed, as well as on the volumes the companies can produce, Aylward told reporters Friday at WHO’s bi-weekly media pandemic briefing. “As you know, some companies are having challenges, so that is going to affect potentially what those volumes actually look like,” said Aylward. COVAX – WHO’s co-led platform dedicated to equitable vaccine distribution – has made its largest deal with AstraZeneca, but the Organization is yet to issue the vaccine an emergency use license (EUL). It expects to have completed its review of the company’s research within the next two weeks. Dr Bruce Aylward, WHO Senior Advisor to the Director General. COVAX is expecting its supply of AstraZeneca vaccines to be produced by the Serum Institute of India, along with a smaller number of Pfizer vaccines, thanks to a recent deal. This week, AstraZeneca informed the European Commission that there would be a 60% shortfall in vaccine deliveries to Europe this quarter due to a manufacturing issue at a production plant in Belgium. But the Commission had its doubts over this given explanation and has said it would establish a new mechanism that grants national regulators the power to refuse exports of vaccines following an investigation into the production facility. Share Vaccines To Ensure Global Coverage Of Health Workers & Elderly Tomorrow marks the first anniversary of the WHO’s declaration of SARS-CoV-2 as a “public health emergency of international concern”. At that time, there were only around 100 known cases. That number has now passed 100 million. At the briefing, Dr Tedros Adhanom Ghebreyesus, WHO Director General, once again appealed for equitable access to vaccines, starting with a global rollout to all health workers and the elderly: “For now, vaccines are a limited resource. We must use them as effectively and as fairly as we can. If we do that, lives will be saved. “That’s why I have challenged governments and industry leaders to work together to ensure that, in the first 100 days of 2021, the vaccination of health workers and older people is underway in all countries.” Harriet Nayiga, a midwife from Kenya, and Sana Baloch, a nurse in Pakistan, both addressed the press conference to explain their vulnerability to infection. “We engage with the patient for more hours than any other health worker, so we need to be prioritised to be vaccinated first,” said Nayiga. Pakistani nurse Sana Baloch appealed for vaccines for all health workers. Baloch said that around 10,000 Pakistani health workers had been infected by the virus and hundreds had died. Her hospital had “a huge influx of patients” and the “nurses, doctors and paramedics were in great distress”, she said. “It is our moral responsibility and our job to take care of those patients. We were the only hope of the patients who were admitted in COVID wards where they were not allowed to meet or to see anybody. We cannot leave them alone. But at the same time, we need protection,” said Baloch. “I appeal to the leaders of the world: please distribute the vaccine on an equitable basis. If you have enough resources to vaccinate all your elderly and all your health care providers, consider donating or help out less developed countries who do not have enough to even vaccinate their health care providers or elders, before moving to the less vulnerable of your population.” Dr Tedros said that countries that had secured vaccines should share these with COVAX. “My message to people in countries that are now rolling out vaccines is to use your voice to advocate for your government to share those. If you’re someone at lower risk, please wait your turn. Health care workers have been on the frontlines of the pandemic but are often under-protected and overexposed. They need vaccines now.” Countries Need To Support Travellers With Quarantine And Testing Dr Michael Ryan, WHO Executive Director of Health Emergencies, said that the expansion of rapid diagnostic tests was “bringing a new and very useful tool to bear, taking pressure off the existing PCR based testing systems”. But he appealed for coherent messages around travel and asked governments to respect the human rights and comfort of travelers, particularly as the process of travel itself has been “significantly de-risked” thanks to efforts from the travel industry. Mike Ryan, Executive Director of WHO Health Emergencies Programme. “Those countries with very low incidents are very, very afraid about re-importing cases, and may have more stringent testing in place. Other countries are worried about the arrival of potential variants that will further complicated situations and they’re targeting reducing movement from certain countries in order to be able to avoid that,” said Ryan. “We do need coherent messaging around travel requirements. If you’re going to require that travellers arriving in the country quarantine for a particular period or have to be tested, governments should be supporting that process. “It is very difficult for a traveller arriving to be able to comply sometimes if they don’t get the support to comply. Governments are continuing to try and increase and ramp up their efforts to break chains of transmission and to manage risks. But we also must do that and invest properly in those mechanisms so that people who are travelling between countries are treated with regard to their comfort and their human rights.” Image Credits: WHO, CIO Look/Flickr, WHO, Screenshot. ‘Gag Rule’ Must Never Be Repeated, International AIDS Society Tells US Gov 29/01/2021 Kerry Cullinan The International AIDS Society urged the Biden administration “to consider legislation preventing the global gag rule from returning in the future”. The International AIDS Society (IAS) has welcomed US President Joe Biden’s repeal of the Mexico City Policy, known as the global “gag rule”, which prevented non-US organisations from getting US aid if they offered abortion services, referrals or advocacy. But the IAS urged the US administration “to consider legislation preventing the global gag rule from returning in the future”, according to its president, Adeeba Kamarulzaman. The gag rule was first introduced by Ronald Reagan to prevent US government aid to foreign family planning organisations offering abortions. The Trump administration expanded it significantly to block any foreign NGO associated with abortion from receiving health development funds from any US source. The rule affected almost $9 billion of US aid, and had a severe impact on organisations offering HIV services, disrupting HIV testing, counselling, condom provision, antiretroviral treatment and care. “As HIV professionals, we saw firsthand the impact of the global gag rule from its first iteration – barring and disrupting access to health care for women around the world,” said IAS Executive Director Birgit Poniatowski. “In its expanded form, the policy threatened to roll back progress in the global HIV response.” Echoing the IAS call, Ugandan health activist Dorothy Amuron from the Center for Health, Human Rights and Development called on the Biden administration “to take bold action to stop this deadly cycle of granting or rescinding human rights when the political tides shift”. “The U.S. has an obligation to safeguard human rights for all. But policies like the global gag rule are an attack on our sovereignty and our humanity,” said Amuron. “We call on the Biden administration to use its power to get rid of them forever.” Ironically, the gag rule was associated with a 40% increase in the rate of abortion and a 13.5% reduction in the use of contraception, according to research published in the Lancet. Image Credits: Mike Beaty/Flickr. COVID-19 Has Outlined Healthcare Systems’ Dangerous Emissions Problem 29/01/2021 Raisa Santos Healthcare’s overreliance on single-use products and equipment contributes to its carbon footprint Failure to align the global recovery from COVID-19 with an equally powerful climate response could threaten the worldwide effort to limit the average global temperature increase, public health experts have said. In a convention in 2015 now known as the Paris Agreement, the United Nations Framework Convention on Climate Change (UNFCCC) established its aim to pause the increase in global average temperature by “well below 2 degrees Celsius above pre-industrial levels and to pursue efforts to limit the temperature increase even further to 1.5 degrees Celsius”. To achieve that, a global effort is required to decrease greenhouse gas emissions by 7.6% each year across five years. This number falls further out of reach each year without action. “The reality is that the next five years are going to be pivotal,” Dr Renee Salas, Harvard T.H. Chan School of Public Health, said during a webinar from the Lancet Countdown last week. The 2020 Report of the Lancet Countdown on Health and Climate Change was published in December, and addressed the converging crises of the COVID-19 pandemic, healthcare systems and climate change. “Healthcare has to show us how we can decarbonize and decarbonize our healthcare system,” she said, adding that it “is truly the embodiment that climate action is a prescription for health”. COVID Has Outlined Healthcare Systems’ Flaws The COVID-19 pandemic has highlighted healthcare’s overreliance on single-use products and equipment, the panel said. Additionally, as using personal protective equipment (PPE) has become a greater necessity, use of disposable products has been extended. The health system in England is responsible for an estimated 4-5% of the country’s carbon footprint, for example. NHS carbon footprint is mostly comprise of procured items from the health supply chain The United Kingdom’s National Health Service listed crutches as accounting for nearly 70% of the carbon footprint for items it procured in 2020. Additionally, the traditional model of outpatient care doesn’t strictly align with the nature of chronic illnesses, which requires patients return for unpredictable emergency treatment. Unpredictable treatment directly leads to increased road traffic and increased air pollution. NHS traffic accounts for 5% of road traffic in England alone. Quantified in terms of environmental, financial, and health outcomes, this means that 753 deaths can be attributed to NHS traffic, and £650 million in NHS expenditure are lost a year. “When [evaluating] the value offered in the delivery of a healthcare service, we need to start capturing data that looks at these consequences, thinking beyond the financial and individual patient outcomes,” said Jennifer Isherwood, a National Medical Director’s Clinical Fellow at the Royal College of Physicians, London. “It’s becoming clear that COVID is not going to be the last pandemic that we see,” Isherwood added. “It may be … disruptive to start addressing challenges of different pathways to different care, but it’s the right tool to start future-proofing our healthcare systems.” Hiten Patel, Senior Strategy Advisor for Greener NHS, said: “There’s always something else happening in healthcare systems that’s [considered] a priority. It’s about how we can try to make carbon emissions and climate change more of a priority within healthcare systems.” Concluded Dr Jodi Sherman, Yale University and Lancet Countdown author, said: “Everything we do in healthcare is through the lens of patient safety. Protecting public health is a matter of patient safety and needs to be integral to everything that we do.” Supply and Services Compose Four-Fifths of Overall Healthcare Carbon Footprint The health supply chain comprises four-fifths of US healthcare carbon footprint While the COVID pandemic has flagged some key flaws in the world’s healthcare systems, what is still unclear are the direct and indirect carbon emissions of the healthcare sector, and the implications these emissions have on health. Direct emissions are established and well understood products of the sector: gas exhausts from ambulance tailpipes to fumes emitted from waste incinerators. But indirect emissions – offsite power generation, the provision of medical supplies and pharmaceuticals, and even research and testing – make up a larger percentage of emissions associated with the healthcare sector. The United States alone spends more than US$3 trillion on healthcare a year. As healthcare expenditures increased, so too did the carbon footprint from goods and services. Around 7% is due to direct emissions from healthcare facilities, and another 10% from offsite energy. But four-fifths of the footprint is the supply chain, composed of key sectors that include food, pharmaceuticals, and chemicals. Dr Matthew Eckelman, Northeastern University, Boston and Lancet Countdown author, called on the health sector to take accountability for its immense carbon footprint. “It’s very clear that buying renewable energy is not the only solution. You really have to work on reducing carbon emissions in the supply chain, as well.” Lower the Infection Risk and Financial Losses by Reducing Health Waste Speakers also addressed how vital it is not to risk patient safety in trying to reduce or cut expenses. Healthcare-acquired infection – when a patient becomes infected while in care – affects hundreds of millions of patients globally each year. This leads to significant morbidity and mortality that incurs financial losses for health systems, in addition to excess pollution. As a result, prevention is essential. “While we do want to reduce waste and reduce costs, we certainly don’t want that to be at the expense of increasing infections,” said Dr Sherman. Dr Sherman also acknowledged, however, that infection prevention methods often contribute to the excessive use of single-use disposable devices, like masks and gloves. Using only disposable laryngoscopes would increase costs for hospitals In a greenhouse gas emissions and cost analysis study comparing reusable and disposable laryngoscopes, Dr Sherman and Eckelman found that disposables – whether plastic or steel – outweigh the reusable in terms of greenhouse gas emissions. Using purely disposables would increase costs by up to US $700,000 a year, for one hospital department. Recycling these disposables would only reduce a small portion of emissions, especially since the laryngoscope cannot be recycled entirely. “In other words, we can’t recycle a way out of this problem,” Dr Sherman said. “The answer isn’t that we should use disposables. It’s that we should clean up our supply.” There needs to be a balance between the “indirect disease burden from all the materials thrown away and lowering the infection risk curve.” The greatest causes of healthcare acquired infections, said Dr Sherman, have to do with staff discipline, such as hand washing, and patient health status, and exposure to infection. But simple hand washing and using more and more disposables is not the solution. Image Credits: Flickr: Marc A. Hermann / MTA New York City Transit, The Lancet Countdown. Pharma Ill-Equipped To Handle 10 Most Infectious Diseases And Future Pandemics, Report Warns 29/01/2021 Raisa Santos A new report has found that current R&D is primarily geared towards COVID-19, with next to no efforts to address other pathogens with the potential pandemic risks like Zika and Sars. With ten of the world’s most infectious diseases not catered by drug firms, pharmaceutical giants remain unprepared to tackle future pandemics, a new report has said. The report, published on Tuesday, found that though current medicine and vaccine research and development is primarily geared towards the COVID-19 pandemic, there are next to no efforts to address other pathogens with the potential pandemic risks: namely Nipah, Zika, and Sars. The Access to Medicine Index evaluates 20 global pharmaceutical companies – including AstraZeneca and Pfizer – and compares how far each goes in fulfilling the role of developing urgently needed health products and improving equitable access to them. The companies’ performance is ranked every two years. Pfizer joins top 5, while GSK retains its number one position, yet only slightly ahead of Novartis. Pfizer moves into the top five. Johnson & Johnson complete the top five companies. Eight of the top ten companies, including the leaders, are setting a new best practice of systematic access planning during R&D. “The state of infectious disease research today is, if I can put it mildly, on thin ice,” said Dr Jayasree Iyer, executive director of The Netherlands-based Access to Medicine Foundation, in an interview with DW. COVID-19 has emphasized the need for both the private and public sectors to actively engage in emerging infectious disease research well before the next pandemic breaks out. It has also shown that ending a pandemic requires suitable products to be developed and equitably distributed: much of the responsibility for which lies with pharmaceutical companies. Without their sustained commitment to pandemic preparedness, the report suggests, the world world will remain vulnerable to pandemics. Increased R&D for COVID-19, but Other Pandemic Risks Unaddressed Pharmaceutical companies are not targeting priority pathogens with epidemic potential through R&D. Excluding coronavirus, pathogens with pandemic potential where pharma companies are active in R&D show very small pipelines in 2020. Out of 16 pathogens, 10 have empty pipelines. Even for pathogens under scrutiny, research activity remains low. With most research focused on coronavirus, there are just 13 R&D projects across five non-COVID-19 diseases (Ebola, Zika, Chukungunya, Marburg, and non-polio enterovirus) and zero for the remaining ten of 16 infectious diseases. Emerging infectious disease (EID) research is concentrated among a few companies. In 2020, 17 companies targeted coronavirus, while nine companies are targeting other EIDs: Bayer, Eisai, Gilead, Johnson & Johnson, MSD, Merck, Roche, and Takeda. This figure shows the number of R&D projects and companies identified by WHO and Policy Cures as emerging infectious diseases, and how this has changed since 2018. What 2020 has highlighted is that large pharmaceutical companies have a critical role to play in preparing for the next pandemic, but that these companies have so far delivered a range of responses: some of them apparently shortsighted. Small biotech companies and academic groups may be able to pioneer new ideas, but it is the big players that are responsible for rapid development and access to vaccines, therapeutics and diagnostics, with the capacity to scale-up both manufacturing and distribution capabilities. Poorer Countries Lacking Access to More Than Half Key Products Covered By Pharma Companies However, the pharmaceutical industry only mobilized against COVID-19 once it became clear that the outbreak affected rich as well as poor countries. “Even in light of COVID-19, there were very few commitments from the pharmaceutical industry last year,” said Iyer. Other than projects developed within the Access to COVID-19 Tools (ACT) Accelerator, there was little evidence in the first months of the pandemic response that there structures in place to ensure access and distribution to COVID-19 vaccines in poorer countries. This has once more shown that the Global South still does not benefit significantly from access strategies implemented by big pharma. Less than half of key products controlled by 20 large companies are being offered in countries classified as either lower-middle income countries (LMICs) or low-income countries (LICs). Low-income countries are most consistently over-looked by access strategies, particularly for products that need to be administered by healthcare practitioners. The response is even more profound in LICs, which are consistently overlooked despite being home to almost 700 million people. Currently, only eight of the 60 – or 13% – critical products that need to be administered by healthcare professionals, like injectable treatments for cancer, are covered by access strategies in at least one LICs. Self-administered medicines such as pills have 26%. The numbers jump slightly in LMICs, and even more so in upper-middle income countries (UMICs), with approximately half of critical products covered by access strategies in UMICs. The greatest number of people also benefited from both healthcare professionals administered medicine and self-administered medicine in UMICs. Many industry access arrangements do not go far enough, with many of the world’s most vulnerable and marginalized not receiving the life-changing medicines they need. Solving the access to medicine problem requires the pharmaceutical industry to take large-scale action, reaching more people with more products across a wider range of the world’s poorest countries. “I believe the past year has demonstrated the pivotal importance of supplying affordable medicines for the many, rather than premium-priced products for the few,” said Iyer. “By investing in fair access to medicine for the poorest and most vulnerable among us, we are also investing in a fair, peaceful and prosperous global community.” Eight Pharma Companies Paving Way Towards Equitable Access Top 6 companies with access planning, with percentage of R&D projects with access plans There are positives: eight companies have taken the lead to integrating systemic access planning into their development processes. Novartis was noted as the first to begin mainstreaming access in the previous Index, and joining them in 2021 are AstraZeneca, GSK, Johnson & Johnson, Merck, Pfizer, Sanofi, and Takeda. Though the 20 companies in the Index have 394 projects in late-stage development that target either global health priorities (114) such as coronavirus, malaria, tuberculosis or HIV, or offer benefits to low- and middle-income countries (280), the majority of these are not supported by an access plan. An access plan can include a wide range of activities – prioritising countries with the highest disease burden to strengthening supply chains to ensure all populations have fair access. To have maximum impact, the Index advises that access plans have a broad geographic focus, explicitly aiming to reach a majority of people affected by a disease or in need of a vaccine or diagnostic tool. The 20 companies in scope have 394 R&D projects in late-stage development that either target established global health priorities or offer clear public health benefits for low- and middle-income countries. The majority of these are not yet supported by an access plan. If this happens, people living in low- and middle-income countries, especially those in resource-limited or remote settings, will no longer be left behind for pharmaceutical innovations. Concluded Iyer: “The power of science to help humanity – whether through new vaccines for common pathogens or novel drugs for rare diseases – is remarkable. But these breakthroughs will only truly deliver for the world if they reach all those who need them.” Image Credits: Access to Medicine Foundation , Access to Medicine Foundation . WHO Executive Board Rejects Israel’s Proposal To Remove Standalone Agenda Item On Palestinian Health Conditions 28/01/2021 Madeleine Hoecklin Meirav Eilon Shahar, Israel’s ambassador to the United Nations in Geneva, speaking to the WHO Executive Board. For the second time in as many years, WHO member states have voted down a proposal by Israel to remove a standalone item from the agenda of the 74th World Health Assembly – devoted exclusively to a report on health conditions in the Occupied Palestinian territories – and consider it as part of WHO’s overall health emergencies agenda. Saying that the agenda item unfairly singles out just one country for criticism, as compared to every other nation in the world, Israel on Tuesday proposed to the WHO Executive Board, which fixes the WHA agenda, that the report be considered as part of the overall discussion on WHO’s work in health emergencies when WHO member states meet in May. In a lengthy and unusual voting process on the closing day of the 10-day EB session, the proposal was rejected in a vote of 15 to seven – with 9 abstentions and 3 countries absent. Those supporting Israel’s position included the United Kingdom, Germany and Austria, joined by the United States, Australia and Colombia. EB members that were opposed included Oman, China, Russia, and Tunisia. Israel’s delegation said the report was a “political” item that does not reflect reality and will not change the situation on the ground. “Item 25 is a political item with only one purpose – to attack Israel and to politicize an otherwise professional organization [WHO]. This must be changed…What I’m asking you to do today is to ensure that the World Health Assembly maintains its focus on health and the truth,” said Israel’s ambassador to the United Nations, Meirav Eilon Shahar. “Regardless of what takes place in Geneva, we, Israel, will continue to work with the Palestinians and with WHO and we’ll continue to work on any problem and assistance intended to improve the health conditions for the Palestinians,” she added. The Palestinian representative, Ibrahim Khraishi, Ambassador of the State of Palestine to the UN, which holds observer status in the World Health Assembly, retorted that: “The [health situation in the occupied territories] is catastrophic and dire…Israel is finding it easy to renege on its responsibility, for example, it is not meeting its requirement…when it comes to vaccination. “When we look at the rate of vaccination for [Israeli] citizens, the figure exceeds two and a half million, whereas not one single Palestinian citizen has had the jab because of Israeli practices,” he said. Khraishi cited the WHO report from the 73rd WHA in November 2020, which he said shows that infant mortality of West Bank Palestinians is six times higher, and maternal mortality nine times higher than that of the 600,000 Israeli settlers living side by side with Palestinians in the Occupied West Bank. The report also describes barriers Palestinians from the West Bank and Gaza face in accessing more health services, such as the more specialized services in Jerusalem, which is directly under Israeli rule and to which access is tightly-controlled. Ibrahim Khraishi, Ambassador of the State of Palestine to the UN and Palestine’s representative to the Executive Board. After the vote among member states, Israel disputed the vaccination claims, saying that Palestinian inmates have received vaccinations and the PA has been provided with emergency supplies for 100 essential health workers – but the overall responsibility to vaccinate the roughly 5 million Palestinians living in the West Bank and Gaza lies with the Palestinian Authority (PA), not Israel. “We are very happy to extend assistance in facilitation of those vaccines in entrance to Israel,” said Eilon Shahar, referring to the expected arrival of PA-purchased vaccine supplies from Russia. PA health officials have not, in fact, officially requested vaccines from Israel, but rather are awaiting the arrival of Russian Sputnik vaccines within the coming two weeks. However, human rights groups have underlined that Israel still holds the ultimate responsibility for health under international law insofar as it still occupies the West Bank, The largely technical issue of where on the WHA agenda the report on Palestinian health conditions should be reviewed, was subject to a lengthy and unusual voting process (most EB decisions are made by consensus). The United States, Australia, and the United Kingdom explained their support of Israel’s proposal, saying that no other country in the world has been singled out in such a way by the WHO. “We’re concerned that the World Health Assembly does not consider the many other difficult health situations around the world in the same way,” said the UK’s delegate. “This item remains the only country specific item at the WHA…We fail our duty to serve people around the world who have vitally important health concerns if we allow WHO to become politicized in this way.” The UK’s delegate to the Executive Board. Australia went a step further, expressing concerns about the introduction of political issues into the WHA through the existence of the stand alone item – and calling for negotiations to permanently remove the item, not only as a stand-alone item but altogether from the agenda. The delegations from Oman and the Syrian Arab Republic countered the arguments made by the UK and US, claiming that the agenda item does not single out Israel. “This is not a country-specific item. This is an item which [reflects] a specific situation, a situation of people under occupation and addresses the legal obligations of the occupying power,” said Syria’s delegate. “The politicization is coming from attempts to go around these facts.” The Palestinian representative concluded the discussion at the closing session of the Executive Board meeting on Tuesday by urging member states to encourage Israel to “shoulder her responsibilities and do her duty towards all citizens for which she is responsible, particularly those in the occupied Syrian Golan, the Gaza Strip, and the other occupied territories.” The Gaza Strip has been under Israeli blockade as a result of repeated Israeli confrontations with the fundamentalist Hamas, which wrested control of the Strip from the PA-supported Fatah in 2007, two years after Israel unilaterally uprooted its settlements and withdrew from the Strip. Israel captured the Golan Heights from Syria in the 1967 Six Day War, and extended Israeli citizenship to the predominantly Druse residents of the Heights who remained after the war. Image Credits: WHO. Africa CDC Head calls for ‘Common Approach’ To Travel Restrictions Based on COVID Test & Not ‘National Origins’; 7 African Nations Report SARS-CoV-2 Variants 28/01/2021 Paul Adepoju Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy and not geographic or national origins, Africa CDC Director Dr John Nkengasong has said. IBADAN – Five African countries have now confirmed cases of the SARS-CoV-2 501Y.V2 variant, which first appeared in South Africa, and there is concern that the variant is circulating undetected elsewhere on the continent. The Gambia and Nigeria have seen cases of the variant B.1.1.7, first identified in the United Kingdom, said WHO’s African Regional Director today, Dr. Matshidiso Moeti, at a press briefing. Meanwhile, Africa CDC Director, Dr John Nkengasong, called for a “common approach” to COVID testing to oil the wings of international air travel – and halt the wave of new travel restrictions that countries have been imposing based on people’s national origin or the origins of flights – including people and flights arriving to Europe and the United States from South Africa. Researchers now believe the variants may be both more infectious but also more deadly than the COVID virus strains that were prevalent until just recently. Researchers also fear the variants could also elude COVID tests and be more resilient to vaccines just being rolled out now – although many unknowns remain. The countries where 501Y.V2 is circulating include: Botswana, Ghana, Kenya and Zambia, as well as South Africa. Beyond Africa, the variant has been confirmed in 24 countries globally. And there’s concern, it is circulating undetected in other countries in Africa,” Moeti told the press briefing. Dr. Matshidiso Moeti, WHO’s African Regional Director. “We are seeing more and more cases of variants and 501Y.V2, which was first identified in South Africa now, cropping up in other countries,” Moeti said. “The evidence suggests that these variants are more transmissible and emerging evidence indicates that the UK variant may cause more severe illness than other common strains, although more research needs to be done.” These variants in conjunction with “the aftermath of year-end gatherings”, Moeti said, “risk powering a perfect storm and driving up Africa’s second wave and overwhelming health facilities”. The continent saw a 50% rise in infections between 29 December 2020 and 25 January 2021, when compared with the previous four weeks, while deaths doubled. Last week, more than 6,200 deaths were reported across Africa, said the WHO.The past week saw a small dip in cases in South Africa, but 22 other countries continued to see numbers surge. Existing COVID-19 vaccines remain effective against the variants, Moeti said. But Professor Tulio de Oliveira, of the University of KwaZuku-Natal, South Africa, noted that these or other emerging variants may likely require individuals receiving booster doses of the vaccine. WHO’s African Region is meanwhile setting up a new surveillance network with Africa CDC to track the spread of the virus mutations and variants across Africa and beyond, Moeti added. “The variant which was first detected in South Africa has spread quickly beyond Africa and so what’s keeping me awake at night right now is that it’s very likely circulating in a number of African countries,” said Moeti. “Africa is at a crossroads. We must stick to our guns and double down on the tactics we know work so well. That is mask wearing, handwashing and safe social distancing. Countless lives depend on it.” WHO’s African CDC Calls for Common COVID Testing Approach For International Travel Dr John Nkengasong issued his call for a rethink of travel policies after several foreign countries, including the United States, are considering or have already banned flights originating from South Africa. Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy – and not geographic or national origins, said Nkengasong. “We should not be banning people because of their geographical origin, but we should be encouraging people to travel with negative tests and facilitate the testing process so that people can travel with a negative test,” Nkengasong said. “If I were to go to Kenya and I show up at the airport with a valid negative test, I pose no threat to the country of Kenya, and that way so you shouldn’t just ban me because I’m coming from a certain country. They should be looking at that test, is your test valid,” Nkengasong added. Dr John Nkengasong, Director of the Africa CDC. Up until now, the World Health Organization has resisted recommending pre-travel COVID testing, ostensibly due to fears that it would put an unnecessary onus on poor countries. In fact, however, many of the poorest African and Asian countries have been requiring pre-flight COVID tests for all incoming passengers – which are paid for privately. Some counties, such as the Democratic Republic of Congo, also demand arrivals briefly quarantine until a post-flight test is completed as well, paid privately as well. Paradoxically, it is wealthier European and American countries that first issued a rash of orders banning passengers of certain nationalities or flights from certain destinations as a result of variant scares – although more developed countries, most recently Switzerland on Wednesday, have adopted testing requirements. Senegal’s Pasteur Institute – At Center Of New Genetic Surveillance Network At the outset of the pandemic, most countries in Africa lacked adequate testing capacity for COVID-19 but this was gradually surmounted as new testing facilities were added. Now, however, the identification of new variants of the virus will require more advanced capacities for gene sequencing that several countries in Africa have yet to obtain. To address this vacuum, the Africa CDC, the WHO and member countries have created a network that enables existing labs with gene sequencing capabilities to collect samples from countries that lack such. One of the labs in the network is the Dakar-based Institut Pasteur de Dakar in Senegal. Its CEO, Dr Amadou Sall, said in addition to providing gene sequencing services for Senegal, the institute is now supporting other countries, Cameroon and Equatorial Guinea notably. Others include Mali, Burkina Faso Guinea-Bissau, Côte d’Ivoire, Niger, Verde, and of course, Guinea. “With the partnership we have with Africa CDC and WHO, we have the possibility of sequencing 500 genomes per week. And we’re trying to increase this capacity and to make these capacities available in different countries,” Sall said. Key to the success of COVID-19 genomic surveillance in Africa, Sall said, will be the willingness and openness of African countries to share information. “We need to be able to share information data and the Pasteur Institute is at the center of a global platform and we’re able to share information; to exchange information rapidly, if countries are willing to do so,” he said. Knowing When to Raise the Alarm While noting that identification of new variants is a significant feat, genomic experts warned that alarm should not be raised every time a new strain is identified. Professor de Oliveira, who heads the KwaZulu-Natal Research and Innovation Sequencing Platform, said attention is raised when new strains are being confirmed in increasing numbers of cases with the new variant and not when just one case has been confirmed. Describing the impacts that variants have on the epidemiology of the pandemic in South Africa, Oliveira said in some regions, the new variant has become the prominent type. But beyond this, he said South Africa is also worried about the variants from elsewhere getting into the country and circulating among its populations. “Today, we just reported the first important case of the B.1.1.7, the variant of concern that is circulating in the UK. And it’s quite common that in addition to our main variant that is dominating, we’re going to still have introductions of new lineages,” Oliveira said. “And in the case they begin to spread very fast, then we will communicate it and then highlight that could be a variant of concern.” He said that while no one can know for sure about the possibility of third or fourth waves of the pandemic in Africa, the variants are highlighting the need for the entire world to globally control the transmission of SARS-CoV-2 as a global community. “We have to really decrease transmission to avoid the next waves and more worry that emergence of new variants of concern will transmit too fast or evade immune response,” he said. “The appearance of these variants in the African continent, but also in South America and Europe really means that more than ever, it is the time that we don’t leave any continent behind, especially on vaccination,” Oliveira said. Silver Lining In Cloud – Variants Also Impetus For Cooperation But within Africa itself, Sall said the various SARS-CoV-2 variants constitute a new impetus for cooperation between countries, to be able to track and measure the circulation of the virus, and to enhance diagnostic capacities that he said will soon be available across Africa. “The new variants are the object of a very thorough study, and the path of our countries is very clear: obtain maximum information and adapt the strategy to contain the transmission,” he said. Moeti enjoined countries and individuals to strive to overcome COVID-19 fatigue and return to the fundamental actions that have been found to be effective against these variants. These measures, she said, need much more emphasis that news that the virus is much more transmissible. “The vaccine is a tool that’s going to make a huge difference all over the world,” she said. But she reminded that “having a corner of the world not protected, the way the world’s economies and peoples are connected, will have negative economic impact even in those countries that managed to vaccinate the entire population. We really are all in it together, and we have to work to support each other to overcome this global crisis.” Image Credits: Paul Adepoju/HealthPolicyWatch, Africa CDC. EU Protests AstraZeneca Vaccine Delays – Could Block UK-Bound Exports 28/01/2021 Madeleine Hoecklin The Oxford/AstraZeneca vaccine is 2 months behind schedule due to an issue in manufacturing. AstraZeneca has joined Pfizer in announcing delays in deliveries of COVID-19 vaccines to countries in Europe, leading furious EU officials to plan for a system of tighter monitoring of vaccine exports. The British-Swedish pharma company that developed its COVID-19 vaccine with researchers at Oxford University, informed the European Commission on Friday that there would be a 60% shortfall in vaccine deliveries this quarter due to a manufacturing issue at a production plant in Belgium. The company is reportedly two months behind schedule with regard to vaccines destined for European countries. Since vaccine deals with the United States and the United Kingdom were signed earlier on, and are based around manufacturing sites in those countries, the company has had a headstart in resolving “glitches” in those supply chains, pharma officials said. But the Commission had its doubts over this given explanation. Following an EU-requested investigation into AstraZeneca’s Belgian-based production facility on Wednesday, the European Commission has said it would establish a new mechanism that grants national regulators the power to refuse exports of vaccines. The mechanism – the criteria for which is expected to be published on Friday – could throw the security of the UK’s 40m-dose deal with Pfizer/BioNTech. The investigation, a spokesperson for the Belgian health ministry said, was to “make sure that the delivery delay is indeed due to a production problem on the Belgian site”. AstraZeneca ‘Scaling Up’ Doses, As EU Leaders Question Pharma Company Pascal Soriot, CEO of AstraZeneca “We are scaling up to hundreds of millions, billions of doses of vaccines at a very high speed. A year ago we didn’t have a vaccine. When you do that, you have glitches, you have scale-up problems. Therefore, the yield varies,” said Pascal Soriot, CEO of AstraZeneca, in an interview with la Repubblica, an Italian newspaper, on Tuesday. News of the delays was met with frustration by EU officials and leaders, who were expecting to receive 80 million doses by the end of March. “This new schedule is not acceptable to the European Union,” said Stella Kyriakides, European Commissioner for Health and Food Safety, in a statement released on Monday. “The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far, and if, or to whom, they have been delivered.” Stella Kyriakides, European Commissioner for Health and Food Safety, at a press briefing on Wednesday. Soriot disputed suggestions that the company sold the doses elsewhere for a higher price, claiming that “there is a lot of silly talk going on right now about all sorts of things,” and the response from the European Commission and EU member states is because “there are a lot of emotions running in this process right now.” “The suggestion [that] we sell to other countries to make more money is not right because we make no profit everywhere…That’s the agreement we have with Oxford University,” said Soriot. “Governments are under pressure. Everybody is getting kind of…aggravated or emotional about those things. But I understand because the Commission is managing the process for the whole of Europe,” he added. In late August, the EU made an upfront payment of €336 million to the company to secure 300 million doses of the vaccine. EU officials have disputed AstraZeneca’s explanation of production issues, claiming there are no excuses for the delay. “The flimsy justification that there are difficulties in the EU supply chain but not anywhere else does not hold water, as it is of course no problem to get the vaccine from the UK to the continent,” said Peter Liese, an EU parliamentarian from Germany’s Christian Democratic Union. Currently AstraZeneca is producing 17 million doses per month. That number will reach 100 million doses from February onwards, according to Soriot, meaning 1.2 billion doses per year. And Europe will receive 17% of the global production in February for a population that represents 5% of the world’s population. The Oxford/AstraZeneca vaccine is in the final stages of the approval process with the European Medicines Agency (EMA) and is expected to receive the recommendation for market authorization on Friday. After being approved, the company plans to deliver three million doses immediately. Meetings between EU officials and AstraZeneca have done little to resolve the issue, with Kyriakides announcing on Twitter: “Discussions with @AstraZeneca today resulted in dissatisfaction with the lack of clarity and insufficient explanations. EU Member States are united: vaccine developers have societal and contractual responsibilities they need to uphold.” With our Member States, we have requested from AZ a detailed planning of vaccine deliveries and when distribution will take place to Member States. Another meeting will be convened on Wednesday to discuss the matter further. — Stella Kyriakides (@SKyriakidesEU) January 25, 2021 The EU Steering Board, the body that oversees vaccine deals, plans to meet with AstraZeneca again on Wednesday at 6:30pm CET and hopes to “resolve this in a spirit of collaboration and responsibility,” according to Kyriakides. The Italian government plans to take legal action against Pfizer and AstraZeneca over their delays in deliveries, according to an announcement made by Foreign Minister Luigi Di Maio on Sunday. “This is a European contract that Pfizer and AstraZeneca are not respecting and so for this reason we will take legal action,” Di Maio said on RAI state television. “We are activating all channels so that the EU Commission does all it can to make these gentlemen respect their contracts.” According to Soriot, however, the vaccine deal signed with the EU was not a contractual commitment but a best effort, so there is no feasible basis for legal action. EU to Establish a Vaccine Export Transparency Mechanism The Oxford/AstraZeneca vaccine is also considered one with global potential – due to its ability to be stored at refrigerator temperatures. Amidst some countries’ suspicions that countries outside Europe are receiving priority for vaccines produced at the Belgium plant, the European Commission announced plans to establish an export transparency mechanism for vaccines to ensure clarity on transactions and to protect its investments in the R&D that led to development of vaccines like AstraZeneca’s. AstraZeneca is also a major supplier of the WHO COVAX global distribution initiative – which has pledged to begin distributing vaccine doses to the 92 lowest-income countries in the world within the next two months. Although most of the COVAX supplies were reportedly to be produced by India’s Serum Institute or in the Republic of Korea, the exact supply lines remain unclear. “Europe invested billions to help develop the world’s first COVID-19 vaccines…And now, the companies must deliver,” said Ursula von der Leyen, President of the European Commission, at the World Economic Forum on Tuesday. “They must honor their obligations. This is why we will set up a vaccine export transparency mechanism. Europe is determined to contribute to this global common good. But it also means business.” Ursula von der Leyen, President of the European Commission, speaking at the World Economic Forum on Tuesday. “In the future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries,” said Commissioner Kyriakides. The aim of the proposed system will be to monitor, but not block, exports, officials said. And humanitarian deliveries would be anyway exempt from this oversight mechanism. EMA Yet To Issue Final Approval – Insufficient Data on Vaccine in Older People Meanwhile, the EMA has yet to issue its final regulatory approval for the two-dose Oxford/AstraZeneca vaccine, and is reportedly considering limiting the age range to people under the age of 65 – due to a lack of data on effectiveness in older people. Unlike mRNA counterparts produced by Moderna and Pfizer, the AstraZeneca/Oxford vaccine uses a disabled, modified version of a chimpanzee adenovirus that can enter human cells but cannot replicate or cause the disease, as a vector to deliver a fragment of SARS-CoV2 spike protein, stimulating COVID-19 immunity. According to data shared by the company, only 10% of participants in the vaccine clinical trials were over the age of 65 because it was first waiting for sufficient safety data in the 18 to 55 age group before vaccinating older individuals. “We don’t have a huge number of older people who have been vaccinated,” said Soriot. “But we have strong data showing very strong antibody production against the virus in the elderly, similar to what we see in younger people.” The results of an ongoing, larger Phase 3 clinical trial with 30,000 participants being conducted in the United States are expected to provide insight into the protection the vaccine provides to older individuals and ethnic minorities populations – groups that were not very well represented in previous trials. In addition, scientists are exploring whether a half-dose of the first vaccine would reliably yield a higher efficacy rating of 90% that was seen in initial trials. The other regime, involving two full doses was only 62% effective, according to the results released by the company in late November and reviewed by an independent Data and Safety Monitoring Board. That still meets key global benchmarks for efficacy, but is significantly lower than the 94-95% efficacy results for the Moderna and Pfizer mRNA vaccines. The AstraZeneca vaccine has, however, already been authorized in the UK, is already being used in British vaccination campaigns, including for people over 70 years old. Image Credits: AstraZeneca, AstraZeneca, Twitter, Twitter. WHO Proposes New Mode Of Engaging With Non-State Actors 28/01/2021 Esther Nakkazi Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, according to WHO. The World Health Organization (WHO) aims to make its engagement with non-state actors (non-state actors) more meaningful and efficient with a new proposal to establish a number of NSA fora that would allow exchange with WHO and member state representatives outside of official meetings. The new proposal — which will be tested during the 74th World Health Assembly (WHA), 24 May to 1 June — would offer multiple side events in which non-state (NSA) actors could engage more informally with member state representatives as well as a forum for exchange between NSAs and WHO regional and technical staff. But at the same time, non-state actors will be allotted a more limited number of constituency statements in formal governing body meetings – and like-minded groups of actors will be asked to combine their official statements together. Non-state actors include civil society groups such as non-governmental organizations, international business and professional associations, and philanthropic foundations. More than 70 non-state actors are recognized as being “in official relations” with WHO, and thus contribute in formal meetings such as the EB and the WHA. However, EB and WHA members have complained that the civil society interventions have become bogged down by too many lengthy, individual statements – and NSAs acknowledge that the statements often had limited impact in member state debates. More informal meetings ahead of the formal meeting dates would help engender more meaningful interaction, WHO said in its proposal for the reform, which was reviewed by the WHO Executive Board on Saturday. Informal meetings will also allow non-state actors to organize themselves into constituencies, consolidating their positions into joint statements to be presented at official events. The new arrangements to be tested in May, will “serve as a trial for potential future virtual informal meetings between non-state actors, Member States and the Secretariat, as a means of enabling more in-depth technical exchanges, as well as discussions on the Health Assembly agenda items,” said the WHO Secretariat, in its presentation to the EB on Saturday. The COVID-19 pandemic has provided added impetus for reforms that have long been in the making – insofar as the limitations of virtual meetings have also curtailed the interactions between member states and non-state actors. According to the new proposal, the informal series of meetings with non-state actors will be held just ahead of the WHA, and thus prepare the groundwork for the formal meeting. Role of Non-State Actors Has Evolved – But Increasing Number of Statements Detracted from Impact In the discussion over the proposal, WHO officials stressed that the Organization “is and remains a Member State Organisation” — engaging with 77 non-state actors, at global, regional and country levels, who also support the development and implementation of the Organization’s policies and recommendations, technical norms and standards. But while non-state actors have “served the Organization well for several decades”, the increasing number of non-governmental organizations and other non-state actors participating — often with a greater number of requests to speak — has “not resulted in a more meaningful involvement”. For example, when civil society representatives speak one-by-one at the end of a discussion, their interventions have little impact on the content or direction of the debate, WHO contends. Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, says the WHO. A virtual consultation by WHO further confirmed that non-state actors’ primary interests in attending governing body meetings are to participate in technical exchanges with the Secretariat and the Member States and to attend consultative hearings that feed into decision-making processes. Meaningful Participation From NGOs Critical, Member States Say The UK delegate said that it would allow NSAs to exert even more credible influence on member states attitudes and positions. The EB representative from the United States flagged that it is critical to ensure and enhance meaningful participation of non-state actors in WHO governing bodies, while also creating greater efficiency in the governance process. “Non-State actor participation must be allowed in a transparent and accountable manner with an open door to input from all stakeholders including the private sector,” the delegate noted. Austria pressed for the Secretariat to provide some more detailed information on the procedure for these meetings. Other states, like Australia, flagged that the trial is very ambitious given the agenda for the 2021 assembly is already very crowded. “We suggest that before agreeing to a trial, the number of meetings proposed to be repeated and streamlined,” the representative said.This would “provide reflections to technical areas in advance of the governing body meetings”. Civil Society Groups Request Clarity and Procedure Details Bodies like Health Action International asked for details as to how NGOs would participate, and for clarity on the processes governing such meetings. “It is a remaining concern to those who have witnessed creeping capacity shrinking of NGO space and poor consultation in recent years,” said an HAI statement. The HAI delegate requested that similar procedures be implemented for WHO regional meetings with member states, also asking that “these informal meetings compliment, but do not replace comprehensive consultations with non-state actors.” Meanwhile, the European Society for Medical Oncology said the views and expertise of non-state actors should be introduced earlier in the WHO decision-making process; it would be of greater value if delivered at the onset of projects, and when member states are drafting zero draft decisions and resolutions. “Direct interaction and discussion between member states, WHO offices, and Non-State actors would provide the opportunity for more in-depth exchanges, and partnerships, as the Member States, develop policies and implement actions to fulfill their WHO commitments,” said the ESMO spokesperson. Silberschmidt stressed that the virtual informal meetings will not replace other channels, but become an additional avenue for interaction – highlighting the fact that Dr Tedros Adhanom Ghebreyesus, WHO Director General, has already established a regular dialogue with civil society groups, to be held every six weeks. Image Credits: WHO / Christopher Black. 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.
Novavax’s COVID Vaccine Shows High Efficacy In Trials; J&J One-Dose Shot Less So – As Europe Feuds With AstraZeneca 29/01/2021 Madeleine Hoecklin Novavax’s vaccine candidate had a vaccine efficacy rate of 89.3%, while Johnson & Johnson’s highly anticipated single-dose COVID-19 vaccine is 66% effective in preventing moderate to severe infection. Novavax has become the first COVID-19 vaccine to show clinical efficacy against two major new SARS-CoV-2 virus variants now circulating worldwide – although the vaccine’s highest efficacy of 95.6% was against the COVID strain that had been predominant up until the end of 2020. The results of a UK-based Phase 3 clinical trial, which enrolled over 15,000 participants between 18 and 84 years of age, showed an efficacy rate of 85.6% for the Novavax vaccine against the B.1.1.7 variant first detected in the United Kingdom. Half of the COVID-19 cases in the trial were reportedly caused by the B.1.1.7 variant. The vaccine had a 60% efficacy rate against the “highly worrisome variant currently circulating in South Africa,” reported the principal investigator of the Novavax trial in South Africa, Professor Shabir Maddi. This left an average vaccine efficacy rate of 89.3% from the all arms of the trial. “[This] is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants,” said Stanley C. Erck, CEO of Novavax, in a press release. Stanley C. Erck, President and CEO of Novavax, in an interview with CNBC. Meanwhile, the United States joined over 30 other countries in reporting infections from the B.1.351 variant (also called 501Y.V2), first identified in South Africa. Novavax’s results also included an analysis of a small Phase 2b trial in South Africa with 4,400 participants, where most of the cases that occurred were caused by the B.1.351 variant. Approximately a third of participants also were previously infected with SARS-CoV-2, which suggests that prior infection may not provide full immunity against the variant. Novavax Results Are First Showing Vaccine Efficacy Against Variants In Large Populations The Novavax results are the first to show vaccine efficacy against the variants in large clinical trials – as compared to lab tests of blood samples. While the vaccine performed less impressively against the variants – the results still are reassuring insofar as they pass the 60% bar that both the World Health Organization and the US Food and Drug Administration had set as a criteria for an effective COVID vaccine. “This is positive news and, if approved by the medicines regulator, the Novavax vaccine will be a significant boost to our vaccination programme and another weapon in our arsenal to beat this awful virus,” said Matt Hancock, UK Secretary of State for Health and Social Care. Other COVID-19 vaccines have only been tested on the variants in labs. Moderna announced on Monday that there was a six fold reduction in neutralizing antibodies with the B.1.351 variant, but suspected that the response would be sufficiently protective. Data from Pfizer’s in vitro studies on certain mutations present in the variants, released on Wednesday, revealed that neutralization against the virus was lower, but “the small differences in viral neutralization observed in these studies are unlikely to lead to a significant reduction in the effectiveness of the vaccine.” Novavax plans to immediately begin clinical development of a vaccine targeting the B.1.351 variant and expects to select a candidate for a booster or a combination bivalent vaccine in the coming days. Clinical testing on the new vaccines will commence between April and June of this year. “We can expect to see, if required, new vaccines or bivalent vaccines where two different strains are joined together in one vaccine. That now can be done at pace so that we can keep up with these variants, should they prove to be difficult to prevent with the vaccine that we have at the moment,” said Professor Paul Heath, Chief Investigator of the UK Novavax trial, in an interview with BBC Radio 4. The Novavax vaccine candidate, unlike the Pfizer/BioNTech and Moderna vaccines, uses fairly traditional vaccine technology to generate antigens derived from the SARS-CoV-2 spike protein, which are then joined with an adjuvant to enhance the immune response. Similar to the Oxford/AstraZeneca vaccine, it can be stored at normal refrigeration temperatures (2-8°C), which simplifies the transport and delivery process. “NVX-CoV2373 has the potential to play an important role in solving this global public health crisis. We look forward to continue to work…to make the vaccine available as quickly as possible,” said Erck. Novavax has signed vaccine deals with Canada for 75 million doses, the UK for 60 million doses, Australia for 51 million doses, New Zealand for 10.7 million doses, and the US for 100 million doses, which Operation Warp Speed paid US$1.6 billion to secure and to fund clinical development. Vaccination doses administered globally, as of 29 January 2021 since 14 December 2020. In addition, Novavax signed a manufacturing agreement with the Serum Institute of India to produce 1 billion doses of the vaccine in 2021, increasing the global manufacturing capacity to over 2 billion annually. Johnson & Johnson’s One-Shot Vaccine Shows Efficacy – But At Lower Levels On a less promising note, Johnson & Johnson’s highly anticipated single-dose COVID-19 vaccine was only 66% effective in preventing moderate to severe infection, according to results of Phase 3 trials released by the company on Friday. But that falls well behind the 90% or more efficacy ratings that Moderna and Pfizer/BioNTech vaccines have received – as well as the results obtained by Novavax and AstraZeneca in some arms of their trials. Among its 43,700 participants in the large J&J multi-country ENSEMBLE trial, the level of protection against moderate to severe infection provided by the vaccine varied by country and region, with the US recording an efficacy rate of 72%, Latin America reporting 66%, and South Africa recording the lowest levels of efficacy at 57%. The lower levels of protection in Latin America and South Africa could be due to the spread of SARS-CoV-2 variants that are more highly transmissible during the trial. Nearly all cases of COVID-19 in the trial in South Africa were linked to the variant, the company said. However it did not provide precisely stratified results against each individual variant. The company said that the Phase 3 ENSEMBLE clinical trial also showed “protection was generally consistent across race, age groups, including adults over 60 years of age.” Some 28 days after vaccination, the vaccine candidate was 85% effective in preventing severe disease – which includes admission to an intensive care unit, respiratory failure, organ failure, or death – in all adults over the age of 18 and in all regions studied. And complete protection against COVID-19-related hospitalization and death was provided by the vaccine candidate. Moderate illness was defined as COVID-19 infection with evidence of pneumonia, abnormal blood oxygen saturation levels, deep vein thrombosis, abnormal respiratory rate, or two or more systemic symptoms of COVID-19. A doctor administering the Johnson & Johnson COVID-19 vaccine candidate during the phase 3 clinical trials. J&J Touts Results On Severe Disease – Says It Will Still File For US FDA Authorization In February The company still plans to file for Emergency Use Authorization with the US Food and Drug Administration (FDA) in early February and expects to begin deploying doses immediately following its authorization. “These topline results with a single-shot COVID-19 vaccine candidate represent a promising moment,” said Paul Stoffels, Chief Scientific Officer at Johnson & Johnson, in a press release. “Eighty-five percent efficacy in preventing severe COVID-19 disease and prevention of COVID-19-related medical interventions will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19. It also offers the hope of helping ease the huge burden placed on healthcare systems and communities.” The vaccine candidate can be stored for at least three months at temperatures of 2-8°C and can be transported using existing cold chain technologies and standard vaccine distribution channels. The logistical advantages of the Johnson & Johnson vaccine could prove instrumental in light of the increasing need to reduce transmission and the emergence of additional variants. “Changing the trajectory of the pandemic will require mass vaccination to create herd immunity, and a single-dose regimen with fast onset of protection and ease of delivery and storage provides a potential solution to reaching as many people as possible,” said Mathai Mammen, Global Head of Research and Development at Janssen Pharmaceuticals. “The ability to avoid hospitalizations and deaths would change the game in combating the pandemic.” J&J Also Signed Deal With COVAX Forecast of the vaccine candidate-specific supply of COVID-19 vaccines to the COVAX Facility, as of 20 January. Johnson & Johnson has also signed an agreement with the COVAX Facility to provide up to 500 million doses for distribution to low- and middle-income countries. Once the agreement is finalized, Gavi, the Vaccine Alliance, the organization co-leading COVAX, will be able to procure up to 200 million doses in 2021 and 300 million in 2022. Unfortunately, Johnson & Johnson is reportedly experiencing manufacturing delays and is lagging behind its previously set timeline. According to US federal government officials, the company is estimated to be two months behind schedule. The pharma company joins several others who have announced issues in vaccine production, a few of which, namely Pfizer, AstraZeneca and most recently Moderna, have delayed the delivery of doses. However, Johnson & Johnson claims to be on track to meet its contractual agreements. “The Company’s anticipated manufacturing timeline will enable it to meet its 2021 supply commitments, including those signed with governments and global organizations,” said the press release. AstraZeneca, Facing Clash with EU, Releases Vaccine Deal Meanwhile, AstraZeneca published its Advanced Purchase Agreement (APA) with the European Commission amid a feud over the delay in the delivery of COVID-19 vaccines to the region. The Advanced Purchase Agreement between AstraZeneca and the EU, signed on 27 August 2020. In the partially redacted contract, signed on 27 August, 2020, AstraZeneca committed to “use its Best Reasonable Efforts…to build capacity to manufacture 300 million doses of the vaccine…for distribution within the EU.” ‘Best Reasonable Efforts’ is defined as “the activities and degree of effort that a company of similar size with a similarly-sized infrastructure and similar resources as AstraZeneca would undertake or use in the development and manufacture of a vaccine at the relevant stage of development.” Since the UK holds its own deal directly with AstraZeneca and won’t face the same shortfall of vaccines, EU leaders have called for the delivery of doses produced in the UK to make up for the shortage. Pascal Soriot, CEO of AstraZeneca, claims that the products manufactured at the two plants in the UK are reserved for its own citizens under the vaccine deal until a sufficient number of doses have been supplied to the UK. EU officials, however, dispute this argument under article 5.4 of the contract, which states that AstraZeneca agrees to “use its Best Reasonable Efforts to manufacture the vaccine at manufacturing sites located within the EU…and may manufacture the vaccine in non-EU facilities.” According to Ursula von der Leyen, President of the European Commission, the pharmaceutical company is legally obligated to use the four manufacturing sites in Europe – two in the UK, one in Belgium, and one in the Netherlands – to fulfil its supply commitments. While the dispute remains unresolved, Spain and France have announced the temporary pause in their vaccine campaigns because of the shortage of doses. Madrid suspended inoculations on Wednesday for the next two week and Paris plans to temporarily halt its program beginning on 2 February. European Commission Establishes Authorization Mechanism for Vaccine Exports In a move to increase transparency surrounding the export of COVID-19 vaccines covered under APAs and to ensure the continuation of vaccination campaigns in the EU, the European Commission has put in place a measure requiring authorization for the export of vaccines produced in the EU. “We gave upfront funding to companies to build the necessary manufacturing capacity to produce vaccines, so deliveries can start as soon as they are authorised,” said Stella Kyriakides, Commissioner for Health and Food Safety, in a press release. “We now need transparency on where the vaccines we secured are going and ensure that they reach our citizens.” Stella Kyriakides, European Commissioner for Health and Food Safety, at a press briefing on Friday. The “time-limited and targeted system” will be in place until the end of March 2021 and will not interfere with the EU’s humanitarian aid commitments, including the delivery of vaccines to low- and middle-income countries through the COVAX Facility, according to Valdis Dombrovskis, Executive Vice-President and Commissioner for Trade of the European Commission. The authorization will be granted or denied by the EU member states where the production of COVID-19 vaccines takes place. The aim of the new measure will not be to restrict exports “any more than absolutely necessary,” but instead to ensure the critical shortages in Europe are relieved in a “targeted, transparent, proportionate, [and] temporary” manner, said the trade document published by the European Commission on Friday. AstraZeneca Vaccine Receives Approval from EU Regulator Hours earlier, the European Medicines Agency (EMA) recommended the Oxford/AstraZeneca vaccine for approval one month after the UK provided it with authorization and began the vaccine rollout. The European Commission followed suit shortly after and granted conditional marketing authorization to the vaccine on Friday, making it the third COVID-19 vaccine authorized in the EU. After much discussion about whether the vaccine rollout should include adults over the age of 55, due to the lack of data in older participants, the EMA decided to recommend the vaccine to individuals aged 18 and older. “There are not yet enough results in older participants…to provide a figure for how well the vaccine will work in this group. However, protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines…EMA’s scientific experts considered that the vaccine can be used in older adults,” said the EMA press release. Overall, the vaccine demonstrated a 60% efficacy rate in clinical trials. “With the AstraZeneca vaccine now authorized, 400 million additional doses will be available in Europe. I expect the company to deliver these doses as agreed, so that Europeans can be vaccinated as soon as possible,” said Ursula von der Leyen, President of the European Commission in a press release. We have just authorised the @AstraZeneca vaccine on the EU market following a positive assessment by @EMA_News I expect the company to deliver the 400 million doses as agreed. We will keep on doing all we can to secure vaccines for Europeans, our neighbours & partners worldwide — Ursula von der Leyen (@vonderleyen) January 29, 2021 Following news of the authorization of the Oxford/AstraZeneca vaccine in the EU, WHO officials expressed their hope to grant the vaccine emergency use listing within two weeks. The Strategic Advisory Group of Experts on Immunisation (SAGE), WHO’s vaccine advisory panel, is scheduled to meet to review the Oxford/AstraZeneca vaccine on 8 February. “We should have an emergency use listing, providing, of course, that everything goes to plan and all the data is there. We can then start receiving doses from the manufacturing sites in India and South Korea,” said Soumya Swaminathan, WHO Chief Scientist, at a press conference on Friday. The Oxford/AstraZeneca vaccine is considered one with global potential – due to its ability to be stored at refrigerator temperatures, making its storage and transportation more manageable, particularly for countries without access to ultra-cold chain storage, which is required for the Pfizer and Moderna vaccines. Status of COVID-19 vaccines in the process of receiving WHO “Emergency Use Listing” approval, as of 25 January. Image Credits: Johnson & Johnson, Johnson & Johnson, CNBC, Our World in Data, Johnson & Johnson, GAVI, European Commission, Twitter – European Commission, WHO. COVAX Will Be Able To Give Country Data On Expected COVID Vaccine Allocations Within ‘Next Day’ 29/01/2021 Kerry Cullinan The COVAX facility was launched to ensure equitable distribution of the COVID-19 vaccine. Member countries will have an idea of how many COVID vaccine doses they will receive via the World Health Organization’s COVAX Facility and when they will arrive within the next day, WHO special advisor Dr Bruce Alyward has said. These “indicative allocations” would depend on when the WHO’s regulatory review of the specific vaccines that COVAX plans to distribute is completed, as well as on the volumes the companies can produce, Aylward told reporters Friday at WHO’s bi-weekly media pandemic briefing. “As you know, some companies are having challenges, so that is going to affect potentially what those volumes actually look like,” said Aylward. COVAX – WHO’s co-led platform dedicated to equitable vaccine distribution – has made its largest deal with AstraZeneca, but the Organization is yet to issue the vaccine an emergency use license (EUL). It expects to have completed its review of the company’s research within the next two weeks. Dr Bruce Aylward, WHO Senior Advisor to the Director General. COVAX is expecting its supply of AstraZeneca vaccines to be produced by the Serum Institute of India, along with a smaller number of Pfizer vaccines, thanks to a recent deal. This week, AstraZeneca informed the European Commission that there would be a 60% shortfall in vaccine deliveries to Europe this quarter due to a manufacturing issue at a production plant in Belgium. But the Commission had its doubts over this given explanation and has said it would establish a new mechanism that grants national regulators the power to refuse exports of vaccines following an investigation into the production facility. Share Vaccines To Ensure Global Coverage Of Health Workers & Elderly Tomorrow marks the first anniversary of the WHO’s declaration of SARS-CoV-2 as a “public health emergency of international concern”. At that time, there were only around 100 known cases. That number has now passed 100 million. At the briefing, Dr Tedros Adhanom Ghebreyesus, WHO Director General, once again appealed for equitable access to vaccines, starting with a global rollout to all health workers and the elderly: “For now, vaccines are a limited resource. We must use them as effectively and as fairly as we can. If we do that, lives will be saved. “That’s why I have challenged governments and industry leaders to work together to ensure that, in the first 100 days of 2021, the vaccination of health workers and older people is underway in all countries.” Harriet Nayiga, a midwife from Kenya, and Sana Baloch, a nurse in Pakistan, both addressed the press conference to explain their vulnerability to infection. “We engage with the patient for more hours than any other health worker, so we need to be prioritised to be vaccinated first,” said Nayiga. Pakistani nurse Sana Baloch appealed for vaccines for all health workers. Baloch said that around 10,000 Pakistani health workers had been infected by the virus and hundreds had died. Her hospital had “a huge influx of patients” and the “nurses, doctors and paramedics were in great distress”, she said. “It is our moral responsibility and our job to take care of those patients. We were the only hope of the patients who were admitted in COVID wards where they were not allowed to meet or to see anybody. We cannot leave them alone. But at the same time, we need protection,” said Baloch. “I appeal to the leaders of the world: please distribute the vaccine on an equitable basis. If you have enough resources to vaccinate all your elderly and all your health care providers, consider donating or help out less developed countries who do not have enough to even vaccinate their health care providers or elders, before moving to the less vulnerable of your population.” Dr Tedros said that countries that had secured vaccines should share these with COVAX. “My message to people in countries that are now rolling out vaccines is to use your voice to advocate for your government to share those. If you’re someone at lower risk, please wait your turn. Health care workers have been on the frontlines of the pandemic but are often under-protected and overexposed. They need vaccines now.” Countries Need To Support Travellers With Quarantine And Testing Dr Michael Ryan, WHO Executive Director of Health Emergencies, said that the expansion of rapid diagnostic tests was “bringing a new and very useful tool to bear, taking pressure off the existing PCR based testing systems”. But he appealed for coherent messages around travel and asked governments to respect the human rights and comfort of travelers, particularly as the process of travel itself has been “significantly de-risked” thanks to efforts from the travel industry. Mike Ryan, Executive Director of WHO Health Emergencies Programme. “Those countries with very low incidents are very, very afraid about re-importing cases, and may have more stringent testing in place. Other countries are worried about the arrival of potential variants that will further complicated situations and they’re targeting reducing movement from certain countries in order to be able to avoid that,” said Ryan. “We do need coherent messaging around travel requirements. If you’re going to require that travellers arriving in the country quarantine for a particular period or have to be tested, governments should be supporting that process. “It is very difficult for a traveller arriving to be able to comply sometimes if they don’t get the support to comply. Governments are continuing to try and increase and ramp up their efforts to break chains of transmission and to manage risks. But we also must do that and invest properly in those mechanisms so that people who are travelling between countries are treated with regard to their comfort and their human rights.” Image Credits: WHO, CIO Look/Flickr, WHO, Screenshot. ‘Gag Rule’ Must Never Be Repeated, International AIDS Society Tells US Gov 29/01/2021 Kerry Cullinan The International AIDS Society urged the Biden administration “to consider legislation preventing the global gag rule from returning in the future”. The International AIDS Society (IAS) has welcomed US President Joe Biden’s repeal of the Mexico City Policy, known as the global “gag rule”, which prevented non-US organisations from getting US aid if they offered abortion services, referrals or advocacy. But the IAS urged the US administration “to consider legislation preventing the global gag rule from returning in the future”, according to its president, Adeeba Kamarulzaman. The gag rule was first introduced by Ronald Reagan to prevent US government aid to foreign family planning organisations offering abortions. The Trump administration expanded it significantly to block any foreign NGO associated with abortion from receiving health development funds from any US source. The rule affected almost $9 billion of US aid, and had a severe impact on organisations offering HIV services, disrupting HIV testing, counselling, condom provision, antiretroviral treatment and care. “As HIV professionals, we saw firsthand the impact of the global gag rule from its first iteration – barring and disrupting access to health care for women around the world,” said IAS Executive Director Birgit Poniatowski. “In its expanded form, the policy threatened to roll back progress in the global HIV response.” Echoing the IAS call, Ugandan health activist Dorothy Amuron from the Center for Health, Human Rights and Development called on the Biden administration “to take bold action to stop this deadly cycle of granting or rescinding human rights when the political tides shift”. “The U.S. has an obligation to safeguard human rights for all. But policies like the global gag rule are an attack on our sovereignty and our humanity,” said Amuron. “We call on the Biden administration to use its power to get rid of them forever.” Ironically, the gag rule was associated with a 40% increase in the rate of abortion and a 13.5% reduction in the use of contraception, according to research published in the Lancet. Image Credits: Mike Beaty/Flickr. COVID-19 Has Outlined Healthcare Systems’ Dangerous Emissions Problem 29/01/2021 Raisa Santos Healthcare’s overreliance on single-use products and equipment contributes to its carbon footprint Failure to align the global recovery from COVID-19 with an equally powerful climate response could threaten the worldwide effort to limit the average global temperature increase, public health experts have said. In a convention in 2015 now known as the Paris Agreement, the United Nations Framework Convention on Climate Change (UNFCCC) established its aim to pause the increase in global average temperature by “well below 2 degrees Celsius above pre-industrial levels and to pursue efforts to limit the temperature increase even further to 1.5 degrees Celsius”. To achieve that, a global effort is required to decrease greenhouse gas emissions by 7.6% each year across five years. This number falls further out of reach each year without action. “The reality is that the next five years are going to be pivotal,” Dr Renee Salas, Harvard T.H. Chan School of Public Health, said during a webinar from the Lancet Countdown last week. The 2020 Report of the Lancet Countdown on Health and Climate Change was published in December, and addressed the converging crises of the COVID-19 pandemic, healthcare systems and climate change. “Healthcare has to show us how we can decarbonize and decarbonize our healthcare system,” she said, adding that it “is truly the embodiment that climate action is a prescription for health”. COVID Has Outlined Healthcare Systems’ Flaws The COVID-19 pandemic has highlighted healthcare’s overreliance on single-use products and equipment, the panel said. Additionally, as using personal protective equipment (PPE) has become a greater necessity, use of disposable products has been extended. The health system in England is responsible for an estimated 4-5% of the country’s carbon footprint, for example. NHS carbon footprint is mostly comprise of procured items from the health supply chain The United Kingdom’s National Health Service listed crutches as accounting for nearly 70% of the carbon footprint for items it procured in 2020. Additionally, the traditional model of outpatient care doesn’t strictly align with the nature of chronic illnesses, which requires patients return for unpredictable emergency treatment. Unpredictable treatment directly leads to increased road traffic and increased air pollution. NHS traffic accounts for 5% of road traffic in England alone. Quantified in terms of environmental, financial, and health outcomes, this means that 753 deaths can be attributed to NHS traffic, and £650 million in NHS expenditure are lost a year. “When [evaluating] the value offered in the delivery of a healthcare service, we need to start capturing data that looks at these consequences, thinking beyond the financial and individual patient outcomes,” said Jennifer Isherwood, a National Medical Director’s Clinical Fellow at the Royal College of Physicians, London. “It’s becoming clear that COVID is not going to be the last pandemic that we see,” Isherwood added. “It may be … disruptive to start addressing challenges of different pathways to different care, but it’s the right tool to start future-proofing our healthcare systems.” Hiten Patel, Senior Strategy Advisor for Greener NHS, said: “There’s always something else happening in healthcare systems that’s [considered] a priority. It’s about how we can try to make carbon emissions and climate change more of a priority within healthcare systems.” Concluded Dr Jodi Sherman, Yale University and Lancet Countdown author, said: “Everything we do in healthcare is through the lens of patient safety. Protecting public health is a matter of patient safety and needs to be integral to everything that we do.” Supply and Services Compose Four-Fifths of Overall Healthcare Carbon Footprint The health supply chain comprises four-fifths of US healthcare carbon footprint While the COVID pandemic has flagged some key flaws in the world’s healthcare systems, what is still unclear are the direct and indirect carbon emissions of the healthcare sector, and the implications these emissions have on health. Direct emissions are established and well understood products of the sector: gas exhausts from ambulance tailpipes to fumes emitted from waste incinerators. But indirect emissions – offsite power generation, the provision of medical supplies and pharmaceuticals, and even research and testing – make up a larger percentage of emissions associated with the healthcare sector. The United States alone spends more than US$3 trillion on healthcare a year. As healthcare expenditures increased, so too did the carbon footprint from goods and services. Around 7% is due to direct emissions from healthcare facilities, and another 10% from offsite energy. But four-fifths of the footprint is the supply chain, composed of key sectors that include food, pharmaceuticals, and chemicals. Dr Matthew Eckelman, Northeastern University, Boston and Lancet Countdown author, called on the health sector to take accountability for its immense carbon footprint. “It’s very clear that buying renewable energy is not the only solution. You really have to work on reducing carbon emissions in the supply chain, as well.” Lower the Infection Risk and Financial Losses by Reducing Health Waste Speakers also addressed how vital it is not to risk patient safety in trying to reduce or cut expenses. Healthcare-acquired infection – when a patient becomes infected while in care – affects hundreds of millions of patients globally each year. This leads to significant morbidity and mortality that incurs financial losses for health systems, in addition to excess pollution. As a result, prevention is essential. “While we do want to reduce waste and reduce costs, we certainly don’t want that to be at the expense of increasing infections,” said Dr Sherman. Dr Sherman also acknowledged, however, that infection prevention methods often contribute to the excessive use of single-use disposable devices, like masks and gloves. Using only disposable laryngoscopes would increase costs for hospitals In a greenhouse gas emissions and cost analysis study comparing reusable and disposable laryngoscopes, Dr Sherman and Eckelman found that disposables – whether plastic or steel – outweigh the reusable in terms of greenhouse gas emissions. Using purely disposables would increase costs by up to US $700,000 a year, for one hospital department. Recycling these disposables would only reduce a small portion of emissions, especially since the laryngoscope cannot be recycled entirely. “In other words, we can’t recycle a way out of this problem,” Dr Sherman said. “The answer isn’t that we should use disposables. It’s that we should clean up our supply.” There needs to be a balance between the “indirect disease burden from all the materials thrown away and lowering the infection risk curve.” The greatest causes of healthcare acquired infections, said Dr Sherman, have to do with staff discipline, such as hand washing, and patient health status, and exposure to infection. But simple hand washing and using more and more disposables is not the solution. Image Credits: Flickr: Marc A. Hermann / MTA New York City Transit, The Lancet Countdown. Pharma Ill-Equipped To Handle 10 Most Infectious Diseases And Future Pandemics, Report Warns 29/01/2021 Raisa Santos A new report has found that current R&D is primarily geared towards COVID-19, with next to no efforts to address other pathogens with the potential pandemic risks like Zika and Sars. With ten of the world’s most infectious diseases not catered by drug firms, pharmaceutical giants remain unprepared to tackle future pandemics, a new report has said. The report, published on Tuesday, found that though current medicine and vaccine research and development is primarily geared towards the COVID-19 pandemic, there are next to no efforts to address other pathogens with the potential pandemic risks: namely Nipah, Zika, and Sars. The Access to Medicine Index evaluates 20 global pharmaceutical companies – including AstraZeneca and Pfizer – and compares how far each goes in fulfilling the role of developing urgently needed health products and improving equitable access to them. The companies’ performance is ranked every two years. Pfizer joins top 5, while GSK retains its number one position, yet only slightly ahead of Novartis. Pfizer moves into the top five. Johnson & Johnson complete the top five companies. Eight of the top ten companies, including the leaders, are setting a new best practice of systematic access planning during R&D. “The state of infectious disease research today is, if I can put it mildly, on thin ice,” said Dr Jayasree Iyer, executive director of The Netherlands-based Access to Medicine Foundation, in an interview with DW. COVID-19 has emphasized the need for both the private and public sectors to actively engage in emerging infectious disease research well before the next pandemic breaks out. It has also shown that ending a pandemic requires suitable products to be developed and equitably distributed: much of the responsibility for which lies with pharmaceutical companies. Without their sustained commitment to pandemic preparedness, the report suggests, the world world will remain vulnerable to pandemics. Increased R&D for COVID-19, but Other Pandemic Risks Unaddressed Pharmaceutical companies are not targeting priority pathogens with epidemic potential through R&D. Excluding coronavirus, pathogens with pandemic potential where pharma companies are active in R&D show very small pipelines in 2020. Out of 16 pathogens, 10 have empty pipelines. Even for pathogens under scrutiny, research activity remains low. With most research focused on coronavirus, there are just 13 R&D projects across five non-COVID-19 diseases (Ebola, Zika, Chukungunya, Marburg, and non-polio enterovirus) and zero for the remaining ten of 16 infectious diseases. Emerging infectious disease (EID) research is concentrated among a few companies. In 2020, 17 companies targeted coronavirus, while nine companies are targeting other EIDs: Bayer, Eisai, Gilead, Johnson & Johnson, MSD, Merck, Roche, and Takeda. This figure shows the number of R&D projects and companies identified by WHO and Policy Cures as emerging infectious diseases, and how this has changed since 2018. What 2020 has highlighted is that large pharmaceutical companies have a critical role to play in preparing for the next pandemic, but that these companies have so far delivered a range of responses: some of them apparently shortsighted. Small biotech companies and academic groups may be able to pioneer new ideas, but it is the big players that are responsible for rapid development and access to vaccines, therapeutics and diagnostics, with the capacity to scale-up both manufacturing and distribution capabilities. Poorer Countries Lacking Access to More Than Half Key Products Covered By Pharma Companies However, the pharmaceutical industry only mobilized against COVID-19 once it became clear that the outbreak affected rich as well as poor countries. “Even in light of COVID-19, there were very few commitments from the pharmaceutical industry last year,” said Iyer. Other than projects developed within the Access to COVID-19 Tools (ACT) Accelerator, there was little evidence in the first months of the pandemic response that there structures in place to ensure access and distribution to COVID-19 vaccines in poorer countries. This has once more shown that the Global South still does not benefit significantly from access strategies implemented by big pharma. Less than half of key products controlled by 20 large companies are being offered in countries classified as either lower-middle income countries (LMICs) or low-income countries (LICs). Low-income countries are most consistently over-looked by access strategies, particularly for products that need to be administered by healthcare practitioners. The response is even more profound in LICs, which are consistently overlooked despite being home to almost 700 million people. Currently, only eight of the 60 – or 13% – critical products that need to be administered by healthcare professionals, like injectable treatments for cancer, are covered by access strategies in at least one LICs. Self-administered medicines such as pills have 26%. The numbers jump slightly in LMICs, and even more so in upper-middle income countries (UMICs), with approximately half of critical products covered by access strategies in UMICs. The greatest number of people also benefited from both healthcare professionals administered medicine and self-administered medicine in UMICs. Many industry access arrangements do not go far enough, with many of the world’s most vulnerable and marginalized not receiving the life-changing medicines they need. Solving the access to medicine problem requires the pharmaceutical industry to take large-scale action, reaching more people with more products across a wider range of the world’s poorest countries. “I believe the past year has demonstrated the pivotal importance of supplying affordable medicines for the many, rather than premium-priced products for the few,” said Iyer. “By investing in fair access to medicine for the poorest and most vulnerable among us, we are also investing in a fair, peaceful and prosperous global community.” Eight Pharma Companies Paving Way Towards Equitable Access Top 6 companies with access planning, with percentage of R&D projects with access plans There are positives: eight companies have taken the lead to integrating systemic access planning into their development processes. Novartis was noted as the first to begin mainstreaming access in the previous Index, and joining them in 2021 are AstraZeneca, GSK, Johnson & Johnson, Merck, Pfizer, Sanofi, and Takeda. Though the 20 companies in the Index have 394 projects in late-stage development that target either global health priorities (114) such as coronavirus, malaria, tuberculosis or HIV, or offer benefits to low- and middle-income countries (280), the majority of these are not supported by an access plan. An access plan can include a wide range of activities – prioritising countries with the highest disease burden to strengthening supply chains to ensure all populations have fair access. To have maximum impact, the Index advises that access plans have a broad geographic focus, explicitly aiming to reach a majority of people affected by a disease or in need of a vaccine or diagnostic tool. The 20 companies in scope have 394 R&D projects in late-stage development that either target established global health priorities or offer clear public health benefits for low- and middle-income countries. The majority of these are not yet supported by an access plan. If this happens, people living in low- and middle-income countries, especially those in resource-limited or remote settings, will no longer be left behind for pharmaceutical innovations. Concluded Iyer: “The power of science to help humanity – whether through new vaccines for common pathogens or novel drugs for rare diseases – is remarkable. But these breakthroughs will only truly deliver for the world if they reach all those who need them.” Image Credits: Access to Medicine Foundation , Access to Medicine Foundation . WHO Executive Board Rejects Israel’s Proposal To Remove Standalone Agenda Item On Palestinian Health Conditions 28/01/2021 Madeleine Hoecklin Meirav Eilon Shahar, Israel’s ambassador to the United Nations in Geneva, speaking to the WHO Executive Board. For the second time in as many years, WHO member states have voted down a proposal by Israel to remove a standalone item from the agenda of the 74th World Health Assembly – devoted exclusively to a report on health conditions in the Occupied Palestinian territories – and consider it as part of WHO’s overall health emergencies agenda. Saying that the agenda item unfairly singles out just one country for criticism, as compared to every other nation in the world, Israel on Tuesday proposed to the WHO Executive Board, which fixes the WHA agenda, that the report be considered as part of the overall discussion on WHO’s work in health emergencies when WHO member states meet in May. In a lengthy and unusual voting process on the closing day of the 10-day EB session, the proposal was rejected in a vote of 15 to seven – with 9 abstentions and 3 countries absent. Those supporting Israel’s position included the United Kingdom, Germany and Austria, joined by the United States, Australia and Colombia. EB members that were opposed included Oman, China, Russia, and Tunisia. Israel’s delegation said the report was a “political” item that does not reflect reality and will not change the situation on the ground. “Item 25 is a political item with only one purpose – to attack Israel and to politicize an otherwise professional organization [WHO]. This must be changed…What I’m asking you to do today is to ensure that the World Health Assembly maintains its focus on health and the truth,” said Israel’s ambassador to the United Nations, Meirav Eilon Shahar. “Regardless of what takes place in Geneva, we, Israel, will continue to work with the Palestinians and with WHO and we’ll continue to work on any problem and assistance intended to improve the health conditions for the Palestinians,” she added. The Palestinian representative, Ibrahim Khraishi, Ambassador of the State of Palestine to the UN, which holds observer status in the World Health Assembly, retorted that: “The [health situation in the occupied territories] is catastrophic and dire…Israel is finding it easy to renege on its responsibility, for example, it is not meeting its requirement…when it comes to vaccination. “When we look at the rate of vaccination for [Israeli] citizens, the figure exceeds two and a half million, whereas not one single Palestinian citizen has had the jab because of Israeli practices,” he said. Khraishi cited the WHO report from the 73rd WHA in November 2020, which he said shows that infant mortality of West Bank Palestinians is six times higher, and maternal mortality nine times higher than that of the 600,000 Israeli settlers living side by side with Palestinians in the Occupied West Bank. The report also describes barriers Palestinians from the West Bank and Gaza face in accessing more health services, such as the more specialized services in Jerusalem, which is directly under Israeli rule and to which access is tightly-controlled. Ibrahim Khraishi, Ambassador of the State of Palestine to the UN and Palestine’s representative to the Executive Board. After the vote among member states, Israel disputed the vaccination claims, saying that Palestinian inmates have received vaccinations and the PA has been provided with emergency supplies for 100 essential health workers – but the overall responsibility to vaccinate the roughly 5 million Palestinians living in the West Bank and Gaza lies with the Palestinian Authority (PA), not Israel. “We are very happy to extend assistance in facilitation of those vaccines in entrance to Israel,” said Eilon Shahar, referring to the expected arrival of PA-purchased vaccine supplies from Russia. PA health officials have not, in fact, officially requested vaccines from Israel, but rather are awaiting the arrival of Russian Sputnik vaccines within the coming two weeks. However, human rights groups have underlined that Israel still holds the ultimate responsibility for health under international law insofar as it still occupies the West Bank, The largely technical issue of where on the WHA agenda the report on Palestinian health conditions should be reviewed, was subject to a lengthy and unusual voting process (most EB decisions are made by consensus). The United States, Australia, and the United Kingdom explained their support of Israel’s proposal, saying that no other country in the world has been singled out in such a way by the WHO. “We’re concerned that the World Health Assembly does not consider the many other difficult health situations around the world in the same way,” said the UK’s delegate. “This item remains the only country specific item at the WHA…We fail our duty to serve people around the world who have vitally important health concerns if we allow WHO to become politicized in this way.” The UK’s delegate to the Executive Board. Australia went a step further, expressing concerns about the introduction of political issues into the WHA through the existence of the stand alone item – and calling for negotiations to permanently remove the item, not only as a stand-alone item but altogether from the agenda. The delegations from Oman and the Syrian Arab Republic countered the arguments made by the UK and US, claiming that the agenda item does not single out Israel. “This is not a country-specific item. This is an item which [reflects] a specific situation, a situation of people under occupation and addresses the legal obligations of the occupying power,” said Syria’s delegate. “The politicization is coming from attempts to go around these facts.” The Palestinian representative concluded the discussion at the closing session of the Executive Board meeting on Tuesday by urging member states to encourage Israel to “shoulder her responsibilities and do her duty towards all citizens for which she is responsible, particularly those in the occupied Syrian Golan, the Gaza Strip, and the other occupied territories.” The Gaza Strip has been under Israeli blockade as a result of repeated Israeli confrontations with the fundamentalist Hamas, which wrested control of the Strip from the PA-supported Fatah in 2007, two years after Israel unilaterally uprooted its settlements and withdrew from the Strip. Israel captured the Golan Heights from Syria in the 1967 Six Day War, and extended Israeli citizenship to the predominantly Druse residents of the Heights who remained after the war. Image Credits: WHO. Africa CDC Head calls for ‘Common Approach’ To Travel Restrictions Based on COVID Test & Not ‘National Origins’; 7 African Nations Report SARS-CoV-2 Variants 28/01/2021 Paul Adepoju Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy and not geographic or national origins, Africa CDC Director Dr John Nkengasong has said. IBADAN – Five African countries have now confirmed cases of the SARS-CoV-2 501Y.V2 variant, which first appeared in South Africa, and there is concern that the variant is circulating undetected elsewhere on the continent. The Gambia and Nigeria have seen cases of the variant B.1.1.7, first identified in the United Kingdom, said WHO’s African Regional Director today, Dr. Matshidiso Moeti, at a press briefing. Meanwhile, Africa CDC Director, Dr John Nkengasong, called for a “common approach” to COVID testing to oil the wings of international air travel – and halt the wave of new travel restrictions that countries have been imposing based on people’s national origin or the origins of flights – including people and flights arriving to Europe and the United States from South Africa. Researchers now believe the variants may be both more infectious but also more deadly than the COVID virus strains that were prevalent until just recently. Researchers also fear the variants could also elude COVID tests and be more resilient to vaccines just being rolled out now – although many unknowns remain. The countries where 501Y.V2 is circulating include: Botswana, Ghana, Kenya and Zambia, as well as South Africa. Beyond Africa, the variant has been confirmed in 24 countries globally. And there’s concern, it is circulating undetected in other countries in Africa,” Moeti told the press briefing. Dr. Matshidiso Moeti, WHO’s African Regional Director. “We are seeing more and more cases of variants and 501Y.V2, which was first identified in South Africa now, cropping up in other countries,” Moeti said. “The evidence suggests that these variants are more transmissible and emerging evidence indicates that the UK variant may cause more severe illness than other common strains, although more research needs to be done.” These variants in conjunction with “the aftermath of year-end gatherings”, Moeti said, “risk powering a perfect storm and driving up Africa’s second wave and overwhelming health facilities”. The continent saw a 50% rise in infections between 29 December 2020 and 25 January 2021, when compared with the previous four weeks, while deaths doubled. Last week, more than 6,200 deaths were reported across Africa, said the WHO.The past week saw a small dip in cases in South Africa, but 22 other countries continued to see numbers surge. Existing COVID-19 vaccines remain effective against the variants, Moeti said. But Professor Tulio de Oliveira, of the University of KwaZuku-Natal, South Africa, noted that these or other emerging variants may likely require individuals receiving booster doses of the vaccine. WHO’s African Region is meanwhile setting up a new surveillance network with Africa CDC to track the spread of the virus mutations and variants across Africa and beyond, Moeti added. “The variant which was first detected in South Africa has spread quickly beyond Africa and so what’s keeping me awake at night right now is that it’s very likely circulating in a number of African countries,” said Moeti. “Africa is at a crossroads. We must stick to our guns and double down on the tactics we know work so well. That is mask wearing, handwashing and safe social distancing. Countless lives depend on it.” WHO’s African CDC Calls for Common COVID Testing Approach For International Travel Dr John Nkengasong issued his call for a rethink of travel policies after several foreign countries, including the United States, are considering or have already banned flights originating from South Africa. Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy – and not geographic or national origins, said Nkengasong. “We should not be banning people because of their geographical origin, but we should be encouraging people to travel with negative tests and facilitate the testing process so that people can travel with a negative test,” Nkengasong said. “If I were to go to Kenya and I show up at the airport with a valid negative test, I pose no threat to the country of Kenya, and that way so you shouldn’t just ban me because I’m coming from a certain country. They should be looking at that test, is your test valid,” Nkengasong added. Dr John Nkengasong, Director of the Africa CDC. Up until now, the World Health Organization has resisted recommending pre-travel COVID testing, ostensibly due to fears that it would put an unnecessary onus on poor countries. In fact, however, many of the poorest African and Asian countries have been requiring pre-flight COVID tests for all incoming passengers – which are paid for privately. Some counties, such as the Democratic Republic of Congo, also demand arrivals briefly quarantine until a post-flight test is completed as well, paid privately as well. Paradoxically, it is wealthier European and American countries that first issued a rash of orders banning passengers of certain nationalities or flights from certain destinations as a result of variant scares – although more developed countries, most recently Switzerland on Wednesday, have adopted testing requirements. Senegal’s Pasteur Institute – At Center Of New Genetic Surveillance Network At the outset of the pandemic, most countries in Africa lacked adequate testing capacity for COVID-19 but this was gradually surmounted as new testing facilities were added. Now, however, the identification of new variants of the virus will require more advanced capacities for gene sequencing that several countries in Africa have yet to obtain. To address this vacuum, the Africa CDC, the WHO and member countries have created a network that enables existing labs with gene sequencing capabilities to collect samples from countries that lack such. One of the labs in the network is the Dakar-based Institut Pasteur de Dakar in Senegal. Its CEO, Dr Amadou Sall, said in addition to providing gene sequencing services for Senegal, the institute is now supporting other countries, Cameroon and Equatorial Guinea notably. Others include Mali, Burkina Faso Guinea-Bissau, Côte d’Ivoire, Niger, Verde, and of course, Guinea. “With the partnership we have with Africa CDC and WHO, we have the possibility of sequencing 500 genomes per week. And we’re trying to increase this capacity and to make these capacities available in different countries,” Sall said. Key to the success of COVID-19 genomic surveillance in Africa, Sall said, will be the willingness and openness of African countries to share information. “We need to be able to share information data and the Pasteur Institute is at the center of a global platform and we’re able to share information; to exchange information rapidly, if countries are willing to do so,” he said. Knowing When to Raise the Alarm While noting that identification of new variants is a significant feat, genomic experts warned that alarm should not be raised every time a new strain is identified. Professor de Oliveira, who heads the KwaZulu-Natal Research and Innovation Sequencing Platform, said attention is raised when new strains are being confirmed in increasing numbers of cases with the new variant and not when just one case has been confirmed. Describing the impacts that variants have on the epidemiology of the pandemic in South Africa, Oliveira said in some regions, the new variant has become the prominent type. But beyond this, he said South Africa is also worried about the variants from elsewhere getting into the country and circulating among its populations. “Today, we just reported the first important case of the B.1.1.7, the variant of concern that is circulating in the UK. And it’s quite common that in addition to our main variant that is dominating, we’re going to still have introductions of new lineages,” Oliveira said. “And in the case they begin to spread very fast, then we will communicate it and then highlight that could be a variant of concern.” He said that while no one can know for sure about the possibility of third or fourth waves of the pandemic in Africa, the variants are highlighting the need for the entire world to globally control the transmission of SARS-CoV-2 as a global community. “We have to really decrease transmission to avoid the next waves and more worry that emergence of new variants of concern will transmit too fast or evade immune response,” he said. “The appearance of these variants in the African continent, but also in South America and Europe really means that more than ever, it is the time that we don’t leave any continent behind, especially on vaccination,” Oliveira said. Silver Lining In Cloud – Variants Also Impetus For Cooperation But within Africa itself, Sall said the various SARS-CoV-2 variants constitute a new impetus for cooperation between countries, to be able to track and measure the circulation of the virus, and to enhance diagnostic capacities that he said will soon be available across Africa. “The new variants are the object of a very thorough study, and the path of our countries is very clear: obtain maximum information and adapt the strategy to contain the transmission,” he said. Moeti enjoined countries and individuals to strive to overcome COVID-19 fatigue and return to the fundamental actions that have been found to be effective against these variants. These measures, she said, need much more emphasis that news that the virus is much more transmissible. “The vaccine is a tool that’s going to make a huge difference all over the world,” she said. But she reminded that “having a corner of the world not protected, the way the world’s economies and peoples are connected, will have negative economic impact even in those countries that managed to vaccinate the entire population. We really are all in it together, and we have to work to support each other to overcome this global crisis.” Image Credits: Paul Adepoju/HealthPolicyWatch, Africa CDC. EU Protests AstraZeneca Vaccine Delays – Could Block UK-Bound Exports 28/01/2021 Madeleine Hoecklin The Oxford/AstraZeneca vaccine is 2 months behind schedule due to an issue in manufacturing. AstraZeneca has joined Pfizer in announcing delays in deliveries of COVID-19 vaccines to countries in Europe, leading furious EU officials to plan for a system of tighter monitoring of vaccine exports. The British-Swedish pharma company that developed its COVID-19 vaccine with researchers at Oxford University, informed the European Commission on Friday that there would be a 60% shortfall in vaccine deliveries this quarter due to a manufacturing issue at a production plant in Belgium. The company is reportedly two months behind schedule with regard to vaccines destined for European countries. Since vaccine deals with the United States and the United Kingdom were signed earlier on, and are based around manufacturing sites in those countries, the company has had a headstart in resolving “glitches” in those supply chains, pharma officials said. But the Commission had its doubts over this given explanation. Following an EU-requested investigation into AstraZeneca’s Belgian-based production facility on Wednesday, the European Commission has said it would establish a new mechanism that grants national regulators the power to refuse exports of vaccines. The mechanism – the criteria for which is expected to be published on Friday – could throw the security of the UK’s 40m-dose deal with Pfizer/BioNTech. The investigation, a spokesperson for the Belgian health ministry said, was to “make sure that the delivery delay is indeed due to a production problem on the Belgian site”. AstraZeneca ‘Scaling Up’ Doses, As EU Leaders Question Pharma Company Pascal Soriot, CEO of AstraZeneca “We are scaling up to hundreds of millions, billions of doses of vaccines at a very high speed. A year ago we didn’t have a vaccine. When you do that, you have glitches, you have scale-up problems. Therefore, the yield varies,” said Pascal Soriot, CEO of AstraZeneca, in an interview with la Repubblica, an Italian newspaper, on Tuesday. News of the delays was met with frustration by EU officials and leaders, who were expecting to receive 80 million doses by the end of March. “This new schedule is not acceptable to the European Union,” said Stella Kyriakides, European Commissioner for Health and Food Safety, in a statement released on Monday. “The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far, and if, or to whom, they have been delivered.” Stella Kyriakides, European Commissioner for Health and Food Safety, at a press briefing on Wednesday. Soriot disputed suggestions that the company sold the doses elsewhere for a higher price, claiming that “there is a lot of silly talk going on right now about all sorts of things,” and the response from the European Commission and EU member states is because “there are a lot of emotions running in this process right now.” “The suggestion [that] we sell to other countries to make more money is not right because we make no profit everywhere…That’s the agreement we have with Oxford University,” said Soriot. “Governments are under pressure. Everybody is getting kind of…aggravated or emotional about those things. But I understand because the Commission is managing the process for the whole of Europe,” he added. In late August, the EU made an upfront payment of €336 million to the company to secure 300 million doses of the vaccine. EU officials have disputed AstraZeneca’s explanation of production issues, claiming there are no excuses for the delay. “The flimsy justification that there are difficulties in the EU supply chain but not anywhere else does not hold water, as it is of course no problem to get the vaccine from the UK to the continent,” said Peter Liese, an EU parliamentarian from Germany’s Christian Democratic Union. Currently AstraZeneca is producing 17 million doses per month. That number will reach 100 million doses from February onwards, according to Soriot, meaning 1.2 billion doses per year. And Europe will receive 17% of the global production in February for a population that represents 5% of the world’s population. The Oxford/AstraZeneca vaccine is in the final stages of the approval process with the European Medicines Agency (EMA) and is expected to receive the recommendation for market authorization on Friday. After being approved, the company plans to deliver three million doses immediately. Meetings between EU officials and AstraZeneca have done little to resolve the issue, with Kyriakides announcing on Twitter: “Discussions with @AstraZeneca today resulted in dissatisfaction with the lack of clarity and insufficient explanations. EU Member States are united: vaccine developers have societal and contractual responsibilities they need to uphold.” With our Member States, we have requested from AZ a detailed planning of vaccine deliveries and when distribution will take place to Member States. Another meeting will be convened on Wednesday to discuss the matter further. — Stella Kyriakides (@SKyriakidesEU) January 25, 2021 The EU Steering Board, the body that oversees vaccine deals, plans to meet with AstraZeneca again on Wednesday at 6:30pm CET and hopes to “resolve this in a spirit of collaboration and responsibility,” according to Kyriakides. The Italian government plans to take legal action against Pfizer and AstraZeneca over their delays in deliveries, according to an announcement made by Foreign Minister Luigi Di Maio on Sunday. “This is a European contract that Pfizer and AstraZeneca are not respecting and so for this reason we will take legal action,” Di Maio said on RAI state television. “We are activating all channels so that the EU Commission does all it can to make these gentlemen respect their contracts.” According to Soriot, however, the vaccine deal signed with the EU was not a contractual commitment but a best effort, so there is no feasible basis for legal action. EU to Establish a Vaccine Export Transparency Mechanism The Oxford/AstraZeneca vaccine is also considered one with global potential – due to its ability to be stored at refrigerator temperatures. Amidst some countries’ suspicions that countries outside Europe are receiving priority for vaccines produced at the Belgium plant, the European Commission announced plans to establish an export transparency mechanism for vaccines to ensure clarity on transactions and to protect its investments in the R&D that led to development of vaccines like AstraZeneca’s. AstraZeneca is also a major supplier of the WHO COVAX global distribution initiative – which has pledged to begin distributing vaccine doses to the 92 lowest-income countries in the world within the next two months. Although most of the COVAX supplies were reportedly to be produced by India’s Serum Institute or in the Republic of Korea, the exact supply lines remain unclear. “Europe invested billions to help develop the world’s first COVID-19 vaccines…And now, the companies must deliver,” said Ursula von der Leyen, President of the European Commission, at the World Economic Forum on Tuesday. “They must honor their obligations. This is why we will set up a vaccine export transparency mechanism. Europe is determined to contribute to this global common good. But it also means business.” Ursula von der Leyen, President of the European Commission, speaking at the World Economic Forum on Tuesday. “In the future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries,” said Commissioner Kyriakides. The aim of the proposed system will be to monitor, but not block, exports, officials said. And humanitarian deliveries would be anyway exempt from this oversight mechanism. EMA Yet To Issue Final Approval – Insufficient Data on Vaccine in Older People Meanwhile, the EMA has yet to issue its final regulatory approval for the two-dose Oxford/AstraZeneca vaccine, and is reportedly considering limiting the age range to people under the age of 65 – due to a lack of data on effectiveness in older people. Unlike mRNA counterparts produced by Moderna and Pfizer, the AstraZeneca/Oxford vaccine uses a disabled, modified version of a chimpanzee adenovirus that can enter human cells but cannot replicate or cause the disease, as a vector to deliver a fragment of SARS-CoV2 spike protein, stimulating COVID-19 immunity. According to data shared by the company, only 10% of participants in the vaccine clinical trials were over the age of 65 because it was first waiting for sufficient safety data in the 18 to 55 age group before vaccinating older individuals. “We don’t have a huge number of older people who have been vaccinated,” said Soriot. “But we have strong data showing very strong antibody production against the virus in the elderly, similar to what we see in younger people.” The results of an ongoing, larger Phase 3 clinical trial with 30,000 participants being conducted in the United States are expected to provide insight into the protection the vaccine provides to older individuals and ethnic minorities populations – groups that were not very well represented in previous trials. In addition, scientists are exploring whether a half-dose of the first vaccine would reliably yield a higher efficacy rating of 90% that was seen in initial trials. The other regime, involving two full doses was only 62% effective, according to the results released by the company in late November and reviewed by an independent Data and Safety Monitoring Board. That still meets key global benchmarks for efficacy, but is significantly lower than the 94-95% efficacy results for the Moderna and Pfizer mRNA vaccines. The AstraZeneca vaccine has, however, already been authorized in the UK, is already being used in British vaccination campaigns, including for people over 70 years old. Image Credits: AstraZeneca, AstraZeneca, Twitter, Twitter. WHO Proposes New Mode Of Engaging With Non-State Actors 28/01/2021 Esther Nakkazi Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, according to WHO. The World Health Organization (WHO) aims to make its engagement with non-state actors (non-state actors) more meaningful and efficient with a new proposal to establish a number of NSA fora that would allow exchange with WHO and member state representatives outside of official meetings. The new proposal — which will be tested during the 74th World Health Assembly (WHA), 24 May to 1 June — would offer multiple side events in which non-state (NSA) actors could engage more informally with member state representatives as well as a forum for exchange between NSAs and WHO regional and technical staff. But at the same time, non-state actors will be allotted a more limited number of constituency statements in formal governing body meetings – and like-minded groups of actors will be asked to combine their official statements together. Non-state actors include civil society groups such as non-governmental organizations, international business and professional associations, and philanthropic foundations. More than 70 non-state actors are recognized as being “in official relations” with WHO, and thus contribute in formal meetings such as the EB and the WHA. However, EB and WHA members have complained that the civil society interventions have become bogged down by too many lengthy, individual statements – and NSAs acknowledge that the statements often had limited impact in member state debates. More informal meetings ahead of the formal meeting dates would help engender more meaningful interaction, WHO said in its proposal for the reform, which was reviewed by the WHO Executive Board on Saturday. Informal meetings will also allow non-state actors to organize themselves into constituencies, consolidating their positions into joint statements to be presented at official events. The new arrangements to be tested in May, will “serve as a trial for potential future virtual informal meetings between non-state actors, Member States and the Secretariat, as a means of enabling more in-depth technical exchanges, as well as discussions on the Health Assembly agenda items,” said the WHO Secretariat, in its presentation to the EB on Saturday. The COVID-19 pandemic has provided added impetus for reforms that have long been in the making – insofar as the limitations of virtual meetings have also curtailed the interactions between member states and non-state actors. According to the new proposal, the informal series of meetings with non-state actors will be held just ahead of the WHA, and thus prepare the groundwork for the formal meeting. Role of Non-State Actors Has Evolved – But Increasing Number of Statements Detracted from Impact In the discussion over the proposal, WHO officials stressed that the Organization “is and remains a Member State Organisation” — engaging with 77 non-state actors, at global, regional and country levels, who also support the development and implementation of the Organization’s policies and recommendations, technical norms and standards. But while non-state actors have “served the Organization well for several decades”, the increasing number of non-governmental organizations and other non-state actors participating — often with a greater number of requests to speak — has “not resulted in a more meaningful involvement”. For example, when civil society representatives speak one-by-one at the end of a discussion, their interventions have little impact on the content or direction of the debate, WHO contends. Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, says the WHO. A virtual consultation by WHO further confirmed that non-state actors’ primary interests in attending governing body meetings are to participate in technical exchanges with the Secretariat and the Member States and to attend consultative hearings that feed into decision-making processes. Meaningful Participation From NGOs Critical, Member States Say The UK delegate said that it would allow NSAs to exert even more credible influence on member states attitudes and positions. The EB representative from the United States flagged that it is critical to ensure and enhance meaningful participation of non-state actors in WHO governing bodies, while also creating greater efficiency in the governance process. “Non-State actor participation must be allowed in a transparent and accountable manner with an open door to input from all stakeholders including the private sector,” the delegate noted. Austria pressed for the Secretariat to provide some more detailed information on the procedure for these meetings. Other states, like Australia, flagged that the trial is very ambitious given the agenda for the 2021 assembly is already very crowded. “We suggest that before agreeing to a trial, the number of meetings proposed to be repeated and streamlined,” the representative said.This would “provide reflections to technical areas in advance of the governing body meetings”. Civil Society Groups Request Clarity and Procedure Details Bodies like Health Action International asked for details as to how NGOs would participate, and for clarity on the processes governing such meetings. “It is a remaining concern to those who have witnessed creeping capacity shrinking of NGO space and poor consultation in recent years,” said an HAI statement. The HAI delegate requested that similar procedures be implemented for WHO regional meetings with member states, also asking that “these informal meetings compliment, but do not replace comprehensive consultations with non-state actors.” Meanwhile, the European Society for Medical Oncology said the views and expertise of non-state actors should be introduced earlier in the WHO decision-making process; it would be of greater value if delivered at the onset of projects, and when member states are drafting zero draft decisions and resolutions. “Direct interaction and discussion between member states, WHO offices, and Non-State actors would provide the opportunity for more in-depth exchanges, and partnerships, as the Member States, develop policies and implement actions to fulfill their WHO commitments,” said the ESMO spokesperson. Silberschmidt stressed that the virtual informal meetings will not replace other channels, but become an additional avenue for interaction – highlighting the fact that Dr Tedros Adhanom Ghebreyesus, WHO Director General, has already established a regular dialogue with civil society groups, to be held every six weeks. Image Credits: WHO / Christopher Black. 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.
COVAX Will Be Able To Give Country Data On Expected COVID Vaccine Allocations Within ‘Next Day’ 29/01/2021 Kerry Cullinan The COVAX facility was launched to ensure equitable distribution of the COVID-19 vaccine. Member countries will have an idea of how many COVID vaccine doses they will receive via the World Health Organization’s COVAX Facility and when they will arrive within the next day, WHO special advisor Dr Bruce Alyward has said. These “indicative allocations” would depend on when the WHO’s regulatory review of the specific vaccines that COVAX plans to distribute is completed, as well as on the volumes the companies can produce, Aylward told reporters Friday at WHO’s bi-weekly media pandemic briefing. “As you know, some companies are having challenges, so that is going to affect potentially what those volumes actually look like,” said Aylward. COVAX – WHO’s co-led platform dedicated to equitable vaccine distribution – has made its largest deal with AstraZeneca, but the Organization is yet to issue the vaccine an emergency use license (EUL). It expects to have completed its review of the company’s research within the next two weeks. Dr Bruce Aylward, WHO Senior Advisor to the Director General. COVAX is expecting its supply of AstraZeneca vaccines to be produced by the Serum Institute of India, along with a smaller number of Pfizer vaccines, thanks to a recent deal. This week, AstraZeneca informed the European Commission that there would be a 60% shortfall in vaccine deliveries to Europe this quarter due to a manufacturing issue at a production plant in Belgium. But the Commission had its doubts over this given explanation and has said it would establish a new mechanism that grants national regulators the power to refuse exports of vaccines following an investigation into the production facility. Share Vaccines To Ensure Global Coverage Of Health Workers & Elderly Tomorrow marks the first anniversary of the WHO’s declaration of SARS-CoV-2 as a “public health emergency of international concern”. At that time, there were only around 100 known cases. That number has now passed 100 million. At the briefing, Dr Tedros Adhanom Ghebreyesus, WHO Director General, once again appealed for equitable access to vaccines, starting with a global rollout to all health workers and the elderly: “For now, vaccines are a limited resource. We must use them as effectively and as fairly as we can. If we do that, lives will be saved. “That’s why I have challenged governments and industry leaders to work together to ensure that, in the first 100 days of 2021, the vaccination of health workers and older people is underway in all countries.” Harriet Nayiga, a midwife from Kenya, and Sana Baloch, a nurse in Pakistan, both addressed the press conference to explain their vulnerability to infection. “We engage with the patient for more hours than any other health worker, so we need to be prioritised to be vaccinated first,” said Nayiga. Pakistani nurse Sana Baloch appealed for vaccines for all health workers. Baloch said that around 10,000 Pakistani health workers had been infected by the virus and hundreds had died. Her hospital had “a huge influx of patients” and the “nurses, doctors and paramedics were in great distress”, she said. “It is our moral responsibility and our job to take care of those patients. We were the only hope of the patients who were admitted in COVID wards where they were not allowed to meet or to see anybody. We cannot leave them alone. But at the same time, we need protection,” said Baloch. “I appeal to the leaders of the world: please distribute the vaccine on an equitable basis. If you have enough resources to vaccinate all your elderly and all your health care providers, consider donating or help out less developed countries who do not have enough to even vaccinate their health care providers or elders, before moving to the less vulnerable of your population.” Dr Tedros said that countries that had secured vaccines should share these with COVAX. “My message to people in countries that are now rolling out vaccines is to use your voice to advocate for your government to share those. If you’re someone at lower risk, please wait your turn. Health care workers have been on the frontlines of the pandemic but are often under-protected and overexposed. They need vaccines now.” Countries Need To Support Travellers With Quarantine And Testing Dr Michael Ryan, WHO Executive Director of Health Emergencies, said that the expansion of rapid diagnostic tests was “bringing a new and very useful tool to bear, taking pressure off the existing PCR based testing systems”. But he appealed for coherent messages around travel and asked governments to respect the human rights and comfort of travelers, particularly as the process of travel itself has been “significantly de-risked” thanks to efforts from the travel industry. Mike Ryan, Executive Director of WHO Health Emergencies Programme. “Those countries with very low incidents are very, very afraid about re-importing cases, and may have more stringent testing in place. Other countries are worried about the arrival of potential variants that will further complicated situations and they’re targeting reducing movement from certain countries in order to be able to avoid that,” said Ryan. “We do need coherent messaging around travel requirements. If you’re going to require that travellers arriving in the country quarantine for a particular period or have to be tested, governments should be supporting that process. “It is very difficult for a traveller arriving to be able to comply sometimes if they don’t get the support to comply. Governments are continuing to try and increase and ramp up their efforts to break chains of transmission and to manage risks. But we also must do that and invest properly in those mechanisms so that people who are travelling between countries are treated with regard to their comfort and their human rights.” Image Credits: WHO, CIO Look/Flickr, WHO, Screenshot. ‘Gag Rule’ Must Never Be Repeated, International AIDS Society Tells US Gov 29/01/2021 Kerry Cullinan The International AIDS Society urged the Biden administration “to consider legislation preventing the global gag rule from returning in the future”. The International AIDS Society (IAS) has welcomed US President Joe Biden’s repeal of the Mexico City Policy, known as the global “gag rule”, which prevented non-US organisations from getting US aid if they offered abortion services, referrals or advocacy. But the IAS urged the US administration “to consider legislation preventing the global gag rule from returning in the future”, according to its president, Adeeba Kamarulzaman. The gag rule was first introduced by Ronald Reagan to prevent US government aid to foreign family planning organisations offering abortions. The Trump administration expanded it significantly to block any foreign NGO associated with abortion from receiving health development funds from any US source. The rule affected almost $9 billion of US aid, and had a severe impact on organisations offering HIV services, disrupting HIV testing, counselling, condom provision, antiretroviral treatment and care. “As HIV professionals, we saw firsthand the impact of the global gag rule from its first iteration – barring and disrupting access to health care for women around the world,” said IAS Executive Director Birgit Poniatowski. “In its expanded form, the policy threatened to roll back progress in the global HIV response.” Echoing the IAS call, Ugandan health activist Dorothy Amuron from the Center for Health, Human Rights and Development called on the Biden administration “to take bold action to stop this deadly cycle of granting or rescinding human rights when the political tides shift”. “The U.S. has an obligation to safeguard human rights for all. But policies like the global gag rule are an attack on our sovereignty and our humanity,” said Amuron. “We call on the Biden administration to use its power to get rid of them forever.” Ironically, the gag rule was associated with a 40% increase in the rate of abortion and a 13.5% reduction in the use of contraception, according to research published in the Lancet. Image Credits: Mike Beaty/Flickr. COVID-19 Has Outlined Healthcare Systems’ Dangerous Emissions Problem 29/01/2021 Raisa Santos Healthcare’s overreliance on single-use products and equipment contributes to its carbon footprint Failure to align the global recovery from COVID-19 with an equally powerful climate response could threaten the worldwide effort to limit the average global temperature increase, public health experts have said. In a convention in 2015 now known as the Paris Agreement, the United Nations Framework Convention on Climate Change (UNFCCC) established its aim to pause the increase in global average temperature by “well below 2 degrees Celsius above pre-industrial levels and to pursue efforts to limit the temperature increase even further to 1.5 degrees Celsius”. To achieve that, a global effort is required to decrease greenhouse gas emissions by 7.6% each year across five years. This number falls further out of reach each year without action. “The reality is that the next five years are going to be pivotal,” Dr Renee Salas, Harvard T.H. Chan School of Public Health, said during a webinar from the Lancet Countdown last week. The 2020 Report of the Lancet Countdown on Health and Climate Change was published in December, and addressed the converging crises of the COVID-19 pandemic, healthcare systems and climate change. “Healthcare has to show us how we can decarbonize and decarbonize our healthcare system,” she said, adding that it “is truly the embodiment that climate action is a prescription for health”. COVID Has Outlined Healthcare Systems’ Flaws The COVID-19 pandemic has highlighted healthcare’s overreliance on single-use products and equipment, the panel said. Additionally, as using personal protective equipment (PPE) has become a greater necessity, use of disposable products has been extended. The health system in England is responsible for an estimated 4-5% of the country’s carbon footprint, for example. NHS carbon footprint is mostly comprise of procured items from the health supply chain The United Kingdom’s National Health Service listed crutches as accounting for nearly 70% of the carbon footprint for items it procured in 2020. Additionally, the traditional model of outpatient care doesn’t strictly align with the nature of chronic illnesses, which requires patients return for unpredictable emergency treatment. Unpredictable treatment directly leads to increased road traffic and increased air pollution. NHS traffic accounts for 5% of road traffic in England alone. Quantified in terms of environmental, financial, and health outcomes, this means that 753 deaths can be attributed to NHS traffic, and £650 million in NHS expenditure are lost a year. “When [evaluating] the value offered in the delivery of a healthcare service, we need to start capturing data that looks at these consequences, thinking beyond the financial and individual patient outcomes,” said Jennifer Isherwood, a National Medical Director’s Clinical Fellow at the Royal College of Physicians, London. “It’s becoming clear that COVID is not going to be the last pandemic that we see,” Isherwood added. “It may be … disruptive to start addressing challenges of different pathways to different care, but it’s the right tool to start future-proofing our healthcare systems.” Hiten Patel, Senior Strategy Advisor for Greener NHS, said: “There’s always something else happening in healthcare systems that’s [considered] a priority. It’s about how we can try to make carbon emissions and climate change more of a priority within healthcare systems.” Concluded Dr Jodi Sherman, Yale University and Lancet Countdown author, said: “Everything we do in healthcare is through the lens of patient safety. Protecting public health is a matter of patient safety and needs to be integral to everything that we do.” Supply and Services Compose Four-Fifths of Overall Healthcare Carbon Footprint The health supply chain comprises four-fifths of US healthcare carbon footprint While the COVID pandemic has flagged some key flaws in the world’s healthcare systems, what is still unclear are the direct and indirect carbon emissions of the healthcare sector, and the implications these emissions have on health. Direct emissions are established and well understood products of the sector: gas exhausts from ambulance tailpipes to fumes emitted from waste incinerators. But indirect emissions – offsite power generation, the provision of medical supplies and pharmaceuticals, and even research and testing – make up a larger percentage of emissions associated with the healthcare sector. The United States alone spends more than US$3 trillion on healthcare a year. As healthcare expenditures increased, so too did the carbon footprint from goods and services. Around 7% is due to direct emissions from healthcare facilities, and another 10% from offsite energy. But four-fifths of the footprint is the supply chain, composed of key sectors that include food, pharmaceuticals, and chemicals. Dr Matthew Eckelman, Northeastern University, Boston and Lancet Countdown author, called on the health sector to take accountability for its immense carbon footprint. “It’s very clear that buying renewable energy is not the only solution. You really have to work on reducing carbon emissions in the supply chain, as well.” Lower the Infection Risk and Financial Losses by Reducing Health Waste Speakers also addressed how vital it is not to risk patient safety in trying to reduce or cut expenses. Healthcare-acquired infection – when a patient becomes infected while in care – affects hundreds of millions of patients globally each year. This leads to significant morbidity and mortality that incurs financial losses for health systems, in addition to excess pollution. As a result, prevention is essential. “While we do want to reduce waste and reduce costs, we certainly don’t want that to be at the expense of increasing infections,” said Dr Sherman. Dr Sherman also acknowledged, however, that infection prevention methods often contribute to the excessive use of single-use disposable devices, like masks and gloves. Using only disposable laryngoscopes would increase costs for hospitals In a greenhouse gas emissions and cost analysis study comparing reusable and disposable laryngoscopes, Dr Sherman and Eckelman found that disposables – whether plastic or steel – outweigh the reusable in terms of greenhouse gas emissions. Using purely disposables would increase costs by up to US $700,000 a year, for one hospital department. Recycling these disposables would only reduce a small portion of emissions, especially since the laryngoscope cannot be recycled entirely. “In other words, we can’t recycle a way out of this problem,” Dr Sherman said. “The answer isn’t that we should use disposables. It’s that we should clean up our supply.” There needs to be a balance between the “indirect disease burden from all the materials thrown away and lowering the infection risk curve.” The greatest causes of healthcare acquired infections, said Dr Sherman, have to do with staff discipline, such as hand washing, and patient health status, and exposure to infection. But simple hand washing and using more and more disposables is not the solution. Image Credits: Flickr: Marc A. Hermann / MTA New York City Transit, The Lancet Countdown. Pharma Ill-Equipped To Handle 10 Most Infectious Diseases And Future Pandemics, Report Warns 29/01/2021 Raisa Santos A new report has found that current R&D is primarily geared towards COVID-19, with next to no efforts to address other pathogens with the potential pandemic risks like Zika and Sars. With ten of the world’s most infectious diseases not catered by drug firms, pharmaceutical giants remain unprepared to tackle future pandemics, a new report has said. The report, published on Tuesday, found that though current medicine and vaccine research and development is primarily geared towards the COVID-19 pandemic, there are next to no efforts to address other pathogens with the potential pandemic risks: namely Nipah, Zika, and Sars. The Access to Medicine Index evaluates 20 global pharmaceutical companies – including AstraZeneca and Pfizer – and compares how far each goes in fulfilling the role of developing urgently needed health products and improving equitable access to them. The companies’ performance is ranked every two years. Pfizer joins top 5, while GSK retains its number one position, yet only slightly ahead of Novartis. Pfizer moves into the top five. Johnson & Johnson complete the top five companies. Eight of the top ten companies, including the leaders, are setting a new best practice of systematic access planning during R&D. “The state of infectious disease research today is, if I can put it mildly, on thin ice,” said Dr Jayasree Iyer, executive director of The Netherlands-based Access to Medicine Foundation, in an interview with DW. COVID-19 has emphasized the need for both the private and public sectors to actively engage in emerging infectious disease research well before the next pandemic breaks out. It has also shown that ending a pandemic requires suitable products to be developed and equitably distributed: much of the responsibility for which lies with pharmaceutical companies. Without their sustained commitment to pandemic preparedness, the report suggests, the world world will remain vulnerable to pandemics. Increased R&D for COVID-19, but Other Pandemic Risks Unaddressed Pharmaceutical companies are not targeting priority pathogens with epidemic potential through R&D. Excluding coronavirus, pathogens with pandemic potential where pharma companies are active in R&D show very small pipelines in 2020. Out of 16 pathogens, 10 have empty pipelines. Even for pathogens under scrutiny, research activity remains low. With most research focused on coronavirus, there are just 13 R&D projects across five non-COVID-19 diseases (Ebola, Zika, Chukungunya, Marburg, and non-polio enterovirus) and zero for the remaining ten of 16 infectious diseases. Emerging infectious disease (EID) research is concentrated among a few companies. In 2020, 17 companies targeted coronavirus, while nine companies are targeting other EIDs: Bayer, Eisai, Gilead, Johnson & Johnson, MSD, Merck, Roche, and Takeda. This figure shows the number of R&D projects and companies identified by WHO and Policy Cures as emerging infectious diseases, and how this has changed since 2018. What 2020 has highlighted is that large pharmaceutical companies have a critical role to play in preparing for the next pandemic, but that these companies have so far delivered a range of responses: some of them apparently shortsighted. Small biotech companies and academic groups may be able to pioneer new ideas, but it is the big players that are responsible for rapid development and access to vaccines, therapeutics and diagnostics, with the capacity to scale-up both manufacturing and distribution capabilities. Poorer Countries Lacking Access to More Than Half Key Products Covered By Pharma Companies However, the pharmaceutical industry only mobilized against COVID-19 once it became clear that the outbreak affected rich as well as poor countries. “Even in light of COVID-19, there were very few commitments from the pharmaceutical industry last year,” said Iyer. Other than projects developed within the Access to COVID-19 Tools (ACT) Accelerator, there was little evidence in the first months of the pandemic response that there structures in place to ensure access and distribution to COVID-19 vaccines in poorer countries. This has once more shown that the Global South still does not benefit significantly from access strategies implemented by big pharma. Less than half of key products controlled by 20 large companies are being offered in countries classified as either lower-middle income countries (LMICs) or low-income countries (LICs). Low-income countries are most consistently over-looked by access strategies, particularly for products that need to be administered by healthcare practitioners. The response is even more profound in LICs, which are consistently overlooked despite being home to almost 700 million people. Currently, only eight of the 60 – or 13% – critical products that need to be administered by healthcare professionals, like injectable treatments for cancer, are covered by access strategies in at least one LICs. Self-administered medicines such as pills have 26%. The numbers jump slightly in LMICs, and even more so in upper-middle income countries (UMICs), with approximately half of critical products covered by access strategies in UMICs. The greatest number of people also benefited from both healthcare professionals administered medicine and self-administered medicine in UMICs. Many industry access arrangements do not go far enough, with many of the world’s most vulnerable and marginalized not receiving the life-changing medicines they need. Solving the access to medicine problem requires the pharmaceutical industry to take large-scale action, reaching more people with more products across a wider range of the world’s poorest countries. “I believe the past year has demonstrated the pivotal importance of supplying affordable medicines for the many, rather than premium-priced products for the few,” said Iyer. “By investing in fair access to medicine for the poorest and most vulnerable among us, we are also investing in a fair, peaceful and prosperous global community.” Eight Pharma Companies Paving Way Towards Equitable Access Top 6 companies with access planning, with percentage of R&D projects with access plans There are positives: eight companies have taken the lead to integrating systemic access planning into their development processes. Novartis was noted as the first to begin mainstreaming access in the previous Index, and joining them in 2021 are AstraZeneca, GSK, Johnson & Johnson, Merck, Pfizer, Sanofi, and Takeda. Though the 20 companies in the Index have 394 projects in late-stage development that target either global health priorities (114) such as coronavirus, malaria, tuberculosis or HIV, or offer benefits to low- and middle-income countries (280), the majority of these are not supported by an access plan. An access plan can include a wide range of activities – prioritising countries with the highest disease burden to strengthening supply chains to ensure all populations have fair access. To have maximum impact, the Index advises that access plans have a broad geographic focus, explicitly aiming to reach a majority of people affected by a disease or in need of a vaccine or diagnostic tool. The 20 companies in scope have 394 R&D projects in late-stage development that either target established global health priorities or offer clear public health benefits for low- and middle-income countries. The majority of these are not yet supported by an access plan. If this happens, people living in low- and middle-income countries, especially those in resource-limited or remote settings, will no longer be left behind for pharmaceutical innovations. Concluded Iyer: “The power of science to help humanity – whether through new vaccines for common pathogens or novel drugs for rare diseases – is remarkable. But these breakthroughs will only truly deliver for the world if they reach all those who need them.” Image Credits: Access to Medicine Foundation , Access to Medicine Foundation . WHO Executive Board Rejects Israel’s Proposal To Remove Standalone Agenda Item On Palestinian Health Conditions 28/01/2021 Madeleine Hoecklin Meirav Eilon Shahar, Israel’s ambassador to the United Nations in Geneva, speaking to the WHO Executive Board. For the second time in as many years, WHO member states have voted down a proposal by Israel to remove a standalone item from the agenda of the 74th World Health Assembly – devoted exclusively to a report on health conditions in the Occupied Palestinian territories – and consider it as part of WHO’s overall health emergencies agenda. Saying that the agenda item unfairly singles out just one country for criticism, as compared to every other nation in the world, Israel on Tuesday proposed to the WHO Executive Board, which fixes the WHA agenda, that the report be considered as part of the overall discussion on WHO’s work in health emergencies when WHO member states meet in May. In a lengthy and unusual voting process on the closing day of the 10-day EB session, the proposal was rejected in a vote of 15 to seven – with 9 abstentions and 3 countries absent. Those supporting Israel’s position included the United Kingdom, Germany and Austria, joined by the United States, Australia and Colombia. EB members that were opposed included Oman, China, Russia, and Tunisia. Israel’s delegation said the report was a “political” item that does not reflect reality and will not change the situation on the ground. “Item 25 is a political item with only one purpose – to attack Israel and to politicize an otherwise professional organization [WHO]. This must be changed…What I’m asking you to do today is to ensure that the World Health Assembly maintains its focus on health and the truth,” said Israel’s ambassador to the United Nations, Meirav Eilon Shahar. “Regardless of what takes place in Geneva, we, Israel, will continue to work with the Palestinians and with WHO and we’ll continue to work on any problem and assistance intended to improve the health conditions for the Palestinians,” she added. The Palestinian representative, Ibrahim Khraishi, Ambassador of the State of Palestine to the UN, which holds observer status in the World Health Assembly, retorted that: “The [health situation in the occupied territories] is catastrophic and dire…Israel is finding it easy to renege on its responsibility, for example, it is not meeting its requirement…when it comes to vaccination. “When we look at the rate of vaccination for [Israeli] citizens, the figure exceeds two and a half million, whereas not one single Palestinian citizen has had the jab because of Israeli practices,” he said. Khraishi cited the WHO report from the 73rd WHA in November 2020, which he said shows that infant mortality of West Bank Palestinians is six times higher, and maternal mortality nine times higher than that of the 600,000 Israeli settlers living side by side with Palestinians in the Occupied West Bank. The report also describes barriers Palestinians from the West Bank and Gaza face in accessing more health services, such as the more specialized services in Jerusalem, which is directly under Israeli rule and to which access is tightly-controlled. Ibrahim Khraishi, Ambassador of the State of Palestine to the UN and Palestine’s representative to the Executive Board. After the vote among member states, Israel disputed the vaccination claims, saying that Palestinian inmates have received vaccinations and the PA has been provided with emergency supplies for 100 essential health workers – but the overall responsibility to vaccinate the roughly 5 million Palestinians living in the West Bank and Gaza lies with the Palestinian Authority (PA), not Israel. “We are very happy to extend assistance in facilitation of those vaccines in entrance to Israel,” said Eilon Shahar, referring to the expected arrival of PA-purchased vaccine supplies from Russia. PA health officials have not, in fact, officially requested vaccines from Israel, but rather are awaiting the arrival of Russian Sputnik vaccines within the coming two weeks. However, human rights groups have underlined that Israel still holds the ultimate responsibility for health under international law insofar as it still occupies the West Bank, The largely technical issue of where on the WHA agenda the report on Palestinian health conditions should be reviewed, was subject to a lengthy and unusual voting process (most EB decisions are made by consensus). The United States, Australia, and the United Kingdom explained their support of Israel’s proposal, saying that no other country in the world has been singled out in such a way by the WHO. “We’re concerned that the World Health Assembly does not consider the many other difficult health situations around the world in the same way,” said the UK’s delegate. “This item remains the only country specific item at the WHA…We fail our duty to serve people around the world who have vitally important health concerns if we allow WHO to become politicized in this way.” The UK’s delegate to the Executive Board. Australia went a step further, expressing concerns about the introduction of political issues into the WHA through the existence of the stand alone item – and calling for negotiations to permanently remove the item, not only as a stand-alone item but altogether from the agenda. The delegations from Oman and the Syrian Arab Republic countered the arguments made by the UK and US, claiming that the agenda item does not single out Israel. “This is not a country-specific item. This is an item which [reflects] a specific situation, a situation of people under occupation and addresses the legal obligations of the occupying power,” said Syria’s delegate. “The politicization is coming from attempts to go around these facts.” The Palestinian representative concluded the discussion at the closing session of the Executive Board meeting on Tuesday by urging member states to encourage Israel to “shoulder her responsibilities and do her duty towards all citizens for which she is responsible, particularly those in the occupied Syrian Golan, the Gaza Strip, and the other occupied territories.” The Gaza Strip has been under Israeli blockade as a result of repeated Israeli confrontations with the fundamentalist Hamas, which wrested control of the Strip from the PA-supported Fatah in 2007, two years after Israel unilaterally uprooted its settlements and withdrew from the Strip. Israel captured the Golan Heights from Syria in the 1967 Six Day War, and extended Israeli citizenship to the predominantly Druse residents of the Heights who remained after the war. Image Credits: WHO. Africa CDC Head calls for ‘Common Approach’ To Travel Restrictions Based on COVID Test & Not ‘National Origins’; 7 African Nations Report SARS-CoV-2 Variants 28/01/2021 Paul Adepoju Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy and not geographic or national origins, Africa CDC Director Dr John Nkengasong has said. IBADAN – Five African countries have now confirmed cases of the SARS-CoV-2 501Y.V2 variant, which first appeared in South Africa, and there is concern that the variant is circulating undetected elsewhere on the continent. The Gambia and Nigeria have seen cases of the variant B.1.1.7, first identified in the United Kingdom, said WHO’s African Regional Director today, Dr. Matshidiso Moeti, at a press briefing. Meanwhile, Africa CDC Director, Dr John Nkengasong, called for a “common approach” to COVID testing to oil the wings of international air travel – and halt the wave of new travel restrictions that countries have been imposing based on people’s national origin or the origins of flights – including people and flights arriving to Europe and the United States from South Africa. Researchers now believe the variants may be both more infectious but also more deadly than the COVID virus strains that were prevalent until just recently. Researchers also fear the variants could also elude COVID tests and be more resilient to vaccines just being rolled out now – although many unknowns remain. The countries where 501Y.V2 is circulating include: Botswana, Ghana, Kenya and Zambia, as well as South Africa. Beyond Africa, the variant has been confirmed in 24 countries globally. And there’s concern, it is circulating undetected in other countries in Africa,” Moeti told the press briefing. Dr. Matshidiso Moeti, WHO’s African Regional Director. “We are seeing more and more cases of variants and 501Y.V2, which was first identified in South Africa now, cropping up in other countries,” Moeti said. “The evidence suggests that these variants are more transmissible and emerging evidence indicates that the UK variant may cause more severe illness than other common strains, although more research needs to be done.” These variants in conjunction with “the aftermath of year-end gatherings”, Moeti said, “risk powering a perfect storm and driving up Africa’s second wave and overwhelming health facilities”. The continent saw a 50% rise in infections between 29 December 2020 and 25 January 2021, when compared with the previous four weeks, while deaths doubled. Last week, more than 6,200 deaths were reported across Africa, said the WHO.The past week saw a small dip in cases in South Africa, but 22 other countries continued to see numbers surge. Existing COVID-19 vaccines remain effective against the variants, Moeti said. But Professor Tulio de Oliveira, of the University of KwaZuku-Natal, South Africa, noted that these or other emerging variants may likely require individuals receiving booster doses of the vaccine. WHO’s African Region is meanwhile setting up a new surveillance network with Africa CDC to track the spread of the virus mutations and variants across Africa and beyond, Moeti added. “The variant which was first detected in South Africa has spread quickly beyond Africa and so what’s keeping me awake at night right now is that it’s very likely circulating in a number of African countries,” said Moeti. “Africa is at a crossroads. We must stick to our guns and double down on the tactics we know work so well. That is mask wearing, handwashing and safe social distancing. Countless lives depend on it.” WHO’s African CDC Calls for Common COVID Testing Approach For International Travel Dr John Nkengasong issued his call for a rethink of travel policies after several foreign countries, including the United States, are considering or have already banned flights originating from South Africa. Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy – and not geographic or national origins, said Nkengasong. “We should not be banning people because of their geographical origin, but we should be encouraging people to travel with negative tests and facilitate the testing process so that people can travel with a negative test,” Nkengasong said. “If I were to go to Kenya and I show up at the airport with a valid negative test, I pose no threat to the country of Kenya, and that way so you shouldn’t just ban me because I’m coming from a certain country. They should be looking at that test, is your test valid,” Nkengasong added. Dr John Nkengasong, Director of the Africa CDC. Up until now, the World Health Organization has resisted recommending pre-travel COVID testing, ostensibly due to fears that it would put an unnecessary onus on poor countries. In fact, however, many of the poorest African and Asian countries have been requiring pre-flight COVID tests for all incoming passengers – which are paid for privately. Some counties, such as the Democratic Republic of Congo, also demand arrivals briefly quarantine until a post-flight test is completed as well, paid privately as well. Paradoxically, it is wealthier European and American countries that first issued a rash of orders banning passengers of certain nationalities or flights from certain destinations as a result of variant scares – although more developed countries, most recently Switzerland on Wednesday, have adopted testing requirements. Senegal’s Pasteur Institute – At Center Of New Genetic Surveillance Network At the outset of the pandemic, most countries in Africa lacked adequate testing capacity for COVID-19 but this was gradually surmounted as new testing facilities were added. Now, however, the identification of new variants of the virus will require more advanced capacities for gene sequencing that several countries in Africa have yet to obtain. To address this vacuum, the Africa CDC, the WHO and member countries have created a network that enables existing labs with gene sequencing capabilities to collect samples from countries that lack such. One of the labs in the network is the Dakar-based Institut Pasteur de Dakar in Senegal. Its CEO, Dr Amadou Sall, said in addition to providing gene sequencing services for Senegal, the institute is now supporting other countries, Cameroon and Equatorial Guinea notably. Others include Mali, Burkina Faso Guinea-Bissau, Côte d’Ivoire, Niger, Verde, and of course, Guinea. “With the partnership we have with Africa CDC and WHO, we have the possibility of sequencing 500 genomes per week. And we’re trying to increase this capacity and to make these capacities available in different countries,” Sall said. Key to the success of COVID-19 genomic surveillance in Africa, Sall said, will be the willingness and openness of African countries to share information. “We need to be able to share information data and the Pasteur Institute is at the center of a global platform and we’re able to share information; to exchange information rapidly, if countries are willing to do so,” he said. Knowing When to Raise the Alarm While noting that identification of new variants is a significant feat, genomic experts warned that alarm should not be raised every time a new strain is identified. Professor de Oliveira, who heads the KwaZulu-Natal Research and Innovation Sequencing Platform, said attention is raised when new strains are being confirmed in increasing numbers of cases with the new variant and not when just one case has been confirmed. Describing the impacts that variants have on the epidemiology of the pandemic in South Africa, Oliveira said in some regions, the new variant has become the prominent type. But beyond this, he said South Africa is also worried about the variants from elsewhere getting into the country and circulating among its populations. “Today, we just reported the first important case of the B.1.1.7, the variant of concern that is circulating in the UK. And it’s quite common that in addition to our main variant that is dominating, we’re going to still have introductions of new lineages,” Oliveira said. “And in the case they begin to spread very fast, then we will communicate it and then highlight that could be a variant of concern.” He said that while no one can know for sure about the possibility of third or fourth waves of the pandemic in Africa, the variants are highlighting the need for the entire world to globally control the transmission of SARS-CoV-2 as a global community. “We have to really decrease transmission to avoid the next waves and more worry that emergence of new variants of concern will transmit too fast or evade immune response,” he said. “The appearance of these variants in the African continent, but also in South America and Europe really means that more than ever, it is the time that we don’t leave any continent behind, especially on vaccination,” Oliveira said. Silver Lining In Cloud – Variants Also Impetus For Cooperation But within Africa itself, Sall said the various SARS-CoV-2 variants constitute a new impetus for cooperation between countries, to be able to track and measure the circulation of the virus, and to enhance diagnostic capacities that he said will soon be available across Africa. “The new variants are the object of a very thorough study, and the path of our countries is very clear: obtain maximum information and adapt the strategy to contain the transmission,” he said. Moeti enjoined countries and individuals to strive to overcome COVID-19 fatigue and return to the fundamental actions that have been found to be effective against these variants. These measures, she said, need much more emphasis that news that the virus is much more transmissible. “The vaccine is a tool that’s going to make a huge difference all over the world,” she said. But she reminded that “having a corner of the world not protected, the way the world’s economies and peoples are connected, will have negative economic impact even in those countries that managed to vaccinate the entire population. We really are all in it together, and we have to work to support each other to overcome this global crisis.” Image Credits: Paul Adepoju/HealthPolicyWatch, Africa CDC. EU Protests AstraZeneca Vaccine Delays – Could Block UK-Bound Exports 28/01/2021 Madeleine Hoecklin The Oxford/AstraZeneca vaccine is 2 months behind schedule due to an issue in manufacturing. AstraZeneca has joined Pfizer in announcing delays in deliveries of COVID-19 vaccines to countries in Europe, leading furious EU officials to plan for a system of tighter monitoring of vaccine exports. The British-Swedish pharma company that developed its COVID-19 vaccine with researchers at Oxford University, informed the European Commission on Friday that there would be a 60% shortfall in vaccine deliveries this quarter due to a manufacturing issue at a production plant in Belgium. The company is reportedly two months behind schedule with regard to vaccines destined for European countries. Since vaccine deals with the United States and the United Kingdom were signed earlier on, and are based around manufacturing sites in those countries, the company has had a headstart in resolving “glitches” in those supply chains, pharma officials said. But the Commission had its doubts over this given explanation. Following an EU-requested investigation into AstraZeneca’s Belgian-based production facility on Wednesday, the European Commission has said it would establish a new mechanism that grants national regulators the power to refuse exports of vaccines. The mechanism – the criteria for which is expected to be published on Friday – could throw the security of the UK’s 40m-dose deal with Pfizer/BioNTech. The investigation, a spokesperson for the Belgian health ministry said, was to “make sure that the delivery delay is indeed due to a production problem on the Belgian site”. AstraZeneca ‘Scaling Up’ Doses, As EU Leaders Question Pharma Company Pascal Soriot, CEO of AstraZeneca “We are scaling up to hundreds of millions, billions of doses of vaccines at a very high speed. A year ago we didn’t have a vaccine. When you do that, you have glitches, you have scale-up problems. Therefore, the yield varies,” said Pascal Soriot, CEO of AstraZeneca, in an interview with la Repubblica, an Italian newspaper, on Tuesday. News of the delays was met with frustration by EU officials and leaders, who were expecting to receive 80 million doses by the end of March. “This new schedule is not acceptable to the European Union,” said Stella Kyriakides, European Commissioner for Health and Food Safety, in a statement released on Monday. “The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far, and if, or to whom, they have been delivered.” Stella Kyriakides, European Commissioner for Health and Food Safety, at a press briefing on Wednesday. Soriot disputed suggestions that the company sold the doses elsewhere for a higher price, claiming that “there is a lot of silly talk going on right now about all sorts of things,” and the response from the European Commission and EU member states is because “there are a lot of emotions running in this process right now.” “The suggestion [that] we sell to other countries to make more money is not right because we make no profit everywhere…That’s the agreement we have with Oxford University,” said Soriot. “Governments are under pressure. Everybody is getting kind of…aggravated or emotional about those things. But I understand because the Commission is managing the process for the whole of Europe,” he added. In late August, the EU made an upfront payment of €336 million to the company to secure 300 million doses of the vaccine. EU officials have disputed AstraZeneca’s explanation of production issues, claiming there are no excuses for the delay. “The flimsy justification that there are difficulties in the EU supply chain but not anywhere else does not hold water, as it is of course no problem to get the vaccine from the UK to the continent,” said Peter Liese, an EU parliamentarian from Germany’s Christian Democratic Union. Currently AstraZeneca is producing 17 million doses per month. That number will reach 100 million doses from February onwards, according to Soriot, meaning 1.2 billion doses per year. And Europe will receive 17% of the global production in February for a population that represents 5% of the world’s population. The Oxford/AstraZeneca vaccine is in the final stages of the approval process with the European Medicines Agency (EMA) and is expected to receive the recommendation for market authorization on Friday. After being approved, the company plans to deliver three million doses immediately. Meetings between EU officials and AstraZeneca have done little to resolve the issue, with Kyriakides announcing on Twitter: “Discussions with @AstraZeneca today resulted in dissatisfaction with the lack of clarity and insufficient explanations. EU Member States are united: vaccine developers have societal and contractual responsibilities they need to uphold.” With our Member States, we have requested from AZ a detailed planning of vaccine deliveries and when distribution will take place to Member States. Another meeting will be convened on Wednesday to discuss the matter further. — Stella Kyriakides (@SKyriakidesEU) January 25, 2021 The EU Steering Board, the body that oversees vaccine deals, plans to meet with AstraZeneca again on Wednesday at 6:30pm CET and hopes to “resolve this in a spirit of collaboration and responsibility,” according to Kyriakides. The Italian government plans to take legal action against Pfizer and AstraZeneca over their delays in deliveries, according to an announcement made by Foreign Minister Luigi Di Maio on Sunday. “This is a European contract that Pfizer and AstraZeneca are not respecting and so for this reason we will take legal action,” Di Maio said on RAI state television. “We are activating all channels so that the EU Commission does all it can to make these gentlemen respect their contracts.” According to Soriot, however, the vaccine deal signed with the EU was not a contractual commitment but a best effort, so there is no feasible basis for legal action. EU to Establish a Vaccine Export Transparency Mechanism The Oxford/AstraZeneca vaccine is also considered one with global potential – due to its ability to be stored at refrigerator temperatures. Amidst some countries’ suspicions that countries outside Europe are receiving priority for vaccines produced at the Belgium plant, the European Commission announced plans to establish an export transparency mechanism for vaccines to ensure clarity on transactions and to protect its investments in the R&D that led to development of vaccines like AstraZeneca’s. AstraZeneca is also a major supplier of the WHO COVAX global distribution initiative – which has pledged to begin distributing vaccine doses to the 92 lowest-income countries in the world within the next two months. Although most of the COVAX supplies were reportedly to be produced by India’s Serum Institute or in the Republic of Korea, the exact supply lines remain unclear. “Europe invested billions to help develop the world’s first COVID-19 vaccines…And now, the companies must deliver,” said Ursula von der Leyen, President of the European Commission, at the World Economic Forum on Tuesday. “They must honor their obligations. This is why we will set up a vaccine export transparency mechanism. Europe is determined to contribute to this global common good. But it also means business.” Ursula von der Leyen, President of the European Commission, speaking at the World Economic Forum on Tuesday. “In the future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries,” said Commissioner Kyriakides. The aim of the proposed system will be to monitor, but not block, exports, officials said. And humanitarian deliveries would be anyway exempt from this oversight mechanism. EMA Yet To Issue Final Approval – Insufficient Data on Vaccine in Older People Meanwhile, the EMA has yet to issue its final regulatory approval for the two-dose Oxford/AstraZeneca vaccine, and is reportedly considering limiting the age range to people under the age of 65 – due to a lack of data on effectiveness in older people. Unlike mRNA counterparts produced by Moderna and Pfizer, the AstraZeneca/Oxford vaccine uses a disabled, modified version of a chimpanzee adenovirus that can enter human cells but cannot replicate or cause the disease, as a vector to deliver a fragment of SARS-CoV2 spike protein, stimulating COVID-19 immunity. According to data shared by the company, only 10% of participants in the vaccine clinical trials were over the age of 65 because it was first waiting for sufficient safety data in the 18 to 55 age group before vaccinating older individuals. “We don’t have a huge number of older people who have been vaccinated,” said Soriot. “But we have strong data showing very strong antibody production against the virus in the elderly, similar to what we see in younger people.” The results of an ongoing, larger Phase 3 clinical trial with 30,000 participants being conducted in the United States are expected to provide insight into the protection the vaccine provides to older individuals and ethnic minorities populations – groups that were not very well represented in previous trials. In addition, scientists are exploring whether a half-dose of the first vaccine would reliably yield a higher efficacy rating of 90% that was seen in initial trials. The other regime, involving two full doses was only 62% effective, according to the results released by the company in late November and reviewed by an independent Data and Safety Monitoring Board. That still meets key global benchmarks for efficacy, but is significantly lower than the 94-95% efficacy results for the Moderna and Pfizer mRNA vaccines. The AstraZeneca vaccine has, however, already been authorized in the UK, is already being used in British vaccination campaigns, including for people over 70 years old. Image Credits: AstraZeneca, AstraZeneca, Twitter, Twitter. WHO Proposes New Mode Of Engaging With Non-State Actors 28/01/2021 Esther Nakkazi Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, according to WHO. The World Health Organization (WHO) aims to make its engagement with non-state actors (non-state actors) more meaningful and efficient with a new proposal to establish a number of NSA fora that would allow exchange with WHO and member state representatives outside of official meetings. The new proposal — which will be tested during the 74th World Health Assembly (WHA), 24 May to 1 June — would offer multiple side events in which non-state (NSA) actors could engage more informally with member state representatives as well as a forum for exchange between NSAs and WHO regional and technical staff. But at the same time, non-state actors will be allotted a more limited number of constituency statements in formal governing body meetings – and like-minded groups of actors will be asked to combine their official statements together. Non-state actors include civil society groups such as non-governmental organizations, international business and professional associations, and philanthropic foundations. More than 70 non-state actors are recognized as being “in official relations” with WHO, and thus contribute in formal meetings such as the EB and the WHA. However, EB and WHA members have complained that the civil society interventions have become bogged down by too many lengthy, individual statements – and NSAs acknowledge that the statements often had limited impact in member state debates. More informal meetings ahead of the formal meeting dates would help engender more meaningful interaction, WHO said in its proposal for the reform, which was reviewed by the WHO Executive Board on Saturday. Informal meetings will also allow non-state actors to organize themselves into constituencies, consolidating their positions into joint statements to be presented at official events. The new arrangements to be tested in May, will “serve as a trial for potential future virtual informal meetings between non-state actors, Member States and the Secretariat, as a means of enabling more in-depth technical exchanges, as well as discussions on the Health Assembly agenda items,” said the WHO Secretariat, in its presentation to the EB on Saturday. The COVID-19 pandemic has provided added impetus for reforms that have long been in the making – insofar as the limitations of virtual meetings have also curtailed the interactions between member states and non-state actors. According to the new proposal, the informal series of meetings with non-state actors will be held just ahead of the WHA, and thus prepare the groundwork for the formal meeting. Role of Non-State Actors Has Evolved – But Increasing Number of Statements Detracted from Impact In the discussion over the proposal, WHO officials stressed that the Organization “is and remains a Member State Organisation” — engaging with 77 non-state actors, at global, regional and country levels, who also support the development and implementation of the Organization’s policies and recommendations, technical norms and standards. But while non-state actors have “served the Organization well for several decades”, the increasing number of non-governmental organizations and other non-state actors participating — often with a greater number of requests to speak — has “not resulted in a more meaningful involvement”. For example, when civil society representatives speak one-by-one at the end of a discussion, their interventions have little impact on the content or direction of the debate, WHO contends. Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, says the WHO. A virtual consultation by WHO further confirmed that non-state actors’ primary interests in attending governing body meetings are to participate in technical exchanges with the Secretariat and the Member States and to attend consultative hearings that feed into decision-making processes. Meaningful Participation From NGOs Critical, Member States Say The UK delegate said that it would allow NSAs to exert even more credible influence on member states attitudes and positions. The EB representative from the United States flagged that it is critical to ensure and enhance meaningful participation of non-state actors in WHO governing bodies, while also creating greater efficiency in the governance process. “Non-State actor participation must be allowed in a transparent and accountable manner with an open door to input from all stakeholders including the private sector,” the delegate noted. Austria pressed for the Secretariat to provide some more detailed information on the procedure for these meetings. Other states, like Australia, flagged that the trial is very ambitious given the agenda for the 2021 assembly is already very crowded. “We suggest that before agreeing to a trial, the number of meetings proposed to be repeated and streamlined,” the representative said.This would “provide reflections to technical areas in advance of the governing body meetings”. Civil Society Groups Request Clarity and Procedure Details Bodies like Health Action International asked for details as to how NGOs would participate, and for clarity on the processes governing such meetings. “It is a remaining concern to those who have witnessed creeping capacity shrinking of NGO space and poor consultation in recent years,” said an HAI statement. The HAI delegate requested that similar procedures be implemented for WHO regional meetings with member states, also asking that “these informal meetings compliment, but do not replace comprehensive consultations with non-state actors.” Meanwhile, the European Society for Medical Oncology said the views and expertise of non-state actors should be introduced earlier in the WHO decision-making process; it would be of greater value if delivered at the onset of projects, and when member states are drafting zero draft decisions and resolutions. “Direct interaction and discussion between member states, WHO offices, and Non-State actors would provide the opportunity for more in-depth exchanges, and partnerships, as the Member States, develop policies and implement actions to fulfill their WHO commitments,” said the ESMO spokesperson. Silberschmidt stressed that the virtual informal meetings will not replace other channels, but become an additional avenue for interaction – highlighting the fact that Dr Tedros Adhanom Ghebreyesus, WHO Director General, has already established a regular dialogue with civil society groups, to be held every six weeks. Image Credits: WHO / Christopher Black. 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.
‘Gag Rule’ Must Never Be Repeated, International AIDS Society Tells US Gov 29/01/2021 Kerry Cullinan The International AIDS Society urged the Biden administration “to consider legislation preventing the global gag rule from returning in the future”. The International AIDS Society (IAS) has welcomed US President Joe Biden’s repeal of the Mexico City Policy, known as the global “gag rule”, which prevented non-US organisations from getting US aid if they offered abortion services, referrals or advocacy. But the IAS urged the US administration “to consider legislation preventing the global gag rule from returning in the future”, according to its president, Adeeba Kamarulzaman. The gag rule was first introduced by Ronald Reagan to prevent US government aid to foreign family planning organisations offering abortions. The Trump administration expanded it significantly to block any foreign NGO associated with abortion from receiving health development funds from any US source. The rule affected almost $9 billion of US aid, and had a severe impact on organisations offering HIV services, disrupting HIV testing, counselling, condom provision, antiretroviral treatment and care. “As HIV professionals, we saw firsthand the impact of the global gag rule from its first iteration – barring and disrupting access to health care for women around the world,” said IAS Executive Director Birgit Poniatowski. “In its expanded form, the policy threatened to roll back progress in the global HIV response.” Echoing the IAS call, Ugandan health activist Dorothy Amuron from the Center for Health, Human Rights and Development called on the Biden administration “to take bold action to stop this deadly cycle of granting or rescinding human rights when the political tides shift”. “The U.S. has an obligation to safeguard human rights for all. But policies like the global gag rule are an attack on our sovereignty and our humanity,” said Amuron. “We call on the Biden administration to use its power to get rid of them forever.” Ironically, the gag rule was associated with a 40% increase in the rate of abortion and a 13.5% reduction in the use of contraception, according to research published in the Lancet. Image Credits: Mike Beaty/Flickr. COVID-19 Has Outlined Healthcare Systems’ Dangerous Emissions Problem 29/01/2021 Raisa Santos Healthcare’s overreliance on single-use products and equipment contributes to its carbon footprint Failure to align the global recovery from COVID-19 with an equally powerful climate response could threaten the worldwide effort to limit the average global temperature increase, public health experts have said. In a convention in 2015 now known as the Paris Agreement, the United Nations Framework Convention on Climate Change (UNFCCC) established its aim to pause the increase in global average temperature by “well below 2 degrees Celsius above pre-industrial levels and to pursue efforts to limit the temperature increase even further to 1.5 degrees Celsius”. To achieve that, a global effort is required to decrease greenhouse gas emissions by 7.6% each year across five years. This number falls further out of reach each year without action. “The reality is that the next five years are going to be pivotal,” Dr Renee Salas, Harvard T.H. Chan School of Public Health, said during a webinar from the Lancet Countdown last week. The 2020 Report of the Lancet Countdown on Health and Climate Change was published in December, and addressed the converging crises of the COVID-19 pandemic, healthcare systems and climate change. “Healthcare has to show us how we can decarbonize and decarbonize our healthcare system,” she said, adding that it “is truly the embodiment that climate action is a prescription for health”. COVID Has Outlined Healthcare Systems’ Flaws The COVID-19 pandemic has highlighted healthcare’s overreliance on single-use products and equipment, the panel said. Additionally, as using personal protective equipment (PPE) has become a greater necessity, use of disposable products has been extended. The health system in England is responsible for an estimated 4-5% of the country’s carbon footprint, for example. NHS carbon footprint is mostly comprise of procured items from the health supply chain The United Kingdom’s National Health Service listed crutches as accounting for nearly 70% of the carbon footprint for items it procured in 2020. Additionally, the traditional model of outpatient care doesn’t strictly align with the nature of chronic illnesses, which requires patients return for unpredictable emergency treatment. Unpredictable treatment directly leads to increased road traffic and increased air pollution. NHS traffic accounts for 5% of road traffic in England alone. Quantified in terms of environmental, financial, and health outcomes, this means that 753 deaths can be attributed to NHS traffic, and £650 million in NHS expenditure are lost a year. “When [evaluating] the value offered in the delivery of a healthcare service, we need to start capturing data that looks at these consequences, thinking beyond the financial and individual patient outcomes,” said Jennifer Isherwood, a National Medical Director’s Clinical Fellow at the Royal College of Physicians, London. “It’s becoming clear that COVID is not going to be the last pandemic that we see,” Isherwood added. “It may be … disruptive to start addressing challenges of different pathways to different care, but it’s the right tool to start future-proofing our healthcare systems.” Hiten Patel, Senior Strategy Advisor for Greener NHS, said: “There’s always something else happening in healthcare systems that’s [considered] a priority. It’s about how we can try to make carbon emissions and climate change more of a priority within healthcare systems.” Concluded Dr Jodi Sherman, Yale University and Lancet Countdown author, said: “Everything we do in healthcare is through the lens of patient safety. Protecting public health is a matter of patient safety and needs to be integral to everything that we do.” Supply and Services Compose Four-Fifths of Overall Healthcare Carbon Footprint The health supply chain comprises four-fifths of US healthcare carbon footprint While the COVID pandemic has flagged some key flaws in the world’s healthcare systems, what is still unclear are the direct and indirect carbon emissions of the healthcare sector, and the implications these emissions have on health. Direct emissions are established and well understood products of the sector: gas exhausts from ambulance tailpipes to fumes emitted from waste incinerators. But indirect emissions – offsite power generation, the provision of medical supplies and pharmaceuticals, and even research and testing – make up a larger percentage of emissions associated with the healthcare sector. The United States alone spends more than US$3 trillion on healthcare a year. As healthcare expenditures increased, so too did the carbon footprint from goods and services. Around 7% is due to direct emissions from healthcare facilities, and another 10% from offsite energy. But four-fifths of the footprint is the supply chain, composed of key sectors that include food, pharmaceuticals, and chemicals. Dr Matthew Eckelman, Northeastern University, Boston and Lancet Countdown author, called on the health sector to take accountability for its immense carbon footprint. “It’s very clear that buying renewable energy is not the only solution. You really have to work on reducing carbon emissions in the supply chain, as well.” Lower the Infection Risk and Financial Losses by Reducing Health Waste Speakers also addressed how vital it is not to risk patient safety in trying to reduce or cut expenses. Healthcare-acquired infection – when a patient becomes infected while in care – affects hundreds of millions of patients globally each year. This leads to significant morbidity and mortality that incurs financial losses for health systems, in addition to excess pollution. As a result, prevention is essential. “While we do want to reduce waste and reduce costs, we certainly don’t want that to be at the expense of increasing infections,” said Dr Sherman. Dr Sherman also acknowledged, however, that infection prevention methods often contribute to the excessive use of single-use disposable devices, like masks and gloves. Using only disposable laryngoscopes would increase costs for hospitals In a greenhouse gas emissions and cost analysis study comparing reusable and disposable laryngoscopes, Dr Sherman and Eckelman found that disposables – whether plastic or steel – outweigh the reusable in terms of greenhouse gas emissions. Using purely disposables would increase costs by up to US $700,000 a year, for one hospital department. Recycling these disposables would only reduce a small portion of emissions, especially since the laryngoscope cannot be recycled entirely. “In other words, we can’t recycle a way out of this problem,” Dr Sherman said. “The answer isn’t that we should use disposables. It’s that we should clean up our supply.” There needs to be a balance between the “indirect disease burden from all the materials thrown away and lowering the infection risk curve.” The greatest causes of healthcare acquired infections, said Dr Sherman, have to do with staff discipline, such as hand washing, and patient health status, and exposure to infection. But simple hand washing and using more and more disposables is not the solution. Image Credits: Flickr: Marc A. Hermann / MTA New York City Transit, The Lancet Countdown. Pharma Ill-Equipped To Handle 10 Most Infectious Diseases And Future Pandemics, Report Warns 29/01/2021 Raisa Santos A new report has found that current R&D is primarily geared towards COVID-19, with next to no efforts to address other pathogens with the potential pandemic risks like Zika and Sars. With ten of the world’s most infectious diseases not catered by drug firms, pharmaceutical giants remain unprepared to tackle future pandemics, a new report has said. The report, published on Tuesday, found that though current medicine and vaccine research and development is primarily geared towards the COVID-19 pandemic, there are next to no efforts to address other pathogens with the potential pandemic risks: namely Nipah, Zika, and Sars. The Access to Medicine Index evaluates 20 global pharmaceutical companies – including AstraZeneca and Pfizer – and compares how far each goes in fulfilling the role of developing urgently needed health products and improving equitable access to them. The companies’ performance is ranked every two years. Pfizer joins top 5, while GSK retains its number one position, yet only slightly ahead of Novartis. Pfizer moves into the top five. Johnson & Johnson complete the top five companies. Eight of the top ten companies, including the leaders, are setting a new best practice of systematic access planning during R&D. “The state of infectious disease research today is, if I can put it mildly, on thin ice,” said Dr Jayasree Iyer, executive director of The Netherlands-based Access to Medicine Foundation, in an interview with DW. COVID-19 has emphasized the need for both the private and public sectors to actively engage in emerging infectious disease research well before the next pandemic breaks out. It has also shown that ending a pandemic requires suitable products to be developed and equitably distributed: much of the responsibility for which lies with pharmaceutical companies. Without their sustained commitment to pandemic preparedness, the report suggests, the world world will remain vulnerable to pandemics. Increased R&D for COVID-19, but Other Pandemic Risks Unaddressed Pharmaceutical companies are not targeting priority pathogens with epidemic potential through R&D. Excluding coronavirus, pathogens with pandemic potential where pharma companies are active in R&D show very small pipelines in 2020. Out of 16 pathogens, 10 have empty pipelines. Even for pathogens under scrutiny, research activity remains low. With most research focused on coronavirus, there are just 13 R&D projects across five non-COVID-19 diseases (Ebola, Zika, Chukungunya, Marburg, and non-polio enterovirus) and zero for the remaining ten of 16 infectious diseases. Emerging infectious disease (EID) research is concentrated among a few companies. In 2020, 17 companies targeted coronavirus, while nine companies are targeting other EIDs: Bayer, Eisai, Gilead, Johnson & Johnson, MSD, Merck, Roche, and Takeda. This figure shows the number of R&D projects and companies identified by WHO and Policy Cures as emerging infectious diseases, and how this has changed since 2018. What 2020 has highlighted is that large pharmaceutical companies have a critical role to play in preparing for the next pandemic, but that these companies have so far delivered a range of responses: some of them apparently shortsighted. Small biotech companies and academic groups may be able to pioneer new ideas, but it is the big players that are responsible for rapid development and access to vaccines, therapeutics and diagnostics, with the capacity to scale-up both manufacturing and distribution capabilities. Poorer Countries Lacking Access to More Than Half Key Products Covered By Pharma Companies However, the pharmaceutical industry only mobilized against COVID-19 once it became clear that the outbreak affected rich as well as poor countries. “Even in light of COVID-19, there were very few commitments from the pharmaceutical industry last year,” said Iyer. Other than projects developed within the Access to COVID-19 Tools (ACT) Accelerator, there was little evidence in the first months of the pandemic response that there structures in place to ensure access and distribution to COVID-19 vaccines in poorer countries. This has once more shown that the Global South still does not benefit significantly from access strategies implemented by big pharma. Less than half of key products controlled by 20 large companies are being offered in countries classified as either lower-middle income countries (LMICs) or low-income countries (LICs). Low-income countries are most consistently over-looked by access strategies, particularly for products that need to be administered by healthcare practitioners. The response is even more profound in LICs, which are consistently overlooked despite being home to almost 700 million people. Currently, only eight of the 60 – or 13% – critical products that need to be administered by healthcare professionals, like injectable treatments for cancer, are covered by access strategies in at least one LICs. Self-administered medicines such as pills have 26%. The numbers jump slightly in LMICs, and even more so in upper-middle income countries (UMICs), with approximately half of critical products covered by access strategies in UMICs. The greatest number of people also benefited from both healthcare professionals administered medicine and self-administered medicine in UMICs. Many industry access arrangements do not go far enough, with many of the world’s most vulnerable and marginalized not receiving the life-changing medicines they need. Solving the access to medicine problem requires the pharmaceutical industry to take large-scale action, reaching more people with more products across a wider range of the world’s poorest countries. “I believe the past year has demonstrated the pivotal importance of supplying affordable medicines for the many, rather than premium-priced products for the few,” said Iyer. “By investing in fair access to medicine for the poorest and most vulnerable among us, we are also investing in a fair, peaceful and prosperous global community.” Eight Pharma Companies Paving Way Towards Equitable Access Top 6 companies with access planning, with percentage of R&D projects with access plans There are positives: eight companies have taken the lead to integrating systemic access planning into their development processes. Novartis was noted as the first to begin mainstreaming access in the previous Index, and joining them in 2021 are AstraZeneca, GSK, Johnson & Johnson, Merck, Pfizer, Sanofi, and Takeda. Though the 20 companies in the Index have 394 projects in late-stage development that target either global health priorities (114) such as coronavirus, malaria, tuberculosis or HIV, or offer benefits to low- and middle-income countries (280), the majority of these are not supported by an access plan. An access plan can include a wide range of activities – prioritising countries with the highest disease burden to strengthening supply chains to ensure all populations have fair access. To have maximum impact, the Index advises that access plans have a broad geographic focus, explicitly aiming to reach a majority of people affected by a disease or in need of a vaccine or diagnostic tool. The 20 companies in scope have 394 R&D projects in late-stage development that either target established global health priorities or offer clear public health benefits for low- and middle-income countries. The majority of these are not yet supported by an access plan. If this happens, people living in low- and middle-income countries, especially those in resource-limited or remote settings, will no longer be left behind for pharmaceutical innovations. Concluded Iyer: “The power of science to help humanity – whether through new vaccines for common pathogens or novel drugs for rare diseases – is remarkable. But these breakthroughs will only truly deliver for the world if they reach all those who need them.” Image Credits: Access to Medicine Foundation , Access to Medicine Foundation . WHO Executive Board Rejects Israel’s Proposal To Remove Standalone Agenda Item On Palestinian Health Conditions 28/01/2021 Madeleine Hoecklin Meirav Eilon Shahar, Israel’s ambassador to the United Nations in Geneva, speaking to the WHO Executive Board. For the second time in as many years, WHO member states have voted down a proposal by Israel to remove a standalone item from the agenda of the 74th World Health Assembly – devoted exclusively to a report on health conditions in the Occupied Palestinian territories – and consider it as part of WHO’s overall health emergencies agenda. Saying that the agenda item unfairly singles out just one country for criticism, as compared to every other nation in the world, Israel on Tuesday proposed to the WHO Executive Board, which fixes the WHA agenda, that the report be considered as part of the overall discussion on WHO’s work in health emergencies when WHO member states meet in May. In a lengthy and unusual voting process on the closing day of the 10-day EB session, the proposal was rejected in a vote of 15 to seven – with 9 abstentions and 3 countries absent. Those supporting Israel’s position included the United Kingdom, Germany and Austria, joined by the United States, Australia and Colombia. EB members that were opposed included Oman, China, Russia, and Tunisia. Israel’s delegation said the report was a “political” item that does not reflect reality and will not change the situation on the ground. “Item 25 is a political item with only one purpose – to attack Israel and to politicize an otherwise professional organization [WHO]. This must be changed…What I’m asking you to do today is to ensure that the World Health Assembly maintains its focus on health and the truth,” said Israel’s ambassador to the United Nations, Meirav Eilon Shahar. “Regardless of what takes place in Geneva, we, Israel, will continue to work with the Palestinians and with WHO and we’ll continue to work on any problem and assistance intended to improve the health conditions for the Palestinians,” she added. The Palestinian representative, Ibrahim Khraishi, Ambassador of the State of Palestine to the UN, which holds observer status in the World Health Assembly, retorted that: “The [health situation in the occupied territories] is catastrophic and dire…Israel is finding it easy to renege on its responsibility, for example, it is not meeting its requirement…when it comes to vaccination. “When we look at the rate of vaccination for [Israeli] citizens, the figure exceeds two and a half million, whereas not one single Palestinian citizen has had the jab because of Israeli practices,” he said. Khraishi cited the WHO report from the 73rd WHA in November 2020, which he said shows that infant mortality of West Bank Palestinians is six times higher, and maternal mortality nine times higher than that of the 600,000 Israeli settlers living side by side with Palestinians in the Occupied West Bank. The report also describes barriers Palestinians from the West Bank and Gaza face in accessing more health services, such as the more specialized services in Jerusalem, which is directly under Israeli rule and to which access is tightly-controlled. Ibrahim Khraishi, Ambassador of the State of Palestine to the UN and Palestine’s representative to the Executive Board. After the vote among member states, Israel disputed the vaccination claims, saying that Palestinian inmates have received vaccinations and the PA has been provided with emergency supplies for 100 essential health workers – but the overall responsibility to vaccinate the roughly 5 million Palestinians living in the West Bank and Gaza lies with the Palestinian Authority (PA), not Israel. “We are very happy to extend assistance in facilitation of those vaccines in entrance to Israel,” said Eilon Shahar, referring to the expected arrival of PA-purchased vaccine supplies from Russia. PA health officials have not, in fact, officially requested vaccines from Israel, but rather are awaiting the arrival of Russian Sputnik vaccines within the coming two weeks. However, human rights groups have underlined that Israel still holds the ultimate responsibility for health under international law insofar as it still occupies the West Bank, The largely technical issue of where on the WHA agenda the report on Palestinian health conditions should be reviewed, was subject to a lengthy and unusual voting process (most EB decisions are made by consensus). The United States, Australia, and the United Kingdom explained their support of Israel’s proposal, saying that no other country in the world has been singled out in such a way by the WHO. “We’re concerned that the World Health Assembly does not consider the many other difficult health situations around the world in the same way,” said the UK’s delegate. “This item remains the only country specific item at the WHA…We fail our duty to serve people around the world who have vitally important health concerns if we allow WHO to become politicized in this way.” The UK’s delegate to the Executive Board. Australia went a step further, expressing concerns about the introduction of political issues into the WHA through the existence of the stand alone item – and calling for negotiations to permanently remove the item, not only as a stand-alone item but altogether from the agenda. The delegations from Oman and the Syrian Arab Republic countered the arguments made by the UK and US, claiming that the agenda item does not single out Israel. “This is not a country-specific item. This is an item which [reflects] a specific situation, a situation of people under occupation and addresses the legal obligations of the occupying power,” said Syria’s delegate. “The politicization is coming from attempts to go around these facts.” The Palestinian representative concluded the discussion at the closing session of the Executive Board meeting on Tuesday by urging member states to encourage Israel to “shoulder her responsibilities and do her duty towards all citizens for which she is responsible, particularly those in the occupied Syrian Golan, the Gaza Strip, and the other occupied territories.” The Gaza Strip has been under Israeli blockade as a result of repeated Israeli confrontations with the fundamentalist Hamas, which wrested control of the Strip from the PA-supported Fatah in 2007, two years after Israel unilaterally uprooted its settlements and withdrew from the Strip. Israel captured the Golan Heights from Syria in the 1967 Six Day War, and extended Israeli citizenship to the predominantly Druse residents of the Heights who remained after the war. Image Credits: WHO. Africa CDC Head calls for ‘Common Approach’ To Travel Restrictions Based on COVID Test & Not ‘National Origins’; 7 African Nations Report SARS-CoV-2 Variants 28/01/2021 Paul Adepoju Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy and not geographic or national origins, Africa CDC Director Dr John Nkengasong has said. IBADAN – Five African countries have now confirmed cases of the SARS-CoV-2 501Y.V2 variant, which first appeared in South Africa, and there is concern that the variant is circulating undetected elsewhere on the continent. The Gambia and Nigeria have seen cases of the variant B.1.1.7, first identified in the United Kingdom, said WHO’s African Regional Director today, Dr. Matshidiso Moeti, at a press briefing. Meanwhile, Africa CDC Director, Dr John Nkengasong, called for a “common approach” to COVID testing to oil the wings of international air travel – and halt the wave of new travel restrictions that countries have been imposing based on people’s national origin or the origins of flights – including people and flights arriving to Europe and the United States from South Africa. Researchers now believe the variants may be both more infectious but also more deadly than the COVID virus strains that were prevalent until just recently. Researchers also fear the variants could also elude COVID tests and be more resilient to vaccines just being rolled out now – although many unknowns remain. The countries where 501Y.V2 is circulating include: Botswana, Ghana, Kenya and Zambia, as well as South Africa. Beyond Africa, the variant has been confirmed in 24 countries globally. And there’s concern, it is circulating undetected in other countries in Africa,” Moeti told the press briefing. Dr. Matshidiso Moeti, WHO’s African Regional Director. “We are seeing more and more cases of variants and 501Y.V2, which was first identified in South Africa now, cropping up in other countries,” Moeti said. “The evidence suggests that these variants are more transmissible and emerging evidence indicates that the UK variant may cause more severe illness than other common strains, although more research needs to be done.” These variants in conjunction with “the aftermath of year-end gatherings”, Moeti said, “risk powering a perfect storm and driving up Africa’s second wave and overwhelming health facilities”. The continent saw a 50% rise in infections between 29 December 2020 and 25 January 2021, when compared with the previous four weeks, while deaths doubled. Last week, more than 6,200 deaths were reported across Africa, said the WHO.The past week saw a small dip in cases in South Africa, but 22 other countries continued to see numbers surge. Existing COVID-19 vaccines remain effective against the variants, Moeti said. But Professor Tulio de Oliveira, of the University of KwaZuku-Natal, South Africa, noted that these or other emerging variants may likely require individuals receiving booster doses of the vaccine. WHO’s African Region is meanwhile setting up a new surveillance network with Africa CDC to track the spread of the virus mutations and variants across Africa and beyond, Moeti added. “The variant which was first detected in South Africa has spread quickly beyond Africa and so what’s keeping me awake at night right now is that it’s very likely circulating in a number of African countries,” said Moeti. “Africa is at a crossroads. We must stick to our guns and double down on the tactics we know work so well. That is mask wearing, handwashing and safe social distancing. Countless lives depend on it.” WHO’s African CDC Calls for Common COVID Testing Approach For International Travel Dr John Nkengasong issued his call for a rethink of travel policies after several foreign countries, including the United States, are considering or have already banned flights originating from South Africa. Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy – and not geographic or national origins, said Nkengasong. “We should not be banning people because of their geographical origin, but we should be encouraging people to travel with negative tests and facilitate the testing process so that people can travel with a negative test,” Nkengasong said. “If I were to go to Kenya and I show up at the airport with a valid negative test, I pose no threat to the country of Kenya, and that way so you shouldn’t just ban me because I’m coming from a certain country. They should be looking at that test, is your test valid,” Nkengasong added. Dr John Nkengasong, Director of the Africa CDC. Up until now, the World Health Organization has resisted recommending pre-travel COVID testing, ostensibly due to fears that it would put an unnecessary onus on poor countries. In fact, however, many of the poorest African and Asian countries have been requiring pre-flight COVID tests for all incoming passengers – which are paid for privately. Some counties, such as the Democratic Republic of Congo, also demand arrivals briefly quarantine until a post-flight test is completed as well, paid privately as well. Paradoxically, it is wealthier European and American countries that first issued a rash of orders banning passengers of certain nationalities or flights from certain destinations as a result of variant scares – although more developed countries, most recently Switzerland on Wednesday, have adopted testing requirements. Senegal’s Pasteur Institute – At Center Of New Genetic Surveillance Network At the outset of the pandemic, most countries in Africa lacked adequate testing capacity for COVID-19 but this was gradually surmounted as new testing facilities were added. Now, however, the identification of new variants of the virus will require more advanced capacities for gene sequencing that several countries in Africa have yet to obtain. To address this vacuum, the Africa CDC, the WHO and member countries have created a network that enables existing labs with gene sequencing capabilities to collect samples from countries that lack such. One of the labs in the network is the Dakar-based Institut Pasteur de Dakar in Senegal. Its CEO, Dr Amadou Sall, said in addition to providing gene sequencing services for Senegal, the institute is now supporting other countries, Cameroon and Equatorial Guinea notably. Others include Mali, Burkina Faso Guinea-Bissau, Côte d’Ivoire, Niger, Verde, and of course, Guinea. “With the partnership we have with Africa CDC and WHO, we have the possibility of sequencing 500 genomes per week. And we’re trying to increase this capacity and to make these capacities available in different countries,” Sall said. Key to the success of COVID-19 genomic surveillance in Africa, Sall said, will be the willingness and openness of African countries to share information. “We need to be able to share information data and the Pasteur Institute is at the center of a global platform and we’re able to share information; to exchange information rapidly, if countries are willing to do so,” he said. Knowing When to Raise the Alarm While noting that identification of new variants is a significant feat, genomic experts warned that alarm should not be raised every time a new strain is identified. Professor de Oliveira, who heads the KwaZulu-Natal Research and Innovation Sequencing Platform, said attention is raised when new strains are being confirmed in increasing numbers of cases with the new variant and not when just one case has been confirmed. Describing the impacts that variants have on the epidemiology of the pandemic in South Africa, Oliveira said in some regions, the new variant has become the prominent type. But beyond this, he said South Africa is also worried about the variants from elsewhere getting into the country and circulating among its populations. “Today, we just reported the first important case of the B.1.1.7, the variant of concern that is circulating in the UK. And it’s quite common that in addition to our main variant that is dominating, we’re going to still have introductions of new lineages,” Oliveira said. “And in the case they begin to spread very fast, then we will communicate it and then highlight that could be a variant of concern.” He said that while no one can know for sure about the possibility of third or fourth waves of the pandemic in Africa, the variants are highlighting the need for the entire world to globally control the transmission of SARS-CoV-2 as a global community. “We have to really decrease transmission to avoid the next waves and more worry that emergence of new variants of concern will transmit too fast or evade immune response,” he said. “The appearance of these variants in the African continent, but also in South America and Europe really means that more than ever, it is the time that we don’t leave any continent behind, especially on vaccination,” Oliveira said. Silver Lining In Cloud – Variants Also Impetus For Cooperation But within Africa itself, Sall said the various SARS-CoV-2 variants constitute a new impetus for cooperation between countries, to be able to track and measure the circulation of the virus, and to enhance diagnostic capacities that he said will soon be available across Africa. “The new variants are the object of a very thorough study, and the path of our countries is very clear: obtain maximum information and adapt the strategy to contain the transmission,” he said. Moeti enjoined countries and individuals to strive to overcome COVID-19 fatigue and return to the fundamental actions that have been found to be effective against these variants. These measures, she said, need much more emphasis that news that the virus is much more transmissible. “The vaccine is a tool that’s going to make a huge difference all over the world,” she said. But she reminded that “having a corner of the world not protected, the way the world’s economies and peoples are connected, will have negative economic impact even in those countries that managed to vaccinate the entire population. We really are all in it together, and we have to work to support each other to overcome this global crisis.” Image Credits: Paul Adepoju/HealthPolicyWatch, Africa CDC. EU Protests AstraZeneca Vaccine Delays – Could Block UK-Bound Exports 28/01/2021 Madeleine Hoecklin The Oxford/AstraZeneca vaccine is 2 months behind schedule due to an issue in manufacturing. AstraZeneca has joined Pfizer in announcing delays in deliveries of COVID-19 vaccines to countries in Europe, leading furious EU officials to plan for a system of tighter monitoring of vaccine exports. The British-Swedish pharma company that developed its COVID-19 vaccine with researchers at Oxford University, informed the European Commission on Friday that there would be a 60% shortfall in vaccine deliveries this quarter due to a manufacturing issue at a production plant in Belgium. The company is reportedly two months behind schedule with regard to vaccines destined for European countries. Since vaccine deals with the United States and the United Kingdom were signed earlier on, and are based around manufacturing sites in those countries, the company has had a headstart in resolving “glitches” in those supply chains, pharma officials said. But the Commission had its doubts over this given explanation. Following an EU-requested investigation into AstraZeneca’s Belgian-based production facility on Wednesday, the European Commission has said it would establish a new mechanism that grants national regulators the power to refuse exports of vaccines. The mechanism – the criteria for which is expected to be published on Friday – could throw the security of the UK’s 40m-dose deal with Pfizer/BioNTech. The investigation, a spokesperson for the Belgian health ministry said, was to “make sure that the delivery delay is indeed due to a production problem on the Belgian site”. AstraZeneca ‘Scaling Up’ Doses, As EU Leaders Question Pharma Company Pascal Soriot, CEO of AstraZeneca “We are scaling up to hundreds of millions, billions of doses of vaccines at a very high speed. A year ago we didn’t have a vaccine. When you do that, you have glitches, you have scale-up problems. Therefore, the yield varies,” said Pascal Soriot, CEO of AstraZeneca, in an interview with la Repubblica, an Italian newspaper, on Tuesday. News of the delays was met with frustration by EU officials and leaders, who were expecting to receive 80 million doses by the end of March. “This new schedule is not acceptable to the European Union,” said Stella Kyriakides, European Commissioner for Health and Food Safety, in a statement released on Monday. “The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far, and if, or to whom, they have been delivered.” Stella Kyriakides, European Commissioner for Health and Food Safety, at a press briefing on Wednesday. Soriot disputed suggestions that the company sold the doses elsewhere for a higher price, claiming that “there is a lot of silly talk going on right now about all sorts of things,” and the response from the European Commission and EU member states is because “there are a lot of emotions running in this process right now.” “The suggestion [that] we sell to other countries to make more money is not right because we make no profit everywhere…That’s the agreement we have with Oxford University,” said Soriot. “Governments are under pressure. Everybody is getting kind of…aggravated or emotional about those things. But I understand because the Commission is managing the process for the whole of Europe,” he added. In late August, the EU made an upfront payment of €336 million to the company to secure 300 million doses of the vaccine. EU officials have disputed AstraZeneca’s explanation of production issues, claiming there are no excuses for the delay. “The flimsy justification that there are difficulties in the EU supply chain but not anywhere else does not hold water, as it is of course no problem to get the vaccine from the UK to the continent,” said Peter Liese, an EU parliamentarian from Germany’s Christian Democratic Union. Currently AstraZeneca is producing 17 million doses per month. That number will reach 100 million doses from February onwards, according to Soriot, meaning 1.2 billion doses per year. And Europe will receive 17% of the global production in February for a population that represents 5% of the world’s population. The Oxford/AstraZeneca vaccine is in the final stages of the approval process with the European Medicines Agency (EMA) and is expected to receive the recommendation for market authorization on Friday. After being approved, the company plans to deliver three million doses immediately. Meetings between EU officials and AstraZeneca have done little to resolve the issue, with Kyriakides announcing on Twitter: “Discussions with @AstraZeneca today resulted in dissatisfaction with the lack of clarity and insufficient explanations. EU Member States are united: vaccine developers have societal and contractual responsibilities they need to uphold.” With our Member States, we have requested from AZ a detailed planning of vaccine deliveries and when distribution will take place to Member States. Another meeting will be convened on Wednesday to discuss the matter further. — Stella Kyriakides (@SKyriakidesEU) January 25, 2021 The EU Steering Board, the body that oversees vaccine deals, plans to meet with AstraZeneca again on Wednesday at 6:30pm CET and hopes to “resolve this in a spirit of collaboration and responsibility,” according to Kyriakides. The Italian government plans to take legal action against Pfizer and AstraZeneca over their delays in deliveries, according to an announcement made by Foreign Minister Luigi Di Maio on Sunday. “This is a European contract that Pfizer and AstraZeneca are not respecting and so for this reason we will take legal action,” Di Maio said on RAI state television. “We are activating all channels so that the EU Commission does all it can to make these gentlemen respect their contracts.” According to Soriot, however, the vaccine deal signed with the EU was not a contractual commitment but a best effort, so there is no feasible basis for legal action. EU to Establish a Vaccine Export Transparency Mechanism The Oxford/AstraZeneca vaccine is also considered one with global potential – due to its ability to be stored at refrigerator temperatures. Amidst some countries’ suspicions that countries outside Europe are receiving priority for vaccines produced at the Belgium plant, the European Commission announced plans to establish an export transparency mechanism for vaccines to ensure clarity on transactions and to protect its investments in the R&D that led to development of vaccines like AstraZeneca’s. AstraZeneca is also a major supplier of the WHO COVAX global distribution initiative – which has pledged to begin distributing vaccine doses to the 92 lowest-income countries in the world within the next two months. Although most of the COVAX supplies were reportedly to be produced by India’s Serum Institute or in the Republic of Korea, the exact supply lines remain unclear. “Europe invested billions to help develop the world’s first COVID-19 vaccines…And now, the companies must deliver,” said Ursula von der Leyen, President of the European Commission, at the World Economic Forum on Tuesday. “They must honor their obligations. This is why we will set up a vaccine export transparency mechanism. Europe is determined to contribute to this global common good. But it also means business.” Ursula von der Leyen, President of the European Commission, speaking at the World Economic Forum on Tuesday. “In the future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries,” said Commissioner Kyriakides. The aim of the proposed system will be to monitor, but not block, exports, officials said. And humanitarian deliveries would be anyway exempt from this oversight mechanism. EMA Yet To Issue Final Approval – Insufficient Data on Vaccine in Older People Meanwhile, the EMA has yet to issue its final regulatory approval for the two-dose Oxford/AstraZeneca vaccine, and is reportedly considering limiting the age range to people under the age of 65 – due to a lack of data on effectiveness in older people. Unlike mRNA counterparts produced by Moderna and Pfizer, the AstraZeneca/Oxford vaccine uses a disabled, modified version of a chimpanzee adenovirus that can enter human cells but cannot replicate or cause the disease, as a vector to deliver a fragment of SARS-CoV2 spike protein, stimulating COVID-19 immunity. According to data shared by the company, only 10% of participants in the vaccine clinical trials were over the age of 65 because it was first waiting for sufficient safety data in the 18 to 55 age group before vaccinating older individuals. “We don’t have a huge number of older people who have been vaccinated,” said Soriot. “But we have strong data showing very strong antibody production against the virus in the elderly, similar to what we see in younger people.” The results of an ongoing, larger Phase 3 clinical trial with 30,000 participants being conducted in the United States are expected to provide insight into the protection the vaccine provides to older individuals and ethnic minorities populations – groups that were not very well represented in previous trials. In addition, scientists are exploring whether a half-dose of the first vaccine would reliably yield a higher efficacy rating of 90% that was seen in initial trials. The other regime, involving two full doses was only 62% effective, according to the results released by the company in late November and reviewed by an independent Data and Safety Monitoring Board. That still meets key global benchmarks for efficacy, but is significantly lower than the 94-95% efficacy results for the Moderna and Pfizer mRNA vaccines. The AstraZeneca vaccine has, however, already been authorized in the UK, is already being used in British vaccination campaigns, including for people over 70 years old. Image Credits: AstraZeneca, AstraZeneca, Twitter, Twitter. WHO Proposes New Mode Of Engaging With Non-State Actors 28/01/2021 Esther Nakkazi Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, according to WHO. The World Health Organization (WHO) aims to make its engagement with non-state actors (non-state actors) more meaningful and efficient with a new proposal to establish a number of NSA fora that would allow exchange with WHO and member state representatives outside of official meetings. The new proposal — which will be tested during the 74th World Health Assembly (WHA), 24 May to 1 June — would offer multiple side events in which non-state (NSA) actors could engage more informally with member state representatives as well as a forum for exchange between NSAs and WHO regional and technical staff. But at the same time, non-state actors will be allotted a more limited number of constituency statements in formal governing body meetings – and like-minded groups of actors will be asked to combine their official statements together. Non-state actors include civil society groups such as non-governmental organizations, international business and professional associations, and philanthropic foundations. More than 70 non-state actors are recognized as being “in official relations” with WHO, and thus contribute in formal meetings such as the EB and the WHA. However, EB and WHA members have complained that the civil society interventions have become bogged down by too many lengthy, individual statements – and NSAs acknowledge that the statements often had limited impact in member state debates. More informal meetings ahead of the formal meeting dates would help engender more meaningful interaction, WHO said in its proposal for the reform, which was reviewed by the WHO Executive Board on Saturday. Informal meetings will also allow non-state actors to organize themselves into constituencies, consolidating their positions into joint statements to be presented at official events. The new arrangements to be tested in May, will “serve as a trial for potential future virtual informal meetings between non-state actors, Member States and the Secretariat, as a means of enabling more in-depth technical exchanges, as well as discussions on the Health Assembly agenda items,” said the WHO Secretariat, in its presentation to the EB on Saturday. The COVID-19 pandemic has provided added impetus for reforms that have long been in the making – insofar as the limitations of virtual meetings have also curtailed the interactions between member states and non-state actors. According to the new proposal, the informal series of meetings with non-state actors will be held just ahead of the WHA, and thus prepare the groundwork for the formal meeting. Role of Non-State Actors Has Evolved – But Increasing Number of Statements Detracted from Impact In the discussion over the proposal, WHO officials stressed that the Organization “is and remains a Member State Organisation” — engaging with 77 non-state actors, at global, regional and country levels, who also support the development and implementation of the Organization’s policies and recommendations, technical norms and standards. But while non-state actors have “served the Organization well for several decades”, the increasing number of non-governmental organizations and other non-state actors participating — often with a greater number of requests to speak — has “not resulted in a more meaningful involvement”. For example, when civil society representatives speak one-by-one at the end of a discussion, their interventions have little impact on the content or direction of the debate, WHO contends. Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, says the WHO. A virtual consultation by WHO further confirmed that non-state actors’ primary interests in attending governing body meetings are to participate in technical exchanges with the Secretariat and the Member States and to attend consultative hearings that feed into decision-making processes. Meaningful Participation From NGOs Critical, Member States Say The UK delegate said that it would allow NSAs to exert even more credible influence on member states attitudes and positions. The EB representative from the United States flagged that it is critical to ensure and enhance meaningful participation of non-state actors in WHO governing bodies, while also creating greater efficiency in the governance process. “Non-State actor participation must be allowed in a transparent and accountable manner with an open door to input from all stakeholders including the private sector,” the delegate noted. Austria pressed for the Secretariat to provide some more detailed information on the procedure for these meetings. Other states, like Australia, flagged that the trial is very ambitious given the agenda for the 2021 assembly is already very crowded. “We suggest that before agreeing to a trial, the number of meetings proposed to be repeated and streamlined,” the representative said.This would “provide reflections to technical areas in advance of the governing body meetings”. Civil Society Groups Request Clarity and Procedure Details Bodies like Health Action International asked for details as to how NGOs would participate, and for clarity on the processes governing such meetings. “It is a remaining concern to those who have witnessed creeping capacity shrinking of NGO space and poor consultation in recent years,” said an HAI statement. The HAI delegate requested that similar procedures be implemented for WHO regional meetings with member states, also asking that “these informal meetings compliment, but do not replace comprehensive consultations with non-state actors.” Meanwhile, the European Society for Medical Oncology said the views and expertise of non-state actors should be introduced earlier in the WHO decision-making process; it would be of greater value if delivered at the onset of projects, and when member states are drafting zero draft decisions and resolutions. “Direct interaction and discussion between member states, WHO offices, and Non-State actors would provide the opportunity for more in-depth exchanges, and partnerships, as the Member States, develop policies and implement actions to fulfill their WHO commitments,” said the ESMO spokesperson. Silberschmidt stressed that the virtual informal meetings will not replace other channels, but become an additional avenue for interaction – highlighting the fact that Dr Tedros Adhanom Ghebreyesus, WHO Director General, has already established a regular dialogue with civil society groups, to be held every six weeks. Image Credits: WHO / Christopher Black. 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.
COVID-19 Has Outlined Healthcare Systems’ Dangerous Emissions Problem 29/01/2021 Raisa Santos Healthcare’s overreliance on single-use products and equipment contributes to its carbon footprint Failure to align the global recovery from COVID-19 with an equally powerful climate response could threaten the worldwide effort to limit the average global temperature increase, public health experts have said. In a convention in 2015 now known as the Paris Agreement, the United Nations Framework Convention on Climate Change (UNFCCC) established its aim to pause the increase in global average temperature by “well below 2 degrees Celsius above pre-industrial levels and to pursue efforts to limit the temperature increase even further to 1.5 degrees Celsius”. To achieve that, a global effort is required to decrease greenhouse gas emissions by 7.6% each year across five years. This number falls further out of reach each year without action. “The reality is that the next five years are going to be pivotal,” Dr Renee Salas, Harvard T.H. Chan School of Public Health, said during a webinar from the Lancet Countdown last week. The 2020 Report of the Lancet Countdown on Health and Climate Change was published in December, and addressed the converging crises of the COVID-19 pandemic, healthcare systems and climate change. “Healthcare has to show us how we can decarbonize and decarbonize our healthcare system,” she said, adding that it “is truly the embodiment that climate action is a prescription for health”. COVID Has Outlined Healthcare Systems’ Flaws The COVID-19 pandemic has highlighted healthcare’s overreliance on single-use products and equipment, the panel said. Additionally, as using personal protective equipment (PPE) has become a greater necessity, use of disposable products has been extended. The health system in England is responsible for an estimated 4-5% of the country’s carbon footprint, for example. NHS carbon footprint is mostly comprise of procured items from the health supply chain The United Kingdom’s National Health Service listed crutches as accounting for nearly 70% of the carbon footprint for items it procured in 2020. Additionally, the traditional model of outpatient care doesn’t strictly align with the nature of chronic illnesses, which requires patients return for unpredictable emergency treatment. Unpredictable treatment directly leads to increased road traffic and increased air pollution. NHS traffic accounts for 5% of road traffic in England alone. Quantified in terms of environmental, financial, and health outcomes, this means that 753 deaths can be attributed to NHS traffic, and £650 million in NHS expenditure are lost a year. “When [evaluating] the value offered in the delivery of a healthcare service, we need to start capturing data that looks at these consequences, thinking beyond the financial and individual patient outcomes,” said Jennifer Isherwood, a National Medical Director’s Clinical Fellow at the Royal College of Physicians, London. “It’s becoming clear that COVID is not going to be the last pandemic that we see,” Isherwood added. “It may be … disruptive to start addressing challenges of different pathways to different care, but it’s the right tool to start future-proofing our healthcare systems.” Hiten Patel, Senior Strategy Advisor for Greener NHS, said: “There’s always something else happening in healthcare systems that’s [considered] a priority. It’s about how we can try to make carbon emissions and climate change more of a priority within healthcare systems.” Concluded Dr Jodi Sherman, Yale University and Lancet Countdown author, said: “Everything we do in healthcare is through the lens of patient safety. Protecting public health is a matter of patient safety and needs to be integral to everything that we do.” Supply and Services Compose Four-Fifths of Overall Healthcare Carbon Footprint The health supply chain comprises four-fifths of US healthcare carbon footprint While the COVID pandemic has flagged some key flaws in the world’s healthcare systems, what is still unclear are the direct and indirect carbon emissions of the healthcare sector, and the implications these emissions have on health. Direct emissions are established and well understood products of the sector: gas exhausts from ambulance tailpipes to fumes emitted from waste incinerators. But indirect emissions – offsite power generation, the provision of medical supplies and pharmaceuticals, and even research and testing – make up a larger percentage of emissions associated with the healthcare sector. The United States alone spends more than US$3 trillion on healthcare a year. As healthcare expenditures increased, so too did the carbon footprint from goods and services. Around 7% is due to direct emissions from healthcare facilities, and another 10% from offsite energy. But four-fifths of the footprint is the supply chain, composed of key sectors that include food, pharmaceuticals, and chemicals. Dr Matthew Eckelman, Northeastern University, Boston and Lancet Countdown author, called on the health sector to take accountability for its immense carbon footprint. “It’s very clear that buying renewable energy is not the only solution. You really have to work on reducing carbon emissions in the supply chain, as well.” Lower the Infection Risk and Financial Losses by Reducing Health Waste Speakers also addressed how vital it is not to risk patient safety in trying to reduce or cut expenses. Healthcare-acquired infection – when a patient becomes infected while in care – affects hundreds of millions of patients globally each year. This leads to significant morbidity and mortality that incurs financial losses for health systems, in addition to excess pollution. As a result, prevention is essential. “While we do want to reduce waste and reduce costs, we certainly don’t want that to be at the expense of increasing infections,” said Dr Sherman. Dr Sherman also acknowledged, however, that infection prevention methods often contribute to the excessive use of single-use disposable devices, like masks and gloves. Using only disposable laryngoscopes would increase costs for hospitals In a greenhouse gas emissions and cost analysis study comparing reusable and disposable laryngoscopes, Dr Sherman and Eckelman found that disposables – whether plastic or steel – outweigh the reusable in terms of greenhouse gas emissions. Using purely disposables would increase costs by up to US $700,000 a year, for one hospital department. Recycling these disposables would only reduce a small portion of emissions, especially since the laryngoscope cannot be recycled entirely. “In other words, we can’t recycle a way out of this problem,” Dr Sherman said. “The answer isn’t that we should use disposables. It’s that we should clean up our supply.” There needs to be a balance between the “indirect disease burden from all the materials thrown away and lowering the infection risk curve.” The greatest causes of healthcare acquired infections, said Dr Sherman, have to do with staff discipline, such as hand washing, and patient health status, and exposure to infection. But simple hand washing and using more and more disposables is not the solution. Image Credits: Flickr: Marc A. Hermann / MTA New York City Transit, The Lancet Countdown. Pharma Ill-Equipped To Handle 10 Most Infectious Diseases And Future Pandemics, Report Warns 29/01/2021 Raisa Santos A new report has found that current R&D is primarily geared towards COVID-19, with next to no efforts to address other pathogens with the potential pandemic risks like Zika and Sars. With ten of the world’s most infectious diseases not catered by drug firms, pharmaceutical giants remain unprepared to tackle future pandemics, a new report has said. The report, published on Tuesday, found that though current medicine and vaccine research and development is primarily geared towards the COVID-19 pandemic, there are next to no efforts to address other pathogens with the potential pandemic risks: namely Nipah, Zika, and Sars. The Access to Medicine Index evaluates 20 global pharmaceutical companies – including AstraZeneca and Pfizer – and compares how far each goes in fulfilling the role of developing urgently needed health products and improving equitable access to them. The companies’ performance is ranked every two years. Pfizer joins top 5, while GSK retains its number one position, yet only slightly ahead of Novartis. Pfizer moves into the top five. Johnson & Johnson complete the top five companies. Eight of the top ten companies, including the leaders, are setting a new best practice of systematic access planning during R&D. “The state of infectious disease research today is, if I can put it mildly, on thin ice,” said Dr Jayasree Iyer, executive director of The Netherlands-based Access to Medicine Foundation, in an interview with DW. COVID-19 has emphasized the need for both the private and public sectors to actively engage in emerging infectious disease research well before the next pandemic breaks out. It has also shown that ending a pandemic requires suitable products to be developed and equitably distributed: much of the responsibility for which lies with pharmaceutical companies. Without their sustained commitment to pandemic preparedness, the report suggests, the world world will remain vulnerable to pandemics. Increased R&D for COVID-19, but Other Pandemic Risks Unaddressed Pharmaceutical companies are not targeting priority pathogens with epidemic potential through R&D. Excluding coronavirus, pathogens with pandemic potential where pharma companies are active in R&D show very small pipelines in 2020. Out of 16 pathogens, 10 have empty pipelines. Even for pathogens under scrutiny, research activity remains low. With most research focused on coronavirus, there are just 13 R&D projects across five non-COVID-19 diseases (Ebola, Zika, Chukungunya, Marburg, and non-polio enterovirus) and zero for the remaining ten of 16 infectious diseases. Emerging infectious disease (EID) research is concentrated among a few companies. In 2020, 17 companies targeted coronavirus, while nine companies are targeting other EIDs: Bayer, Eisai, Gilead, Johnson & Johnson, MSD, Merck, Roche, and Takeda. This figure shows the number of R&D projects and companies identified by WHO and Policy Cures as emerging infectious diseases, and how this has changed since 2018. What 2020 has highlighted is that large pharmaceutical companies have a critical role to play in preparing for the next pandemic, but that these companies have so far delivered a range of responses: some of them apparently shortsighted. Small biotech companies and academic groups may be able to pioneer new ideas, but it is the big players that are responsible for rapid development and access to vaccines, therapeutics and diagnostics, with the capacity to scale-up both manufacturing and distribution capabilities. Poorer Countries Lacking Access to More Than Half Key Products Covered By Pharma Companies However, the pharmaceutical industry only mobilized against COVID-19 once it became clear that the outbreak affected rich as well as poor countries. “Even in light of COVID-19, there were very few commitments from the pharmaceutical industry last year,” said Iyer. Other than projects developed within the Access to COVID-19 Tools (ACT) Accelerator, there was little evidence in the first months of the pandemic response that there structures in place to ensure access and distribution to COVID-19 vaccines in poorer countries. This has once more shown that the Global South still does not benefit significantly from access strategies implemented by big pharma. Less than half of key products controlled by 20 large companies are being offered in countries classified as either lower-middle income countries (LMICs) or low-income countries (LICs). Low-income countries are most consistently over-looked by access strategies, particularly for products that need to be administered by healthcare practitioners. The response is even more profound in LICs, which are consistently overlooked despite being home to almost 700 million people. Currently, only eight of the 60 – or 13% – critical products that need to be administered by healthcare professionals, like injectable treatments for cancer, are covered by access strategies in at least one LICs. Self-administered medicines such as pills have 26%. The numbers jump slightly in LMICs, and even more so in upper-middle income countries (UMICs), with approximately half of critical products covered by access strategies in UMICs. The greatest number of people also benefited from both healthcare professionals administered medicine and self-administered medicine in UMICs. Many industry access arrangements do not go far enough, with many of the world’s most vulnerable and marginalized not receiving the life-changing medicines they need. Solving the access to medicine problem requires the pharmaceutical industry to take large-scale action, reaching more people with more products across a wider range of the world’s poorest countries. “I believe the past year has demonstrated the pivotal importance of supplying affordable medicines for the many, rather than premium-priced products for the few,” said Iyer. “By investing in fair access to medicine for the poorest and most vulnerable among us, we are also investing in a fair, peaceful and prosperous global community.” Eight Pharma Companies Paving Way Towards Equitable Access Top 6 companies with access planning, with percentage of R&D projects with access plans There are positives: eight companies have taken the lead to integrating systemic access planning into their development processes. Novartis was noted as the first to begin mainstreaming access in the previous Index, and joining them in 2021 are AstraZeneca, GSK, Johnson & Johnson, Merck, Pfizer, Sanofi, and Takeda. Though the 20 companies in the Index have 394 projects in late-stage development that target either global health priorities (114) such as coronavirus, malaria, tuberculosis or HIV, or offer benefits to low- and middle-income countries (280), the majority of these are not supported by an access plan. An access plan can include a wide range of activities – prioritising countries with the highest disease burden to strengthening supply chains to ensure all populations have fair access. To have maximum impact, the Index advises that access plans have a broad geographic focus, explicitly aiming to reach a majority of people affected by a disease or in need of a vaccine or diagnostic tool. The 20 companies in scope have 394 R&D projects in late-stage development that either target established global health priorities or offer clear public health benefits for low- and middle-income countries. The majority of these are not yet supported by an access plan. If this happens, people living in low- and middle-income countries, especially those in resource-limited or remote settings, will no longer be left behind for pharmaceutical innovations. Concluded Iyer: “The power of science to help humanity – whether through new vaccines for common pathogens or novel drugs for rare diseases – is remarkable. But these breakthroughs will only truly deliver for the world if they reach all those who need them.” Image Credits: Access to Medicine Foundation , Access to Medicine Foundation . WHO Executive Board Rejects Israel’s Proposal To Remove Standalone Agenda Item On Palestinian Health Conditions 28/01/2021 Madeleine Hoecklin Meirav Eilon Shahar, Israel’s ambassador to the United Nations in Geneva, speaking to the WHO Executive Board. For the second time in as many years, WHO member states have voted down a proposal by Israel to remove a standalone item from the agenda of the 74th World Health Assembly – devoted exclusively to a report on health conditions in the Occupied Palestinian territories – and consider it as part of WHO’s overall health emergencies agenda. Saying that the agenda item unfairly singles out just one country for criticism, as compared to every other nation in the world, Israel on Tuesday proposed to the WHO Executive Board, which fixes the WHA agenda, that the report be considered as part of the overall discussion on WHO’s work in health emergencies when WHO member states meet in May. In a lengthy and unusual voting process on the closing day of the 10-day EB session, the proposal was rejected in a vote of 15 to seven – with 9 abstentions and 3 countries absent. Those supporting Israel’s position included the United Kingdom, Germany and Austria, joined by the United States, Australia and Colombia. EB members that were opposed included Oman, China, Russia, and Tunisia. Israel’s delegation said the report was a “political” item that does not reflect reality and will not change the situation on the ground. “Item 25 is a political item with only one purpose – to attack Israel and to politicize an otherwise professional organization [WHO]. This must be changed…What I’m asking you to do today is to ensure that the World Health Assembly maintains its focus on health and the truth,” said Israel’s ambassador to the United Nations, Meirav Eilon Shahar. “Regardless of what takes place in Geneva, we, Israel, will continue to work with the Palestinians and with WHO and we’ll continue to work on any problem and assistance intended to improve the health conditions for the Palestinians,” she added. The Palestinian representative, Ibrahim Khraishi, Ambassador of the State of Palestine to the UN, which holds observer status in the World Health Assembly, retorted that: “The [health situation in the occupied territories] is catastrophic and dire…Israel is finding it easy to renege on its responsibility, for example, it is not meeting its requirement…when it comes to vaccination. “When we look at the rate of vaccination for [Israeli] citizens, the figure exceeds two and a half million, whereas not one single Palestinian citizen has had the jab because of Israeli practices,” he said. Khraishi cited the WHO report from the 73rd WHA in November 2020, which he said shows that infant mortality of West Bank Palestinians is six times higher, and maternal mortality nine times higher than that of the 600,000 Israeli settlers living side by side with Palestinians in the Occupied West Bank. The report also describes barriers Palestinians from the West Bank and Gaza face in accessing more health services, such as the more specialized services in Jerusalem, which is directly under Israeli rule and to which access is tightly-controlled. Ibrahim Khraishi, Ambassador of the State of Palestine to the UN and Palestine’s representative to the Executive Board. After the vote among member states, Israel disputed the vaccination claims, saying that Palestinian inmates have received vaccinations and the PA has been provided with emergency supplies for 100 essential health workers – but the overall responsibility to vaccinate the roughly 5 million Palestinians living in the West Bank and Gaza lies with the Palestinian Authority (PA), not Israel. “We are very happy to extend assistance in facilitation of those vaccines in entrance to Israel,” said Eilon Shahar, referring to the expected arrival of PA-purchased vaccine supplies from Russia. PA health officials have not, in fact, officially requested vaccines from Israel, but rather are awaiting the arrival of Russian Sputnik vaccines within the coming two weeks. However, human rights groups have underlined that Israel still holds the ultimate responsibility for health under international law insofar as it still occupies the West Bank, The largely technical issue of where on the WHA agenda the report on Palestinian health conditions should be reviewed, was subject to a lengthy and unusual voting process (most EB decisions are made by consensus). The United States, Australia, and the United Kingdom explained their support of Israel’s proposal, saying that no other country in the world has been singled out in such a way by the WHO. “We’re concerned that the World Health Assembly does not consider the many other difficult health situations around the world in the same way,” said the UK’s delegate. “This item remains the only country specific item at the WHA…We fail our duty to serve people around the world who have vitally important health concerns if we allow WHO to become politicized in this way.” The UK’s delegate to the Executive Board. Australia went a step further, expressing concerns about the introduction of political issues into the WHA through the existence of the stand alone item – and calling for negotiations to permanently remove the item, not only as a stand-alone item but altogether from the agenda. The delegations from Oman and the Syrian Arab Republic countered the arguments made by the UK and US, claiming that the agenda item does not single out Israel. “This is not a country-specific item. This is an item which [reflects] a specific situation, a situation of people under occupation and addresses the legal obligations of the occupying power,” said Syria’s delegate. “The politicization is coming from attempts to go around these facts.” The Palestinian representative concluded the discussion at the closing session of the Executive Board meeting on Tuesday by urging member states to encourage Israel to “shoulder her responsibilities and do her duty towards all citizens for which she is responsible, particularly those in the occupied Syrian Golan, the Gaza Strip, and the other occupied territories.” The Gaza Strip has been under Israeli blockade as a result of repeated Israeli confrontations with the fundamentalist Hamas, which wrested control of the Strip from the PA-supported Fatah in 2007, two years after Israel unilaterally uprooted its settlements and withdrew from the Strip. Israel captured the Golan Heights from Syria in the 1967 Six Day War, and extended Israeli citizenship to the predominantly Druse residents of the Heights who remained after the war. Image Credits: WHO. Africa CDC Head calls for ‘Common Approach’ To Travel Restrictions Based on COVID Test & Not ‘National Origins’; 7 African Nations Report SARS-CoV-2 Variants 28/01/2021 Paul Adepoju Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy and not geographic or national origins, Africa CDC Director Dr John Nkengasong has said. IBADAN – Five African countries have now confirmed cases of the SARS-CoV-2 501Y.V2 variant, which first appeared in South Africa, and there is concern that the variant is circulating undetected elsewhere on the continent. The Gambia and Nigeria have seen cases of the variant B.1.1.7, first identified in the United Kingdom, said WHO’s African Regional Director today, Dr. Matshidiso Moeti, at a press briefing. Meanwhile, Africa CDC Director, Dr John Nkengasong, called for a “common approach” to COVID testing to oil the wings of international air travel – and halt the wave of new travel restrictions that countries have been imposing based on people’s national origin or the origins of flights – including people and flights arriving to Europe and the United States from South Africa. Researchers now believe the variants may be both more infectious but also more deadly than the COVID virus strains that were prevalent until just recently. Researchers also fear the variants could also elude COVID tests and be more resilient to vaccines just being rolled out now – although many unknowns remain. The countries where 501Y.V2 is circulating include: Botswana, Ghana, Kenya and Zambia, as well as South Africa. Beyond Africa, the variant has been confirmed in 24 countries globally. And there’s concern, it is circulating undetected in other countries in Africa,” Moeti told the press briefing. Dr. Matshidiso Moeti, WHO’s African Regional Director. “We are seeing more and more cases of variants and 501Y.V2, which was first identified in South Africa now, cropping up in other countries,” Moeti said. “The evidence suggests that these variants are more transmissible and emerging evidence indicates that the UK variant may cause more severe illness than other common strains, although more research needs to be done.” These variants in conjunction with “the aftermath of year-end gatherings”, Moeti said, “risk powering a perfect storm and driving up Africa’s second wave and overwhelming health facilities”. The continent saw a 50% rise in infections between 29 December 2020 and 25 January 2021, when compared with the previous four weeks, while deaths doubled. Last week, more than 6,200 deaths were reported across Africa, said the WHO.The past week saw a small dip in cases in South Africa, but 22 other countries continued to see numbers surge. Existing COVID-19 vaccines remain effective against the variants, Moeti said. But Professor Tulio de Oliveira, of the University of KwaZuku-Natal, South Africa, noted that these or other emerging variants may likely require individuals receiving booster doses of the vaccine. WHO’s African Region is meanwhile setting up a new surveillance network with Africa CDC to track the spread of the virus mutations and variants across Africa and beyond, Moeti added. “The variant which was first detected in South Africa has spread quickly beyond Africa and so what’s keeping me awake at night right now is that it’s very likely circulating in a number of African countries,” said Moeti. “Africa is at a crossroads. We must stick to our guns and double down on the tactics we know work so well. That is mask wearing, handwashing and safe social distancing. Countless lives depend on it.” WHO’s African CDC Calls for Common COVID Testing Approach For International Travel Dr John Nkengasong issued his call for a rethink of travel policies after several foreign countries, including the United States, are considering or have already banned flights originating from South Africa. Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy – and not geographic or national origins, said Nkengasong. “We should not be banning people because of their geographical origin, but we should be encouraging people to travel with negative tests and facilitate the testing process so that people can travel with a negative test,” Nkengasong said. “If I were to go to Kenya and I show up at the airport with a valid negative test, I pose no threat to the country of Kenya, and that way so you shouldn’t just ban me because I’m coming from a certain country. They should be looking at that test, is your test valid,” Nkengasong added. Dr John Nkengasong, Director of the Africa CDC. Up until now, the World Health Organization has resisted recommending pre-travel COVID testing, ostensibly due to fears that it would put an unnecessary onus on poor countries. In fact, however, many of the poorest African and Asian countries have been requiring pre-flight COVID tests for all incoming passengers – which are paid for privately. Some counties, such as the Democratic Republic of Congo, also demand arrivals briefly quarantine until a post-flight test is completed as well, paid privately as well. Paradoxically, it is wealthier European and American countries that first issued a rash of orders banning passengers of certain nationalities or flights from certain destinations as a result of variant scares – although more developed countries, most recently Switzerland on Wednesday, have adopted testing requirements. Senegal’s Pasteur Institute – At Center Of New Genetic Surveillance Network At the outset of the pandemic, most countries in Africa lacked adequate testing capacity for COVID-19 but this was gradually surmounted as new testing facilities were added. Now, however, the identification of new variants of the virus will require more advanced capacities for gene sequencing that several countries in Africa have yet to obtain. To address this vacuum, the Africa CDC, the WHO and member countries have created a network that enables existing labs with gene sequencing capabilities to collect samples from countries that lack such. One of the labs in the network is the Dakar-based Institut Pasteur de Dakar in Senegal. Its CEO, Dr Amadou Sall, said in addition to providing gene sequencing services for Senegal, the institute is now supporting other countries, Cameroon and Equatorial Guinea notably. Others include Mali, Burkina Faso Guinea-Bissau, Côte d’Ivoire, Niger, Verde, and of course, Guinea. “With the partnership we have with Africa CDC and WHO, we have the possibility of sequencing 500 genomes per week. And we’re trying to increase this capacity and to make these capacities available in different countries,” Sall said. Key to the success of COVID-19 genomic surveillance in Africa, Sall said, will be the willingness and openness of African countries to share information. “We need to be able to share information data and the Pasteur Institute is at the center of a global platform and we’re able to share information; to exchange information rapidly, if countries are willing to do so,” he said. Knowing When to Raise the Alarm While noting that identification of new variants is a significant feat, genomic experts warned that alarm should not be raised every time a new strain is identified. Professor de Oliveira, who heads the KwaZulu-Natal Research and Innovation Sequencing Platform, said attention is raised when new strains are being confirmed in increasing numbers of cases with the new variant and not when just one case has been confirmed. Describing the impacts that variants have on the epidemiology of the pandemic in South Africa, Oliveira said in some regions, the new variant has become the prominent type. But beyond this, he said South Africa is also worried about the variants from elsewhere getting into the country and circulating among its populations. “Today, we just reported the first important case of the B.1.1.7, the variant of concern that is circulating in the UK. And it’s quite common that in addition to our main variant that is dominating, we’re going to still have introductions of new lineages,” Oliveira said. “And in the case they begin to spread very fast, then we will communicate it and then highlight that could be a variant of concern.” He said that while no one can know for sure about the possibility of third or fourth waves of the pandemic in Africa, the variants are highlighting the need for the entire world to globally control the transmission of SARS-CoV-2 as a global community. “We have to really decrease transmission to avoid the next waves and more worry that emergence of new variants of concern will transmit too fast or evade immune response,” he said. “The appearance of these variants in the African continent, but also in South America and Europe really means that more than ever, it is the time that we don’t leave any continent behind, especially on vaccination,” Oliveira said. Silver Lining In Cloud – Variants Also Impetus For Cooperation But within Africa itself, Sall said the various SARS-CoV-2 variants constitute a new impetus for cooperation between countries, to be able to track and measure the circulation of the virus, and to enhance diagnostic capacities that he said will soon be available across Africa. “The new variants are the object of a very thorough study, and the path of our countries is very clear: obtain maximum information and adapt the strategy to contain the transmission,” he said. Moeti enjoined countries and individuals to strive to overcome COVID-19 fatigue and return to the fundamental actions that have been found to be effective against these variants. These measures, she said, need much more emphasis that news that the virus is much more transmissible. “The vaccine is a tool that’s going to make a huge difference all over the world,” she said. But she reminded that “having a corner of the world not protected, the way the world’s economies and peoples are connected, will have negative economic impact even in those countries that managed to vaccinate the entire population. We really are all in it together, and we have to work to support each other to overcome this global crisis.” Image Credits: Paul Adepoju/HealthPolicyWatch, Africa CDC. EU Protests AstraZeneca Vaccine Delays – Could Block UK-Bound Exports 28/01/2021 Madeleine Hoecklin The Oxford/AstraZeneca vaccine is 2 months behind schedule due to an issue in manufacturing. AstraZeneca has joined Pfizer in announcing delays in deliveries of COVID-19 vaccines to countries in Europe, leading furious EU officials to plan for a system of tighter monitoring of vaccine exports. The British-Swedish pharma company that developed its COVID-19 vaccine with researchers at Oxford University, informed the European Commission on Friday that there would be a 60% shortfall in vaccine deliveries this quarter due to a manufacturing issue at a production plant in Belgium. The company is reportedly two months behind schedule with regard to vaccines destined for European countries. Since vaccine deals with the United States and the United Kingdom were signed earlier on, and are based around manufacturing sites in those countries, the company has had a headstart in resolving “glitches” in those supply chains, pharma officials said. But the Commission had its doubts over this given explanation. Following an EU-requested investigation into AstraZeneca’s Belgian-based production facility on Wednesday, the European Commission has said it would establish a new mechanism that grants national regulators the power to refuse exports of vaccines. The mechanism – the criteria for which is expected to be published on Friday – could throw the security of the UK’s 40m-dose deal with Pfizer/BioNTech. The investigation, a spokesperson for the Belgian health ministry said, was to “make sure that the delivery delay is indeed due to a production problem on the Belgian site”. AstraZeneca ‘Scaling Up’ Doses, As EU Leaders Question Pharma Company Pascal Soriot, CEO of AstraZeneca “We are scaling up to hundreds of millions, billions of doses of vaccines at a very high speed. A year ago we didn’t have a vaccine. When you do that, you have glitches, you have scale-up problems. Therefore, the yield varies,” said Pascal Soriot, CEO of AstraZeneca, in an interview with la Repubblica, an Italian newspaper, on Tuesday. News of the delays was met with frustration by EU officials and leaders, who were expecting to receive 80 million doses by the end of March. “This new schedule is not acceptable to the European Union,” said Stella Kyriakides, European Commissioner for Health and Food Safety, in a statement released on Monday. “The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far, and if, or to whom, they have been delivered.” Stella Kyriakides, European Commissioner for Health and Food Safety, at a press briefing on Wednesday. Soriot disputed suggestions that the company sold the doses elsewhere for a higher price, claiming that “there is a lot of silly talk going on right now about all sorts of things,” and the response from the European Commission and EU member states is because “there are a lot of emotions running in this process right now.” “The suggestion [that] we sell to other countries to make more money is not right because we make no profit everywhere…That’s the agreement we have with Oxford University,” said Soriot. “Governments are under pressure. Everybody is getting kind of…aggravated or emotional about those things. But I understand because the Commission is managing the process for the whole of Europe,” he added. In late August, the EU made an upfront payment of €336 million to the company to secure 300 million doses of the vaccine. EU officials have disputed AstraZeneca’s explanation of production issues, claiming there are no excuses for the delay. “The flimsy justification that there are difficulties in the EU supply chain but not anywhere else does not hold water, as it is of course no problem to get the vaccine from the UK to the continent,” said Peter Liese, an EU parliamentarian from Germany’s Christian Democratic Union. Currently AstraZeneca is producing 17 million doses per month. That number will reach 100 million doses from February onwards, according to Soriot, meaning 1.2 billion doses per year. And Europe will receive 17% of the global production in February for a population that represents 5% of the world’s population. The Oxford/AstraZeneca vaccine is in the final stages of the approval process with the European Medicines Agency (EMA) and is expected to receive the recommendation for market authorization on Friday. After being approved, the company plans to deliver three million doses immediately. Meetings between EU officials and AstraZeneca have done little to resolve the issue, with Kyriakides announcing on Twitter: “Discussions with @AstraZeneca today resulted in dissatisfaction with the lack of clarity and insufficient explanations. EU Member States are united: vaccine developers have societal and contractual responsibilities they need to uphold.” With our Member States, we have requested from AZ a detailed planning of vaccine deliveries and when distribution will take place to Member States. Another meeting will be convened on Wednesday to discuss the matter further. — Stella Kyriakides (@SKyriakidesEU) January 25, 2021 The EU Steering Board, the body that oversees vaccine deals, plans to meet with AstraZeneca again on Wednesday at 6:30pm CET and hopes to “resolve this in a spirit of collaboration and responsibility,” according to Kyriakides. The Italian government plans to take legal action against Pfizer and AstraZeneca over their delays in deliveries, according to an announcement made by Foreign Minister Luigi Di Maio on Sunday. “This is a European contract that Pfizer and AstraZeneca are not respecting and so for this reason we will take legal action,” Di Maio said on RAI state television. “We are activating all channels so that the EU Commission does all it can to make these gentlemen respect their contracts.” According to Soriot, however, the vaccine deal signed with the EU was not a contractual commitment but a best effort, so there is no feasible basis for legal action. EU to Establish a Vaccine Export Transparency Mechanism The Oxford/AstraZeneca vaccine is also considered one with global potential – due to its ability to be stored at refrigerator temperatures. Amidst some countries’ suspicions that countries outside Europe are receiving priority for vaccines produced at the Belgium plant, the European Commission announced plans to establish an export transparency mechanism for vaccines to ensure clarity on transactions and to protect its investments in the R&D that led to development of vaccines like AstraZeneca’s. AstraZeneca is also a major supplier of the WHO COVAX global distribution initiative – which has pledged to begin distributing vaccine doses to the 92 lowest-income countries in the world within the next two months. Although most of the COVAX supplies were reportedly to be produced by India’s Serum Institute or in the Republic of Korea, the exact supply lines remain unclear. “Europe invested billions to help develop the world’s first COVID-19 vaccines…And now, the companies must deliver,” said Ursula von der Leyen, President of the European Commission, at the World Economic Forum on Tuesday. “They must honor their obligations. This is why we will set up a vaccine export transparency mechanism. Europe is determined to contribute to this global common good. But it also means business.” Ursula von der Leyen, President of the European Commission, speaking at the World Economic Forum on Tuesday. “In the future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries,” said Commissioner Kyriakides. The aim of the proposed system will be to monitor, but not block, exports, officials said. And humanitarian deliveries would be anyway exempt from this oversight mechanism. EMA Yet To Issue Final Approval – Insufficient Data on Vaccine in Older People Meanwhile, the EMA has yet to issue its final regulatory approval for the two-dose Oxford/AstraZeneca vaccine, and is reportedly considering limiting the age range to people under the age of 65 – due to a lack of data on effectiveness in older people. Unlike mRNA counterparts produced by Moderna and Pfizer, the AstraZeneca/Oxford vaccine uses a disabled, modified version of a chimpanzee adenovirus that can enter human cells but cannot replicate or cause the disease, as a vector to deliver a fragment of SARS-CoV2 spike protein, stimulating COVID-19 immunity. According to data shared by the company, only 10% of participants in the vaccine clinical trials were over the age of 65 because it was first waiting for sufficient safety data in the 18 to 55 age group before vaccinating older individuals. “We don’t have a huge number of older people who have been vaccinated,” said Soriot. “But we have strong data showing very strong antibody production against the virus in the elderly, similar to what we see in younger people.” The results of an ongoing, larger Phase 3 clinical trial with 30,000 participants being conducted in the United States are expected to provide insight into the protection the vaccine provides to older individuals and ethnic minorities populations – groups that were not very well represented in previous trials. In addition, scientists are exploring whether a half-dose of the first vaccine would reliably yield a higher efficacy rating of 90% that was seen in initial trials. The other regime, involving two full doses was only 62% effective, according to the results released by the company in late November and reviewed by an independent Data and Safety Monitoring Board. That still meets key global benchmarks for efficacy, but is significantly lower than the 94-95% efficacy results for the Moderna and Pfizer mRNA vaccines. The AstraZeneca vaccine has, however, already been authorized in the UK, is already being used in British vaccination campaigns, including for people over 70 years old. Image Credits: AstraZeneca, AstraZeneca, Twitter, Twitter. WHO Proposes New Mode Of Engaging With Non-State Actors 28/01/2021 Esther Nakkazi Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, according to WHO. The World Health Organization (WHO) aims to make its engagement with non-state actors (non-state actors) more meaningful and efficient with a new proposal to establish a number of NSA fora that would allow exchange with WHO and member state representatives outside of official meetings. The new proposal — which will be tested during the 74th World Health Assembly (WHA), 24 May to 1 June — would offer multiple side events in which non-state (NSA) actors could engage more informally with member state representatives as well as a forum for exchange between NSAs and WHO regional and technical staff. But at the same time, non-state actors will be allotted a more limited number of constituency statements in formal governing body meetings – and like-minded groups of actors will be asked to combine their official statements together. Non-state actors include civil society groups such as non-governmental organizations, international business and professional associations, and philanthropic foundations. More than 70 non-state actors are recognized as being “in official relations” with WHO, and thus contribute in formal meetings such as the EB and the WHA. However, EB and WHA members have complained that the civil society interventions have become bogged down by too many lengthy, individual statements – and NSAs acknowledge that the statements often had limited impact in member state debates. More informal meetings ahead of the formal meeting dates would help engender more meaningful interaction, WHO said in its proposal for the reform, which was reviewed by the WHO Executive Board on Saturday. Informal meetings will also allow non-state actors to organize themselves into constituencies, consolidating their positions into joint statements to be presented at official events. The new arrangements to be tested in May, will “serve as a trial for potential future virtual informal meetings between non-state actors, Member States and the Secretariat, as a means of enabling more in-depth technical exchanges, as well as discussions on the Health Assembly agenda items,” said the WHO Secretariat, in its presentation to the EB on Saturday. The COVID-19 pandemic has provided added impetus for reforms that have long been in the making – insofar as the limitations of virtual meetings have also curtailed the interactions between member states and non-state actors. According to the new proposal, the informal series of meetings with non-state actors will be held just ahead of the WHA, and thus prepare the groundwork for the formal meeting. Role of Non-State Actors Has Evolved – But Increasing Number of Statements Detracted from Impact In the discussion over the proposal, WHO officials stressed that the Organization “is and remains a Member State Organisation” — engaging with 77 non-state actors, at global, regional and country levels, who also support the development and implementation of the Organization’s policies and recommendations, technical norms and standards. But while non-state actors have “served the Organization well for several decades”, the increasing number of non-governmental organizations and other non-state actors participating — often with a greater number of requests to speak — has “not resulted in a more meaningful involvement”. For example, when civil society representatives speak one-by-one at the end of a discussion, their interventions have little impact on the content or direction of the debate, WHO contends. Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, says the WHO. A virtual consultation by WHO further confirmed that non-state actors’ primary interests in attending governing body meetings are to participate in technical exchanges with the Secretariat and the Member States and to attend consultative hearings that feed into decision-making processes. Meaningful Participation From NGOs Critical, Member States Say The UK delegate said that it would allow NSAs to exert even more credible influence on member states attitudes and positions. The EB representative from the United States flagged that it is critical to ensure and enhance meaningful participation of non-state actors in WHO governing bodies, while also creating greater efficiency in the governance process. “Non-State actor participation must be allowed in a transparent and accountable manner with an open door to input from all stakeholders including the private sector,” the delegate noted. Austria pressed for the Secretariat to provide some more detailed information on the procedure for these meetings. Other states, like Australia, flagged that the trial is very ambitious given the agenda for the 2021 assembly is already very crowded. “We suggest that before agreeing to a trial, the number of meetings proposed to be repeated and streamlined,” the representative said.This would “provide reflections to technical areas in advance of the governing body meetings”. Civil Society Groups Request Clarity and Procedure Details Bodies like Health Action International asked for details as to how NGOs would participate, and for clarity on the processes governing such meetings. “It is a remaining concern to those who have witnessed creeping capacity shrinking of NGO space and poor consultation in recent years,” said an HAI statement. The HAI delegate requested that similar procedures be implemented for WHO regional meetings with member states, also asking that “these informal meetings compliment, but do not replace comprehensive consultations with non-state actors.” Meanwhile, the European Society for Medical Oncology said the views and expertise of non-state actors should be introduced earlier in the WHO decision-making process; it would be of greater value if delivered at the onset of projects, and when member states are drafting zero draft decisions and resolutions. “Direct interaction and discussion between member states, WHO offices, and Non-State actors would provide the opportunity for more in-depth exchanges, and partnerships, as the Member States, develop policies and implement actions to fulfill their WHO commitments,” said the ESMO spokesperson. Silberschmidt stressed that the virtual informal meetings will not replace other channels, but become an additional avenue for interaction – highlighting the fact that Dr Tedros Adhanom Ghebreyesus, WHO Director General, has already established a regular dialogue with civil society groups, to be held every six weeks. Image Credits: WHO / Christopher Black. 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.
Pharma Ill-Equipped To Handle 10 Most Infectious Diseases And Future Pandemics, Report Warns 29/01/2021 Raisa Santos A new report has found that current R&D is primarily geared towards COVID-19, with next to no efforts to address other pathogens with the potential pandemic risks like Zika and Sars. With ten of the world’s most infectious diseases not catered by drug firms, pharmaceutical giants remain unprepared to tackle future pandemics, a new report has said. The report, published on Tuesday, found that though current medicine and vaccine research and development is primarily geared towards the COVID-19 pandemic, there are next to no efforts to address other pathogens with the potential pandemic risks: namely Nipah, Zika, and Sars. The Access to Medicine Index evaluates 20 global pharmaceutical companies – including AstraZeneca and Pfizer – and compares how far each goes in fulfilling the role of developing urgently needed health products and improving equitable access to them. The companies’ performance is ranked every two years. Pfizer joins top 5, while GSK retains its number one position, yet only slightly ahead of Novartis. Pfizer moves into the top five. Johnson & Johnson complete the top five companies. Eight of the top ten companies, including the leaders, are setting a new best practice of systematic access planning during R&D. “The state of infectious disease research today is, if I can put it mildly, on thin ice,” said Dr Jayasree Iyer, executive director of The Netherlands-based Access to Medicine Foundation, in an interview with DW. COVID-19 has emphasized the need for both the private and public sectors to actively engage in emerging infectious disease research well before the next pandemic breaks out. It has also shown that ending a pandemic requires suitable products to be developed and equitably distributed: much of the responsibility for which lies with pharmaceutical companies. Without their sustained commitment to pandemic preparedness, the report suggests, the world world will remain vulnerable to pandemics. Increased R&D for COVID-19, but Other Pandemic Risks Unaddressed Pharmaceutical companies are not targeting priority pathogens with epidemic potential through R&D. Excluding coronavirus, pathogens with pandemic potential where pharma companies are active in R&D show very small pipelines in 2020. Out of 16 pathogens, 10 have empty pipelines. Even for pathogens under scrutiny, research activity remains low. With most research focused on coronavirus, there are just 13 R&D projects across five non-COVID-19 diseases (Ebola, Zika, Chukungunya, Marburg, and non-polio enterovirus) and zero for the remaining ten of 16 infectious diseases. Emerging infectious disease (EID) research is concentrated among a few companies. In 2020, 17 companies targeted coronavirus, while nine companies are targeting other EIDs: Bayer, Eisai, Gilead, Johnson & Johnson, MSD, Merck, Roche, and Takeda. This figure shows the number of R&D projects and companies identified by WHO and Policy Cures as emerging infectious diseases, and how this has changed since 2018. What 2020 has highlighted is that large pharmaceutical companies have a critical role to play in preparing for the next pandemic, but that these companies have so far delivered a range of responses: some of them apparently shortsighted. Small biotech companies and academic groups may be able to pioneer new ideas, but it is the big players that are responsible for rapid development and access to vaccines, therapeutics and diagnostics, with the capacity to scale-up both manufacturing and distribution capabilities. Poorer Countries Lacking Access to More Than Half Key Products Covered By Pharma Companies However, the pharmaceutical industry only mobilized against COVID-19 once it became clear that the outbreak affected rich as well as poor countries. “Even in light of COVID-19, there were very few commitments from the pharmaceutical industry last year,” said Iyer. Other than projects developed within the Access to COVID-19 Tools (ACT) Accelerator, there was little evidence in the first months of the pandemic response that there structures in place to ensure access and distribution to COVID-19 vaccines in poorer countries. This has once more shown that the Global South still does not benefit significantly from access strategies implemented by big pharma. Less than half of key products controlled by 20 large companies are being offered in countries classified as either lower-middle income countries (LMICs) or low-income countries (LICs). Low-income countries are most consistently over-looked by access strategies, particularly for products that need to be administered by healthcare practitioners. The response is even more profound in LICs, which are consistently overlooked despite being home to almost 700 million people. Currently, only eight of the 60 – or 13% – critical products that need to be administered by healthcare professionals, like injectable treatments for cancer, are covered by access strategies in at least one LICs. Self-administered medicines such as pills have 26%. The numbers jump slightly in LMICs, and even more so in upper-middle income countries (UMICs), with approximately half of critical products covered by access strategies in UMICs. The greatest number of people also benefited from both healthcare professionals administered medicine and self-administered medicine in UMICs. Many industry access arrangements do not go far enough, with many of the world’s most vulnerable and marginalized not receiving the life-changing medicines they need. Solving the access to medicine problem requires the pharmaceutical industry to take large-scale action, reaching more people with more products across a wider range of the world’s poorest countries. “I believe the past year has demonstrated the pivotal importance of supplying affordable medicines for the many, rather than premium-priced products for the few,” said Iyer. “By investing in fair access to medicine for the poorest and most vulnerable among us, we are also investing in a fair, peaceful and prosperous global community.” Eight Pharma Companies Paving Way Towards Equitable Access Top 6 companies with access planning, with percentage of R&D projects with access plans There are positives: eight companies have taken the lead to integrating systemic access planning into their development processes. Novartis was noted as the first to begin mainstreaming access in the previous Index, and joining them in 2021 are AstraZeneca, GSK, Johnson & Johnson, Merck, Pfizer, Sanofi, and Takeda. Though the 20 companies in the Index have 394 projects in late-stage development that target either global health priorities (114) such as coronavirus, malaria, tuberculosis or HIV, or offer benefits to low- and middle-income countries (280), the majority of these are not supported by an access plan. An access plan can include a wide range of activities – prioritising countries with the highest disease burden to strengthening supply chains to ensure all populations have fair access. To have maximum impact, the Index advises that access plans have a broad geographic focus, explicitly aiming to reach a majority of people affected by a disease or in need of a vaccine or diagnostic tool. The 20 companies in scope have 394 R&D projects in late-stage development that either target established global health priorities or offer clear public health benefits for low- and middle-income countries. The majority of these are not yet supported by an access plan. If this happens, people living in low- and middle-income countries, especially those in resource-limited or remote settings, will no longer be left behind for pharmaceutical innovations. Concluded Iyer: “The power of science to help humanity – whether through new vaccines for common pathogens or novel drugs for rare diseases – is remarkable. But these breakthroughs will only truly deliver for the world if they reach all those who need them.” Image Credits: Access to Medicine Foundation , Access to Medicine Foundation . WHO Executive Board Rejects Israel’s Proposal To Remove Standalone Agenda Item On Palestinian Health Conditions 28/01/2021 Madeleine Hoecklin Meirav Eilon Shahar, Israel’s ambassador to the United Nations in Geneva, speaking to the WHO Executive Board. For the second time in as many years, WHO member states have voted down a proposal by Israel to remove a standalone item from the agenda of the 74th World Health Assembly – devoted exclusively to a report on health conditions in the Occupied Palestinian territories – and consider it as part of WHO’s overall health emergencies agenda. Saying that the agenda item unfairly singles out just one country for criticism, as compared to every other nation in the world, Israel on Tuesday proposed to the WHO Executive Board, which fixes the WHA agenda, that the report be considered as part of the overall discussion on WHO’s work in health emergencies when WHO member states meet in May. In a lengthy and unusual voting process on the closing day of the 10-day EB session, the proposal was rejected in a vote of 15 to seven – with 9 abstentions and 3 countries absent. Those supporting Israel’s position included the United Kingdom, Germany and Austria, joined by the United States, Australia and Colombia. EB members that were opposed included Oman, China, Russia, and Tunisia. Israel’s delegation said the report was a “political” item that does not reflect reality and will not change the situation on the ground. “Item 25 is a political item with only one purpose – to attack Israel and to politicize an otherwise professional organization [WHO]. This must be changed…What I’m asking you to do today is to ensure that the World Health Assembly maintains its focus on health and the truth,” said Israel’s ambassador to the United Nations, Meirav Eilon Shahar. “Regardless of what takes place in Geneva, we, Israel, will continue to work with the Palestinians and with WHO and we’ll continue to work on any problem and assistance intended to improve the health conditions for the Palestinians,” she added. The Palestinian representative, Ibrahim Khraishi, Ambassador of the State of Palestine to the UN, which holds observer status in the World Health Assembly, retorted that: “The [health situation in the occupied territories] is catastrophic and dire…Israel is finding it easy to renege on its responsibility, for example, it is not meeting its requirement…when it comes to vaccination. “When we look at the rate of vaccination for [Israeli] citizens, the figure exceeds two and a half million, whereas not one single Palestinian citizen has had the jab because of Israeli practices,” he said. Khraishi cited the WHO report from the 73rd WHA in November 2020, which he said shows that infant mortality of West Bank Palestinians is six times higher, and maternal mortality nine times higher than that of the 600,000 Israeli settlers living side by side with Palestinians in the Occupied West Bank. The report also describes barriers Palestinians from the West Bank and Gaza face in accessing more health services, such as the more specialized services in Jerusalem, which is directly under Israeli rule and to which access is tightly-controlled. Ibrahim Khraishi, Ambassador of the State of Palestine to the UN and Palestine’s representative to the Executive Board. After the vote among member states, Israel disputed the vaccination claims, saying that Palestinian inmates have received vaccinations and the PA has been provided with emergency supplies for 100 essential health workers – but the overall responsibility to vaccinate the roughly 5 million Palestinians living in the West Bank and Gaza lies with the Palestinian Authority (PA), not Israel. “We are very happy to extend assistance in facilitation of those vaccines in entrance to Israel,” said Eilon Shahar, referring to the expected arrival of PA-purchased vaccine supplies from Russia. PA health officials have not, in fact, officially requested vaccines from Israel, but rather are awaiting the arrival of Russian Sputnik vaccines within the coming two weeks. However, human rights groups have underlined that Israel still holds the ultimate responsibility for health under international law insofar as it still occupies the West Bank, The largely technical issue of where on the WHA agenda the report on Palestinian health conditions should be reviewed, was subject to a lengthy and unusual voting process (most EB decisions are made by consensus). The United States, Australia, and the United Kingdom explained their support of Israel’s proposal, saying that no other country in the world has been singled out in such a way by the WHO. “We’re concerned that the World Health Assembly does not consider the many other difficult health situations around the world in the same way,” said the UK’s delegate. “This item remains the only country specific item at the WHA…We fail our duty to serve people around the world who have vitally important health concerns if we allow WHO to become politicized in this way.” The UK’s delegate to the Executive Board. Australia went a step further, expressing concerns about the introduction of political issues into the WHA through the existence of the stand alone item – and calling for negotiations to permanently remove the item, not only as a stand-alone item but altogether from the agenda. The delegations from Oman and the Syrian Arab Republic countered the arguments made by the UK and US, claiming that the agenda item does not single out Israel. “This is not a country-specific item. This is an item which [reflects] a specific situation, a situation of people under occupation and addresses the legal obligations of the occupying power,” said Syria’s delegate. “The politicization is coming from attempts to go around these facts.” The Palestinian representative concluded the discussion at the closing session of the Executive Board meeting on Tuesday by urging member states to encourage Israel to “shoulder her responsibilities and do her duty towards all citizens for which she is responsible, particularly those in the occupied Syrian Golan, the Gaza Strip, and the other occupied territories.” The Gaza Strip has been under Israeli blockade as a result of repeated Israeli confrontations with the fundamentalist Hamas, which wrested control of the Strip from the PA-supported Fatah in 2007, two years after Israel unilaterally uprooted its settlements and withdrew from the Strip. Israel captured the Golan Heights from Syria in the 1967 Six Day War, and extended Israeli citizenship to the predominantly Druse residents of the Heights who remained after the war. Image Credits: WHO. Africa CDC Head calls for ‘Common Approach’ To Travel Restrictions Based on COVID Test & Not ‘National Origins’; 7 African Nations Report SARS-CoV-2 Variants 28/01/2021 Paul Adepoju Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy and not geographic or national origins, Africa CDC Director Dr John Nkengasong has said. IBADAN – Five African countries have now confirmed cases of the SARS-CoV-2 501Y.V2 variant, which first appeared in South Africa, and there is concern that the variant is circulating undetected elsewhere on the continent. The Gambia and Nigeria have seen cases of the variant B.1.1.7, first identified in the United Kingdom, said WHO’s African Regional Director today, Dr. Matshidiso Moeti, at a press briefing. Meanwhile, Africa CDC Director, Dr John Nkengasong, called for a “common approach” to COVID testing to oil the wings of international air travel – and halt the wave of new travel restrictions that countries have been imposing based on people’s national origin or the origins of flights – including people and flights arriving to Europe and the United States from South Africa. Researchers now believe the variants may be both more infectious but also more deadly than the COVID virus strains that were prevalent until just recently. Researchers also fear the variants could also elude COVID tests and be more resilient to vaccines just being rolled out now – although many unknowns remain. The countries where 501Y.V2 is circulating include: Botswana, Ghana, Kenya and Zambia, as well as South Africa. Beyond Africa, the variant has been confirmed in 24 countries globally. And there’s concern, it is circulating undetected in other countries in Africa,” Moeti told the press briefing. Dr. Matshidiso Moeti, WHO’s African Regional Director. “We are seeing more and more cases of variants and 501Y.V2, which was first identified in South Africa now, cropping up in other countries,” Moeti said. “The evidence suggests that these variants are more transmissible and emerging evidence indicates that the UK variant may cause more severe illness than other common strains, although more research needs to be done.” These variants in conjunction with “the aftermath of year-end gatherings”, Moeti said, “risk powering a perfect storm and driving up Africa’s second wave and overwhelming health facilities”. The continent saw a 50% rise in infections between 29 December 2020 and 25 January 2021, when compared with the previous four weeks, while deaths doubled. Last week, more than 6,200 deaths were reported across Africa, said the WHO.The past week saw a small dip in cases in South Africa, but 22 other countries continued to see numbers surge. Existing COVID-19 vaccines remain effective against the variants, Moeti said. But Professor Tulio de Oliveira, of the University of KwaZuku-Natal, South Africa, noted that these or other emerging variants may likely require individuals receiving booster doses of the vaccine. WHO’s African Region is meanwhile setting up a new surveillance network with Africa CDC to track the spread of the virus mutations and variants across Africa and beyond, Moeti added. “The variant which was first detected in South Africa has spread quickly beyond Africa and so what’s keeping me awake at night right now is that it’s very likely circulating in a number of African countries,” said Moeti. “Africa is at a crossroads. We must stick to our guns and double down on the tactics we know work so well. That is mask wearing, handwashing and safe social distancing. Countless lives depend on it.” WHO’s African CDC Calls for Common COVID Testing Approach For International Travel Dr John Nkengasong issued his call for a rethink of travel policies after several foreign countries, including the United States, are considering or have already banned flights originating from South Africa. Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy – and not geographic or national origins, said Nkengasong. “We should not be banning people because of their geographical origin, but we should be encouraging people to travel with negative tests and facilitate the testing process so that people can travel with a negative test,” Nkengasong said. “If I were to go to Kenya and I show up at the airport with a valid negative test, I pose no threat to the country of Kenya, and that way so you shouldn’t just ban me because I’m coming from a certain country. They should be looking at that test, is your test valid,” Nkengasong added. Dr John Nkengasong, Director of the Africa CDC. Up until now, the World Health Organization has resisted recommending pre-travel COVID testing, ostensibly due to fears that it would put an unnecessary onus on poor countries. In fact, however, many of the poorest African and Asian countries have been requiring pre-flight COVID tests for all incoming passengers – which are paid for privately. Some counties, such as the Democratic Republic of Congo, also demand arrivals briefly quarantine until a post-flight test is completed as well, paid privately as well. Paradoxically, it is wealthier European and American countries that first issued a rash of orders banning passengers of certain nationalities or flights from certain destinations as a result of variant scares – although more developed countries, most recently Switzerland on Wednesday, have adopted testing requirements. Senegal’s Pasteur Institute – At Center Of New Genetic Surveillance Network At the outset of the pandemic, most countries in Africa lacked adequate testing capacity for COVID-19 but this was gradually surmounted as new testing facilities were added. Now, however, the identification of new variants of the virus will require more advanced capacities for gene sequencing that several countries in Africa have yet to obtain. To address this vacuum, the Africa CDC, the WHO and member countries have created a network that enables existing labs with gene sequencing capabilities to collect samples from countries that lack such. One of the labs in the network is the Dakar-based Institut Pasteur de Dakar in Senegal. Its CEO, Dr Amadou Sall, said in addition to providing gene sequencing services for Senegal, the institute is now supporting other countries, Cameroon and Equatorial Guinea notably. Others include Mali, Burkina Faso Guinea-Bissau, Côte d’Ivoire, Niger, Verde, and of course, Guinea. “With the partnership we have with Africa CDC and WHO, we have the possibility of sequencing 500 genomes per week. And we’re trying to increase this capacity and to make these capacities available in different countries,” Sall said. Key to the success of COVID-19 genomic surveillance in Africa, Sall said, will be the willingness and openness of African countries to share information. “We need to be able to share information data and the Pasteur Institute is at the center of a global platform and we’re able to share information; to exchange information rapidly, if countries are willing to do so,” he said. Knowing When to Raise the Alarm While noting that identification of new variants is a significant feat, genomic experts warned that alarm should not be raised every time a new strain is identified. Professor de Oliveira, who heads the KwaZulu-Natal Research and Innovation Sequencing Platform, said attention is raised when new strains are being confirmed in increasing numbers of cases with the new variant and not when just one case has been confirmed. Describing the impacts that variants have on the epidemiology of the pandemic in South Africa, Oliveira said in some regions, the new variant has become the prominent type. But beyond this, he said South Africa is also worried about the variants from elsewhere getting into the country and circulating among its populations. “Today, we just reported the first important case of the B.1.1.7, the variant of concern that is circulating in the UK. And it’s quite common that in addition to our main variant that is dominating, we’re going to still have introductions of new lineages,” Oliveira said. “And in the case they begin to spread very fast, then we will communicate it and then highlight that could be a variant of concern.” He said that while no one can know for sure about the possibility of third or fourth waves of the pandemic in Africa, the variants are highlighting the need for the entire world to globally control the transmission of SARS-CoV-2 as a global community. “We have to really decrease transmission to avoid the next waves and more worry that emergence of new variants of concern will transmit too fast or evade immune response,” he said. “The appearance of these variants in the African continent, but also in South America and Europe really means that more than ever, it is the time that we don’t leave any continent behind, especially on vaccination,” Oliveira said. Silver Lining In Cloud – Variants Also Impetus For Cooperation But within Africa itself, Sall said the various SARS-CoV-2 variants constitute a new impetus for cooperation between countries, to be able to track and measure the circulation of the virus, and to enhance diagnostic capacities that he said will soon be available across Africa. “The new variants are the object of a very thorough study, and the path of our countries is very clear: obtain maximum information and adapt the strategy to contain the transmission,” he said. Moeti enjoined countries and individuals to strive to overcome COVID-19 fatigue and return to the fundamental actions that have been found to be effective against these variants. These measures, she said, need much more emphasis that news that the virus is much more transmissible. “The vaccine is a tool that’s going to make a huge difference all over the world,” she said. But she reminded that “having a corner of the world not protected, the way the world’s economies and peoples are connected, will have negative economic impact even in those countries that managed to vaccinate the entire population. We really are all in it together, and we have to work to support each other to overcome this global crisis.” Image Credits: Paul Adepoju/HealthPolicyWatch, Africa CDC. EU Protests AstraZeneca Vaccine Delays – Could Block UK-Bound Exports 28/01/2021 Madeleine Hoecklin The Oxford/AstraZeneca vaccine is 2 months behind schedule due to an issue in manufacturing. AstraZeneca has joined Pfizer in announcing delays in deliveries of COVID-19 vaccines to countries in Europe, leading furious EU officials to plan for a system of tighter monitoring of vaccine exports. The British-Swedish pharma company that developed its COVID-19 vaccine with researchers at Oxford University, informed the European Commission on Friday that there would be a 60% shortfall in vaccine deliveries this quarter due to a manufacturing issue at a production plant in Belgium. The company is reportedly two months behind schedule with regard to vaccines destined for European countries. Since vaccine deals with the United States and the United Kingdom were signed earlier on, and are based around manufacturing sites in those countries, the company has had a headstart in resolving “glitches” in those supply chains, pharma officials said. But the Commission had its doubts over this given explanation. Following an EU-requested investigation into AstraZeneca’s Belgian-based production facility on Wednesday, the European Commission has said it would establish a new mechanism that grants national regulators the power to refuse exports of vaccines. The mechanism – the criteria for which is expected to be published on Friday – could throw the security of the UK’s 40m-dose deal with Pfizer/BioNTech. The investigation, a spokesperson for the Belgian health ministry said, was to “make sure that the delivery delay is indeed due to a production problem on the Belgian site”. AstraZeneca ‘Scaling Up’ Doses, As EU Leaders Question Pharma Company Pascal Soriot, CEO of AstraZeneca “We are scaling up to hundreds of millions, billions of doses of vaccines at a very high speed. A year ago we didn’t have a vaccine. When you do that, you have glitches, you have scale-up problems. Therefore, the yield varies,” said Pascal Soriot, CEO of AstraZeneca, in an interview with la Repubblica, an Italian newspaper, on Tuesday. News of the delays was met with frustration by EU officials and leaders, who were expecting to receive 80 million doses by the end of March. “This new schedule is not acceptable to the European Union,” said Stella Kyriakides, European Commissioner for Health and Food Safety, in a statement released on Monday. “The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far, and if, or to whom, they have been delivered.” Stella Kyriakides, European Commissioner for Health and Food Safety, at a press briefing on Wednesday. Soriot disputed suggestions that the company sold the doses elsewhere for a higher price, claiming that “there is a lot of silly talk going on right now about all sorts of things,” and the response from the European Commission and EU member states is because “there are a lot of emotions running in this process right now.” “The suggestion [that] we sell to other countries to make more money is not right because we make no profit everywhere…That’s the agreement we have with Oxford University,” said Soriot. “Governments are under pressure. Everybody is getting kind of…aggravated or emotional about those things. But I understand because the Commission is managing the process for the whole of Europe,” he added. In late August, the EU made an upfront payment of €336 million to the company to secure 300 million doses of the vaccine. EU officials have disputed AstraZeneca’s explanation of production issues, claiming there are no excuses for the delay. “The flimsy justification that there are difficulties in the EU supply chain but not anywhere else does not hold water, as it is of course no problem to get the vaccine from the UK to the continent,” said Peter Liese, an EU parliamentarian from Germany’s Christian Democratic Union. Currently AstraZeneca is producing 17 million doses per month. That number will reach 100 million doses from February onwards, according to Soriot, meaning 1.2 billion doses per year. And Europe will receive 17% of the global production in February for a population that represents 5% of the world’s population. The Oxford/AstraZeneca vaccine is in the final stages of the approval process with the European Medicines Agency (EMA) and is expected to receive the recommendation for market authorization on Friday. After being approved, the company plans to deliver three million doses immediately. Meetings between EU officials and AstraZeneca have done little to resolve the issue, with Kyriakides announcing on Twitter: “Discussions with @AstraZeneca today resulted in dissatisfaction with the lack of clarity and insufficient explanations. EU Member States are united: vaccine developers have societal and contractual responsibilities they need to uphold.” With our Member States, we have requested from AZ a detailed planning of vaccine deliveries and when distribution will take place to Member States. Another meeting will be convened on Wednesday to discuss the matter further. — Stella Kyriakides (@SKyriakidesEU) January 25, 2021 The EU Steering Board, the body that oversees vaccine deals, plans to meet with AstraZeneca again on Wednesday at 6:30pm CET and hopes to “resolve this in a spirit of collaboration and responsibility,” according to Kyriakides. The Italian government plans to take legal action against Pfizer and AstraZeneca over their delays in deliveries, according to an announcement made by Foreign Minister Luigi Di Maio on Sunday. “This is a European contract that Pfizer and AstraZeneca are not respecting and so for this reason we will take legal action,” Di Maio said on RAI state television. “We are activating all channels so that the EU Commission does all it can to make these gentlemen respect their contracts.” According to Soriot, however, the vaccine deal signed with the EU was not a contractual commitment but a best effort, so there is no feasible basis for legal action. EU to Establish a Vaccine Export Transparency Mechanism The Oxford/AstraZeneca vaccine is also considered one with global potential – due to its ability to be stored at refrigerator temperatures. Amidst some countries’ suspicions that countries outside Europe are receiving priority for vaccines produced at the Belgium plant, the European Commission announced plans to establish an export transparency mechanism for vaccines to ensure clarity on transactions and to protect its investments in the R&D that led to development of vaccines like AstraZeneca’s. AstraZeneca is also a major supplier of the WHO COVAX global distribution initiative – which has pledged to begin distributing vaccine doses to the 92 lowest-income countries in the world within the next two months. Although most of the COVAX supplies were reportedly to be produced by India’s Serum Institute or in the Republic of Korea, the exact supply lines remain unclear. “Europe invested billions to help develop the world’s first COVID-19 vaccines…And now, the companies must deliver,” said Ursula von der Leyen, President of the European Commission, at the World Economic Forum on Tuesday. “They must honor their obligations. This is why we will set up a vaccine export transparency mechanism. Europe is determined to contribute to this global common good. But it also means business.” Ursula von der Leyen, President of the European Commission, speaking at the World Economic Forum on Tuesday. “In the future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries,” said Commissioner Kyriakides. The aim of the proposed system will be to monitor, but not block, exports, officials said. And humanitarian deliveries would be anyway exempt from this oversight mechanism. EMA Yet To Issue Final Approval – Insufficient Data on Vaccine in Older People Meanwhile, the EMA has yet to issue its final regulatory approval for the two-dose Oxford/AstraZeneca vaccine, and is reportedly considering limiting the age range to people under the age of 65 – due to a lack of data on effectiveness in older people. Unlike mRNA counterparts produced by Moderna and Pfizer, the AstraZeneca/Oxford vaccine uses a disabled, modified version of a chimpanzee adenovirus that can enter human cells but cannot replicate or cause the disease, as a vector to deliver a fragment of SARS-CoV2 spike protein, stimulating COVID-19 immunity. According to data shared by the company, only 10% of participants in the vaccine clinical trials were over the age of 65 because it was first waiting for sufficient safety data in the 18 to 55 age group before vaccinating older individuals. “We don’t have a huge number of older people who have been vaccinated,” said Soriot. “But we have strong data showing very strong antibody production against the virus in the elderly, similar to what we see in younger people.” The results of an ongoing, larger Phase 3 clinical trial with 30,000 participants being conducted in the United States are expected to provide insight into the protection the vaccine provides to older individuals and ethnic minorities populations – groups that were not very well represented in previous trials. In addition, scientists are exploring whether a half-dose of the first vaccine would reliably yield a higher efficacy rating of 90% that was seen in initial trials. The other regime, involving two full doses was only 62% effective, according to the results released by the company in late November and reviewed by an independent Data and Safety Monitoring Board. That still meets key global benchmarks for efficacy, but is significantly lower than the 94-95% efficacy results for the Moderna and Pfizer mRNA vaccines. The AstraZeneca vaccine has, however, already been authorized in the UK, is already being used in British vaccination campaigns, including for people over 70 years old. Image Credits: AstraZeneca, AstraZeneca, Twitter, Twitter. WHO Proposes New Mode Of Engaging With Non-State Actors 28/01/2021 Esther Nakkazi Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, according to WHO. The World Health Organization (WHO) aims to make its engagement with non-state actors (non-state actors) more meaningful and efficient with a new proposal to establish a number of NSA fora that would allow exchange with WHO and member state representatives outside of official meetings. The new proposal — which will be tested during the 74th World Health Assembly (WHA), 24 May to 1 June — would offer multiple side events in which non-state (NSA) actors could engage more informally with member state representatives as well as a forum for exchange between NSAs and WHO regional and technical staff. But at the same time, non-state actors will be allotted a more limited number of constituency statements in formal governing body meetings – and like-minded groups of actors will be asked to combine their official statements together. Non-state actors include civil society groups such as non-governmental organizations, international business and professional associations, and philanthropic foundations. More than 70 non-state actors are recognized as being “in official relations” with WHO, and thus contribute in formal meetings such as the EB and the WHA. However, EB and WHA members have complained that the civil society interventions have become bogged down by too many lengthy, individual statements – and NSAs acknowledge that the statements often had limited impact in member state debates. More informal meetings ahead of the formal meeting dates would help engender more meaningful interaction, WHO said in its proposal for the reform, which was reviewed by the WHO Executive Board on Saturday. Informal meetings will also allow non-state actors to organize themselves into constituencies, consolidating their positions into joint statements to be presented at official events. The new arrangements to be tested in May, will “serve as a trial for potential future virtual informal meetings between non-state actors, Member States and the Secretariat, as a means of enabling more in-depth technical exchanges, as well as discussions on the Health Assembly agenda items,” said the WHO Secretariat, in its presentation to the EB on Saturday. The COVID-19 pandemic has provided added impetus for reforms that have long been in the making – insofar as the limitations of virtual meetings have also curtailed the interactions between member states and non-state actors. According to the new proposal, the informal series of meetings with non-state actors will be held just ahead of the WHA, and thus prepare the groundwork for the formal meeting. Role of Non-State Actors Has Evolved – But Increasing Number of Statements Detracted from Impact In the discussion over the proposal, WHO officials stressed that the Organization “is and remains a Member State Organisation” — engaging with 77 non-state actors, at global, regional and country levels, who also support the development and implementation of the Organization’s policies and recommendations, technical norms and standards. But while non-state actors have “served the Organization well for several decades”, the increasing number of non-governmental organizations and other non-state actors participating — often with a greater number of requests to speak — has “not resulted in a more meaningful involvement”. For example, when civil society representatives speak one-by-one at the end of a discussion, their interventions have little impact on the content or direction of the debate, WHO contends. Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, says the WHO. A virtual consultation by WHO further confirmed that non-state actors’ primary interests in attending governing body meetings are to participate in technical exchanges with the Secretariat and the Member States and to attend consultative hearings that feed into decision-making processes. Meaningful Participation From NGOs Critical, Member States Say The UK delegate said that it would allow NSAs to exert even more credible influence on member states attitudes and positions. The EB representative from the United States flagged that it is critical to ensure and enhance meaningful participation of non-state actors in WHO governing bodies, while also creating greater efficiency in the governance process. “Non-State actor participation must be allowed in a transparent and accountable manner with an open door to input from all stakeholders including the private sector,” the delegate noted. Austria pressed for the Secretariat to provide some more detailed information on the procedure for these meetings. Other states, like Australia, flagged that the trial is very ambitious given the agenda for the 2021 assembly is already very crowded. “We suggest that before agreeing to a trial, the number of meetings proposed to be repeated and streamlined,” the representative said.This would “provide reflections to technical areas in advance of the governing body meetings”. Civil Society Groups Request Clarity and Procedure Details Bodies like Health Action International asked for details as to how NGOs would participate, and for clarity on the processes governing such meetings. “It is a remaining concern to those who have witnessed creeping capacity shrinking of NGO space and poor consultation in recent years,” said an HAI statement. The HAI delegate requested that similar procedures be implemented for WHO regional meetings with member states, also asking that “these informal meetings compliment, but do not replace comprehensive consultations with non-state actors.” Meanwhile, the European Society for Medical Oncology said the views and expertise of non-state actors should be introduced earlier in the WHO decision-making process; it would be of greater value if delivered at the onset of projects, and when member states are drafting zero draft decisions and resolutions. “Direct interaction and discussion between member states, WHO offices, and Non-State actors would provide the opportunity for more in-depth exchanges, and partnerships, as the Member States, develop policies and implement actions to fulfill their WHO commitments,” said the ESMO spokesperson. Silberschmidt stressed that the virtual informal meetings will not replace other channels, but become an additional avenue for interaction – highlighting the fact that Dr Tedros Adhanom Ghebreyesus, WHO Director General, has already established a regular dialogue with civil society groups, to be held every six weeks. Image Credits: WHO / Christopher Black. 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.
WHO Executive Board Rejects Israel’s Proposal To Remove Standalone Agenda Item On Palestinian Health Conditions 28/01/2021 Madeleine Hoecklin Meirav Eilon Shahar, Israel’s ambassador to the United Nations in Geneva, speaking to the WHO Executive Board. For the second time in as many years, WHO member states have voted down a proposal by Israel to remove a standalone item from the agenda of the 74th World Health Assembly – devoted exclusively to a report on health conditions in the Occupied Palestinian territories – and consider it as part of WHO’s overall health emergencies agenda. Saying that the agenda item unfairly singles out just one country for criticism, as compared to every other nation in the world, Israel on Tuesday proposed to the WHO Executive Board, which fixes the WHA agenda, that the report be considered as part of the overall discussion on WHO’s work in health emergencies when WHO member states meet in May. In a lengthy and unusual voting process on the closing day of the 10-day EB session, the proposal was rejected in a vote of 15 to seven – with 9 abstentions and 3 countries absent. Those supporting Israel’s position included the United Kingdom, Germany and Austria, joined by the United States, Australia and Colombia. EB members that were opposed included Oman, China, Russia, and Tunisia. Israel’s delegation said the report was a “political” item that does not reflect reality and will not change the situation on the ground. “Item 25 is a political item with only one purpose – to attack Israel and to politicize an otherwise professional organization [WHO]. This must be changed…What I’m asking you to do today is to ensure that the World Health Assembly maintains its focus on health and the truth,” said Israel’s ambassador to the United Nations, Meirav Eilon Shahar. “Regardless of what takes place in Geneva, we, Israel, will continue to work with the Palestinians and with WHO and we’ll continue to work on any problem and assistance intended to improve the health conditions for the Palestinians,” she added. The Palestinian representative, Ibrahim Khraishi, Ambassador of the State of Palestine to the UN, which holds observer status in the World Health Assembly, retorted that: “The [health situation in the occupied territories] is catastrophic and dire…Israel is finding it easy to renege on its responsibility, for example, it is not meeting its requirement…when it comes to vaccination. “When we look at the rate of vaccination for [Israeli] citizens, the figure exceeds two and a half million, whereas not one single Palestinian citizen has had the jab because of Israeli practices,” he said. Khraishi cited the WHO report from the 73rd WHA in November 2020, which he said shows that infant mortality of West Bank Palestinians is six times higher, and maternal mortality nine times higher than that of the 600,000 Israeli settlers living side by side with Palestinians in the Occupied West Bank. The report also describes barriers Palestinians from the West Bank and Gaza face in accessing more health services, such as the more specialized services in Jerusalem, which is directly under Israeli rule and to which access is tightly-controlled. Ibrahim Khraishi, Ambassador of the State of Palestine to the UN and Palestine’s representative to the Executive Board. After the vote among member states, Israel disputed the vaccination claims, saying that Palestinian inmates have received vaccinations and the PA has been provided with emergency supplies for 100 essential health workers – but the overall responsibility to vaccinate the roughly 5 million Palestinians living in the West Bank and Gaza lies with the Palestinian Authority (PA), not Israel. “We are very happy to extend assistance in facilitation of those vaccines in entrance to Israel,” said Eilon Shahar, referring to the expected arrival of PA-purchased vaccine supplies from Russia. PA health officials have not, in fact, officially requested vaccines from Israel, but rather are awaiting the arrival of Russian Sputnik vaccines within the coming two weeks. However, human rights groups have underlined that Israel still holds the ultimate responsibility for health under international law insofar as it still occupies the West Bank, The largely technical issue of where on the WHA agenda the report on Palestinian health conditions should be reviewed, was subject to a lengthy and unusual voting process (most EB decisions are made by consensus). The United States, Australia, and the United Kingdom explained their support of Israel’s proposal, saying that no other country in the world has been singled out in such a way by the WHO. “We’re concerned that the World Health Assembly does not consider the many other difficult health situations around the world in the same way,” said the UK’s delegate. “This item remains the only country specific item at the WHA…We fail our duty to serve people around the world who have vitally important health concerns if we allow WHO to become politicized in this way.” The UK’s delegate to the Executive Board. Australia went a step further, expressing concerns about the introduction of political issues into the WHA through the existence of the stand alone item – and calling for negotiations to permanently remove the item, not only as a stand-alone item but altogether from the agenda. The delegations from Oman and the Syrian Arab Republic countered the arguments made by the UK and US, claiming that the agenda item does not single out Israel. “This is not a country-specific item. This is an item which [reflects] a specific situation, a situation of people under occupation and addresses the legal obligations of the occupying power,” said Syria’s delegate. “The politicization is coming from attempts to go around these facts.” The Palestinian representative concluded the discussion at the closing session of the Executive Board meeting on Tuesday by urging member states to encourage Israel to “shoulder her responsibilities and do her duty towards all citizens for which she is responsible, particularly those in the occupied Syrian Golan, the Gaza Strip, and the other occupied territories.” The Gaza Strip has been under Israeli blockade as a result of repeated Israeli confrontations with the fundamentalist Hamas, which wrested control of the Strip from the PA-supported Fatah in 2007, two years after Israel unilaterally uprooted its settlements and withdrew from the Strip. Israel captured the Golan Heights from Syria in the 1967 Six Day War, and extended Israeli citizenship to the predominantly Druse residents of the Heights who remained after the war. Image Credits: WHO. Africa CDC Head calls for ‘Common Approach’ To Travel Restrictions Based on COVID Test & Not ‘National Origins’; 7 African Nations Report SARS-CoV-2 Variants 28/01/2021 Paul Adepoju Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy and not geographic or national origins, Africa CDC Director Dr John Nkengasong has said. IBADAN – Five African countries have now confirmed cases of the SARS-CoV-2 501Y.V2 variant, which first appeared in South Africa, and there is concern that the variant is circulating undetected elsewhere on the continent. The Gambia and Nigeria have seen cases of the variant B.1.1.7, first identified in the United Kingdom, said WHO’s African Regional Director today, Dr. Matshidiso Moeti, at a press briefing. Meanwhile, Africa CDC Director, Dr John Nkengasong, called for a “common approach” to COVID testing to oil the wings of international air travel – and halt the wave of new travel restrictions that countries have been imposing based on people’s national origin or the origins of flights – including people and flights arriving to Europe and the United States from South Africa. Researchers now believe the variants may be both more infectious but also more deadly than the COVID virus strains that were prevalent until just recently. Researchers also fear the variants could also elude COVID tests and be more resilient to vaccines just being rolled out now – although many unknowns remain. The countries where 501Y.V2 is circulating include: Botswana, Ghana, Kenya and Zambia, as well as South Africa. Beyond Africa, the variant has been confirmed in 24 countries globally. And there’s concern, it is circulating undetected in other countries in Africa,” Moeti told the press briefing. Dr. Matshidiso Moeti, WHO’s African Regional Director. “We are seeing more and more cases of variants and 501Y.V2, which was first identified in South Africa now, cropping up in other countries,” Moeti said. “The evidence suggests that these variants are more transmissible and emerging evidence indicates that the UK variant may cause more severe illness than other common strains, although more research needs to be done.” These variants in conjunction with “the aftermath of year-end gatherings”, Moeti said, “risk powering a perfect storm and driving up Africa’s second wave and overwhelming health facilities”. The continent saw a 50% rise in infections between 29 December 2020 and 25 January 2021, when compared with the previous four weeks, while deaths doubled. Last week, more than 6,200 deaths were reported across Africa, said the WHO.The past week saw a small dip in cases in South Africa, but 22 other countries continued to see numbers surge. Existing COVID-19 vaccines remain effective against the variants, Moeti said. But Professor Tulio de Oliveira, of the University of KwaZuku-Natal, South Africa, noted that these or other emerging variants may likely require individuals receiving booster doses of the vaccine. WHO’s African Region is meanwhile setting up a new surveillance network with Africa CDC to track the spread of the virus mutations and variants across Africa and beyond, Moeti added. “The variant which was first detected in South Africa has spread quickly beyond Africa and so what’s keeping me awake at night right now is that it’s very likely circulating in a number of African countries,” said Moeti. “Africa is at a crossroads. We must stick to our guns and double down on the tactics we know work so well. That is mask wearing, handwashing and safe social distancing. Countless lives depend on it.” WHO’s African CDC Calls for Common COVID Testing Approach For International Travel Dr John Nkengasong issued his call for a rethink of travel policies after several foreign countries, including the United States, are considering or have already banned flights originating from South Africa. Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy – and not geographic or national origins, said Nkengasong. “We should not be banning people because of their geographical origin, but we should be encouraging people to travel with negative tests and facilitate the testing process so that people can travel with a negative test,” Nkengasong said. “If I were to go to Kenya and I show up at the airport with a valid negative test, I pose no threat to the country of Kenya, and that way so you shouldn’t just ban me because I’m coming from a certain country. They should be looking at that test, is your test valid,” Nkengasong added. Dr John Nkengasong, Director of the Africa CDC. Up until now, the World Health Organization has resisted recommending pre-travel COVID testing, ostensibly due to fears that it would put an unnecessary onus on poor countries. In fact, however, many of the poorest African and Asian countries have been requiring pre-flight COVID tests for all incoming passengers – which are paid for privately. Some counties, such as the Democratic Republic of Congo, also demand arrivals briefly quarantine until a post-flight test is completed as well, paid privately as well. Paradoxically, it is wealthier European and American countries that first issued a rash of orders banning passengers of certain nationalities or flights from certain destinations as a result of variant scares – although more developed countries, most recently Switzerland on Wednesday, have adopted testing requirements. Senegal’s Pasteur Institute – At Center Of New Genetic Surveillance Network At the outset of the pandemic, most countries in Africa lacked adequate testing capacity for COVID-19 but this was gradually surmounted as new testing facilities were added. Now, however, the identification of new variants of the virus will require more advanced capacities for gene sequencing that several countries in Africa have yet to obtain. To address this vacuum, the Africa CDC, the WHO and member countries have created a network that enables existing labs with gene sequencing capabilities to collect samples from countries that lack such. One of the labs in the network is the Dakar-based Institut Pasteur de Dakar in Senegal. Its CEO, Dr Amadou Sall, said in addition to providing gene sequencing services for Senegal, the institute is now supporting other countries, Cameroon and Equatorial Guinea notably. Others include Mali, Burkina Faso Guinea-Bissau, Côte d’Ivoire, Niger, Verde, and of course, Guinea. “With the partnership we have with Africa CDC and WHO, we have the possibility of sequencing 500 genomes per week. And we’re trying to increase this capacity and to make these capacities available in different countries,” Sall said. Key to the success of COVID-19 genomic surveillance in Africa, Sall said, will be the willingness and openness of African countries to share information. “We need to be able to share information data and the Pasteur Institute is at the center of a global platform and we’re able to share information; to exchange information rapidly, if countries are willing to do so,” he said. Knowing When to Raise the Alarm While noting that identification of new variants is a significant feat, genomic experts warned that alarm should not be raised every time a new strain is identified. Professor de Oliveira, who heads the KwaZulu-Natal Research and Innovation Sequencing Platform, said attention is raised when new strains are being confirmed in increasing numbers of cases with the new variant and not when just one case has been confirmed. Describing the impacts that variants have on the epidemiology of the pandemic in South Africa, Oliveira said in some regions, the new variant has become the prominent type. But beyond this, he said South Africa is also worried about the variants from elsewhere getting into the country and circulating among its populations. “Today, we just reported the first important case of the B.1.1.7, the variant of concern that is circulating in the UK. And it’s quite common that in addition to our main variant that is dominating, we’re going to still have introductions of new lineages,” Oliveira said. “And in the case they begin to spread very fast, then we will communicate it and then highlight that could be a variant of concern.” He said that while no one can know for sure about the possibility of third or fourth waves of the pandemic in Africa, the variants are highlighting the need for the entire world to globally control the transmission of SARS-CoV-2 as a global community. “We have to really decrease transmission to avoid the next waves and more worry that emergence of new variants of concern will transmit too fast or evade immune response,” he said. “The appearance of these variants in the African continent, but also in South America and Europe really means that more than ever, it is the time that we don’t leave any continent behind, especially on vaccination,” Oliveira said. Silver Lining In Cloud – Variants Also Impetus For Cooperation But within Africa itself, Sall said the various SARS-CoV-2 variants constitute a new impetus for cooperation between countries, to be able to track and measure the circulation of the virus, and to enhance diagnostic capacities that he said will soon be available across Africa. “The new variants are the object of a very thorough study, and the path of our countries is very clear: obtain maximum information and adapt the strategy to contain the transmission,” he said. Moeti enjoined countries and individuals to strive to overcome COVID-19 fatigue and return to the fundamental actions that have been found to be effective against these variants. These measures, she said, need much more emphasis that news that the virus is much more transmissible. “The vaccine is a tool that’s going to make a huge difference all over the world,” she said. But she reminded that “having a corner of the world not protected, the way the world’s economies and peoples are connected, will have negative economic impact even in those countries that managed to vaccinate the entire population. We really are all in it together, and we have to work to support each other to overcome this global crisis.” Image Credits: Paul Adepoju/HealthPolicyWatch, Africa CDC. EU Protests AstraZeneca Vaccine Delays – Could Block UK-Bound Exports 28/01/2021 Madeleine Hoecklin The Oxford/AstraZeneca vaccine is 2 months behind schedule due to an issue in manufacturing. AstraZeneca has joined Pfizer in announcing delays in deliveries of COVID-19 vaccines to countries in Europe, leading furious EU officials to plan for a system of tighter monitoring of vaccine exports. The British-Swedish pharma company that developed its COVID-19 vaccine with researchers at Oxford University, informed the European Commission on Friday that there would be a 60% shortfall in vaccine deliveries this quarter due to a manufacturing issue at a production plant in Belgium. The company is reportedly two months behind schedule with regard to vaccines destined for European countries. Since vaccine deals with the United States and the United Kingdom were signed earlier on, and are based around manufacturing sites in those countries, the company has had a headstart in resolving “glitches” in those supply chains, pharma officials said. But the Commission had its doubts over this given explanation. Following an EU-requested investigation into AstraZeneca’s Belgian-based production facility on Wednesday, the European Commission has said it would establish a new mechanism that grants national regulators the power to refuse exports of vaccines. The mechanism – the criteria for which is expected to be published on Friday – could throw the security of the UK’s 40m-dose deal with Pfizer/BioNTech. The investigation, a spokesperson for the Belgian health ministry said, was to “make sure that the delivery delay is indeed due to a production problem on the Belgian site”. AstraZeneca ‘Scaling Up’ Doses, As EU Leaders Question Pharma Company Pascal Soriot, CEO of AstraZeneca “We are scaling up to hundreds of millions, billions of doses of vaccines at a very high speed. A year ago we didn’t have a vaccine. When you do that, you have glitches, you have scale-up problems. Therefore, the yield varies,” said Pascal Soriot, CEO of AstraZeneca, in an interview with la Repubblica, an Italian newspaper, on Tuesday. News of the delays was met with frustration by EU officials and leaders, who were expecting to receive 80 million doses by the end of March. “This new schedule is not acceptable to the European Union,” said Stella Kyriakides, European Commissioner for Health and Food Safety, in a statement released on Monday. “The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far, and if, or to whom, they have been delivered.” Stella Kyriakides, European Commissioner for Health and Food Safety, at a press briefing on Wednesday. Soriot disputed suggestions that the company sold the doses elsewhere for a higher price, claiming that “there is a lot of silly talk going on right now about all sorts of things,” and the response from the European Commission and EU member states is because “there are a lot of emotions running in this process right now.” “The suggestion [that] we sell to other countries to make more money is not right because we make no profit everywhere…That’s the agreement we have with Oxford University,” said Soriot. “Governments are under pressure. Everybody is getting kind of…aggravated or emotional about those things. But I understand because the Commission is managing the process for the whole of Europe,” he added. In late August, the EU made an upfront payment of €336 million to the company to secure 300 million doses of the vaccine. EU officials have disputed AstraZeneca’s explanation of production issues, claiming there are no excuses for the delay. “The flimsy justification that there are difficulties in the EU supply chain but not anywhere else does not hold water, as it is of course no problem to get the vaccine from the UK to the continent,” said Peter Liese, an EU parliamentarian from Germany’s Christian Democratic Union. Currently AstraZeneca is producing 17 million doses per month. That number will reach 100 million doses from February onwards, according to Soriot, meaning 1.2 billion doses per year. And Europe will receive 17% of the global production in February for a population that represents 5% of the world’s population. The Oxford/AstraZeneca vaccine is in the final stages of the approval process with the European Medicines Agency (EMA) and is expected to receive the recommendation for market authorization on Friday. After being approved, the company plans to deliver three million doses immediately. Meetings between EU officials and AstraZeneca have done little to resolve the issue, with Kyriakides announcing on Twitter: “Discussions with @AstraZeneca today resulted in dissatisfaction with the lack of clarity and insufficient explanations. EU Member States are united: vaccine developers have societal and contractual responsibilities they need to uphold.” With our Member States, we have requested from AZ a detailed planning of vaccine deliveries and when distribution will take place to Member States. Another meeting will be convened on Wednesday to discuss the matter further. — Stella Kyriakides (@SKyriakidesEU) January 25, 2021 The EU Steering Board, the body that oversees vaccine deals, plans to meet with AstraZeneca again on Wednesday at 6:30pm CET and hopes to “resolve this in a spirit of collaboration and responsibility,” according to Kyriakides. The Italian government plans to take legal action against Pfizer and AstraZeneca over their delays in deliveries, according to an announcement made by Foreign Minister Luigi Di Maio on Sunday. “This is a European contract that Pfizer and AstraZeneca are not respecting and so for this reason we will take legal action,” Di Maio said on RAI state television. “We are activating all channels so that the EU Commission does all it can to make these gentlemen respect their contracts.” According to Soriot, however, the vaccine deal signed with the EU was not a contractual commitment but a best effort, so there is no feasible basis for legal action. EU to Establish a Vaccine Export Transparency Mechanism The Oxford/AstraZeneca vaccine is also considered one with global potential – due to its ability to be stored at refrigerator temperatures. Amidst some countries’ suspicions that countries outside Europe are receiving priority for vaccines produced at the Belgium plant, the European Commission announced plans to establish an export transparency mechanism for vaccines to ensure clarity on transactions and to protect its investments in the R&D that led to development of vaccines like AstraZeneca’s. AstraZeneca is also a major supplier of the WHO COVAX global distribution initiative – which has pledged to begin distributing vaccine doses to the 92 lowest-income countries in the world within the next two months. Although most of the COVAX supplies were reportedly to be produced by India’s Serum Institute or in the Republic of Korea, the exact supply lines remain unclear. “Europe invested billions to help develop the world’s first COVID-19 vaccines…And now, the companies must deliver,” said Ursula von der Leyen, President of the European Commission, at the World Economic Forum on Tuesday. “They must honor their obligations. This is why we will set up a vaccine export transparency mechanism. Europe is determined to contribute to this global common good. But it also means business.” Ursula von der Leyen, President of the European Commission, speaking at the World Economic Forum on Tuesday. “In the future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries,” said Commissioner Kyriakides. The aim of the proposed system will be to monitor, but not block, exports, officials said. And humanitarian deliveries would be anyway exempt from this oversight mechanism. EMA Yet To Issue Final Approval – Insufficient Data on Vaccine in Older People Meanwhile, the EMA has yet to issue its final regulatory approval for the two-dose Oxford/AstraZeneca vaccine, and is reportedly considering limiting the age range to people under the age of 65 – due to a lack of data on effectiveness in older people. Unlike mRNA counterparts produced by Moderna and Pfizer, the AstraZeneca/Oxford vaccine uses a disabled, modified version of a chimpanzee adenovirus that can enter human cells but cannot replicate or cause the disease, as a vector to deliver a fragment of SARS-CoV2 spike protein, stimulating COVID-19 immunity. According to data shared by the company, only 10% of participants in the vaccine clinical trials were over the age of 65 because it was first waiting for sufficient safety data in the 18 to 55 age group before vaccinating older individuals. “We don’t have a huge number of older people who have been vaccinated,” said Soriot. “But we have strong data showing very strong antibody production against the virus in the elderly, similar to what we see in younger people.” The results of an ongoing, larger Phase 3 clinical trial with 30,000 participants being conducted in the United States are expected to provide insight into the protection the vaccine provides to older individuals and ethnic minorities populations – groups that were not very well represented in previous trials. In addition, scientists are exploring whether a half-dose of the first vaccine would reliably yield a higher efficacy rating of 90% that was seen in initial trials. The other regime, involving two full doses was only 62% effective, according to the results released by the company in late November and reviewed by an independent Data and Safety Monitoring Board. That still meets key global benchmarks for efficacy, but is significantly lower than the 94-95% efficacy results for the Moderna and Pfizer mRNA vaccines. The AstraZeneca vaccine has, however, already been authorized in the UK, is already being used in British vaccination campaigns, including for people over 70 years old. Image Credits: AstraZeneca, AstraZeneca, Twitter, Twitter. WHO Proposes New Mode Of Engaging With Non-State Actors 28/01/2021 Esther Nakkazi Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, according to WHO. The World Health Organization (WHO) aims to make its engagement with non-state actors (non-state actors) more meaningful and efficient with a new proposal to establish a number of NSA fora that would allow exchange with WHO and member state representatives outside of official meetings. The new proposal — which will be tested during the 74th World Health Assembly (WHA), 24 May to 1 June — would offer multiple side events in which non-state (NSA) actors could engage more informally with member state representatives as well as a forum for exchange between NSAs and WHO regional and technical staff. But at the same time, non-state actors will be allotted a more limited number of constituency statements in formal governing body meetings – and like-minded groups of actors will be asked to combine their official statements together. Non-state actors include civil society groups such as non-governmental organizations, international business and professional associations, and philanthropic foundations. More than 70 non-state actors are recognized as being “in official relations” with WHO, and thus contribute in formal meetings such as the EB and the WHA. However, EB and WHA members have complained that the civil society interventions have become bogged down by too many lengthy, individual statements – and NSAs acknowledge that the statements often had limited impact in member state debates. More informal meetings ahead of the formal meeting dates would help engender more meaningful interaction, WHO said in its proposal for the reform, which was reviewed by the WHO Executive Board on Saturday. Informal meetings will also allow non-state actors to organize themselves into constituencies, consolidating their positions into joint statements to be presented at official events. The new arrangements to be tested in May, will “serve as a trial for potential future virtual informal meetings between non-state actors, Member States and the Secretariat, as a means of enabling more in-depth technical exchanges, as well as discussions on the Health Assembly agenda items,” said the WHO Secretariat, in its presentation to the EB on Saturday. The COVID-19 pandemic has provided added impetus for reforms that have long been in the making – insofar as the limitations of virtual meetings have also curtailed the interactions between member states and non-state actors. According to the new proposal, the informal series of meetings with non-state actors will be held just ahead of the WHA, and thus prepare the groundwork for the formal meeting. Role of Non-State Actors Has Evolved – But Increasing Number of Statements Detracted from Impact In the discussion over the proposal, WHO officials stressed that the Organization “is and remains a Member State Organisation” — engaging with 77 non-state actors, at global, regional and country levels, who also support the development and implementation of the Organization’s policies and recommendations, technical norms and standards. But while non-state actors have “served the Organization well for several decades”, the increasing number of non-governmental organizations and other non-state actors participating — often with a greater number of requests to speak — has “not resulted in a more meaningful involvement”. For example, when civil society representatives speak one-by-one at the end of a discussion, their interventions have little impact on the content or direction of the debate, WHO contends. Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, says the WHO. A virtual consultation by WHO further confirmed that non-state actors’ primary interests in attending governing body meetings are to participate in technical exchanges with the Secretariat and the Member States and to attend consultative hearings that feed into decision-making processes. Meaningful Participation From NGOs Critical, Member States Say The UK delegate said that it would allow NSAs to exert even more credible influence on member states attitudes and positions. The EB representative from the United States flagged that it is critical to ensure and enhance meaningful participation of non-state actors in WHO governing bodies, while also creating greater efficiency in the governance process. “Non-State actor participation must be allowed in a transparent and accountable manner with an open door to input from all stakeholders including the private sector,” the delegate noted. Austria pressed for the Secretariat to provide some more detailed information on the procedure for these meetings. Other states, like Australia, flagged that the trial is very ambitious given the agenda for the 2021 assembly is already very crowded. “We suggest that before agreeing to a trial, the number of meetings proposed to be repeated and streamlined,” the representative said.This would “provide reflections to technical areas in advance of the governing body meetings”. Civil Society Groups Request Clarity and Procedure Details Bodies like Health Action International asked for details as to how NGOs would participate, and for clarity on the processes governing such meetings. “It is a remaining concern to those who have witnessed creeping capacity shrinking of NGO space and poor consultation in recent years,” said an HAI statement. The HAI delegate requested that similar procedures be implemented for WHO regional meetings with member states, also asking that “these informal meetings compliment, but do not replace comprehensive consultations with non-state actors.” Meanwhile, the European Society for Medical Oncology said the views and expertise of non-state actors should be introduced earlier in the WHO decision-making process; it would be of greater value if delivered at the onset of projects, and when member states are drafting zero draft decisions and resolutions. “Direct interaction and discussion between member states, WHO offices, and Non-State actors would provide the opportunity for more in-depth exchanges, and partnerships, as the Member States, develop policies and implement actions to fulfill their WHO commitments,” said the ESMO spokesperson. Silberschmidt stressed that the virtual informal meetings will not replace other channels, but become an additional avenue for interaction – highlighting the fact that Dr Tedros Adhanom Ghebreyesus, WHO Director General, has already established a regular dialogue with civil society groups, to be held every six weeks. Image Credits: WHO / Christopher Black. 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.
Africa CDC Head calls for ‘Common Approach’ To Travel Restrictions Based on COVID Test & Not ‘National Origins’; 7 African Nations Report SARS-CoV-2 Variants 28/01/2021 Paul Adepoju Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy and not geographic or national origins, Africa CDC Director Dr John Nkengasong has said. IBADAN – Five African countries have now confirmed cases of the SARS-CoV-2 501Y.V2 variant, which first appeared in South Africa, and there is concern that the variant is circulating undetected elsewhere on the continent. The Gambia and Nigeria have seen cases of the variant B.1.1.7, first identified in the United Kingdom, said WHO’s African Regional Director today, Dr. Matshidiso Moeti, at a press briefing. Meanwhile, Africa CDC Director, Dr John Nkengasong, called for a “common approach” to COVID testing to oil the wings of international air travel – and halt the wave of new travel restrictions that countries have been imposing based on people’s national origin or the origins of flights – including people and flights arriving to Europe and the United States from South Africa. Researchers now believe the variants may be both more infectious but also more deadly than the COVID virus strains that were prevalent until just recently. Researchers also fear the variants could also elude COVID tests and be more resilient to vaccines just being rolled out now – although many unknowns remain. The countries where 501Y.V2 is circulating include: Botswana, Ghana, Kenya and Zambia, as well as South Africa. Beyond Africa, the variant has been confirmed in 24 countries globally. And there’s concern, it is circulating undetected in other countries in Africa,” Moeti told the press briefing. Dr. Matshidiso Moeti, WHO’s African Regional Director. “We are seeing more and more cases of variants and 501Y.V2, which was first identified in South Africa now, cropping up in other countries,” Moeti said. “The evidence suggests that these variants are more transmissible and emerging evidence indicates that the UK variant may cause more severe illness than other common strains, although more research needs to be done.” These variants in conjunction with “the aftermath of year-end gatherings”, Moeti said, “risk powering a perfect storm and driving up Africa’s second wave and overwhelming health facilities”. The continent saw a 50% rise in infections between 29 December 2020 and 25 January 2021, when compared with the previous four weeks, while deaths doubled. Last week, more than 6,200 deaths were reported across Africa, said the WHO.The past week saw a small dip in cases in South Africa, but 22 other countries continued to see numbers surge. Existing COVID-19 vaccines remain effective against the variants, Moeti said. But Professor Tulio de Oliveira, of the University of KwaZuku-Natal, South Africa, noted that these or other emerging variants may likely require individuals receiving booster doses of the vaccine. WHO’s African Region is meanwhile setting up a new surveillance network with Africa CDC to track the spread of the virus mutations and variants across Africa and beyond, Moeti added. “The variant which was first detected in South Africa has spread quickly beyond Africa and so what’s keeping me awake at night right now is that it’s very likely circulating in a number of African countries,” said Moeti. “Africa is at a crossroads. We must stick to our guns and double down on the tactics we know work so well. That is mask wearing, handwashing and safe social distancing. Countless lives depend on it.” WHO’s African CDC Calls for Common COVID Testing Approach For International Travel Dr John Nkengasong issued his call for a rethink of travel policies after several foreign countries, including the United States, are considering or have already banned flights originating from South Africa. Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy – and not geographic or national origins, said Nkengasong. “We should not be banning people because of their geographical origin, but we should be encouraging people to travel with negative tests and facilitate the testing process so that people can travel with a negative test,” Nkengasong said. “If I were to go to Kenya and I show up at the airport with a valid negative test, I pose no threat to the country of Kenya, and that way so you shouldn’t just ban me because I’m coming from a certain country. They should be looking at that test, is your test valid,” Nkengasong added. Dr John Nkengasong, Director of the Africa CDC. Up until now, the World Health Organization has resisted recommending pre-travel COVID testing, ostensibly due to fears that it would put an unnecessary onus on poor countries. In fact, however, many of the poorest African and Asian countries have been requiring pre-flight COVID tests for all incoming passengers – which are paid for privately. Some counties, such as the Democratic Republic of Congo, also demand arrivals briefly quarantine until a post-flight test is completed as well, paid privately as well. Paradoxically, it is wealthier European and American countries that first issued a rash of orders banning passengers of certain nationalities or flights from certain destinations as a result of variant scares – although more developed countries, most recently Switzerland on Wednesday, have adopted testing requirements. Senegal’s Pasteur Institute – At Center Of New Genetic Surveillance Network At the outset of the pandemic, most countries in Africa lacked adequate testing capacity for COVID-19 but this was gradually surmounted as new testing facilities were added. Now, however, the identification of new variants of the virus will require more advanced capacities for gene sequencing that several countries in Africa have yet to obtain. To address this vacuum, the Africa CDC, the WHO and member countries have created a network that enables existing labs with gene sequencing capabilities to collect samples from countries that lack such. One of the labs in the network is the Dakar-based Institut Pasteur de Dakar in Senegal. Its CEO, Dr Amadou Sall, said in addition to providing gene sequencing services for Senegal, the institute is now supporting other countries, Cameroon and Equatorial Guinea notably. Others include Mali, Burkina Faso Guinea-Bissau, Côte d’Ivoire, Niger, Verde, and of course, Guinea. “With the partnership we have with Africa CDC and WHO, we have the possibility of sequencing 500 genomes per week. And we’re trying to increase this capacity and to make these capacities available in different countries,” Sall said. Key to the success of COVID-19 genomic surveillance in Africa, Sall said, will be the willingness and openness of African countries to share information. “We need to be able to share information data and the Pasteur Institute is at the center of a global platform and we’re able to share information; to exchange information rapidly, if countries are willing to do so,” he said. Knowing When to Raise the Alarm While noting that identification of new variants is a significant feat, genomic experts warned that alarm should not be raised every time a new strain is identified. Professor de Oliveira, who heads the KwaZulu-Natal Research and Innovation Sequencing Platform, said attention is raised when new strains are being confirmed in increasing numbers of cases with the new variant and not when just one case has been confirmed. Describing the impacts that variants have on the epidemiology of the pandemic in South Africa, Oliveira said in some regions, the new variant has become the prominent type. But beyond this, he said South Africa is also worried about the variants from elsewhere getting into the country and circulating among its populations. “Today, we just reported the first important case of the B.1.1.7, the variant of concern that is circulating in the UK. And it’s quite common that in addition to our main variant that is dominating, we’re going to still have introductions of new lineages,” Oliveira said. “And in the case they begin to spread very fast, then we will communicate it and then highlight that could be a variant of concern.” He said that while no one can know for sure about the possibility of third or fourth waves of the pandemic in Africa, the variants are highlighting the need for the entire world to globally control the transmission of SARS-CoV-2 as a global community. “We have to really decrease transmission to avoid the next waves and more worry that emergence of new variants of concern will transmit too fast or evade immune response,” he said. “The appearance of these variants in the African continent, but also in South America and Europe really means that more than ever, it is the time that we don’t leave any continent behind, especially on vaccination,” Oliveira said. Silver Lining In Cloud – Variants Also Impetus For Cooperation But within Africa itself, Sall said the various SARS-CoV-2 variants constitute a new impetus for cooperation between countries, to be able to track and measure the circulation of the virus, and to enhance diagnostic capacities that he said will soon be available across Africa. “The new variants are the object of a very thorough study, and the path of our countries is very clear: obtain maximum information and adapt the strategy to contain the transmission,” he said. Moeti enjoined countries and individuals to strive to overcome COVID-19 fatigue and return to the fundamental actions that have been found to be effective against these variants. These measures, she said, need much more emphasis that news that the virus is much more transmissible. “The vaccine is a tool that’s going to make a huge difference all over the world,” she said. But she reminded that “having a corner of the world not protected, the way the world’s economies and peoples are connected, will have negative economic impact even in those countries that managed to vaccinate the entire population. We really are all in it together, and we have to work to support each other to overcome this global crisis.” Image Credits: Paul Adepoju/HealthPolicyWatch, Africa CDC. EU Protests AstraZeneca Vaccine Delays – Could Block UK-Bound Exports 28/01/2021 Madeleine Hoecklin The Oxford/AstraZeneca vaccine is 2 months behind schedule due to an issue in manufacturing. AstraZeneca has joined Pfizer in announcing delays in deliveries of COVID-19 vaccines to countries in Europe, leading furious EU officials to plan for a system of tighter monitoring of vaccine exports. The British-Swedish pharma company that developed its COVID-19 vaccine with researchers at Oxford University, informed the European Commission on Friday that there would be a 60% shortfall in vaccine deliveries this quarter due to a manufacturing issue at a production plant in Belgium. The company is reportedly two months behind schedule with regard to vaccines destined for European countries. Since vaccine deals with the United States and the United Kingdom were signed earlier on, and are based around manufacturing sites in those countries, the company has had a headstart in resolving “glitches” in those supply chains, pharma officials said. But the Commission had its doubts over this given explanation. Following an EU-requested investigation into AstraZeneca’s Belgian-based production facility on Wednesday, the European Commission has said it would establish a new mechanism that grants national regulators the power to refuse exports of vaccines. The mechanism – the criteria for which is expected to be published on Friday – could throw the security of the UK’s 40m-dose deal with Pfizer/BioNTech. The investigation, a spokesperson for the Belgian health ministry said, was to “make sure that the delivery delay is indeed due to a production problem on the Belgian site”. AstraZeneca ‘Scaling Up’ Doses, As EU Leaders Question Pharma Company Pascal Soriot, CEO of AstraZeneca “We are scaling up to hundreds of millions, billions of doses of vaccines at a very high speed. A year ago we didn’t have a vaccine. When you do that, you have glitches, you have scale-up problems. Therefore, the yield varies,” said Pascal Soriot, CEO of AstraZeneca, in an interview with la Repubblica, an Italian newspaper, on Tuesday. News of the delays was met with frustration by EU officials and leaders, who were expecting to receive 80 million doses by the end of March. “This new schedule is not acceptable to the European Union,” said Stella Kyriakides, European Commissioner for Health and Food Safety, in a statement released on Monday. “The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far, and if, or to whom, they have been delivered.” Stella Kyriakides, European Commissioner for Health and Food Safety, at a press briefing on Wednesday. Soriot disputed suggestions that the company sold the doses elsewhere for a higher price, claiming that “there is a lot of silly talk going on right now about all sorts of things,” and the response from the European Commission and EU member states is because “there are a lot of emotions running in this process right now.” “The suggestion [that] we sell to other countries to make more money is not right because we make no profit everywhere…That’s the agreement we have with Oxford University,” said Soriot. “Governments are under pressure. Everybody is getting kind of…aggravated or emotional about those things. But I understand because the Commission is managing the process for the whole of Europe,” he added. In late August, the EU made an upfront payment of €336 million to the company to secure 300 million doses of the vaccine. EU officials have disputed AstraZeneca’s explanation of production issues, claiming there are no excuses for the delay. “The flimsy justification that there are difficulties in the EU supply chain but not anywhere else does not hold water, as it is of course no problem to get the vaccine from the UK to the continent,” said Peter Liese, an EU parliamentarian from Germany’s Christian Democratic Union. Currently AstraZeneca is producing 17 million doses per month. That number will reach 100 million doses from February onwards, according to Soriot, meaning 1.2 billion doses per year. And Europe will receive 17% of the global production in February for a population that represents 5% of the world’s population. The Oxford/AstraZeneca vaccine is in the final stages of the approval process with the European Medicines Agency (EMA) and is expected to receive the recommendation for market authorization on Friday. After being approved, the company plans to deliver three million doses immediately. Meetings between EU officials and AstraZeneca have done little to resolve the issue, with Kyriakides announcing on Twitter: “Discussions with @AstraZeneca today resulted in dissatisfaction with the lack of clarity and insufficient explanations. EU Member States are united: vaccine developers have societal and contractual responsibilities they need to uphold.” With our Member States, we have requested from AZ a detailed planning of vaccine deliveries and when distribution will take place to Member States. Another meeting will be convened on Wednesday to discuss the matter further. — Stella Kyriakides (@SKyriakidesEU) January 25, 2021 The EU Steering Board, the body that oversees vaccine deals, plans to meet with AstraZeneca again on Wednesday at 6:30pm CET and hopes to “resolve this in a spirit of collaboration and responsibility,” according to Kyriakides. The Italian government plans to take legal action against Pfizer and AstraZeneca over their delays in deliveries, according to an announcement made by Foreign Minister Luigi Di Maio on Sunday. “This is a European contract that Pfizer and AstraZeneca are not respecting and so for this reason we will take legal action,” Di Maio said on RAI state television. “We are activating all channels so that the EU Commission does all it can to make these gentlemen respect their contracts.” According to Soriot, however, the vaccine deal signed with the EU was not a contractual commitment but a best effort, so there is no feasible basis for legal action. EU to Establish a Vaccine Export Transparency Mechanism The Oxford/AstraZeneca vaccine is also considered one with global potential – due to its ability to be stored at refrigerator temperatures. Amidst some countries’ suspicions that countries outside Europe are receiving priority for vaccines produced at the Belgium plant, the European Commission announced plans to establish an export transparency mechanism for vaccines to ensure clarity on transactions and to protect its investments in the R&D that led to development of vaccines like AstraZeneca’s. AstraZeneca is also a major supplier of the WHO COVAX global distribution initiative – which has pledged to begin distributing vaccine doses to the 92 lowest-income countries in the world within the next two months. Although most of the COVAX supplies were reportedly to be produced by India’s Serum Institute or in the Republic of Korea, the exact supply lines remain unclear. “Europe invested billions to help develop the world’s first COVID-19 vaccines…And now, the companies must deliver,” said Ursula von der Leyen, President of the European Commission, at the World Economic Forum on Tuesday. “They must honor their obligations. This is why we will set up a vaccine export transparency mechanism. Europe is determined to contribute to this global common good. But it also means business.” Ursula von der Leyen, President of the European Commission, speaking at the World Economic Forum on Tuesday. “In the future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries,” said Commissioner Kyriakides. The aim of the proposed system will be to monitor, but not block, exports, officials said. And humanitarian deliveries would be anyway exempt from this oversight mechanism. EMA Yet To Issue Final Approval – Insufficient Data on Vaccine in Older People Meanwhile, the EMA has yet to issue its final regulatory approval for the two-dose Oxford/AstraZeneca vaccine, and is reportedly considering limiting the age range to people under the age of 65 – due to a lack of data on effectiveness in older people. Unlike mRNA counterparts produced by Moderna and Pfizer, the AstraZeneca/Oxford vaccine uses a disabled, modified version of a chimpanzee adenovirus that can enter human cells but cannot replicate or cause the disease, as a vector to deliver a fragment of SARS-CoV2 spike protein, stimulating COVID-19 immunity. According to data shared by the company, only 10% of participants in the vaccine clinical trials were over the age of 65 because it was first waiting for sufficient safety data in the 18 to 55 age group before vaccinating older individuals. “We don’t have a huge number of older people who have been vaccinated,” said Soriot. “But we have strong data showing very strong antibody production against the virus in the elderly, similar to what we see in younger people.” The results of an ongoing, larger Phase 3 clinical trial with 30,000 participants being conducted in the United States are expected to provide insight into the protection the vaccine provides to older individuals and ethnic minorities populations – groups that were not very well represented in previous trials. In addition, scientists are exploring whether a half-dose of the first vaccine would reliably yield a higher efficacy rating of 90% that was seen in initial trials. The other regime, involving two full doses was only 62% effective, according to the results released by the company in late November and reviewed by an independent Data and Safety Monitoring Board. That still meets key global benchmarks for efficacy, but is significantly lower than the 94-95% efficacy results for the Moderna and Pfizer mRNA vaccines. The AstraZeneca vaccine has, however, already been authorized in the UK, is already being used in British vaccination campaigns, including for people over 70 years old. Image Credits: AstraZeneca, AstraZeneca, Twitter, Twitter. WHO Proposes New Mode Of Engaging With Non-State Actors 28/01/2021 Esther Nakkazi Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, according to WHO. The World Health Organization (WHO) aims to make its engagement with non-state actors (non-state actors) more meaningful and efficient with a new proposal to establish a number of NSA fora that would allow exchange with WHO and member state representatives outside of official meetings. The new proposal — which will be tested during the 74th World Health Assembly (WHA), 24 May to 1 June — would offer multiple side events in which non-state (NSA) actors could engage more informally with member state representatives as well as a forum for exchange between NSAs and WHO regional and technical staff. But at the same time, non-state actors will be allotted a more limited number of constituency statements in formal governing body meetings – and like-minded groups of actors will be asked to combine their official statements together. Non-state actors include civil society groups such as non-governmental organizations, international business and professional associations, and philanthropic foundations. More than 70 non-state actors are recognized as being “in official relations” with WHO, and thus contribute in formal meetings such as the EB and the WHA. However, EB and WHA members have complained that the civil society interventions have become bogged down by too many lengthy, individual statements – and NSAs acknowledge that the statements often had limited impact in member state debates. More informal meetings ahead of the formal meeting dates would help engender more meaningful interaction, WHO said in its proposal for the reform, which was reviewed by the WHO Executive Board on Saturday. Informal meetings will also allow non-state actors to organize themselves into constituencies, consolidating their positions into joint statements to be presented at official events. The new arrangements to be tested in May, will “serve as a trial for potential future virtual informal meetings between non-state actors, Member States and the Secretariat, as a means of enabling more in-depth technical exchanges, as well as discussions on the Health Assembly agenda items,” said the WHO Secretariat, in its presentation to the EB on Saturday. The COVID-19 pandemic has provided added impetus for reforms that have long been in the making – insofar as the limitations of virtual meetings have also curtailed the interactions between member states and non-state actors. According to the new proposal, the informal series of meetings with non-state actors will be held just ahead of the WHA, and thus prepare the groundwork for the formal meeting. Role of Non-State Actors Has Evolved – But Increasing Number of Statements Detracted from Impact In the discussion over the proposal, WHO officials stressed that the Organization “is and remains a Member State Organisation” — engaging with 77 non-state actors, at global, regional and country levels, who also support the development and implementation of the Organization’s policies and recommendations, technical norms and standards. But while non-state actors have “served the Organization well for several decades”, the increasing number of non-governmental organizations and other non-state actors participating — often with a greater number of requests to speak — has “not resulted in a more meaningful involvement”. For example, when civil society representatives speak one-by-one at the end of a discussion, their interventions have little impact on the content or direction of the debate, WHO contends. Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, says the WHO. A virtual consultation by WHO further confirmed that non-state actors’ primary interests in attending governing body meetings are to participate in technical exchanges with the Secretariat and the Member States and to attend consultative hearings that feed into decision-making processes. Meaningful Participation From NGOs Critical, Member States Say The UK delegate said that it would allow NSAs to exert even more credible influence on member states attitudes and positions. The EB representative from the United States flagged that it is critical to ensure and enhance meaningful participation of non-state actors in WHO governing bodies, while also creating greater efficiency in the governance process. “Non-State actor participation must be allowed in a transparent and accountable manner with an open door to input from all stakeholders including the private sector,” the delegate noted. Austria pressed for the Secretariat to provide some more detailed information on the procedure for these meetings. Other states, like Australia, flagged that the trial is very ambitious given the agenda for the 2021 assembly is already very crowded. “We suggest that before agreeing to a trial, the number of meetings proposed to be repeated and streamlined,” the representative said.This would “provide reflections to technical areas in advance of the governing body meetings”. Civil Society Groups Request Clarity and Procedure Details Bodies like Health Action International asked for details as to how NGOs would participate, and for clarity on the processes governing such meetings. “It is a remaining concern to those who have witnessed creeping capacity shrinking of NGO space and poor consultation in recent years,” said an HAI statement. The HAI delegate requested that similar procedures be implemented for WHO regional meetings with member states, also asking that “these informal meetings compliment, but do not replace comprehensive consultations with non-state actors.” Meanwhile, the European Society for Medical Oncology said the views and expertise of non-state actors should be introduced earlier in the WHO decision-making process; it would be of greater value if delivered at the onset of projects, and when member states are drafting zero draft decisions and resolutions. “Direct interaction and discussion between member states, WHO offices, and Non-State actors would provide the opportunity for more in-depth exchanges, and partnerships, as the Member States, develop policies and implement actions to fulfill their WHO commitments,” said the ESMO spokesperson. Silberschmidt stressed that the virtual informal meetings will not replace other channels, but become an additional avenue for interaction – highlighting the fact that Dr Tedros Adhanom Ghebreyesus, WHO Director General, has already established a regular dialogue with civil society groups, to be held every six weeks. Image Credits: WHO / Christopher Black. 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 Protests AstraZeneca Vaccine Delays – Could Block UK-Bound Exports 28/01/2021 Madeleine Hoecklin The Oxford/AstraZeneca vaccine is 2 months behind schedule due to an issue in manufacturing. AstraZeneca has joined Pfizer in announcing delays in deliveries of COVID-19 vaccines to countries in Europe, leading furious EU officials to plan for a system of tighter monitoring of vaccine exports. The British-Swedish pharma company that developed its COVID-19 vaccine with researchers at Oxford University, informed the European Commission on Friday that there would be a 60% shortfall in vaccine deliveries this quarter due to a manufacturing issue at a production plant in Belgium. The company is reportedly two months behind schedule with regard to vaccines destined for European countries. Since vaccine deals with the United States and the United Kingdom were signed earlier on, and are based around manufacturing sites in those countries, the company has had a headstart in resolving “glitches” in those supply chains, pharma officials said. But the Commission had its doubts over this given explanation. Following an EU-requested investigation into AstraZeneca’s Belgian-based production facility on Wednesday, the European Commission has said it would establish a new mechanism that grants national regulators the power to refuse exports of vaccines. The mechanism – the criteria for which is expected to be published on Friday – could throw the security of the UK’s 40m-dose deal with Pfizer/BioNTech. The investigation, a spokesperson for the Belgian health ministry said, was to “make sure that the delivery delay is indeed due to a production problem on the Belgian site”. AstraZeneca ‘Scaling Up’ Doses, As EU Leaders Question Pharma Company Pascal Soriot, CEO of AstraZeneca “We are scaling up to hundreds of millions, billions of doses of vaccines at a very high speed. A year ago we didn’t have a vaccine. When you do that, you have glitches, you have scale-up problems. Therefore, the yield varies,” said Pascal Soriot, CEO of AstraZeneca, in an interview with la Repubblica, an Italian newspaper, on Tuesday. News of the delays was met with frustration by EU officials and leaders, who were expecting to receive 80 million doses by the end of March. “This new schedule is not acceptable to the European Union,” said Stella Kyriakides, European Commissioner for Health and Food Safety, in a statement released on Monday. “The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far, and if, or to whom, they have been delivered.” Stella Kyriakides, European Commissioner for Health and Food Safety, at a press briefing on Wednesday. Soriot disputed suggestions that the company sold the doses elsewhere for a higher price, claiming that “there is a lot of silly talk going on right now about all sorts of things,” and the response from the European Commission and EU member states is because “there are a lot of emotions running in this process right now.” “The suggestion [that] we sell to other countries to make more money is not right because we make no profit everywhere…That’s the agreement we have with Oxford University,” said Soriot. “Governments are under pressure. Everybody is getting kind of…aggravated or emotional about those things. But I understand because the Commission is managing the process for the whole of Europe,” he added. In late August, the EU made an upfront payment of €336 million to the company to secure 300 million doses of the vaccine. EU officials have disputed AstraZeneca’s explanation of production issues, claiming there are no excuses for the delay. “The flimsy justification that there are difficulties in the EU supply chain but not anywhere else does not hold water, as it is of course no problem to get the vaccine from the UK to the continent,” said Peter Liese, an EU parliamentarian from Germany’s Christian Democratic Union. Currently AstraZeneca is producing 17 million doses per month. That number will reach 100 million doses from February onwards, according to Soriot, meaning 1.2 billion doses per year. And Europe will receive 17% of the global production in February for a population that represents 5% of the world’s population. The Oxford/AstraZeneca vaccine is in the final stages of the approval process with the European Medicines Agency (EMA) and is expected to receive the recommendation for market authorization on Friday. After being approved, the company plans to deliver three million doses immediately. Meetings between EU officials and AstraZeneca have done little to resolve the issue, with Kyriakides announcing on Twitter: “Discussions with @AstraZeneca today resulted in dissatisfaction with the lack of clarity and insufficient explanations. EU Member States are united: vaccine developers have societal and contractual responsibilities they need to uphold.” With our Member States, we have requested from AZ a detailed planning of vaccine deliveries and when distribution will take place to Member States. Another meeting will be convened on Wednesday to discuss the matter further. — Stella Kyriakides (@SKyriakidesEU) January 25, 2021 The EU Steering Board, the body that oversees vaccine deals, plans to meet with AstraZeneca again on Wednesday at 6:30pm CET and hopes to “resolve this in a spirit of collaboration and responsibility,” according to Kyriakides. The Italian government plans to take legal action against Pfizer and AstraZeneca over their delays in deliveries, according to an announcement made by Foreign Minister Luigi Di Maio on Sunday. “This is a European contract that Pfizer and AstraZeneca are not respecting and so for this reason we will take legal action,” Di Maio said on RAI state television. “We are activating all channels so that the EU Commission does all it can to make these gentlemen respect their contracts.” According to Soriot, however, the vaccine deal signed with the EU was not a contractual commitment but a best effort, so there is no feasible basis for legal action. EU to Establish a Vaccine Export Transparency Mechanism The Oxford/AstraZeneca vaccine is also considered one with global potential – due to its ability to be stored at refrigerator temperatures. Amidst some countries’ suspicions that countries outside Europe are receiving priority for vaccines produced at the Belgium plant, the European Commission announced plans to establish an export transparency mechanism for vaccines to ensure clarity on transactions and to protect its investments in the R&D that led to development of vaccines like AstraZeneca’s. AstraZeneca is also a major supplier of the WHO COVAX global distribution initiative – which has pledged to begin distributing vaccine doses to the 92 lowest-income countries in the world within the next two months. Although most of the COVAX supplies were reportedly to be produced by India’s Serum Institute or in the Republic of Korea, the exact supply lines remain unclear. “Europe invested billions to help develop the world’s first COVID-19 vaccines…And now, the companies must deliver,” said Ursula von der Leyen, President of the European Commission, at the World Economic Forum on Tuesday. “They must honor their obligations. This is why we will set up a vaccine export transparency mechanism. Europe is determined to contribute to this global common good. But it also means business.” Ursula von der Leyen, President of the European Commission, speaking at the World Economic Forum on Tuesday. “In the future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries,” said Commissioner Kyriakides. The aim of the proposed system will be to monitor, but not block, exports, officials said. And humanitarian deliveries would be anyway exempt from this oversight mechanism. EMA Yet To Issue Final Approval – Insufficient Data on Vaccine in Older People Meanwhile, the EMA has yet to issue its final regulatory approval for the two-dose Oxford/AstraZeneca vaccine, and is reportedly considering limiting the age range to people under the age of 65 – due to a lack of data on effectiveness in older people. Unlike mRNA counterparts produced by Moderna and Pfizer, the AstraZeneca/Oxford vaccine uses a disabled, modified version of a chimpanzee adenovirus that can enter human cells but cannot replicate or cause the disease, as a vector to deliver a fragment of SARS-CoV2 spike protein, stimulating COVID-19 immunity. According to data shared by the company, only 10% of participants in the vaccine clinical trials were over the age of 65 because it was first waiting for sufficient safety data in the 18 to 55 age group before vaccinating older individuals. “We don’t have a huge number of older people who have been vaccinated,” said Soriot. “But we have strong data showing very strong antibody production against the virus in the elderly, similar to what we see in younger people.” The results of an ongoing, larger Phase 3 clinical trial with 30,000 participants being conducted in the United States are expected to provide insight into the protection the vaccine provides to older individuals and ethnic minorities populations – groups that were not very well represented in previous trials. In addition, scientists are exploring whether a half-dose of the first vaccine would reliably yield a higher efficacy rating of 90% that was seen in initial trials. The other regime, involving two full doses was only 62% effective, according to the results released by the company in late November and reviewed by an independent Data and Safety Monitoring Board. That still meets key global benchmarks for efficacy, but is significantly lower than the 94-95% efficacy results for the Moderna and Pfizer mRNA vaccines. The AstraZeneca vaccine has, however, already been authorized in the UK, is already being used in British vaccination campaigns, including for people over 70 years old. Image Credits: AstraZeneca, AstraZeneca, Twitter, Twitter. WHO Proposes New Mode Of Engaging With Non-State Actors 28/01/2021 Esther Nakkazi Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, according to WHO. The World Health Organization (WHO) aims to make its engagement with non-state actors (non-state actors) more meaningful and efficient with a new proposal to establish a number of NSA fora that would allow exchange with WHO and member state representatives outside of official meetings. The new proposal — which will be tested during the 74th World Health Assembly (WHA), 24 May to 1 June — would offer multiple side events in which non-state (NSA) actors could engage more informally with member state representatives as well as a forum for exchange between NSAs and WHO regional and technical staff. But at the same time, non-state actors will be allotted a more limited number of constituency statements in formal governing body meetings – and like-minded groups of actors will be asked to combine their official statements together. Non-state actors include civil society groups such as non-governmental organizations, international business and professional associations, and philanthropic foundations. More than 70 non-state actors are recognized as being “in official relations” with WHO, and thus contribute in formal meetings such as the EB and the WHA. However, EB and WHA members have complained that the civil society interventions have become bogged down by too many lengthy, individual statements – and NSAs acknowledge that the statements often had limited impact in member state debates. More informal meetings ahead of the formal meeting dates would help engender more meaningful interaction, WHO said in its proposal for the reform, which was reviewed by the WHO Executive Board on Saturday. Informal meetings will also allow non-state actors to organize themselves into constituencies, consolidating their positions into joint statements to be presented at official events. The new arrangements to be tested in May, will “serve as a trial for potential future virtual informal meetings between non-state actors, Member States and the Secretariat, as a means of enabling more in-depth technical exchanges, as well as discussions on the Health Assembly agenda items,” said the WHO Secretariat, in its presentation to the EB on Saturday. The COVID-19 pandemic has provided added impetus for reforms that have long been in the making – insofar as the limitations of virtual meetings have also curtailed the interactions between member states and non-state actors. According to the new proposal, the informal series of meetings with non-state actors will be held just ahead of the WHA, and thus prepare the groundwork for the formal meeting. Role of Non-State Actors Has Evolved – But Increasing Number of Statements Detracted from Impact In the discussion over the proposal, WHO officials stressed that the Organization “is and remains a Member State Organisation” — engaging with 77 non-state actors, at global, regional and country levels, who also support the development and implementation of the Organization’s policies and recommendations, technical norms and standards. But while non-state actors have “served the Organization well for several decades”, the increasing number of non-governmental organizations and other non-state actors participating — often with a greater number of requests to speak — has “not resulted in a more meaningful involvement”. For example, when civil society representatives speak one-by-one at the end of a discussion, their interventions have little impact on the content or direction of the debate, WHO contends. Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, says the WHO. A virtual consultation by WHO further confirmed that non-state actors’ primary interests in attending governing body meetings are to participate in technical exchanges with the Secretariat and the Member States and to attend consultative hearings that feed into decision-making processes. Meaningful Participation From NGOs Critical, Member States Say The UK delegate said that it would allow NSAs to exert even more credible influence on member states attitudes and positions. The EB representative from the United States flagged that it is critical to ensure and enhance meaningful participation of non-state actors in WHO governing bodies, while also creating greater efficiency in the governance process. “Non-State actor participation must be allowed in a transparent and accountable manner with an open door to input from all stakeholders including the private sector,” the delegate noted. Austria pressed for the Secretariat to provide some more detailed information on the procedure for these meetings. Other states, like Australia, flagged that the trial is very ambitious given the agenda for the 2021 assembly is already very crowded. “We suggest that before agreeing to a trial, the number of meetings proposed to be repeated and streamlined,” the representative said.This would “provide reflections to technical areas in advance of the governing body meetings”. Civil Society Groups Request Clarity and Procedure Details Bodies like Health Action International asked for details as to how NGOs would participate, and for clarity on the processes governing such meetings. “It is a remaining concern to those who have witnessed creeping capacity shrinking of NGO space and poor consultation in recent years,” said an HAI statement. The HAI delegate requested that similar procedures be implemented for WHO regional meetings with member states, also asking that “these informal meetings compliment, but do not replace comprehensive consultations with non-state actors.” Meanwhile, the European Society for Medical Oncology said the views and expertise of non-state actors should be introduced earlier in the WHO decision-making process; it would be of greater value if delivered at the onset of projects, and when member states are drafting zero draft decisions and resolutions. “Direct interaction and discussion between member states, WHO offices, and Non-State actors would provide the opportunity for more in-depth exchanges, and partnerships, as the Member States, develop policies and implement actions to fulfill their WHO commitments,” said the ESMO spokesperson. Silberschmidt stressed that the virtual informal meetings will not replace other channels, but become an additional avenue for interaction – highlighting the fact that Dr Tedros Adhanom Ghebreyesus, WHO Director General, has already established a regular dialogue with civil society groups, to be held every six weeks. Image Credits: WHO / Christopher Black. 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
WHO Proposes New Mode Of Engaging With Non-State Actors 28/01/2021 Esther Nakkazi Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, according to WHO. The World Health Organization (WHO) aims to make its engagement with non-state actors (non-state actors) more meaningful and efficient with a new proposal to establish a number of NSA fora that would allow exchange with WHO and member state representatives outside of official meetings. The new proposal — which will be tested during the 74th World Health Assembly (WHA), 24 May to 1 June — would offer multiple side events in which non-state (NSA) actors could engage more informally with member state representatives as well as a forum for exchange between NSAs and WHO regional and technical staff. But at the same time, non-state actors will be allotted a more limited number of constituency statements in formal governing body meetings – and like-minded groups of actors will be asked to combine their official statements together. Non-state actors include civil society groups such as non-governmental organizations, international business and professional associations, and philanthropic foundations. More than 70 non-state actors are recognized as being “in official relations” with WHO, and thus contribute in formal meetings such as the EB and the WHA. However, EB and WHA members have complained that the civil society interventions have become bogged down by too many lengthy, individual statements – and NSAs acknowledge that the statements often had limited impact in member state debates. More informal meetings ahead of the formal meeting dates would help engender more meaningful interaction, WHO said in its proposal for the reform, which was reviewed by the WHO Executive Board on Saturday. Informal meetings will also allow non-state actors to organize themselves into constituencies, consolidating their positions into joint statements to be presented at official events. The new arrangements to be tested in May, will “serve as a trial for potential future virtual informal meetings between non-state actors, Member States and the Secretariat, as a means of enabling more in-depth technical exchanges, as well as discussions on the Health Assembly agenda items,” said the WHO Secretariat, in its presentation to the EB on Saturday. The COVID-19 pandemic has provided added impetus for reforms that have long been in the making – insofar as the limitations of virtual meetings have also curtailed the interactions between member states and non-state actors. According to the new proposal, the informal series of meetings with non-state actors will be held just ahead of the WHA, and thus prepare the groundwork for the formal meeting. Role of Non-State Actors Has Evolved – But Increasing Number of Statements Detracted from Impact In the discussion over the proposal, WHO officials stressed that the Organization “is and remains a Member State Organisation” — engaging with 77 non-state actors, at global, regional and country levels, who also support the development and implementation of the Organization’s policies and recommendations, technical norms and standards. But while non-state actors have “served the Organization well for several decades”, the increasing number of non-governmental organizations and other non-state actors participating — often with a greater number of requests to speak — has “not resulted in a more meaningful involvement”. For example, when civil society representatives speak one-by-one at the end of a discussion, their interventions have little impact on the content or direction of the debate, WHO contends. Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, says the WHO. A virtual consultation by WHO further confirmed that non-state actors’ primary interests in attending governing body meetings are to participate in technical exchanges with the Secretariat and the Member States and to attend consultative hearings that feed into decision-making processes. Meaningful Participation From NGOs Critical, Member States Say The UK delegate said that it would allow NSAs to exert even more credible influence on member states attitudes and positions. The EB representative from the United States flagged that it is critical to ensure and enhance meaningful participation of non-state actors in WHO governing bodies, while also creating greater efficiency in the governance process. “Non-State actor participation must be allowed in a transparent and accountable manner with an open door to input from all stakeholders including the private sector,” the delegate noted. Austria pressed for the Secretariat to provide some more detailed information on the procedure for these meetings. Other states, like Australia, flagged that the trial is very ambitious given the agenda for the 2021 assembly is already very crowded. “We suggest that before agreeing to a trial, the number of meetings proposed to be repeated and streamlined,” the representative said.This would “provide reflections to technical areas in advance of the governing body meetings”. Civil Society Groups Request Clarity and Procedure Details Bodies like Health Action International asked for details as to how NGOs would participate, and for clarity on the processes governing such meetings. “It is a remaining concern to those who have witnessed creeping capacity shrinking of NGO space and poor consultation in recent years,” said an HAI statement. The HAI delegate requested that similar procedures be implemented for WHO regional meetings with member states, also asking that “these informal meetings compliment, but do not replace comprehensive consultations with non-state actors.” Meanwhile, the European Society for Medical Oncology said the views and expertise of non-state actors should be introduced earlier in the WHO decision-making process; it would be of greater value if delivered at the onset of projects, and when member states are drafting zero draft decisions and resolutions. “Direct interaction and discussion between member states, WHO offices, and Non-State actors would provide the opportunity for more in-depth exchanges, and partnerships, as the Member States, develop policies and implement actions to fulfill their WHO commitments,” said the ESMO spokesperson. Silberschmidt stressed that the virtual informal meetings will not replace other channels, but become an additional avenue for interaction – highlighting the fact that Dr Tedros Adhanom Ghebreyesus, WHO Director General, has already established a regular dialogue with civil society groups, to be held every six weeks. Image Credits: WHO / Christopher Black. Posts navigation Older postsNewer posts