Pakistani Migrant Workers Fear Job Losses as Saudi Arabia and UAE Don’t Recognise Chinese Vaccines 28/06/2021 Rahul Basharat Rajput & Mohammed Nadeem Chaudhry Pakistani workers protest against being given Chinese vaccines. ISLAMABAD – Thousands of Pakistani migrant labourers fear that they might lose their jobs after the governments of Saudi Arabia and the United Arab Emirates (UAE) banned entry for Pakistanis vaccinated with COVID-19 vaccines produced in China. Meanwhile, Europe’s digital ‘Green Pass’ is not available to those vaccinated by the AstraZeneca vaccine made by the Serum Institute of India – all the COVAX recipients – as the European Medicines Agency (EMA) has only approved the Vaxzevria version of the AstraZeneca vaccine that was produced and manufactured in the United Kingdom or other sites around Europe, Health Policy Watch reported last Friday. In the past two weeks, dozens of Pakistanis have held protests outside a mass vaccination center in Islamabad, demanding that health authorities vaccinate them only with vaccines approved by the two countries and not any of those produced by the Chinese. The UAE has authorised Sinopharm but Saudi Arabia has not authorised any of the Chinese COVID-19 vaccines, while most Pakistanis are vaccinated with Sinovac. The protestors say that if they are not vaccinated with the UAE and Saudi-approved vaccines, they will not be able to return to their jobs in those countries. Those who have not been vaccinated with vaccines approved by the Gulf states either face exclusion or have to undergo a 10-day quarantine at their own expense, which is unaffordable to ordinary workers. Last month, Saudi Arabia updated its travel restrictions to enable travellers vaccinated with the Pfizer, AstraZeneca, Moderna and Johnson & Johnson vaccines to enter the country – excluding the five vaccines produced by China, including Sinovac and Sinopharm which have been widely used in Pakistan. Last week, the UAE lifted its ban on passengers from India, requiring them to be fully vaccinated and to undergo a PCR test on entry and remain in quarantine until the test results were known. Passengers from South Africa and Nigeria will also no longer be banned from the UAE. Pakistan’s foreign office spokesperson, Zahid Hafeez Chaudhri, told a press briefing on 17 June that the UAE government had suspended the entry of passengers from Pakistan and some other South Asian countries in mid-May based on COVID-19 numbers. “We hope that the UAE will review its COVID-related advisory for all Pakistanis soon. Currently, Pakistanis having diplomatic and official visas and UAE Golden visas can travel to the UAE,” he said. “We have proposed inclusion of some of the Chinese vaccines used in Pakistan in the list of vaccines approved by the Saudi authorities. The Ministry of Foreign Affairs is actively pursuing this matter,” Chaudhri added. AstraZeneca to be Offered to Workers A few days earlier, the government had buckled under the pressure from the protesting workers and amended the criteria for those eligible for the AstraZeneca vaccine from 40 years and over to anyone above 18. However, a spokesperson for Pakistan’s Ministry of National Health Services Regulations and Coordination (NHSR&C), Sajid Hussain Shah, told Health Policy Watch that those under 40 would only be given the AstraZeneca jab after submitting a consent form. This decision had been taken after analysing the scientific data by the authorities and considering the situation of expats working in other countries. “Labour class and students would have to show work and study visas to get AstraZeneca jab. The vaccine will also be administered to work permit holders in Saudi Arabia,” Shah said. When asked about sudden change in the health guidelines of the AstraZeneca vaccine and its side effects, NHSR&C Director General Dr Rana Muhammad Safdar said that “there is no harm at all” in administering AstraZeneca to people below age 40. “Consent was required only as the expert committee recommended it under 40 due to limited availability of data,” said Safdar. However, the country faces a shortage of AstraZeneca vaccines, which are no longer being exported by its main manufacturer, the Serum Institute of India. Pervaiz Khan, one of the protesters from the north-western city of Mardan, works in a construction company in Saudi Arabia. Khan has prepared a ‘consent form’ declaring that he “has viewed the information related to adverse effects of the AstraZeneca vaccine and requests to get this vaccine”. “Our visas are getting expired, and we will lose our jobs if we don’t get Kingdom of Saudi Arabia (KSA) approved vaccine jabs,” said Khan. Pakistan Reneged on its Pfizer Announcement Pakistan had announced that it would administer the Pfizer vaccine to migrant workers returning to Gulf countries, but later reneged on this due to a lack of sufficient Pfizer vaccines, Khan said. Workers staged their first protest on 14 June when authorities changed the vaccines to be administered back to AstraZeneca due to a lack of Pfizer supplies, but now, even AstraZeneca is said to be in short supply. “This is a disappointing situation for low-income laborers struggling for their bread and butter in gulf countries, where Saudi Arabia does not approve Chinese vaccines, and the Pakistan government is not smoothly administering Pfizer and AstraZeneca to them,” a frustrated Khan said. Saudi Arabia has refused to recognize any Chinese-made vaccines for visitors and migrant workers; the UAE has only allowed SinoPharm vaccine for travelers entering the Gulf states. Pakistan has mostly administered Chinese vaccines including Sinopharm, SinoVac and CanSino to its citizens. Although Saudi Arabia and the UAE have imposed strict travel restrictions for Pakistani nationals, those visiting the United Kingdom (UK), European Union (EU) and the United States (US) have not faced such hurdles. The US, UK and EU made it compulsory for passengers from Pakistan to have a negative PCR COVID-19 test, but have not raised concerns about which vaccines travellers have received. Lower efficacy of Sinopharm and Sinovac China has sold and donated millions of Sinopharm and Sinovac doses to low-income countries in Asia, Latin America and Africa. However, there are concerns that the two vaccines are less efficacious than Pfizer, AstraZeneca Moderna and Sputnik-V vaccines following COVID-19 outbreaks in countries with high vaccination rates with these vaccines. However, the World Health Organization’s (WHO) Chief Scientist, Soumya Swaminathan, told a recent press briefing that more data was needed “from well-designed studies on the efficacy of the different vaccines that are in use in different countries against the different variants.” Latin America and the Asia-Pacific region have bought up around 80% of the 759 million doses of Chinese vaccines sold to date. About 511 million of these are from Sinovac, and the rest from Sinopharm. The WHO recently granted both vaccines Emergency Use Listing. Sinovac’s vaccine efficacy stands at 51% against symptomatic disease and 100% against severe disease, while Sinopharm showed an efficacy rate of 79% protection against mild and hospitalized disease. Health Policy Watch recently reported a surge in COVID-19 cases in a number of African and Latin American countries that had vaccinated fairly extensively with the Chinese vaccines. This has added to concerns about the lack of follow-up surveillance of the vaccine’s real-life impacts. Pakistan Reliance on Chinese Vaccines According to the NHSR&C, the country has procured about 14 million doses of five different COVID-19 vaccines. Of these, 12 million were from China, with one million doses each of AstraZeneca and Pfizer vaccines procured through COVAX, the global vaccine-sharing facility, Special Assistant to Prime Minister on Health Dr Faisal Sultan said that 76% of the vaccines had been bought and the remainder were donations. A total of 10 million doses of vaccine have been administered so far this month, according to the health ministry. As we reach our 10 millionth vaccine dose administered today, two things to consider: 1. Gratitude for everyone who has made this possible – too many to list in a tweet!2. A resolve to continue and enhance this process to allow us a return to normalcy — Faisal Sultan (@fslsltn) June 9, 2021 Director General Safdar told Health Policy Watch that another Chinese vaccine, CanSino, was being produced in the country under the name of PakVac, with 3 million doses being produced per month. Meanwhile Pfizer Pakistan and BioNTech SE announced an agreement last week with the Pakistan government to supply 13 million doses of their COVID-19 Vaccine (BNT162b2). Deliveries are expected during the course of 2021. Pakistan Depends on Remittances From Labour Force in Gulf Pakistan is considered a strategic partner to Saudi Arabia and the UAE. It provides a huge labor force to the Gulf countries, and they provide financial assistance to Pakistan’s unstable economy. Around 2.6 million Pakistanis are working in Saudi Arabia, while 1.5 million are in the UAE, according to the International Labor Organization (ILO). An August 2020 report by the State Bank of Pakistan states that in the 2019/2020 financial year, Pakistan workers’ remittances received from Saudi Arabia was US $ 821.6 million and UAE US $ 538.2 million). Most COVAX Vaccine Recipients Excluded From New EU COVID ‘Green Pass’ – Thanks to Unapproved AstraZeneca Jab 25/06/2021 Paul Adepoju & Elaine Ruth Fletcher WHO representative in Ghana, Francis Kasolo, on left, with UNICEF’s representative, Anne-Claire Dufay as first COVAX vaccine doses arrive on 24 February in Accra, Ghana, Most vaccine recipients won’t be eligible for an EU “Green Passport.” The much-trumpeted European Union COVID Digital Green Pass, which launches 1 July and is meant to vastly ease travel to Europe for vaccinated and recovered passengers is being rolled out with one important hitch. Anyone vaccinated with an AstraZeneca vaccine produced by the Serum Institute of India would not be qualified to get the pass – and that includes most citizens of low- and middle-income countries who were immunised with vaccines distributed by the WHO co-sponsored COVAX initiative. That’s because the EU green pass will only recognise the Vaxzevria version of the AstraZeneca vaccine that was produced and manufactured in the United Kingdom or other sites around Europe, and thus approved by the European Medicines Agency (EMA). In contrast, most of the COVAX facility’s global procurement and distribution was built around the “Covishield” AstraZeneca vaccine, produced by the Serum Institute of India. Rude Shock Proportion of different vaccines distributed by the COVAX initiative – Africa CDC As of 25 June, more than 89 million vaccines have been distributed by the COVAX initiative to some 133 mostly low- and middle-income countries of Africa, Asia and Latin America, according to Gavi, the Vaccine Alliance, which is administering the massive programme. That’s a drop in the ocean of the more than 2.6 billion doses of COVID vaccines administered so far globally, according to WHO. But, it constitutes the majority of vaccines received in many of the world’s poorest countries. According to the COVID-19 vaccination dashboard of the Africa CDC, over 90% of vaccine doses administered so far, are Covishield. Only Four EU-Approved Vaccines EU digital green passport Under the EU Digital COVID Certificate system, freedom will be restored to the region for individuals that have been fully vaccinated with one of the vaccines approved by EMA, in addition to individuals that have recently recovered from the virus, and those who tested negative. While WHO has opposed issuing COVID passports at all, a key practical bone of contention emerging is the non-inclusion of Covishield and other WHO-approved vaccines on the list of EMA-approved products that can be considered for the EU digital green pass. When Health Policy Watch searched for Covishield on EMA’s website, there was no record of the vaccine even though Vaxzevria, the version produced in Europe, is listed. Traveller information issued by the authorities of the “Schenghen Zone” which includes EU countries plus several other non-EU European states like Norway and Switzerland, also clearly states: “As the Member States reopen the borders for travel from non-EU countries for non-essential purposes, they also intend to issue EU COVID travel certificates to travellers from third countries intending to enter their territory. The Commission also intends to accept certificates issued in third countries, which are issued under the same conditions as the ones by the EU….In order for the traveller to be able to get the vaccine, he/she should be vaccinated with one of the EU-approved vaccines.” The advice adds, however, a caveat stating that individual: “Member States, can, however, issue the certificate even to those who have been vaccinated with other vaccines if they are willing to do so.” In all, only four vaccines have been authorised by the EMA, and they are ComirnatyⓇ (BioNTech, Pfizer), ModernaⓇ, Vaxzevria Ⓡ (previously COVID-19 Vaccine AstraZeneca) and JanssenⓇ (Johnson & Johnson). Covishield is not even listed among the vaccines that are under review by the agency which has listed CVnCoVⓇ (CureVac), NVX-CoV2373Ⓡ (Novavax), Sputnik V Ⓡ(Gam-COVID-Vac), COVID-19 VaccineⓇ (Vero Cell) and CoronaVac Ⓡ(Sinovac). Even though the passport regime is expected to go into effect next week, more than ten countries in the region, including Germany, Greece and Spain are already issuing the green digital pass. Second Class COVID Travellers The double standard of EU recognition for identical AstraZeneca vaccines is beginning to send ripples across the African continent and African media – stimulating anger as well as stoking vaccine hesitancy, as reported by the French media channel, RFI.fr this week. “When the [AstraZeneca] vaccine was received, representatives of the international community were present at Ivato airport in Antananarivo, including representatives of the European Union, to encourage people to be vaccinated,” said Emée Ratsimbazafy, vice-president of a Madagascar civil society association, told RFI. “And then, all of a sudden, we learn that this vaccine is not recognised by the European health authorities. Why not? Many people are now wondering if this vaccine is really harmless and effective. Some people are now reluctant to be vaccinated,” he said, noting that the dual standard has raised fears that the COVAX vaccines are of inferior quality. Madagascar’s Minister of Health, Professor Jean-Louis Rakotovao-Hanitrala, said he was “surprised and shocked” to learn that the vaccines being distributed wouldn’t be accepted in Europe. “This vaccine was given to us by the WHO and welcomed by the European Union and all the UN agencies,” he was quoted as saying. That , he said “makes us wonder if there is not one vaccine for Africans and another for Europeans”. On the other side of the continent, Nigerian health experts are also worried that the EU policy may stimulate more vaccine hesitancy – threatening the delicately built trust in the vaccine that is most widely available. “Something is definitely fishy somewhere. We need these people to come clean and tell us what is happening. My parents received this vaccine. Should we be worried?” one Nigerian woman, who asked to remain anonymous, told Health Policy Watch. African countries do not have luxury of choices like European countries have and as such they need to continue to build acceptance around Covishield, stressed Oyewale Tomori, a Nigerian professor of virology and chairman of Nigeria’s Ministerial Expert Advisory committee on COVID-19. “This is the vaccine that we have and we will continue to encourage our people to take while ensuring that we do not find ourselves again at the mercy of the rest of the world in future pandemics,” Tomori told Health Policy Watch. WHO Officials – Protest in Africa, Silent In Geneva WHO Regional Director for Africa Dr Matshidiso Moeti speaking about the EU COVID Green Pass at Thursday’s Regional press briefing, At Thursday’s Africa Regional press briefing, WHO’s Regional Director for Africa, Dr Matshidiso Moeti, protested the double standard, telling reporters that the European green pass programme should recognize all eight vaccines that have been approved by the WHO, which include the AstraZeneca vaccines produced in India, as well as two Chinese-made vaccines, rather than only those that are EU approved. “Increasingly proof of vaccination permits the removal of travel restrictions, and even if it is important to secure the frontiers and prevent the propagation of the virus, African’s shouldn’t be subject to any more restrictions because they can’t access a particular vaccine,” she noted. “Only four of the eight vaccines recognised by the WHO are recognised by the European Medicines Agency for the digital passport system put in place by the European Union. We hope that all countries will respect the principles of the International Health Regulations, and see to it that all vaccines are approved by the WHO and are accessible to everyone, before they can become a prerequisite for travel,” she sai. Moeti said the WHO and EMA use the same standards in assessing vaccines. “The safety and efficacy of all WHO emergency use listed vaccines has been proven globally in preventing severe COVID-19 illness and death.” Added Richard Mihigo, African regional director for immunisation and vaccines development: “Actually, WHO is in the process of working with the European Union so that there can be a harmonisation and a recognition by all of the EU members, for all of the products that were approved by the WHO, in a general manner.” “What people have to understand is that the EMA only approves products that are being used in the EU. For those [vaccines] not being used by the EU, they are not even submitted for approval to the EMA, and that is the case for AstraZeneca CoviShield, being produced by the Serum Institute of India, which was from the beginning intended to fulfil the needs for a segment of the market – the COVAX countries. Mihigo stressed that there was “no ambiguity about the quality of this vaccine produced in India”. “It’s strictly an administrative process, which has nothing to do with the quality of the AZ vaccine, which is being produced in several countries in Europe, the United States, India, and South Korea.” At Geneva’s headquarters, however, WHO officials speaking at a Friday press conference made no reference to the EU conundrum – despite protesting, in principle, the fact that COVID passports are being used at all in travel – when access remains so limited in many countries. “WHO should not be recommending a requirement for vaccination as a condition of travel,” declared Michael Ryan, executive director of health emergencies, “and that is particularly related to the scarcity of vaccines and the fact that there is such an inequity of distribution of those vaccines – plus uncertainties regarding the extent to which vaccination prevents infection, or transmission of the disease”. “Any imposition of such a requirement for vaccination, around the world does, in effect, deliver a double inequality as individuals from countries who have no access to vaccines will then have no access to travel, and therefore it is very important that if we’re going to impose restrictions on the travel of individuals, we must at least attempt to do that from a level playing field of having access to vaccine,” Ryan added. A Health Policy Watch request to WHO/HQ for comment regarding the exclusion of the Serum Institute version of the AZ vaccine from the EU green pass received no response, as of press time. Image Credits: UNICEF, African CDC , Tourism Watch. US had Nearly 5 Times More COVID-19 Cases Than Reported In First Half of 2020 – Study Finds 25/06/2021 Chandre Prince An estimated 20 million Americans were infected with COVID-19 in mid-July 2020 – 17 million more than the three milion officially recorded, a new study has found. The United States may have experienced nearly 17 million additional COVID-19 cases in the first six months of the COVID-19 pandemic, according to a new study by the National Institutes of Health (NIH). The NIH study, published this week in Science Translational Medicine, suggests that for every coronavirus infection recorded until mid-2020, nearly 4.8 more asymptomatic cases went undetected. In the United States alone, a total of 16.8 million infections with SARS-CoV2 were undected, as of mid-July 2020 – meaning that as many as 20 million Americans were infected with COVID-19 by mid-July 2020 – in comparison to the the three million cases officially recorded in that period. “This study helps account for how quickly the virus spread to all corners of the country and the globe,” said Bruce Tromberg, director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB), one of the NIH institutes that runs the NIH SARS-CoV-2 Seroprevalence Project, in a statement on Tuesday. Blood samples were collected from 8,058 volunteer participants between 10 May and 31 July 2020, among people who were not previously diagnosed with COVID-19. Of the sampled blood, approximate 304 contained antibodies against COVID-19. Based on the analysis of the data , NIH researchers estimated that for every diagnosed COVID-19 case during the spring and summer of 2020, there were 4.8 undiagnosed cases – representing an additional 16.8 million cases. The research team observed that Black participants had the highest estimated rate of positive COVID-19 antibody tests (14.2%), followed by Native American/Alaska Native (6.8%), Hispanic (6.1%), white (2.5%) and Asian (2%) respondents. When comparing age groups, the youngest participants – those between the ages of 18 and 44 – had the highest estimated rate, at 5.9%, the study found. Women (5.5%) had a higher positivity rate than men (3.5%); and numbers for those living in urban areas (5.3%) were higher compared with rural participants (1.1%). Pandemic Hallmark – Many People Infected with Few or No Symptoms “A hallmark of the coronavirus pandemic is that there are people infected with the virus that causes COVID-19 who have few or no symptoms,” Dr Matthew Memoli, director of the Laboratory of Infectious Diseases Clinical Studies Unit at the National Institute of Allergy and Infectious Diseases, which participated in the research team, said in a statement. “While counting the numbers of symptomatic people in the United States is essential to contend with the impact of the pandemic and public health response, gaining a full appreciation of the COVID-19 prevalence requires counting the people who are undiagnosed.” The research team also included scientists from the National Institute of Allergy and Infectious Diseases (NIAID), the National Center for Advancing Translational Sciences (NCATS); and the Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute (NCI). The team argues that the USA’s official COVID-19 numbers should be revised upwards from the three million cases reported in mid-July 2020 to almost 20 million, once the proportion of asymptomatic positive results are included. Said senior co-author Kaitlyn Sadtler, chief of the NIBIB Section on Immunoengineering: “This wide gap between the known cases at the time and these asymptomatic infections has implications not only for retrospectively understanding this pandemic, but future pandemic preparedness.” The research team said they are currently following up with the study participants to evaluate the presence of antibodies after six and 12 months, as well as antibody reactivity to variants of concern, the medical research agency said “The information will be invaluable as we assess the best public health measures needed to keep people safe, as new – and even more transmissible – variants emerge and vaccine antibody response changes over time,” said Tromberg. Frontline Health Workers Critical to Improving Mental Health Response During and After COVID-19 Pandemic 25/06/2021 Raisa Santos Nurses celebrate Nurses Appreciation Week in New York City, 2020, at the height of the COVID pandemic. Healthcare professionals, and particularly community health workers who have been the backbone of local and national health systems during the COVID crisis, are also unsung ‘first responders’ to the massive mental health fallout from the pandemic, now and going forward. That is the central theme of a webinar panel on ‘COVID-19 and Frontline Workers’, Wednesday, 30th June, 13:00 – 15:00 CET, which featuring COVID response and mental health experts from the World Health Organization, the International Council of Nurses and consumer groups. The panel is sponsored by the Geneva-based Global Self-Care Federation with Health Policy Watch serving as media partners for the event. Protecting Healthcare Workers’ Wellbeing Through Inclusive Mental Health Care While the tireless work of nurses and healthcare professionals has been championed and celebrated throughout the pandemic, those workers have, for the most part, been ‘largely absent from the mental health discourse’, said Judy Stenmark, Director-General of GSCF, in a recent blog post on mental health. Stenmark calls for a more ‘more inclusive approach that brings all stakeholders into the equation’ to both consider the mental health needs of health workers during the pandemic period – as well as optimising their contribution to community-based mental health response. “Without healthcare workers, there’s no chance we will see this pandemic through. Therefore, a greater consideration of self-care for healthcare workers is essential as we learn more about the consequences of the pandemic on healthcare systems,” she said in her blog, adding: “Unless we take proactive measures to ensure staff are safe at work and have sustainable working conditions – we’re at risk of losing the means that make healthcare possible.” WHO Action Plan Extension Receives Wide Support During WHA The Maldives’ delegate at the 74th World Health Assembly on Monday. Those messages also echo ones heard during last month’s 74th World Health Assembly, in which WHO Director General Dr Tedros Adhanom Ghebreyesus called for a rethinking of mental health treatment and delivery: “One day this pandemic will be over – but many of the psychological scars linked to the pandemic will stay with us for a long, long time,” he stated, at the Assembly, in which a special session saw WHO officials and member states acknowledging how the ‘mass trauma’ of COVID-19 has worsened mental health worldwide. A draft decision endorsing an updated version of WHO’s Mental Health Action Plan also was adopted during the 74th WHA. The updated WHO Action Plan will include a greater forums on suicide prevention, workplace mental health, universal health coverage, mental health of children, mental health across the life course, and the involvement of people with lived experience of mental health conditions. “It is crucial to prioritize the actions to minimize mental health consequences of the pandemic and incorporate these actions into emergency and disaster risk management strategies,” said Asim Ahmed, Permanent Representative at the Permanent Mission of the Maldives to the UN in Geneva, during the 74th WHA. Incorporating Mental Health into COVID-19 Response Plans Mental health services for children and adolescents have been disrupted due to COVID-19 During the pandemic, WHO and its Member States have also worked to incorporate mental health and psychosocial support into COVID-19 response plans. That has included WHO’s development of a wide range of resources in collaboration with partners, including: a stress management guide for the general public; a guide for COVID-19 responders on basic psychosocial skills; and a toolkit to help older adults maintain mental well-being. “Doing What Matters in Times of Stress: An Illustrated Guide” is a stress management guide aimed at equipping people with practical skills to help cope with stress, especially in the early stages of the pandemic. The Inter-Agency Standing Committee Reference Group on Mental Health and Psychosocial Support in Emergency Settings, co-chaired by the WHO and the International Federation of Red Cross and Red Crescent Societies, has created an illustrated guide aimed at building basic psychosocial skills among all essential workers responding to COVID-19. The group has also produced a storybook for children, “My Hero is You, how kids can fight COVID-19”, to help children of 6-11 years learn how to protect themselves, their families and friends from coronavirus, and how to manage difficult emotions during the pandemic. A sequel that addresses the concerns of children during the current stage of the pandemic is planned for the third quarter of 2021. New WHO Guidance on Community-Based Mental Health Alternatives A lay counsellor on the Friendship Bench in Zimbabwe – part of an innovative community-based mental health programme rolled out in the country. With community-based services the backbone of better mental health services, WHO has recently highlighted successful examples of person-centered and rights-based community mental health services from across the world in a new report, released on 10 June. The report, ‘Guidance on community mental health service: promoting person-centered and rights-based approaches’, offers over two-dozen peer-reviewed examples of mental health services around the world that demonstrated good practices that are non-coercive, incorporate the community, and respect people’s agency, or their right to make decisions about their treatment and life. These include examples of cost-effective initiatives in low- and middle-income countries that promote frontline health workers, social workers, trained lay experts, and guided self-care networks as a backbone of service delivery to people in need. Examples include initiatives such as the Friendship Bench in Zimbabwe, Atmiyata in India, as well as self-help groups, such as Kenya’s Users and Survivors of Psychiatry (USP-Kenya). These services also feature alternative methods of treatment that ireduce compulsory hospitalization, over-prescription of anti-psychotic drugs – and critically, incorporate the voices of those with their own experiences with mental health conditions and psychosocial disabilities through peer-support groups. “[The value of peer-support groups] has been about restoring power, voice, and choice to persons with psychosocial disabilities,” said USP-Kenya CEO Michael Njenga. Nurses and healthcare workers are the frontline of the health workforce Image Credits: R Santos, Raisa Santos , WHO, WHO/NOOR/Sebastian Liste, Tim Kubacki/Flick. WHO, World Trade Organization & World Intellectual Property Organization Map Out Joint Approach to COVID Pandemic 24/06/2021 Elaine Ruth Fletcher Directors-General of WIPO (far left) WHO (back center) and WTO (far right) discuss stepped up cooperation on combatting COVID-19 pandemic In a first-ever tripartite meeting this year, the heads of the World Health Organization, the World Trade Organization (WTO) and the World Intellectual Property Organization (WIPO), have agreed to step up their collaboration on tools and resources for fighting the COVID-19 pandemic. The meeting was the first formal tripartite meeting since Ngozi Okonjo-Iweala was elected as head of WTO earlier this spring, following the election of Daren Tang as the new head of WIPO late last year. In a joint statement issued after the meeting the three heads of agencies, including WHO’s Director General Dr Tedros Adhanom Ghebreyesus, pledged to collaborate more closely on a joint platform for tripartite technical assistance to member governments relating to their needs for medical technologies as well as a series of workshops – to augment capacity and information flow. In a joint statement issued following their meeting 15 June, the three agency heads stated that they would ramp up cooperation focusing first on “the organization of practical, capacity-building workshops to enhance the flow of updated information on current developments in the pandemic and responses to achieve equitable access to COVID-19 health technologies. “The aim of these workshops is to strengthen the capacity of policymakers and experts in member governments to address the pandemic accordingly. “The first workshop in the series will be a workshop on technology transfer and licensing, scheduled for September. The workshop will help our members update their knowledge and understanding of how intellectual property, know-how and technology transfer work in actuality. This would be in the context of medical technologies and related products and services. This first workshop will be followed by others on related practical themes.” A second prong of the joint initiative, will be the joint platform for technical assistance, that aims to provide “a one-stop shop that will makae available the full range of expertise on access, IP and trade matters provided by our organizations, and other partners, in a coordinated and systematic manner.” The platform will focus, in particular, on: supporting countries to assess and prioritize unmet needs for COVID-19 vaccines, medicines and related technologies, and; providing “timely and tailored technical assistance in making full use of all available options to access vaccines, medicines and technologies, including through coordination between members facing similar challenges to facilitate collective responses.” The effort would also include “periodical update” of baseline resources maintained by the three organizations, mapped in the joint publication: “Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade”, the statemnt said. The initiative appears to bring WIPO closer into the circle that has already been established by WTO and WHO on pandemic response – following last year’s change of administration in the agency that maintains a critical repository of data on intellectual property on health products for manufacturers worldwide – but has been too often accused of remaining outside of the loop of practical advice on IP use to low- and middle-income countries. Image Credits: World Trade Organization . Third COVID Wave Racing Across Africa — New Case Rates in South Africa & Tunisia Outstrip United Kingdom 24/06/2021 Paul Adepoju A quiet street in Cape Town, South Africa, during one of the hard lockdown periods of 2020, which helped curb the spread of COVID-19 last year. A “terrible third wave” of the COVID-19 pandemic is now hitting Africa in full force – with about 20 of the continent’s 54 countries experiencing particularly sharp rises in new infections, African Centers for Disease Control director, John Nkengasong told Health Policy Watch at a press briefing on Thursday. Per-capita rates of new SARS-CoV2 cases in South Africa and Tunisia now outstrip those in the United Kingdom – and spiralling 5-6 times higher than those in the United States and India. Although the continent-wide average is still only about 27 new cases per million, below the current US average, (34/million), the increases seen are prompting worries that Africa could even become a new global epicentre for the pandemic. That after nearly a year when it managed to maintain comparatively low case counts. Daily new cases per million people in Tunisia and South Africa are now running at nearly 200 infections/million. In comparison, in the United Kingdom new cases now stand at 149/million and in hard-hit India at 40 per million, over the last week. The new wave has already stretched several health systems on the continent beyond their limits, Nkengasong said. “This is the first time that we are seeing countries report that their health systems are completely overwhelmed,” he said. Zambia, Uganda & DRC In Zambia, daily new infections are averaging 138/million the highest ever recorded since the pandemic was declared. That, in turn, is biting health systems hard, Nkengasong said. According to the latest figures, on June 23, the country reported 3,367 new cases of COVID-19 over the past 24 hours – the highest number of daily reported cases yet in the country. It was also nearly double the number of cases (1,796) reported on 16 January 2021 when the country reached the peak of its second wave. Nkengasong revealed that aside from the already dispatched commodities, Africa CDC will also be sending a team of experts to Zambia to help the country cope with the third wave. “They are completely overwhelmed,” he said. The health systems of Uganda and the Democratic Republic of Congo are facing similar crises, he added. In conflict-ridden DRC, meanwhile, the lack of strong systems for COVID testing and case reporting may also be keeping the numbers artificially low, inside observers told Health Policy Watch. DRC has also been one of the most vaccine hesitant countries – turning back a large shipment of COVAX vaccines that it received to Africa CDC in April because it did not have the means to administer the doses. Even among the country’s large presence of UN forces and support teams, who have ready access to dedicated vaccine donations from India, vaccinations have progressed at painfully slow rates, observers told Health Policy Watch. Steepest COVID-19 Surge Yet — WHO WHO Regional Director for Africa Dr Matshidiso Moeti believes Afric can still blunt the impact of the currently fast-rising infection wave if precaution is taken against transmitting the virus. At a separate WHO briefing, WHO Regional Director for Africa Matshidiso Moeti described the third wave as the pandemic’s steepest surge yet continent-wide. According to WHO’s data, the number of cases have risen for five consecutive weeks since 3 May. As of 20 June—day 48 into the new wave—Africa had recorded around 474 000 new cases—a 21% higher rate as compared with the first 48 days of the second wave. At the current rate of infections, the ongoing surge is set to surpass the previous one by early July, WHO stated. “With rapidly rising case numbers and increasing reports of serious illness, the latest surge threatens to be Africa’s worst yet,” Moeti warned. But even though the window of opportunity may be closing, she noted that Africa can still blunt the impact of the currently fast-rising infections. “Everyone everywhere can do their bit by taking precautions to prevent transmission,” she said. For instance, after Uganda slapped on new restrictions last week, new cases there appeared to be plateauing. Vaccine Supplies May Not Arrive In Time Africa CDC director Dr John Nkengasong Despite promises of hundreds of millions of doses from different partners, including the United States government, the timeline for the delivery of the doses may not see their arrival in time to really help African countries combat the third wave, both WHO and Africa CDC officials warned. Globally, of the 2.7 billion vaccine doses administered, under 1.5% have been in the arms of Africans. According to the Africa CDC, 61.4 million COVID-19 vaccine doses have been received so far by 51 African member states out of which 48.6 million doses have been administered (79.52%). So far, only 1.12% of the African population has been fully vaccinated. Most of those supplies were received in March & April this year through the WHO co-sponsored COVAX vaccine facility – before COVAX supplies produced by the Serum Institute of India dried up as a result of India’s COVID infection spike. “Cases are outpacing vaccination, leaving more people exposed. Now we need international solidarity and innovation to increase our supply,” Moeti said. Nkengasong agreed: “What we need is rapid access to vaccines to member states. It is extremely frightening to look at the graphs from some African countries. We just really need vaccines to get into people’s arms very quickly.” Without any intentional actions to speed up vaccine dose supply to Africa, Nkengasong said member states may have to wait until August when doses are expected to start becoming available through African Union’s COVID-19 Africa Vaccine Acquisition Task Team (AVATT). Delta Variant Spreading Across Africa WHO and Africa CDC also called attention to the rapid spread of the Delta variant of the virus that was first reported in India, across the African continent. The Delta variant, has already been reported in 14 countries in Africa, rapidly catching up with other variants, Moeti said. “In the Democratic Republic of the Congo and Uganda that are experiencing COVID-19 resurgence, the Delta variant has been detected in most samples sequenced in the past month,” she noted. “We have seen that variant really aggressively taking over from other variants, not just in Uganda, but in other countries like the DRC,” Nkengasong added. In addition, the Beta variant which was first identified in South Africa, has since been reported in 29 African countries. And the Alpha variant that was first reported in the UK and is now being reported in 30 African countries, according to the Africa CDC. WHO said it is taking steps towards expanding the capabilities of various African countries to track the spread and evolution of the virus in order to guide epidemiological decisions. “We are supporting South Africa-based regional laboratories to monitor variants of concern,” Moeti said. “WHO is also boosting innovative technological support to other laboratories in the region without sequencing capacities to better monitor the evolution of the virus. In the next six months, WHO is aiming for an eight- to ten-fold increase in the samples sequenced each month in Southern African countries.” Leading Researchers Highlight the Impact of COVID-19 on Global Liver Disease 24/06/2021 Chandre Prince Dr Rifaat Safadi, director of the Liver Unit at Hadassah Hebrew University Medical Center, in Jerusalem, Israel. Patients who had liver transplants or those with advanced liver fibrosis may not be adequately protected against COVID-19 after two doses of the Pfizer-BioNTech vaccine, in light of the findings of a new study presented Wednesday on the opening day of the International Liver Congress(ILC) 2021. Presenting abstracts from the soon-to-be-released study on Wednesday, Dr Rifaat Safadi, director of the Liver Unit at Hadassah Hebrew University Medical Center, in Jerusalem, Israel, said the study suggests that such patients with low levels of antibodies to the SARS-CoV-2 virus should get a third booster Pfizer shot to increase their chances of protection against the virus. The global virtual conference, convened by the European Association for the Study of the Liver (EASL), is taking place Wednesday – Saturday. This year’s conference brings together leading liver disease researchers from around the world to explore new science around the prevention and treatment of liver disease caused by Hepatitis C, alcohol abuse and other risk factors, as well as the impact of the COVID-19 pandemic on people living with liver diseases and on liver disease medications. This year’s conference proceedings are highlighting the extreme vulnerability of people with liver disease to COVID – with one new study finding the chronic liver disease increased the odds of COVID-19 death by 80%. On the more positive side, another study however, found that the antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B. Research on the impact of COVID-19 on alcohol-related liver disease is also being showcased at this year’s conference session, along with new or improved treatments for people suffering from HCV. “We are beginning to understand more clearly just how disproportionately COVID-19 is impacting on people living with liver-related diseases and the studies presented at ILC 2021 advance our knowledge on multiple fronts, knowledge that can potentially help inform policy responses to the pandemic going forward,” said Philip Newsome, General Secretary of EASL and Director of the Centre for Liver Research at the University of Birmingham in the UK, at Wednesday’s opening session. Pfizer-BioNTech Vaccine Offers Low Immunity for People with Advanced Liver Disease Data from an Israeli study found that patients with advanced liver fibrosis may not be adequately protected against COVID-19 after two doses of the Pfizer-BioNTech vaccine. With regards to the Pfizer vaccine on patients with liver disease, Safadi, who will present the full results of the Israeli study on Saturday, explained that “older age”, advanced fibrosis and decreased steatosis appear to be risk factors for lower vaccine response among people with related forms of liver disease. The study analysed data from 88 patients living with hepatic fibrosis who had tested positive for COVID-19 and who had received both doses of Pfizer’s-BioNTech vaccine. It found that elderly patients with advanced liver fibrosis had a lower response to Pfizer’s vaccine, with Safadi suggesting that those patients may need a third booster shot. “Therefore, we have to think about the booster vaccination… we are thinking now about boosting the third shot, especially those with high risk for non responsiveness or lower response,” said Safadi. The study’s recommendation, however, goes beyond current US Food and Drug Administration (FDA) recommendations. The FDA has so far not recommended the use of antibody tests to check the effectiveness of vaccination against the virus, nor has it approved a three-dose regimen or booster of any SARS-CoV-2 vaccine. Tenofovir Reduces Severity of COVID-19 in Patients with Chronic Hepatitis B Encouraging data from another new study found that antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B. A study conducted in Spain found that antiretrovira drug tenofovir reduced the severity of COVID-19 in patients with chronic Hepatitis B. Beatriz Mateos Muñoz, PhD Specialist in Gastroenterology and Hepatology at the Hospital Universitario Ramón in Spain, said the study analysed data from 4736 patients from 28 Spanish hospitals. Of the 117 COVID-19 positive patients who were identified, 67 were taking tenofovir and 50 were on entecavir, an antiviral drug in the treatment of hepatitis B virus infection. Muñoz said the incidence of COVID-19 in patients on tenofovir or entecavir were similar, but that patients on entecavir “more often had severe COVID-19, required ICU, ventilatory support, had longer hospitalization or died”. The study found that tenofovir seemed to offer some protection in patients with chronic hepatitis B infected by COVID-19. “In multivariate logistic regression adjusted by age, sex, obesity, comorbidities and fibrosis stage, tenofovir reduced by 6-fold the risk of severe COVID-19. Patients with chronic hepatitis B on tenofovir have a lower risk of severe COVID-19 infection than those on entecavir.” COVID-19 Related Alcohol Sales May Have Increased Alcohol-related Liver Disease Abdel-Aziz Shaheen, assistant professor at the Gastroenterology and Hepatology at the University of Calgary in Canada, said a large population-based study found a significant increase in the number of patients with alcoholic hepatitis who were hospitalised last year in Alberta, Canada last year, with the highest admission rate recorded in April 2020. Shaheen said a significant increase in alcohol sales across Europe and North America during the early months of the pandemic had alarming consequences for patients with alcoholic hepatitis. He said most of the newer patients with alcoholic hepatitis were younger and mainly from rural areas. “There was a significant 9% increase in alcoholic hepatitis admissions per month between March and September and the average rate of alcoholic hepatitis hospitalizations compared to overall hospitalizations rate doubled from 11.6/ 10,000 general hospitalizations to 22.1/ 10,000 general hospitalizations for the same period,” said Shaheen. More worrying, said Shaheen was that: “Our results show that the increase in alcohol sales post pandemic will significantly impact the natural history of alcoholic liver disease in Canada”. Chronic Liver Disease Increased the Odds of Covid-19 Death by 80% Vincent Mallet, Managing Senior Physician and Professor, Hepatology Unit, Cochin University Another study that used the French National Hospital Discharge database for patients who were hospitalised for COVID-19 found that chronic liver disease increased the odds of COVID-19 death by 80%. Vincent Mallet, Managing Senior Physician and Professor, Hepatology Unit, Cochin University said the hospital records showed that 3, 943 of the 16,338 patients diagnosed with chronic liver disease who were admitted for Covid-19 in France in 2020 died, including 2518 after liver-related complications. He said liver complications and alcohol use disorders may have contributed to the COVID-19 deaths of patients with chronic liver disease. People with Obesity & Diabetes Related Fatty Liver Disease Also at Higher Risk from COVID-19 Similarly, a small study in Mexico of 348 patients found that people living with Metabolic Associated Fatty Liver Disease (MAFLD) were five times more likely to die during hospitalization for COVID-19 than people without these factors. The patients studied were admitted with the SARS-COV-2 infection to a number of tertiary referral hospitals between 4 April and 24 June 2020, said Martin Uriel Vázquez Medina, Researcher at the Laboratory of Biomathematical and Biostatistical Modelling for Health Escuela Superior de Medicina, México. Major risk factors for the chronic conditions are obesity and type-2 diabetes, common conditions in many parts of Latin America, also closely associated with unhealthy diets, including high sugar consumption, and lack of physical activity. Medina added: “We also want to show with this result that [patients in] Latin American countries that have this overhead problem of obesity, diabetes, and pre-diabetes, could also be associated with increased risk from COVID-19”. The ILC continues until Saturday. Six More African Countries Needed to Ratify Treaty Creating the First Continent-Wide Medicines Regulator 23/06/2021 Paul Adepoju The African Medicines Agency’s framework would help combat falsified products and by ensuring harmonized drug standards and approvals, ease access to more affordable medicines and vaccines for people throughout the continent. Michel Sidibé, Special Envoy of the African Union and Minister of Health of Mali has high hopes that 15 African countries will have finally ratified the African Medicines Agency (AMA) Treaty in time for the 35th African Union (AU) Summit, scheduled for early 2022. Fifteen is the magic number of countries that must ratify the treaty creating the AMA – in order to birth the agency into operational existence. By the time of the summit, Sidibé also predicts that 30 or more countries will also have signed the framework agreement on the creation of the agency – an agreement that was first approved by the African Union in February 2019. He was speaking at a virtual session on Tuesday, From civil society to the pharma industry, establishment of the continent-wide AMA is regarded as an important step forward that would help improve the functioning of national medicines regulatory agencies – combating fake medicines and streamlining approval of new medicines and vaccines. That, in turn, should also help reduce prices and boost access for people throughout the continent, observers predict. Snail Speed Pace of Ratification So Far However, snail-speed ratification of the treaty by the legislatures and parliaments of the AU’s 54 member states has become a major hurdle to actually opening the doors of the new agency. This is despite the strong support displayed by global health actors actors ranging from the World Health Organization, Africa Centres for Disease Control, as well as other regional drug regulatory agencies such as the European Medicines Authority. However, Sidibé said he is confident the new agency, once it finally begins operations, can build upon the continent’s existing expertise in pharmacovigilance – developed by national agencies such as the Moroccan agency for medicines and the Nigerian Agency for Foods, Drugs Administration and Control (NAFDAC). As for concerns regarding the slow pace of country approvals of the framework agreement and formal ratification, Sidibé said the plan has been to first target a balance of countries in diverse African regions as “low-hanging fruit” – followed by others. In fact, so far most of the countries signing and then ratifying the agreemeht have been West African and/or Francophone. But as the critical mass of ratifications is approached, momentum elsewhere is also building. “Our strategy was to go for different regional balances… , to make sure that we can have a low hanging fruit so we can get quickly the 15 countries,” he said. “Now we are almost there. I am sure by the next meeting of the African Union, we can come and present to the leaders that we managed to have 15 countries,” he said, adding that the priority is to ensure that all African countries are soon on board. Getting buy-in from all African countries will involve actively engaging with governments that are yet to sign and/or ratify the treaty, one by one. Top countries earmarked now for the next stage include north and west African regional leaders such as Ethiopia and Nigeria, as well as the Democratic Republic of Congo. “We are learning from different experiences and ensuring that we are not losing time. We are making sure we bring different partners together to implement the agenda quickly,” Sidibé added. The Long Road to Ratification In October 2020 Health Policy Watch reported that only 18 of Africa’s 55 countries had signed the framework agreement to establish the agency, while only 5 countries – Rwanda, Mali, Burkina Faso, Ghana and Seychelles – had actually ratified the agreement. At the time, Africa CDC Director John Nkengasong, told Health Policy Watch the delay in the treaty ratification was due to the COVID-19 pandemic. “I don’t think it is because countries do not want to sign on. I think it is because of the process that is required to make them sign that treaty, and the countries are currently focusing more on COVID-19,” said Nkengasong. “I think it’s a much needed institution. If we had the AMA, it would be working very closely with the WHO and other bodies to facilitate regulatory issues on drugs to help control the COVID-19 pandemic.” Since then, Zimbabwe and the Seychelles have signed the AMA framework treaty, raising the total number of signatories to 20. Guinea, Namibia and Sierra Leone have ratified the treaty, followed by Algeria this month, raising the number of countries that have fully completed the two-step approval process to nine. In order to get across the finish line, a new African Medicines Agency Treaty Alliance (AMATA) has also recently been created, said Kawaldip Sehmi of the International Alliance of Patients Organizations (IAPO), at Tuesday’s session. The Alliance, led by IAPO and including patient groups, researchers and academics, and industry, will advocate for rapid AMA ratification continent wide. It will also work to establish meaningful engagement with patients, industry and other relevant parties once the Agency becomes operational. The WHO is also actively supporting the emergence of the AMA, with its Director-General, Dr Tedros Adhanom Ghebreyesus describing the lack of strong national regulatory systems as “one of the biggest obstacles to improving access to medical products in Africa”. WHO Regional Director in Africa, Dr Matshidiso Moeti, has also reiterated the importance of the agency, telling Health Policy Watch: “AMA is a very important platform for medicines to be available and affordable equitably, and to be of good quality so that we have both good outcomes for the money that people and countries are spending, and that we prevent problems.” Other Benefits – International Partnerships and Support for Local Production The AMA will also help strengthen global collaborations, including participation of African researchers and patients in clinical research trials of new medicines, especially in the area of cancer, said Emer Cooke, Executive Director of the European Medicines Agency, speaking at Tuesday’s event. “We’re already collaborating with a number of initiatives on clinical trials with African regulators, particularly in the context of the African Vaccines Regulatory Forum. We can use forums such as this to build on the collaborative activities that take place to share our experiences and to help us to work on training and capacity building initiatives,” Cooke said. “I think we should be heartened by the fact that there’s already good discussion and collaboration in the context of clinical trials.” Fighting Fake Medicines Meanwhile, Lotfi Benbahmed, minister of the pharmaceutical industry of Algeria, said the AMA can help improve the reliability of Africa’s medicines — a feat that he said requires the existence of a regional framework to fight fake drugs. “So what we need to do is to harmonise rules and regulations, and enable countries to fight the illegal markets, and the informal markets,” Benbahmed said, who spoke alongside other African ministers of health from Algeria, the Democratic Republic of Congo, Egypt and Cape Verde. . According to him, a similar framework can be deployed to tackle the challenge of low quality drugs on the continent from the point of production, including setting up measures to inspect and control equipment in laboratories. At the same time, delays being encountered in the finalisation of the agency are “understandable”, said Dr Margareth Ndomondo-Sigonda, African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD), who highlighted the extensive harmonisation processes that needs to be undertaken between national governments to birth the new agency. “It takes time to get to the point where you’ve achieved regulatory harmonisation of African medicines and harmonization of regulatory standards. You have to make sure that through harmonization of these technical requirements, you know the quality standards and practice and you build trust,” Ndomondo-Sigonda said. She was however hopeful that once AMA comes into force, it will be able to deal with many outstanding issues regarding the harmonisation of Africa’s medicines landscape. Image Credits: Marco Verch/Flickr. Urgent Government Action and Investment Needed Against Antimicrobial Resistance, Says New Report 23/06/2021 Raisa Santos Launch of the AMR Preparedness Index Panel – left to right – James Anderson, Susan Schwarz, Neil Clancy, Anand Anandkumar, Christine Ardal, Mike Hodin, Norio Ohmagari, Tiemo Wolken Government action against the threat of “superbugs” in most of the world’s leading economies gets a score of less than 50%, according to a new AMR Preparedness Index, released today by a global coalition committed to fighting current trends. Great Britain, the United States, Germany and France rated highest on a score of 1-100 in an assessment of responses in 11 of the world’s leading economies to antimicrobial resistance (AMR) threats. Meanwhile, emerging economies such as Brazil, China, and India scored the worst in the assessment that looked at national strategy; awareness and prevention; innovation; access; appropriate and responsible use; AMR and the environment; and collaborative engagement. The index was launched today by the Global Coalition on Aging (GCOA) and the Infectious Diseases Society of America (IDSA), to shine more light on how the governments are living up to their commitments to address antimicrobial resistance (AMR). “We need health systems and policymakers to really step up and advocate that federal, state, and local governments prioritize AMR,” said Neil Clancy of the AMR Committee, Infectious Disease Society of America, during an event Wednesday launching the Index. “Without significant national and global coordination and multi-party interventions in this area, our efforts are not going to succeed.” The AMR Preparedness Index ranked 11 countries across 7 categories in a 1-100 point scale. UN Report Warns That AMR Could Cause As Many as 10 Million Deaths/ Year Livestock applications of antibiotics in metric tons/year, among countries reporting use. (The Antibiotic Footprint) An estimated 700,000 people already die each year from drug-resistant infections and the lack of antimicrobials to treat them. A 2019 UN report warned that if trends are ignored, AMR could cause as many as 10 million deaths per year, and GDP losses of more than US $100 trillion by 2050. The report assigns scores to each of the 11 countries across seven categories for needed and achievable policy action. Although the assessment considered national policies on “AMR and the Environment” it was unclear how heavily weighted that issue was in the overall index. Per capita, the US agricultural industry is one of the heaviest users of antibiotics in the world. COVID-19 Is a Warning Light to Act Preemptively on AMR The cost of AMR action pales in comparison to the future costs of inaction, participants underlined, drawing comparisons with the COVID-19 pandemic. Delays in responding to urgent public health crises have deadly consequences. “If the pandemic has taught us one thing, it is that we are not well-prepared to combat the serious threat that emerging infectious diseases can pose to human health and our economies,” said Tiemo Wölken, member of the European Parliament, Germany. In Europe, AMR causes the annual death of 33,000 people and costs 1.5 billion Euros in regards to healthcare costs and productivity losses. COVID-19 has highlighted the need for increased monitoring tools, more improved detection, prevention, and control practices, said Wölken. “The time to act is now. COVID already put our healthcare systems under extreme pressure, and this could only be a foretaste of what we could expect from a world where antibiotic microbials are no longer effective.” All Countries Fail in Awareness & Prevention of AMR Testing for antimicrobial resistance at the Liverpool School of Tropical Science. The analysis identified critical opportunities for all governments to act upon to slow the growth of drug resistant bugs. “Despite the progress that’s being made and despite the good work being done in countries throughout the world, we need to do more,” said Clancy. Several trends have emerged from an analysis of the different indices that went into the combined score. All countries performed insufficiently with regards to awareness and prevention of AMR, with India lagging furthest behind. More developed countries tended to fare better in the appropriate and responsible use of existing antibiotics and other antimicrobial agents – as compared to developing country counterparts. Outside of the UK and US, most other countries performed poorly in assessments of the quality of national strategies, innovations, and collaboration. Innovation Important Training on standardized and harmonized surveillance methods for antimicrobial resistance in food animals in Southeast Asia Innovation is another area that requires more significant action going forward, said James Anderson, Executive Director of Global Health at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). “We do need to really drive pipelines. We do need investments in AMR.” In the fight against the borderless threat of drug resistance, the Index included key insights and guidance for governments to immediately prioritize in order to fulfill their commitments on AMR. Overall, the top-level priorities identified in the Index were to: Strengthen and fully implement national AMR strategies; and raise awareness of AMR and its consequences. Along with that, other key priorities were to: Bolster surveillance and leverage data across AMR efforts; Enable a restructured antimicrobial marketplace to stimulate innovation; Promote responsible and appropriate use of antibiotics; Enable reliable and consistent access to needed and novel antimicrobials; More effectively integrate the One Health Approach, including environmental concerns, into national strategies; Better engage with other governments, third-party organizations, and advocacy groups Despite AMR being one of the top five global health challenges, as cited by the WHO, a large majority of the public remains unaware of their role. Local, national, and international efforts are needed in raising awareness and investment in AMR. “All of us have a stake in preserving antibiotics and assuring the development of new antibiotics,” said Clancy. Vaccinating Older Groups Against COVID – Can Help Fight AMR 93-year-old Lebanese actor Salah Tizani, who falls into the elderly priority group, receives his first vaccine dose against COVID-19 in Beirut on Feb. 14, 2021. In terms of the battle against COVID and AMR, the report underlines how vaccinating older adults can help fight overuse of antibiotics during the pandemic. That is because people who become seriously ill with COVID, are often given antibiotics preventively in order to ward off secondary infections. Adequately vaccinating older populations against other infections such as pneumococcal pneumonia and tuberculosis, and even infections like influenza is also critical step to combatting AMR. In other ways, too, older adults have a key stake in fighting AMR, because they tend to be major consumers of health services, and also may be more vulnerable to drug resistant bacteria and viruses overall. “We are at a time now when the megatrend of aging is at the top of our agenda, not just the public health agenda but the economic and social agenda as well,” said GCOA CEO Michael Hodin. As the UN Decade of Healthy Aging was launched in January, AMR needs to be a central part of this initiative, applied not only to older people but to all of us for a healthy and active aging, Hodin added. Coordination and Collaboration Across Low- and Middle-income Countries and High-Income Countries Most countries examined in the report are not making adequate investments to combat the AMR threat, with the lack of commitment felt globally. Huge disparities in total public AMR research funding remains an issue across high, middle, and low-income countries. “We cannot afford to be only US-centric, or only LMIC centric. It takes a very globalized approach,” said Anand Anandkumar, Founder and CEO of Bugworks Research, India. Greater support and collaboration is necessary to increase capacity for AMR initiatives, such as monitoring and surveillance in many low and middle-income countries (LMICs). Consequently, high income countries must collect and provide more complete data to increase the robustness of international, regional, and domestic efforts. “Access and equity are global challenges and the central tilt to competitive AMR,” said Clancy. “[We need to ensure] that we get antibiotics and access to these drugs in an equitable fashion. We’re all at risk from AMR.” Image Credits: USAID Asia/Flickr, GC, antibioticfootprint.net, Flickr – UK Department for International Development, World Bank: Mohamed Azakir. COVAX Shortcomings Under Microscope Ahead of Gavi, Vaccine Alliance Board Meeting 22/06/2021 Elaine Ruth Fletcher & Svĕt Lustig Vijay COVAX vaccine deliveries in Africa – a much trumpeted solution to vaccine inequalities in troubled waters. As the board of Gavi, The Vaccine Alliance is set to meet this Wednesday and Thursday, the COVAX global vaccine facility – a cornerstone of the global health sector response on vaccine access – is coming under increased fire for its shortcomings. A bitter opinion piece by Médecins Sans Frontières, published today, has called for a “drastic change of model” in the global procurement mechanism “that was supposed to deliver COVID-19 vaccine equity.” Co-launched by a range of partners, including WHO, the COVAX facility is legally administered by GAVI. What started out with a much-trumpeted bang of vaccine distributions across African nations has fizzled after the primary vaccine supplier, the Serum Institute of India, began redirecting its available COVID doses to domestic vaccine needs. Massive commitments by rich countries for further vaccine sharing, made at the recent G-7 meeting, are supposed to be funnelled through COVAX. Yet most of those donations will likely only be realized in the latter part of 2021 or early 2022, leaving the current shortfalls over the summer, as Africa faces yet another COVID wave. “COVAX is currently grossly behind on achieving its goals,” said MSF’s Katie Elder, senior vaccines policy advisor. “COVAX had aimed to provide 2 billion doses by the end of 2021, but so far has only distributed 88 million (the goal by the end of June was to distribute around 337 million). Less than half of one percent of total populations of COVAX countries have received at least a first dose of vaccine through COVAX.” She blames the fundamental model of the facility – in which it has been forced to compete on the open market for COVID vaccines – which were still often subsidized by public and government players – for the failings. AstraZeneca vaccine doses are unloaded at Bole International Airport in Addis Ababa, Ethiopia. Not Set Up to Succeed “COVAX was not set up to succeed,” she said. “It was constructed to work within the current parameters of the pharmaceutical market, where you see how much money you can raise and then see what you can negotiate with industry for it. “Loud calls early in the pandemic to depart from a business as usual approach were ignored—pharmaceutical corporations developing vaccines received billions in government money without any strings attached, so were free to charge prices they chose and to sell to the highest bidder. Unsurprisingly, this led to the very same governments that had touted the importance of equity …. and the governments that Gavi spent so much time courting to join the COVAX Facility – ultimately pursuing national interests and securing the bulk of future promised vaccines. “COVAX was left behind as wealthy governments secured their doses through bilateral deals with an industry that acted as expected: selling doses first to the buyers who could afford to pay the most.” The net result now leaves the Gavi Board struggling with how to continue the participation of upper income countries in the facility at all. “The fact that Gavi’s board is now reviewing the way in which wealthier countries (so called ‘Self-financing participants’) can continue to participate in the facility is in part a recognition that the set up does not work,” she added. “Allowing wealthy countries so much flexibility to decide how they join COVAX and how many vaccines they procure, has caused delays and undermined its objectives. A more equitable model would have encouraged regional leadership with decentralized methods of procurement at their core. In the future, we must support these regional initiatives that aim for self-sufficiency and self-determination.” A Beautiful idea: How the COVAX has Fallen Short To date, COVAX has distributed over 20 million doses to rich countries and 80 million doses to poorer countries. The result has been an awkward legal situation for the facility which is still required to provide 20% of its doses for higher income countries – even though most have now met their vaccine needs and hoarded even more, notably Canada, which bought enough vaccine doses to cover its population four times over. “The failure to entice wealthy countries to join COVAX in large numbers has left the managers of the facility in an awkward situation,” said global health journalist Ann Aanaiya Usher in a critique published by The Lancet. “On one hand, not enough self-financing participants joined COVAX to give it the massive buying power that was hoped. On the other, even though COVAX is desperately short of vaccines, the facility is now contractually obliged to reserve one in five doses for a few rich countries, she said, adding that so far, COVAX has distributed 80 million doses to LMICs and over 20 million doses to high-income countries (HICs), including the UK and Canada. She slams the COVAX facility for its “naive” set-up that failed to anticipate widespread vaccine nationalism that has locked up most of the vaccine doses that are available. “It was a beautiful idea, born out of solidarity”, Duke University’s Gavin Yamey was quoted as saying. “Unfortunately, it didn’t happen…Rich countries behaved worse than anyone’s worst nightmares.” COVAX should have also diversified its portfolio earlier on, in anticipation of supply shortages that crippled the facility after India’s Serum Institute halted vaccine exports to fend off a tragic second wave on the subcontinent that has claimed the lives of almost 400,000 people. “Supply shortages should have been anticipated and ramping up supplies should have been baked into the design of COVAX from the start,” observed Georgetown University’s Lawrence Gostin. He added, however, that it would be “literally impossible” to ramp up vaccine supplies without greater investments in manufacturing hubs in lower-income countries, as well as broad waiver on intellectual property rights to vaccine know-how. In its struggle to get rich countries to sign up, the COVAX facility’s offer to allow rich countries to choose which vaccines they would receive has also drawn widespread criticism for leading to “double standards” – which seemingly defy the very purpose of the facility, critics have said. A beautiful idea: how COVAX has fallen short https://t.co/QpG6o5zbqt This is the most complete & readable analysis of COVAX I have seen. The title says it all. COVAX was a beautiful idea & we must make it better & permanent — Lawrence Gostin (@LawrenceGostin) June 18, 2021 Facility Needs Equity Funds to Compete in the Marketplace Even Gavi, the Vaccine Alliance, has acknowledged that its slow mobilization of resources has hampered its ability to quickly procure, and thus deliver as many doses as possible to those who need them most. “If we had secured financing earlier, then we could have locked in doses earlier, as opposed to the second half of this year when COVAX’s volume will start ramping up,” a Gavi spokesperson said. The spokesperson was referring to the fact that most of the funds to procure and distribute vaccines for the 92 low- and middle-income countries (LMICs) that signed up for the scheme were pledged in late December or early 2021 – after high-income countries had already snapped up large vaccine pre-orders. That is a point of view shared by some independent observers as well as industry leaders, who maintain that the facility needs fine-tuning for the next pandemic. “Had COVAX had sufficient and readily available early funding it would have been better able to secure enough immediate supply to meet its aim,” said the Independent Panel for Pandemic Preparedness said, which reviewed the global pandemic response, under a mandate from the World Health Organization. Going forward, what COVAX needs is a “pot of money” to be able to pre-order vaccine doses earlier on in a global health emergency, said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations, in a recent Q&A with Health Policy Watch. That, he maintains, would allow the global facility to compete on a more equal footing with rich countries in the vaccines marketplace. Added Peter Hotez, a prominent vaccine scientist and dean at Baylor College of Medicine in Texas: “I think it’s important that we don’t sell COVAX short. It still has a lot going for it, and is innovative in its design. But it needs more vaccines to share,” Asked for comment by Health Policy Watch, GAVI did not respond. Image Credits: UNICEF, WHO, WHO. 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.
Most COVAX Vaccine Recipients Excluded From New EU COVID ‘Green Pass’ – Thanks to Unapproved AstraZeneca Jab 25/06/2021 Paul Adepoju & Elaine Ruth Fletcher WHO representative in Ghana, Francis Kasolo, on left, with UNICEF’s representative, Anne-Claire Dufay as first COVAX vaccine doses arrive on 24 February in Accra, Ghana, Most vaccine recipients won’t be eligible for an EU “Green Passport.” The much-trumpeted European Union COVID Digital Green Pass, which launches 1 July and is meant to vastly ease travel to Europe for vaccinated and recovered passengers is being rolled out with one important hitch. Anyone vaccinated with an AstraZeneca vaccine produced by the Serum Institute of India would not be qualified to get the pass – and that includes most citizens of low- and middle-income countries who were immunised with vaccines distributed by the WHO co-sponsored COVAX initiative. That’s because the EU green pass will only recognise the Vaxzevria version of the AstraZeneca vaccine that was produced and manufactured in the United Kingdom or other sites around Europe, and thus approved by the European Medicines Agency (EMA). In contrast, most of the COVAX facility’s global procurement and distribution was built around the “Covishield” AstraZeneca vaccine, produced by the Serum Institute of India. Rude Shock Proportion of different vaccines distributed by the COVAX initiative – Africa CDC As of 25 June, more than 89 million vaccines have been distributed by the COVAX initiative to some 133 mostly low- and middle-income countries of Africa, Asia and Latin America, according to Gavi, the Vaccine Alliance, which is administering the massive programme. That’s a drop in the ocean of the more than 2.6 billion doses of COVID vaccines administered so far globally, according to WHO. But, it constitutes the majority of vaccines received in many of the world’s poorest countries. According to the COVID-19 vaccination dashboard of the Africa CDC, over 90% of vaccine doses administered so far, are Covishield. Only Four EU-Approved Vaccines EU digital green passport Under the EU Digital COVID Certificate system, freedom will be restored to the region for individuals that have been fully vaccinated with one of the vaccines approved by EMA, in addition to individuals that have recently recovered from the virus, and those who tested negative. While WHO has opposed issuing COVID passports at all, a key practical bone of contention emerging is the non-inclusion of Covishield and other WHO-approved vaccines on the list of EMA-approved products that can be considered for the EU digital green pass. When Health Policy Watch searched for Covishield on EMA’s website, there was no record of the vaccine even though Vaxzevria, the version produced in Europe, is listed. Traveller information issued by the authorities of the “Schenghen Zone” which includes EU countries plus several other non-EU European states like Norway and Switzerland, also clearly states: “As the Member States reopen the borders for travel from non-EU countries for non-essential purposes, they also intend to issue EU COVID travel certificates to travellers from third countries intending to enter their territory. The Commission also intends to accept certificates issued in third countries, which are issued under the same conditions as the ones by the EU….In order for the traveller to be able to get the vaccine, he/she should be vaccinated with one of the EU-approved vaccines.” The advice adds, however, a caveat stating that individual: “Member States, can, however, issue the certificate even to those who have been vaccinated with other vaccines if they are willing to do so.” In all, only four vaccines have been authorised by the EMA, and they are ComirnatyⓇ (BioNTech, Pfizer), ModernaⓇ, Vaxzevria Ⓡ (previously COVID-19 Vaccine AstraZeneca) and JanssenⓇ (Johnson & Johnson). Covishield is not even listed among the vaccines that are under review by the agency which has listed CVnCoVⓇ (CureVac), NVX-CoV2373Ⓡ (Novavax), Sputnik V Ⓡ(Gam-COVID-Vac), COVID-19 VaccineⓇ (Vero Cell) and CoronaVac Ⓡ(Sinovac). Even though the passport regime is expected to go into effect next week, more than ten countries in the region, including Germany, Greece and Spain are already issuing the green digital pass. Second Class COVID Travellers The double standard of EU recognition for identical AstraZeneca vaccines is beginning to send ripples across the African continent and African media – stimulating anger as well as stoking vaccine hesitancy, as reported by the French media channel, RFI.fr this week. “When the [AstraZeneca] vaccine was received, representatives of the international community were present at Ivato airport in Antananarivo, including representatives of the European Union, to encourage people to be vaccinated,” said Emée Ratsimbazafy, vice-president of a Madagascar civil society association, told RFI. “And then, all of a sudden, we learn that this vaccine is not recognised by the European health authorities. Why not? Many people are now wondering if this vaccine is really harmless and effective. Some people are now reluctant to be vaccinated,” he said, noting that the dual standard has raised fears that the COVAX vaccines are of inferior quality. Madagascar’s Minister of Health, Professor Jean-Louis Rakotovao-Hanitrala, said he was “surprised and shocked” to learn that the vaccines being distributed wouldn’t be accepted in Europe. “This vaccine was given to us by the WHO and welcomed by the European Union and all the UN agencies,” he was quoted as saying. That , he said “makes us wonder if there is not one vaccine for Africans and another for Europeans”. On the other side of the continent, Nigerian health experts are also worried that the EU policy may stimulate more vaccine hesitancy – threatening the delicately built trust in the vaccine that is most widely available. “Something is definitely fishy somewhere. We need these people to come clean and tell us what is happening. My parents received this vaccine. Should we be worried?” one Nigerian woman, who asked to remain anonymous, told Health Policy Watch. African countries do not have luxury of choices like European countries have and as such they need to continue to build acceptance around Covishield, stressed Oyewale Tomori, a Nigerian professor of virology and chairman of Nigeria’s Ministerial Expert Advisory committee on COVID-19. “This is the vaccine that we have and we will continue to encourage our people to take while ensuring that we do not find ourselves again at the mercy of the rest of the world in future pandemics,” Tomori told Health Policy Watch. WHO Officials – Protest in Africa, Silent In Geneva WHO Regional Director for Africa Dr Matshidiso Moeti speaking about the EU COVID Green Pass at Thursday’s Regional press briefing, At Thursday’s Africa Regional press briefing, WHO’s Regional Director for Africa, Dr Matshidiso Moeti, protested the double standard, telling reporters that the European green pass programme should recognize all eight vaccines that have been approved by the WHO, which include the AstraZeneca vaccines produced in India, as well as two Chinese-made vaccines, rather than only those that are EU approved. “Increasingly proof of vaccination permits the removal of travel restrictions, and even if it is important to secure the frontiers and prevent the propagation of the virus, African’s shouldn’t be subject to any more restrictions because they can’t access a particular vaccine,” she noted. “Only four of the eight vaccines recognised by the WHO are recognised by the European Medicines Agency for the digital passport system put in place by the European Union. We hope that all countries will respect the principles of the International Health Regulations, and see to it that all vaccines are approved by the WHO and are accessible to everyone, before they can become a prerequisite for travel,” she sai. Moeti said the WHO and EMA use the same standards in assessing vaccines. “The safety and efficacy of all WHO emergency use listed vaccines has been proven globally in preventing severe COVID-19 illness and death.” Added Richard Mihigo, African regional director for immunisation and vaccines development: “Actually, WHO is in the process of working with the European Union so that there can be a harmonisation and a recognition by all of the EU members, for all of the products that were approved by the WHO, in a general manner.” “What people have to understand is that the EMA only approves products that are being used in the EU. For those [vaccines] not being used by the EU, they are not even submitted for approval to the EMA, and that is the case for AstraZeneca CoviShield, being produced by the Serum Institute of India, which was from the beginning intended to fulfil the needs for a segment of the market – the COVAX countries. Mihigo stressed that there was “no ambiguity about the quality of this vaccine produced in India”. “It’s strictly an administrative process, which has nothing to do with the quality of the AZ vaccine, which is being produced in several countries in Europe, the United States, India, and South Korea.” At Geneva’s headquarters, however, WHO officials speaking at a Friday press conference made no reference to the EU conundrum – despite protesting, in principle, the fact that COVID passports are being used at all in travel – when access remains so limited in many countries. “WHO should not be recommending a requirement for vaccination as a condition of travel,” declared Michael Ryan, executive director of health emergencies, “and that is particularly related to the scarcity of vaccines and the fact that there is such an inequity of distribution of those vaccines – plus uncertainties regarding the extent to which vaccination prevents infection, or transmission of the disease”. “Any imposition of such a requirement for vaccination, around the world does, in effect, deliver a double inequality as individuals from countries who have no access to vaccines will then have no access to travel, and therefore it is very important that if we’re going to impose restrictions on the travel of individuals, we must at least attempt to do that from a level playing field of having access to vaccine,” Ryan added. A Health Policy Watch request to WHO/HQ for comment regarding the exclusion of the Serum Institute version of the AZ vaccine from the EU green pass received no response, as of press time. Image Credits: UNICEF, African CDC , Tourism Watch. US had Nearly 5 Times More COVID-19 Cases Than Reported In First Half of 2020 – Study Finds 25/06/2021 Chandre Prince An estimated 20 million Americans were infected with COVID-19 in mid-July 2020 – 17 million more than the three milion officially recorded, a new study has found. The United States may have experienced nearly 17 million additional COVID-19 cases in the first six months of the COVID-19 pandemic, according to a new study by the National Institutes of Health (NIH). The NIH study, published this week in Science Translational Medicine, suggests that for every coronavirus infection recorded until mid-2020, nearly 4.8 more asymptomatic cases went undetected. In the United States alone, a total of 16.8 million infections with SARS-CoV2 were undected, as of mid-July 2020 – meaning that as many as 20 million Americans were infected with COVID-19 by mid-July 2020 – in comparison to the the three million cases officially recorded in that period. “This study helps account for how quickly the virus spread to all corners of the country and the globe,” said Bruce Tromberg, director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB), one of the NIH institutes that runs the NIH SARS-CoV-2 Seroprevalence Project, in a statement on Tuesday. Blood samples were collected from 8,058 volunteer participants between 10 May and 31 July 2020, among people who were not previously diagnosed with COVID-19. Of the sampled blood, approximate 304 contained antibodies against COVID-19. Based on the analysis of the data , NIH researchers estimated that for every diagnosed COVID-19 case during the spring and summer of 2020, there were 4.8 undiagnosed cases – representing an additional 16.8 million cases. The research team observed that Black participants had the highest estimated rate of positive COVID-19 antibody tests (14.2%), followed by Native American/Alaska Native (6.8%), Hispanic (6.1%), white (2.5%) and Asian (2%) respondents. When comparing age groups, the youngest participants – those between the ages of 18 and 44 – had the highest estimated rate, at 5.9%, the study found. Women (5.5%) had a higher positivity rate than men (3.5%); and numbers for those living in urban areas (5.3%) were higher compared with rural participants (1.1%). Pandemic Hallmark – Many People Infected with Few or No Symptoms “A hallmark of the coronavirus pandemic is that there are people infected with the virus that causes COVID-19 who have few or no symptoms,” Dr Matthew Memoli, director of the Laboratory of Infectious Diseases Clinical Studies Unit at the National Institute of Allergy and Infectious Diseases, which participated in the research team, said in a statement. “While counting the numbers of symptomatic people in the United States is essential to contend with the impact of the pandemic and public health response, gaining a full appreciation of the COVID-19 prevalence requires counting the people who are undiagnosed.” The research team also included scientists from the National Institute of Allergy and Infectious Diseases (NIAID), the National Center for Advancing Translational Sciences (NCATS); and the Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute (NCI). The team argues that the USA’s official COVID-19 numbers should be revised upwards from the three million cases reported in mid-July 2020 to almost 20 million, once the proportion of asymptomatic positive results are included. Said senior co-author Kaitlyn Sadtler, chief of the NIBIB Section on Immunoengineering: “This wide gap between the known cases at the time and these asymptomatic infections has implications not only for retrospectively understanding this pandemic, but future pandemic preparedness.” The research team said they are currently following up with the study participants to evaluate the presence of antibodies after six and 12 months, as well as antibody reactivity to variants of concern, the medical research agency said “The information will be invaluable as we assess the best public health measures needed to keep people safe, as new – and even more transmissible – variants emerge and vaccine antibody response changes over time,” said Tromberg. Frontline Health Workers Critical to Improving Mental Health Response During and After COVID-19 Pandemic 25/06/2021 Raisa Santos Nurses celebrate Nurses Appreciation Week in New York City, 2020, at the height of the COVID pandemic. Healthcare professionals, and particularly community health workers who have been the backbone of local and national health systems during the COVID crisis, are also unsung ‘first responders’ to the massive mental health fallout from the pandemic, now and going forward. That is the central theme of a webinar panel on ‘COVID-19 and Frontline Workers’, Wednesday, 30th June, 13:00 – 15:00 CET, which featuring COVID response and mental health experts from the World Health Organization, the International Council of Nurses and consumer groups. The panel is sponsored by the Geneva-based Global Self-Care Federation with Health Policy Watch serving as media partners for the event. Protecting Healthcare Workers’ Wellbeing Through Inclusive Mental Health Care While the tireless work of nurses and healthcare professionals has been championed and celebrated throughout the pandemic, those workers have, for the most part, been ‘largely absent from the mental health discourse’, said Judy Stenmark, Director-General of GSCF, in a recent blog post on mental health. Stenmark calls for a more ‘more inclusive approach that brings all stakeholders into the equation’ to both consider the mental health needs of health workers during the pandemic period – as well as optimising their contribution to community-based mental health response. “Without healthcare workers, there’s no chance we will see this pandemic through. Therefore, a greater consideration of self-care for healthcare workers is essential as we learn more about the consequences of the pandemic on healthcare systems,” she said in her blog, adding: “Unless we take proactive measures to ensure staff are safe at work and have sustainable working conditions – we’re at risk of losing the means that make healthcare possible.” WHO Action Plan Extension Receives Wide Support During WHA The Maldives’ delegate at the 74th World Health Assembly on Monday. Those messages also echo ones heard during last month’s 74th World Health Assembly, in which WHO Director General Dr Tedros Adhanom Ghebreyesus called for a rethinking of mental health treatment and delivery: “One day this pandemic will be over – but many of the psychological scars linked to the pandemic will stay with us for a long, long time,” he stated, at the Assembly, in which a special session saw WHO officials and member states acknowledging how the ‘mass trauma’ of COVID-19 has worsened mental health worldwide. A draft decision endorsing an updated version of WHO’s Mental Health Action Plan also was adopted during the 74th WHA. The updated WHO Action Plan will include a greater forums on suicide prevention, workplace mental health, universal health coverage, mental health of children, mental health across the life course, and the involvement of people with lived experience of mental health conditions. “It is crucial to prioritize the actions to minimize mental health consequences of the pandemic and incorporate these actions into emergency and disaster risk management strategies,” said Asim Ahmed, Permanent Representative at the Permanent Mission of the Maldives to the UN in Geneva, during the 74th WHA. Incorporating Mental Health into COVID-19 Response Plans Mental health services for children and adolescents have been disrupted due to COVID-19 During the pandemic, WHO and its Member States have also worked to incorporate mental health and psychosocial support into COVID-19 response plans. That has included WHO’s development of a wide range of resources in collaboration with partners, including: a stress management guide for the general public; a guide for COVID-19 responders on basic psychosocial skills; and a toolkit to help older adults maintain mental well-being. “Doing What Matters in Times of Stress: An Illustrated Guide” is a stress management guide aimed at equipping people with practical skills to help cope with stress, especially in the early stages of the pandemic. The Inter-Agency Standing Committee Reference Group on Mental Health and Psychosocial Support in Emergency Settings, co-chaired by the WHO and the International Federation of Red Cross and Red Crescent Societies, has created an illustrated guide aimed at building basic psychosocial skills among all essential workers responding to COVID-19. The group has also produced a storybook for children, “My Hero is You, how kids can fight COVID-19”, to help children of 6-11 years learn how to protect themselves, their families and friends from coronavirus, and how to manage difficult emotions during the pandemic. A sequel that addresses the concerns of children during the current stage of the pandemic is planned for the third quarter of 2021. New WHO Guidance on Community-Based Mental Health Alternatives A lay counsellor on the Friendship Bench in Zimbabwe – part of an innovative community-based mental health programme rolled out in the country. With community-based services the backbone of better mental health services, WHO has recently highlighted successful examples of person-centered and rights-based community mental health services from across the world in a new report, released on 10 June. The report, ‘Guidance on community mental health service: promoting person-centered and rights-based approaches’, offers over two-dozen peer-reviewed examples of mental health services around the world that demonstrated good practices that are non-coercive, incorporate the community, and respect people’s agency, or their right to make decisions about their treatment and life. These include examples of cost-effective initiatives in low- and middle-income countries that promote frontline health workers, social workers, trained lay experts, and guided self-care networks as a backbone of service delivery to people in need. Examples include initiatives such as the Friendship Bench in Zimbabwe, Atmiyata in India, as well as self-help groups, such as Kenya’s Users and Survivors of Psychiatry (USP-Kenya). These services also feature alternative methods of treatment that ireduce compulsory hospitalization, over-prescription of anti-psychotic drugs – and critically, incorporate the voices of those with their own experiences with mental health conditions and psychosocial disabilities through peer-support groups. “[The value of peer-support groups] has been about restoring power, voice, and choice to persons with psychosocial disabilities,” said USP-Kenya CEO Michael Njenga. Nurses and healthcare workers are the frontline of the health workforce Image Credits: R Santos, Raisa Santos , WHO, WHO/NOOR/Sebastian Liste, Tim Kubacki/Flick. WHO, World Trade Organization & World Intellectual Property Organization Map Out Joint Approach to COVID Pandemic 24/06/2021 Elaine Ruth Fletcher Directors-General of WIPO (far left) WHO (back center) and WTO (far right) discuss stepped up cooperation on combatting COVID-19 pandemic In a first-ever tripartite meeting this year, the heads of the World Health Organization, the World Trade Organization (WTO) and the World Intellectual Property Organization (WIPO), have agreed to step up their collaboration on tools and resources for fighting the COVID-19 pandemic. The meeting was the first formal tripartite meeting since Ngozi Okonjo-Iweala was elected as head of WTO earlier this spring, following the election of Daren Tang as the new head of WIPO late last year. In a joint statement issued after the meeting the three heads of agencies, including WHO’s Director General Dr Tedros Adhanom Ghebreyesus, pledged to collaborate more closely on a joint platform for tripartite technical assistance to member governments relating to their needs for medical technologies as well as a series of workshops – to augment capacity and information flow. In a joint statement issued following their meeting 15 June, the three agency heads stated that they would ramp up cooperation focusing first on “the organization of practical, capacity-building workshops to enhance the flow of updated information on current developments in the pandemic and responses to achieve equitable access to COVID-19 health technologies. “The aim of these workshops is to strengthen the capacity of policymakers and experts in member governments to address the pandemic accordingly. “The first workshop in the series will be a workshop on technology transfer and licensing, scheduled for September. The workshop will help our members update their knowledge and understanding of how intellectual property, know-how and technology transfer work in actuality. This would be in the context of medical technologies and related products and services. This first workshop will be followed by others on related practical themes.” A second prong of the joint initiative, will be the joint platform for technical assistance, that aims to provide “a one-stop shop that will makae available the full range of expertise on access, IP and trade matters provided by our organizations, and other partners, in a coordinated and systematic manner.” The platform will focus, in particular, on: supporting countries to assess and prioritize unmet needs for COVID-19 vaccines, medicines and related technologies, and; providing “timely and tailored technical assistance in making full use of all available options to access vaccines, medicines and technologies, including through coordination between members facing similar challenges to facilitate collective responses.” The effort would also include “periodical update” of baseline resources maintained by the three organizations, mapped in the joint publication: “Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade”, the statemnt said. The initiative appears to bring WIPO closer into the circle that has already been established by WTO and WHO on pandemic response – following last year’s change of administration in the agency that maintains a critical repository of data on intellectual property on health products for manufacturers worldwide – but has been too often accused of remaining outside of the loop of practical advice on IP use to low- and middle-income countries. Image Credits: World Trade Organization . Third COVID Wave Racing Across Africa — New Case Rates in South Africa & Tunisia Outstrip United Kingdom 24/06/2021 Paul Adepoju A quiet street in Cape Town, South Africa, during one of the hard lockdown periods of 2020, which helped curb the spread of COVID-19 last year. A “terrible third wave” of the COVID-19 pandemic is now hitting Africa in full force – with about 20 of the continent’s 54 countries experiencing particularly sharp rises in new infections, African Centers for Disease Control director, John Nkengasong told Health Policy Watch at a press briefing on Thursday. Per-capita rates of new SARS-CoV2 cases in South Africa and Tunisia now outstrip those in the United Kingdom – and spiralling 5-6 times higher than those in the United States and India. Although the continent-wide average is still only about 27 new cases per million, below the current US average, (34/million), the increases seen are prompting worries that Africa could even become a new global epicentre for the pandemic. That after nearly a year when it managed to maintain comparatively low case counts. Daily new cases per million people in Tunisia and South Africa are now running at nearly 200 infections/million. In comparison, in the United Kingdom new cases now stand at 149/million and in hard-hit India at 40 per million, over the last week. The new wave has already stretched several health systems on the continent beyond their limits, Nkengasong said. “This is the first time that we are seeing countries report that their health systems are completely overwhelmed,” he said. Zambia, Uganda & DRC In Zambia, daily new infections are averaging 138/million the highest ever recorded since the pandemic was declared. That, in turn, is biting health systems hard, Nkengasong said. According to the latest figures, on June 23, the country reported 3,367 new cases of COVID-19 over the past 24 hours – the highest number of daily reported cases yet in the country. It was also nearly double the number of cases (1,796) reported on 16 January 2021 when the country reached the peak of its second wave. Nkengasong revealed that aside from the already dispatched commodities, Africa CDC will also be sending a team of experts to Zambia to help the country cope with the third wave. “They are completely overwhelmed,” he said. The health systems of Uganda and the Democratic Republic of Congo are facing similar crises, he added. In conflict-ridden DRC, meanwhile, the lack of strong systems for COVID testing and case reporting may also be keeping the numbers artificially low, inside observers told Health Policy Watch. DRC has also been one of the most vaccine hesitant countries – turning back a large shipment of COVAX vaccines that it received to Africa CDC in April because it did not have the means to administer the doses. Even among the country’s large presence of UN forces and support teams, who have ready access to dedicated vaccine donations from India, vaccinations have progressed at painfully slow rates, observers told Health Policy Watch. Steepest COVID-19 Surge Yet — WHO WHO Regional Director for Africa Dr Matshidiso Moeti believes Afric can still blunt the impact of the currently fast-rising infection wave if precaution is taken against transmitting the virus. At a separate WHO briefing, WHO Regional Director for Africa Matshidiso Moeti described the third wave as the pandemic’s steepest surge yet continent-wide. According to WHO’s data, the number of cases have risen for five consecutive weeks since 3 May. As of 20 June—day 48 into the new wave—Africa had recorded around 474 000 new cases—a 21% higher rate as compared with the first 48 days of the second wave. At the current rate of infections, the ongoing surge is set to surpass the previous one by early July, WHO stated. “With rapidly rising case numbers and increasing reports of serious illness, the latest surge threatens to be Africa’s worst yet,” Moeti warned. But even though the window of opportunity may be closing, she noted that Africa can still blunt the impact of the currently fast-rising infections. “Everyone everywhere can do their bit by taking precautions to prevent transmission,” she said. For instance, after Uganda slapped on new restrictions last week, new cases there appeared to be plateauing. Vaccine Supplies May Not Arrive In Time Africa CDC director Dr John Nkengasong Despite promises of hundreds of millions of doses from different partners, including the United States government, the timeline for the delivery of the doses may not see their arrival in time to really help African countries combat the third wave, both WHO and Africa CDC officials warned. Globally, of the 2.7 billion vaccine doses administered, under 1.5% have been in the arms of Africans. According to the Africa CDC, 61.4 million COVID-19 vaccine doses have been received so far by 51 African member states out of which 48.6 million doses have been administered (79.52%). So far, only 1.12% of the African population has been fully vaccinated. Most of those supplies were received in March & April this year through the WHO co-sponsored COVAX vaccine facility – before COVAX supplies produced by the Serum Institute of India dried up as a result of India’s COVID infection spike. “Cases are outpacing vaccination, leaving more people exposed. Now we need international solidarity and innovation to increase our supply,” Moeti said. Nkengasong agreed: “What we need is rapid access to vaccines to member states. It is extremely frightening to look at the graphs from some African countries. We just really need vaccines to get into people’s arms very quickly.” Without any intentional actions to speed up vaccine dose supply to Africa, Nkengasong said member states may have to wait until August when doses are expected to start becoming available through African Union’s COVID-19 Africa Vaccine Acquisition Task Team (AVATT). Delta Variant Spreading Across Africa WHO and Africa CDC also called attention to the rapid spread of the Delta variant of the virus that was first reported in India, across the African continent. The Delta variant, has already been reported in 14 countries in Africa, rapidly catching up with other variants, Moeti said. “In the Democratic Republic of the Congo and Uganda that are experiencing COVID-19 resurgence, the Delta variant has been detected in most samples sequenced in the past month,” she noted. “We have seen that variant really aggressively taking over from other variants, not just in Uganda, but in other countries like the DRC,” Nkengasong added. In addition, the Beta variant which was first identified in South Africa, has since been reported in 29 African countries. And the Alpha variant that was first reported in the UK and is now being reported in 30 African countries, according to the Africa CDC. WHO said it is taking steps towards expanding the capabilities of various African countries to track the spread and evolution of the virus in order to guide epidemiological decisions. “We are supporting South Africa-based regional laboratories to monitor variants of concern,” Moeti said. “WHO is also boosting innovative technological support to other laboratories in the region without sequencing capacities to better monitor the evolution of the virus. In the next six months, WHO is aiming for an eight- to ten-fold increase in the samples sequenced each month in Southern African countries.” Leading Researchers Highlight the Impact of COVID-19 on Global Liver Disease 24/06/2021 Chandre Prince Dr Rifaat Safadi, director of the Liver Unit at Hadassah Hebrew University Medical Center, in Jerusalem, Israel. Patients who had liver transplants or those with advanced liver fibrosis may not be adequately protected against COVID-19 after two doses of the Pfizer-BioNTech vaccine, in light of the findings of a new study presented Wednesday on the opening day of the International Liver Congress(ILC) 2021. Presenting abstracts from the soon-to-be-released study on Wednesday, Dr Rifaat Safadi, director of the Liver Unit at Hadassah Hebrew University Medical Center, in Jerusalem, Israel, said the study suggests that such patients with low levels of antibodies to the SARS-CoV-2 virus should get a third booster Pfizer shot to increase their chances of protection against the virus. The global virtual conference, convened by the European Association for the Study of the Liver (EASL), is taking place Wednesday – Saturday. This year’s conference brings together leading liver disease researchers from around the world to explore new science around the prevention and treatment of liver disease caused by Hepatitis C, alcohol abuse and other risk factors, as well as the impact of the COVID-19 pandemic on people living with liver diseases and on liver disease medications. This year’s conference proceedings are highlighting the extreme vulnerability of people with liver disease to COVID – with one new study finding the chronic liver disease increased the odds of COVID-19 death by 80%. On the more positive side, another study however, found that the antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B. Research on the impact of COVID-19 on alcohol-related liver disease is also being showcased at this year’s conference session, along with new or improved treatments for people suffering from HCV. “We are beginning to understand more clearly just how disproportionately COVID-19 is impacting on people living with liver-related diseases and the studies presented at ILC 2021 advance our knowledge on multiple fronts, knowledge that can potentially help inform policy responses to the pandemic going forward,” said Philip Newsome, General Secretary of EASL and Director of the Centre for Liver Research at the University of Birmingham in the UK, at Wednesday’s opening session. Pfizer-BioNTech Vaccine Offers Low Immunity for People with Advanced Liver Disease Data from an Israeli study found that patients with advanced liver fibrosis may not be adequately protected against COVID-19 after two doses of the Pfizer-BioNTech vaccine. With regards to the Pfizer vaccine on patients with liver disease, Safadi, who will present the full results of the Israeli study on Saturday, explained that “older age”, advanced fibrosis and decreased steatosis appear to be risk factors for lower vaccine response among people with related forms of liver disease. The study analysed data from 88 patients living with hepatic fibrosis who had tested positive for COVID-19 and who had received both doses of Pfizer’s-BioNTech vaccine. It found that elderly patients with advanced liver fibrosis had a lower response to Pfizer’s vaccine, with Safadi suggesting that those patients may need a third booster shot. “Therefore, we have to think about the booster vaccination… we are thinking now about boosting the third shot, especially those with high risk for non responsiveness or lower response,” said Safadi. The study’s recommendation, however, goes beyond current US Food and Drug Administration (FDA) recommendations. The FDA has so far not recommended the use of antibody tests to check the effectiveness of vaccination against the virus, nor has it approved a three-dose regimen or booster of any SARS-CoV-2 vaccine. Tenofovir Reduces Severity of COVID-19 in Patients with Chronic Hepatitis B Encouraging data from another new study found that antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B. A study conducted in Spain found that antiretrovira drug tenofovir reduced the severity of COVID-19 in patients with chronic Hepatitis B. Beatriz Mateos Muñoz, PhD Specialist in Gastroenterology and Hepatology at the Hospital Universitario Ramón in Spain, said the study analysed data from 4736 patients from 28 Spanish hospitals. Of the 117 COVID-19 positive patients who were identified, 67 were taking tenofovir and 50 were on entecavir, an antiviral drug in the treatment of hepatitis B virus infection. Muñoz said the incidence of COVID-19 in patients on tenofovir or entecavir were similar, but that patients on entecavir “more often had severe COVID-19, required ICU, ventilatory support, had longer hospitalization or died”. The study found that tenofovir seemed to offer some protection in patients with chronic hepatitis B infected by COVID-19. “In multivariate logistic regression adjusted by age, sex, obesity, comorbidities and fibrosis stage, tenofovir reduced by 6-fold the risk of severe COVID-19. Patients with chronic hepatitis B on tenofovir have a lower risk of severe COVID-19 infection than those on entecavir.” COVID-19 Related Alcohol Sales May Have Increased Alcohol-related Liver Disease Abdel-Aziz Shaheen, assistant professor at the Gastroenterology and Hepatology at the University of Calgary in Canada, said a large population-based study found a significant increase in the number of patients with alcoholic hepatitis who were hospitalised last year in Alberta, Canada last year, with the highest admission rate recorded in April 2020. Shaheen said a significant increase in alcohol sales across Europe and North America during the early months of the pandemic had alarming consequences for patients with alcoholic hepatitis. He said most of the newer patients with alcoholic hepatitis were younger and mainly from rural areas. “There was a significant 9% increase in alcoholic hepatitis admissions per month between March and September and the average rate of alcoholic hepatitis hospitalizations compared to overall hospitalizations rate doubled from 11.6/ 10,000 general hospitalizations to 22.1/ 10,000 general hospitalizations for the same period,” said Shaheen. More worrying, said Shaheen was that: “Our results show that the increase in alcohol sales post pandemic will significantly impact the natural history of alcoholic liver disease in Canada”. Chronic Liver Disease Increased the Odds of Covid-19 Death by 80% Vincent Mallet, Managing Senior Physician and Professor, Hepatology Unit, Cochin University Another study that used the French National Hospital Discharge database for patients who were hospitalised for COVID-19 found that chronic liver disease increased the odds of COVID-19 death by 80%. Vincent Mallet, Managing Senior Physician and Professor, Hepatology Unit, Cochin University said the hospital records showed that 3, 943 of the 16,338 patients diagnosed with chronic liver disease who were admitted for Covid-19 in France in 2020 died, including 2518 after liver-related complications. He said liver complications and alcohol use disorders may have contributed to the COVID-19 deaths of patients with chronic liver disease. People with Obesity & Diabetes Related Fatty Liver Disease Also at Higher Risk from COVID-19 Similarly, a small study in Mexico of 348 patients found that people living with Metabolic Associated Fatty Liver Disease (MAFLD) were five times more likely to die during hospitalization for COVID-19 than people without these factors. The patients studied were admitted with the SARS-COV-2 infection to a number of tertiary referral hospitals between 4 April and 24 June 2020, said Martin Uriel Vázquez Medina, Researcher at the Laboratory of Biomathematical and Biostatistical Modelling for Health Escuela Superior de Medicina, México. Major risk factors for the chronic conditions are obesity and type-2 diabetes, common conditions in many parts of Latin America, also closely associated with unhealthy diets, including high sugar consumption, and lack of physical activity. Medina added: “We also want to show with this result that [patients in] Latin American countries that have this overhead problem of obesity, diabetes, and pre-diabetes, could also be associated with increased risk from COVID-19”. The ILC continues until Saturday. Six More African Countries Needed to Ratify Treaty Creating the First Continent-Wide Medicines Regulator 23/06/2021 Paul Adepoju The African Medicines Agency’s framework would help combat falsified products and by ensuring harmonized drug standards and approvals, ease access to more affordable medicines and vaccines for people throughout the continent. Michel Sidibé, Special Envoy of the African Union and Minister of Health of Mali has high hopes that 15 African countries will have finally ratified the African Medicines Agency (AMA) Treaty in time for the 35th African Union (AU) Summit, scheduled for early 2022. Fifteen is the magic number of countries that must ratify the treaty creating the AMA – in order to birth the agency into operational existence. By the time of the summit, Sidibé also predicts that 30 or more countries will also have signed the framework agreement on the creation of the agency – an agreement that was first approved by the African Union in February 2019. He was speaking at a virtual session on Tuesday, From civil society to the pharma industry, establishment of the continent-wide AMA is regarded as an important step forward that would help improve the functioning of national medicines regulatory agencies – combating fake medicines and streamlining approval of new medicines and vaccines. That, in turn, should also help reduce prices and boost access for people throughout the continent, observers predict. Snail Speed Pace of Ratification So Far However, snail-speed ratification of the treaty by the legislatures and parliaments of the AU’s 54 member states has become a major hurdle to actually opening the doors of the new agency. This is despite the strong support displayed by global health actors actors ranging from the World Health Organization, Africa Centres for Disease Control, as well as other regional drug regulatory agencies such as the European Medicines Authority. However, Sidibé said he is confident the new agency, once it finally begins operations, can build upon the continent’s existing expertise in pharmacovigilance – developed by national agencies such as the Moroccan agency for medicines and the Nigerian Agency for Foods, Drugs Administration and Control (NAFDAC). As for concerns regarding the slow pace of country approvals of the framework agreement and formal ratification, Sidibé said the plan has been to first target a balance of countries in diverse African regions as “low-hanging fruit” – followed by others. In fact, so far most of the countries signing and then ratifying the agreemeht have been West African and/or Francophone. But as the critical mass of ratifications is approached, momentum elsewhere is also building. “Our strategy was to go for different regional balances… , to make sure that we can have a low hanging fruit so we can get quickly the 15 countries,” he said. “Now we are almost there. I am sure by the next meeting of the African Union, we can come and present to the leaders that we managed to have 15 countries,” he said, adding that the priority is to ensure that all African countries are soon on board. Getting buy-in from all African countries will involve actively engaging with governments that are yet to sign and/or ratify the treaty, one by one. Top countries earmarked now for the next stage include north and west African regional leaders such as Ethiopia and Nigeria, as well as the Democratic Republic of Congo. “We are learning from different experiences and ensuring that we are not losing time. We are making sure we bring different partners together to implement the agenda quickly,” Sidibé added. The Long Road to Ratification In October 2020 Health Policy Watch reported that only 18 of Africa’s 55 countries had signed the framework agreement to establish the agency, while only 5 countries – Rwanda, Mali, Burkina Faso, Ghana and Seychelles – had actually ratified the agreement. At the time, Africa CDC Director John Nkengasong, told Health Policy Watch the delay in the treaty ratification was due to the COVID-19 pandemic. “I don’t think it is because countries do not want to sign on. I think it is because of the process that is required to make them sign that treaty, and the countries are currently focusing more on COVID-19,” said Nkengasong. “I think it’s a much needed institution. If we had the AMA, it would be working very closely with the WHO and other bodies to facilitate regulatory issues on drugs to help control the COVID-19 pandemic.” Since then, Zimbabwe and the Seychelles have signed the AMA framework treaty, raising the total number of signatories to 20. Guinea, Namibia and Sierra Leone have ratified the treaty, followed by Algeria this month, raising the number of countries that have fully completed the two-step approval process to nine. In order to get across the finish line, a new African Medicines Agency Treaty Alliance (AMATA) has also recently been created, said Kawaldip Sehmi of the International Alliance of Patients Organizations (IAPO), at Tuesday’s session. The Alliance, led by IAPO and including patient groups, researchers and academics, and industry, will advocate for rapid AMA ratification continent wide. It will also work to establish meaningful engagement with patients, industry and other relevant parties once the Agency becomes operational. The WHO is also actively supporting the emergence of the AMA, with its Director-General, Dr Tedros Adhanom Ghebreyesus describing the lack of strong national regulatory systems as “one of the biggest obstacles to improving access to medical products in Africa”. WHO Regional Director in Africa, Dr Matshidiso Moeti, has also reiterated the importance of the agency, telling Health Policy Watch: “AMA is a very important platform for medicines to be available and affordable equitably, and to be of good quality so that we have both good outcomes for the money that people and countries are spending, and that we prevent problems.” Other Benefits – International Partnerships and Support for Local Production The AMA will also help strengthen global collaborations, including participation of African researchers and patients in clinical research trials of new medicines, especially in the area of cancer, said Emer Cooke, Executive Director of the European Medicines Agency, speaking at Tuesday’s event. “We’re already collaborating with a number of initiatives on clinical trials with African regulators, particularly in the context of the African Vaccines Regulatory Forum. We can use forums such as this to build on the collaborative activities that take place to share our experiences and to help us to work on training and capacity building initiatives,” Cooke said. “I think we should be heartened by the fact that there’s already good discussion and collaboration in the context of clinical trials.” Fighting Fake Medicines Meanwhile, Lotfi Benbahmed, minister of the pharmaceutical industry of Algeria, said the AMA can help improve the reliability of Africa’s medicines — a feat that he said requires the existence of a regional framework to fight fake drugs. “So what we need to do is to harmonise rules and regulations, and enable countries to fight the illegal markets, and the informal markets,” Benbahmed said, who spoke alongside other African ministers of health from Algeria, the Democratic Republic of Congo, Egypt and Cape Verde. . According to him, a similar framework can be deployed to tackle the challenge of low quality drugs on the continent from the point of production, including setting up measures to inspect and control equipment in laboratories. At the same time, delays being encountered in the finalisation of the agency are “understandable”, said Dr Margareth Ndomondo-Sigonda, African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD), who highlighted the extensive harmonisation processes that needs to be undertaken between national governments to birth the new agency. “It takes time to get to the point where you’ve achieved regulatory harmonisation of African medicines and harmonization of regulatory standards. You have to make sure that through harmonization of these technical requirements, you know the quality standards and practice and you build trust,” Ndomondo-Sigonda said. She was however hopeful that once AMA comes into force, it will be able to deal with many outstanding issues regarding the harmonisation of Africa’s medicines landscape. Image Credits: Marco Verch/Flickr. Urgent Government Action and Investment Needed Against Antimicrobial Resistance, Says New Report 23/06/2021 Raisa Santos Launch of the AMR Preparedness Index Panel – left to right – James Anderson, Susan Schwarz, Neil Clancy, Anand Anandkumar, Christine Ardal, Mike Hodin, Norio Ohmagari, Tiemo Wolken Government action against the threat of “superbugs” in most of the world’s leading economies gets a score of less than 50%, according to a new AMR Preparedness Index, released today by a global coalition committed to fighting current trends. Great Britain, the United States, Germany and France rated highest on a score of 1-100 in an assessment of responses in 11 of the world’s leading economies to antimicrobial resistance (AMR) threats. Meanwhile, emerging economies such as Brazil, China, and India scored the worst in the assessment that looked at national strategy; awareness and prevention; innovation; access; appropriate and responsible use; AMR and the environment; and collaborative engagement. The index was launched today by the Global Coalition on Aging (GCOA) and the Infectious Diseases Society of America (IDSA), to shine more light on how the governments are living up to their commitments to address antimicrobial resistance (AMR). “We need health systems and policymakers to really step up and advocate that federal, state, and local governments prioritize AMR,” said Neil Clancy of the AMR Committee, Infectious Disease Society of America, during an event Wednesday launching the Index. “Without significant national and global coordination and multi-party interventions in this area, our efforts are not going to succeed.” The AMR Preparedness Index ranked 11 countries across 7 categories in a 1-100 point scale. UN Report Warns That AMR Could Cause As Many as 10 Million Deaths/ Year Livestock applications of antibiotics in metric tons/year, among countries reporting use. (The Antibiotic Footprint) An estimated 700,000 people already die each year from drug-resistant infections and the lack of antimicrobials to treat them. A 2019 UN report warned that if trends are ignored, AMR could cause as many as 10 million deaths per year, and GDP losses of more than US $100 trillion by 2050. The report assigns scores to each of the 11 countries across seven categories for needed and achievable policy action. Although the assessment considered national policies on “AMR and the Environment” it was unclear how heavily weighted that issue was in the overall index. Per capita, the US agricultural industry is one of the heaviest users of antibiotics in the world. COVID-19 Is a Warning Light to Act Preemptively on AMR The cost of AMR action pales in comparison to the future costs of inaction, participants underlined, drawing comparisons with the COVID-19 pandemic. Delays in responding to urgent public health crises have deadly consequences. “If the pandemic has taught us one thing, it is that we are not well-prepared to combat the serious threat that emerging infectious diseases can pose to human health and our economies,” said Tiemo Wölken, member of the European Parliament, Germany. In Europe, AMR causes the annual death of 33,000 people and costs 1.5 billion Euros in regards to healthcare costs and productivity losses. COVID-19 has highlighted the need for increased monitoring tools, more improved detection, prevention, and control practices, said Wölken. “The time to act is now. COVID already put our healthcare systems under extreme pressure, and this could only be a foretaste of what we could expect from a world where antibiotic microbials are no longer effective.” All Countries Fail in Awareness & Prevention of AMR Testing for antimicrobial resistance at the Liverpool School of Tropical Science. The analysis identified critical opportunities for all governments to act upon to slow the growth of drug resistant bugs. “Despite the progress that’s being made and despite the good work being done in countries throughout the world, we need to do more,” said Clancy. Several trends have emerged from an analysis of the different indices that went into the combined score. All countries performed insufficiently with regards to awareness and prevention of AMR, with India lagging furthest behind. More developed countries tended to fare better in the appropriate and responsible use of existing antibiotics and other antimicrobial agents – as compared to developing country counterparts. Outside of the UK and US, most other countries performed poorly in assessments of the quality of national strategies, innovations, and collaboration. Innovation Important Training on standardized and harmonized surveillance methods for antimicrobial resistance in food animals in Southeast Asia Innovation is another area that requires more significant action going forward, said James Anderson, Executive Director of Global Health at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). “We do need to really drive pipelines. We do need investments in AMR.” In the fight against the borderless threat of drug resistance, the Index included key insights and guidance for governments to immediately prioritize in order to fulfill their commitments on AMR. Overall, the top-level priorities identified in the Index were to: Strengthen and fully implement national AMR strategies; and raise awareness of AMR and its consequences. Along with that, other key priorities were to: Bolster surveillance and leverage data across AMR efforts; Enable a restructured antimicrobial marketplace to stimulate innovation; Promote responsible and appropriate use of antibiotics; Enable reliable and consistent access to needed and novel antimicrobials; More effectively integrate the One Health Approach, including environmental concerns, into national strategies; Better engage with other governments, third-party organizations, and advocacy groups Despite AMR being one of the top five global health challenges, as cited by the WHO, a large majority of the public remains unaware of their role. Local, national, and international efforts are needed in raising awareness and investment in AMR. “All of us have a stake in preserving antibiotics and assuring the development of new antibiotics,” said Clancy. Vaccinating Older Groups Against COVID – Can Help Fight AMR 93-year-old Lebanese actor Salah Tizani, who falls into the elderly priority group, receives his first vaccine dose against COVID-19 in Beirut on Feb. 14, 2021. In terms of the battle against COVID and AMR, the report underlines how vaccinating older adults can help fight overuse of antibiotics during the pandemic. That is because people who become seriously ill with COVID, are often given antibiotics preventively in order to ward off secondary infections. Adequately vaccinating older populations against other infections such as pneumococcal pneumonia and tuberculosis, and even infections like influenza is also critical step to combatting AMR. In other ways, too, older adults have a key stake in fighting AMR, because they tend to be major consumers of health services, and also may be more vulnerable to drug resistant bacteria and viruses overall. “We are at a time now when the megatrend of aging is at the top of our agenda, not just the public health agenda but the economic and social agenda as well,” said GCOA CEO Michael Hodin. As the UN Decade of Healthy Aging was launched in January, AMR needs to be a central part of this initiative, applied not only to older people but to all of us for a healthy and active aging, Hodin added. Coordination and Collaboration Across Low- and Middle-income Countries and High-Income Countries Most countries examined in the report are not making adequate investments to combat the AMR threat, with the lack of commitment felt globally. Huge disparities in total public AMR research funding remains an issue across high, middle, and low-income countries. “We cannot afford to be only US-centric, or only LMIC centric. It takes a very globalized approach,” said Anand Anandkumar, Founder and CEO of Bugworks Research, India. Greater support and collaboration is necessary to increase capacity for AMR initiatives, such as monitoring and surveillance in many low and middle-income countries (LMICs). Consequently, high income countries must collect and provide more complete data to increase the robustness of international, regional, and domestic efforts. “Access and equity are global challenges and the central tilt to competitive AMR,” said Clancy. “[We need to ensure] that we get antibiotics and access to these drugs in an equitable fashion. We’re all at risk from AMR.” Image Credits: USAID Asia/Flickr, GC, antibioticfootprint.net, Flickr – UK Department for International Development, World Bank: Mohamed Azakir. COVAX Shortcomings Under Microscope Ahead of Gavi, Vaccine Alliance Board Meeting 22/06/2021 Elaine Ruth Fletcher & Svĕt Lustig Vijay COVAX vaccine deliveries in Africa – a much trumpeted solution to vaccine inequalities in troubled waters. As the board of Gavi, The Vaccine Alliance is set to meet this Wednesday and Thursday, the COVAX global vaccine facility – a cornerstone of the global health sector response on vaccine access – is coming under increased fire for its shortcomings. A bitter opinion piece by Médecins Sans Frontières, published today, has called for a “drastic change of model” in the global procurement mechanism “that was supposed to deliver COVID-19 vaccine equity.” Co-launched by a range of partners, including WHO, the COVAX facility is legally administered by GAVI. What started out with a much-trumpeted bang of vaccine distributions across African nations has fizzled after the primary vaccine supplier, the Serum Institute of India, began redirecting its available COVID doses to domestic vaccine needs. Massive commitments by rich countries for further vaccine sharing, made at the recent G-7 meeting, are supposed to be funnelled through COVAX. Yet most of those donations will likely only be realized in the latter part of 2021 or early 2022, leaving the current shortfalls over the summer, as Africa faces yet another COVID wave. “COVAX is currently grossly behind on achieving its goals,” said MSF’s Katie Elder, senior vaccines policy advisor. “COVAX had aimed to provide 2 billion doses by the end of 2021, but so far has only distributed 88 million (the goal by the end of June was to distribute around 337 million). Less than half of one percent of total populations of COVAX countries have received at least a first dose of vaccine through COVAX.” She blames the fundamental model of the facility – in which it has been forced to compete on the open market for COVID vaccines – which were still often subsidized by public and government players – for the failings. AstraZeneca vaccine doses are unloaded at Bole International Airport in Addis Ababa, Ethiopia. Not Set Up to Succeed “COVAX was not set up to succeed,” she said. “It was constructed to work within the current parameters of the pharmaceutical market, where you see how much money you can raise and then see what you can negotiate with industry for it. “Loud calls early in the pandemic to depart from a business as usual approach were ignored—pharmaceutical corporations developing vaccines received billions in government money without any strings attached, so were free to charge prices they chose and to sell to the highest bidder. Unsurprisingly, this led to the very same governments that had touted the importance of equity …. and the governments that Gavi spent so much time courting to join the COVAX Facility – ultimately pursuing national interests and securing the bulk of future promised vaccines. “COVAX was left behind as wealthy governments secured their doses through bilateral deals with an industry that acted as expected: selling doses first to the buyers who could afford to pay the most.” The net result now leaves the Gavi Board struggling with how to continue the participation of upper income countries in the facility at all. “The fact that Gavi’s board is now reviewing the way in which wealthier countries (so called ‘Self-financing participants’) can continue to participate in the facility is in part a recognition that the set up does not work,” she added. “Allowing wealthy countries so much flexibility to decide how they join COVAX and how many vaccines they procure, has caused delays and undermined its objectives. A more equitable model would have encouraged regional leadership with decentralized methods of procurement at their core. In the future, we must support these regional initiatives that aim for self-sufficiency and self-determination.” A Beautiful idea: How the COVAX has Fallen Short To date, COVAX has distributed over 20 million doses to rich countries and 80 million doses to poorer countries. The result has been an awkward legal situation for the facility which is still required to provide 20% of its doses for higher income countries – even though most have now met their vaccine needs and hoarded even more, notably Canada, which bought enough vaccine doses to cover its population four times over. “The failure to entice wealthy countries to join COVAX in large numbers has left the managers of the facility in an awkward situation,” said global health journalist Ann Aanaiya Usher in a critique published by The Lancet. “On one hand, not enough self-financing participants joined COVAX to give it the massive buying power that was hoped. On the other, even though COVAX is desperately short of vaccines, the facility is now contractually obliged to reserve one in five doses for a few rich countries, she said, adding that so far, COVAX has distributed 80 million doses to LMICs and over 20 million doses to high-income countries (HICs), including the UK and Canada. She slams the COVAX facility for its “naive” set-up that failed to anticipate widespread vaccine nationalism that has locked up most of the vaccine doses that are available. “It was a beautiful idea, born out of solidarity”, Duke University’s Gavin Yamey was quoted as saying. “Unfortunately, it didn’t happen…Rich countries behaved worse than anyone’s worst nightmares.” COVAX should have also diversified its portfolio earlier on, in anticipation of supply shortages that crippled the facility after India’s Serum Institute halted vaccine exports to fend off a tragic second wave on the subcontinent that has claimed the lives of almost 400,000 people. “Supply shortages should have been anticipated and ramping up supplies should have been baked into the design of COVAX from the start,” observed Georgetown University’s Lawrence Gostin. He added, however, that it would be “literally impossible” to ramp up vaccine supplies without greater investments in manufacturing hubs in lower-income countries, as well as broad waiver on intellectual property rights to vaccine know-how. In its struggle to get rich countries to sign up, the COVAX facility’s offer to allow rich countries to choose which vaccines they would receive has also drawn widespread criticism for leading to “double standards” – which seemingly defy the very purpose of the facility, critics have said. A beautiful idea: how COVAX has fallen short https://t.co/QpG6o5zbqt This is the most complete & readable analysis of COVAX I have seen. The title says it all. COVAX was a beautiful idea & we must make it better & permanent — Lawrence Gostin (@LawrenceGostin) June 18, 2021 Facility Needs Equity Funds to Compete in the Marketplace Even Gavi, the Vaccine Alliance, has acknowledged that its slow mobilization of resources has hampered its ability to quickly procure, and thus deliver as many doses as possible to those who need them most. “If we had secured financing earlier, then we could have locked in doses earlier, as opposed to the second half of this year when COVAX’s volume will start ramping up,” a Gavi spokesperson said. The spokesperson was referring to the fact that most of the funds to procure and distribute vaccines for the 92 low- and middle-income countries (LMICs) that signed up for the scheme were pledged in late December or early 2021 – after high-income countries had already snapped up large vaccine pre-orders. That is a point of view shared by some independent observers as well as industry leaders, who maintain that the facility needs fine-tuning for the next pandemic. “Had COVAX had sufficient and readily available early funding it would have been better able to secure enough immediate supply to meet its aim,” said the Independent Panel for Pandemic Preparedness said, which reviewed the global pandemic response, under a mandate from the World Health Organization. Going forward, what COVAX needs is a “pot of money” to be able to pre-order vaccine doses earlier on in a global health emergency, said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations, in a recent Q&A with Health Policy Watch. That, he maintains, would allow the global facility to compete on a more equal footing with rich countries in the vaccines marketplace. Added Peter Hotez, a prominent vaccine scientist and dean at Baylor College of Medicine in Texas: “I think it’s important that we don’t sell COVAX short. It still has a lot going for it, and is innovative in its design. But it needs more vaccines to share,” Asked for comment by Health Policy Watch, GAVI did not respond. Image Credits: UNICEF, WHO, WHO. 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.
US had Nearly 5 Times More COVID-19 Cases Than Reported In First Half of 2020 – Study Finds 25/06/2021 Chandre Prince An estimated 20 million Americans were infected with COVID-19 in mid-July 2020 – 17 million more than the three milion officially recorded, a new study has found. The United States may have experienced nearly 17 million additional COVID-19 cases in the first six months of the COVID-19 pandemic, according to a new study by the National Institutes of Health (NIH). The NIH study, published this week in Science Translational Medicine, suggests that for every coronavirus infection recorded until mid-2020, nearly 4.8 more asymptomatic cases went undetected. In the United States alone, a total of 16.8 million infections with SARS-CoV2 were undected, as of mid-July 2020 – meaning that as many as 20 million Americans were infected with COVID-19 by mid-July 2020 – in comparison to the the three million cases officially recorded in that period. “This study helps account for how quickly the virus spread to all corners of the country and the globe,” said Bruce Tromberg, director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB), one of the NIH institutes that runs the NIH SARS-CoV-2 Seroprevalence Project, in a statement on Tuesday. Blood samples were collected from 8,058 volunteer participants between 10 May and 31 July 2020, among people who were not previously diagnosed with COVID-19. Of the sampled blood, approximate 304 contained antibodies against COVID-19. Based on the analysis of the data , NIH researchers estimated that for every diagnosed COVID-19 case during the spring and summer of 2020, there were 4.8 undiagnosed cases – representing an additional 16.8 million cases. The research team observed that Black participants had the highest estimated rate of positive COVID-19 antibody tests (14.2%), followed by Native American/Alaska Native (6.8%), Hispanic (6.1%), white (2.5%) and Asian (2%) respondents. When comparing age groups, the youngest participants – those between the ages of 18 and 44 – had the highest estimated rate, at 5.9%, the study found. Women (5.5%) had a higher positivity rate than men (3.5%); and numbers for those living in urban areas (5.3%) were higher compared with rural participants (1.1%). Pandemic Hallmark – Many People Infected with Few or No Symptoms “A hallmark of the coronavirus pandemic is that there are people infected with the virus that causes COVID-19 who have few or no symptoms,” Dr Matthew Memoli, director of the Laboratory of Infectious Diseases Clinical Studies Unit at the National Institute of Allergy and Infectious Diseases, which participated in the research team, said in a statement. “While counting the numbers of symptomatic people in the United States is essential to contend with the impact of the pandemic and public health response, gaining a full appreciation of the COVID-19 prevalence requires counting the people who are undiagnosed.” The research team also included scientists from the National Institute of Allergy and Infectious Diseases (NIAID), the National Center for Advancing Translational Sciences (NCATS); and the Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute (NCI). The team argues that the USA’s official COVID-19 numbers should be revised upwards from the three million cases reported in mid-July 2020 to almost 20 million, once the proportion of asymptomatic positive results are included. Said senior co-author Kaitlyn Sadtler, chief of the NIBIB Section on Immunoengineering: “This wide gap between the known cases at the time and these asymptomatic infections has implications not only for retrospectively understanding this pandemic, but future pandemic preparedness.” The research team said they are currently following up with the study participants to evaluate the presence of antibodies after six and 12 months, as well as antibody reactivity to variants of concern, the medical research agency said “The information will be invaluable as we assess the best public health measures needed to keep people safe, as new – and even more transmissible – variants emerge and vaccine antibody response changes over time,” said Tromberg. Frontline Health Workers Critical to Improving Mental Health Response During and After COVID-19 Pandemic 25/06/2021 Raisa Santos Nurses celebrate Nurses Appreciation Week in New York City, 2020, at the height of the COVID pandemic. Healthcare professionals, and particularly community health workers who have been the backbone of local and national health systems during the COVID crisis, are also unsung ‘first responders’ to the massive mental health fallout from the pandemic, now and going forward. That is the central theme of a webinar panel on ‘COVID-19 and Frontline Workers’, Wednesday, 30th June, 13:00 – 15:00 CET, which featuring COVID response and mental health experts from the World Health Organization, the International Council of Nurses and consumer groups. The panel is sponsored by the Geneva-based Global Self-Care Federation with Health Policy Watch serving as media partners for the event. Protecting Healthcare Workers’ Wellbeing Through Inclusive Mental Health Care While the tireless work of nurses and healthcare professionals has been championed and celebrated throughout the pandemic, those workers have, for the most part, been ‘largely absent from the mental health discourse’, said Judy Stenmark, Director-General of GSCF, in a recent blog post on mental health. Stenmark calls for a more ‘more inclusive approach that brings all stakeholders into the equation’ to both consider the mental health needs of health workers during the pandemic period – as well as optimising their contribution to community-based mental health response. “Without healthcare workers, there’s no chance we will see this pandemic through. Therefore, a greater consideration of self-care for healthcare workers is essential as we learn more about the consequences of the pandemic on healthcare systems,” she said in her blog, adding: “Unless we take proactive measures to ensure staff are safe at work and have sustainable working conditions – we’re at risk of losing the means that make healthcare possible.” WHO Action Plan Extension Receives Wide Support During WHA The Maldives’ delegate at the 74th World Health Assembly on Monday. Those messages also echo ones heard during last month’s 74th World Health Assembly, in which WHO Director General Dr Tedros Adhanom Ghebreyesus called for a rethinking of mental health treatment and delivery: “One day this pandemic will be over – but many of the psychological scars linked to the pandemic will stay with us for a long, long time,” he stated, at the Assembly, in which a special session saw WHO officials and member states acknowledging how the ‘mass trauma’ of COVID-19 has worsened mental health worldwide. A draft decision endorsing an updated version of WHO’s Mental Health Action Plan also was adopted during the 74th WHA. The updated WHO Action Plan will include a greater forums on suicide prevention, workplace mental health, universal health coverage, mental health of children, mental health across the life course, and the involvement of people with lived experience of mental health conditions. “It is crucial to prioritize the actions to minimize mental health consequences of the pandemic and incorporate these actions into emergency and disaster risk management strategies,” said Asim Ahmed, Permanent Representative at the Permanent Mission of the Maldives to the UN in Geneva, during the 74th WHA. Incorporating Mental Health into COVID-19 Response Plans Mental health services for children and adolescents have been disrupted due to COVID-19 During the pandemic, WHO and its Member States have also worked to incorporate mental health and psychosocial support into COVID-19 response plans. That has included WHO’s development of a wide range of resources in collaboration with partners, including: a stress management guide for the general public; a guide for COVID-19 responders on basic psychosocial skills; and a toolkit to help older adults maintain mental well-being. “Doing What Matters in Times of Stress: An Illustrated Guide” is a stress management guide aimed at equipping people with practical skills to help cope with stress, especially in the early stages of the pandemic. The Inter-Agency Standing Committee Reference Group on Mental Health and Psychosocial Support in Emergency Settings, co-chaired by the WHO and the International Federation of Red Cross and Red Crescent Societies, has created an illustrated guide aimed at building basic psychosocial skills among all essential workers responding to COVID-19. The group has also produced a storybook for children, “My Hero is You, how kids can fight COVID-19”, to help children of 6-11 years learn how to protect themselves, their families and friends from coronavirus, and how to manage difficult emotions during the pandemic. A sequel that addresses the concerns of children during the current stage of the pandemic is planned for the third quarter of 2021. New WHO Guidance on Community-Based Mental Health Alternatives A lay counsellor on the Friendship Bench in Zimbabwe – part of an innovative community-based mental health programme rolled out in the country. With community-based services the backbone of better mental health services, WHO has recently highlighted successful examples of person-centered and rights-based community mental health services from across the world in a new report, released on 10 June. The report, ‘Guidance on community mental health service: promoting person-centered and rights-based approaches’, offers over two-dozen peer-reviewed examples of mental health services around the world that demonstrated good practices that are non-coercive, incorporate the community, and respect people’s agency, or their right to make decisions about their treatment and life. These include examples of cost-effective initiatives in low- and middle-income countries that promote frontline health workers, social workers, trained lay experts, and guided self-care networks as a backbone of service delivery to people in need. Examples include initiatives such as the Friendship Bench in Zimbabwe, Atmiyata in India, as well as self-help groups, such as Kenya’s Users and Survivors of Psychiatry (USP-Kenya). These services also feature alternative methods of treatment that ireduce compulsory hospitalization, over-prescription of anti-psychotic drugs – and critically, incorporate the voices of those with their own experiences with mental health conditions and psychosocial disabilities through peer-support groups. “[The value of peer-support groups] has been about restoring power, voice, and choice to persons with psychosocial disabilities,” said USP-Kenya CEO Michael Njenga. Nurses and healthcare workers are the frontline of the health workforce Image Credits: R Santos, Raisa Santos , WHO, WHO/NOOR/Sebastian Liste, Tim Kubacki/Flick. WHO, World Trade Organization & World Intellectual Property Organization Map Out Joint Approach to COVID Pandemic 24/06/2021 Elaine Ruth Fletcher Directors-General of WIPO (far left) WHO (back center) and WTO (far right) discuss stepped up cooperation on combatting COVID-19 pandemic In a first-ever tripartite meeting this year, the heads of the World Health Organization, the World Trade Organization (WTO) and the World Intellectual Property Organization (WIPO), have agreed to step up their collaboration on tools and resources for fighting the COVID-19 pandemic. The meeting was the first formal tripartite meeting since Ngozi Okonjo-Iweala was elected as head of WTO earlier this spring, following the election of Daren Tang as the new head of WIPO late last year. In a joint statement issued after the meeting the three heads of agencies, including WHO’s Director General Dr Tedros Adhanom Ghebreyesus, pledged to collaborate more closely on a joint platform for tripartite technical assistance to member governments relating to their needs for medical technologies as well as a series of workshops – to augment capacity and information flow. In a joint statement issued following their meeting 15 June, the three agency heads stated that they would ramp up cooperation focusing first on “the organization of practical, capacity-building workshops to enhance the flow of updated information on current developments in the pandemic and responses to achieve equitable access to COVID-19 health technologies. “The aim of these workshops is to strengthen the capacity of policymakers and experts in member governments to address the pandemic accordingly. “The first workshop in the series will be a workshop on technology transfer and licensing, scheduled for September. The workshop will help our members update their knowledge and understanding of how intellectual property, know-how and technology transfer work in actuality. This would be in the context of medical technologies and related products and services. This first workshop will be followed by others on related practical themes.” A second prong of the joint initiative, will be the joint platform for technical assistance, that aims to provide “a one-stop shop that will makae available the full range of expertise on access, IP and trade matters provided by our organizations, and other partners, in a coordinated and systematic manner.” The platform will focus, in particular, on: supporting countries to assess and prioritize unmet needs for COVID-19 vaccines, medicines and related technologies, and; providing “timely and tailored technical assistance in making full use of all available options to access vaccines, medicines and technologies, including through coordination between members facing similar challenges to facilitate collective responses.” The effort would also include “periodical update” of baseline resources maintained by the three organizations, mapped in the joint publication: “Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade”, the statemnt said. The initiative appears to bring WIPO closer into the circle that has already been established by WTO and WHO on pandemic response – following last year’s change of administration in the agency that maintains a critical repository of data on intellectual property on health products for manufacturers worldwide – but has been too often accused of remaining outside of the loop of practical advice on IP use to low- and middle-income countries. Image Credits: World Trade Organization . Third COVID Wave Racing Across Africa — New Case Rates in South Africa & Tunisia Outstrip United Kingdom 24/06/2021 Paul Adepoju A quiet street in Cape Town, South Africa, during one of the hard lockdown periods of 2020, which helped curb the spread of COVID-19 last year. A “terrible third wave” of the COVID-19 pandemic is now hitting Africa in full force – with about 20 of the continent’s 54 countries experiencing particularly sharp rises in new infections, African Centers for Disease Control director, John Nkengasong told Health Policy Watch at a press briefing on Thursday. Per-capita rates of new SARS-CoV2 cases in South Africa and Tunisia now outstrip those in the United Kingdom – and spiralling 5-6 times higher than those in the United States and India. Although the continent-wide average is still only about 27 new cases per million, below the current US average, (34/million), the increases seen are prompting worries that Africa could even become a new global epicentre for the pandemic. That after nearly a year when it managed to maintain comparatively low case counts. Daily new cases per million people in Tunisia and South Africa are now running at nearly 200 infections/million. In comparison, in the United Kingdom new cases now stand at 149/million and in hard-hit India at 40 per million, over the last week. The new wave has already stretched several health systems on the continent beyond their limits, Nkengasong said. “This is the first time that we are seeing countries report that their health systems are completely overwhelmed,” he said. Zambia, Uganda & DRC In Zambia, daily new infections are averaging 138/million the highest ever recorded since the pandemic was declared. That, in turn, is biting health systems hard, Nkengasong said. According to the latest figures, on June 23, the country reported 3,367 new cases of COVID-19 over the past 24 hours – the highest number of daily reported cases yet in the country. It was also nearly double the number of cases (1,796) reported on 16 January 2021 when the country reached the peak of its second wave. Nkengasong revealed that aside from the already dispatched commodities, Africa CDC will also be sending a team of experts to Zambia to help the country cope with the third wave. “They are completely overwhelmed,” he said. The health systems of Uganda and the Democratic Republic of Congo are facing similar crises, he added. In conflict-ridden DRC, meanwhile, the lack of strong systems for COVID testing and case reporting may also be keeping the numbers artificially low, inside observers told Health Policy Watch. DRC has also been one of the most vaccine hesitant countries – turning back a large shipment of COVAX vaccines that it received to Africa CDC in April because it did not have the means to administer the doses. Even among the country’s large presence of UN forces and support teams, who have ready access to dedicated vaccine donations from India, vaccinations have progressed at painfully slow rates, observers told Health Policy Watch. Steepest COVID-19 Surge Yet — WHO WHO Regional Director for Africa Dr Matshidiso Moeti believes Afric can still blunt the impact of the currently fast-rising infection wave if precaution is taken against transmitting the virus. At a separate WHO briefing, WHO Regional Director for Africa Matshidiso Moeti described the third wave as the pandemic’s steepest surge yet continent-wide. According to WHO’s data, the number of cases have risen for five consecutive weeks since 3 May. As of 20 June—day 48 into the new wave—Africa had recorded around 474 000 new cases—a 21% higher rate as compared with the first 48 days of the second wave. At the current rate of infections, the ongoing surge is set to surpass the previous one by early July, WHO stated. “With rapidly rising case numbers and increasing reports of serious illness, the latest surge threatens to be Africa’s worst yet,” Moeti warned. But even though the window of opportunity may be closing, she noted that Africa can still blunt the impact of the currently fast-rising infections. “Everyone everywhere can do their bit by taking precautions to prevent transmission,” she said. For instance, after Uganda slapped on new restrictions last week, new cases there appeared to be plateauing. Vaccine Supplies May Not Arrive In Time Africa CDC director Dr John Nkengasong Despite promises of hundreds of millions of doses from different partners, including the United States government, the timeline for the delivery of the doses may not see their arrival in time to really help African countries combat the third wave, both WHO and Africa CDC officials warned. Globally, of the 2.7 billion vaccine doses administered, under 1.5% have been in the arms of Africans. According to the Africa CDC, 61.4 million COVID-19 vaccine doses have been received so far by 51 African member states out of which 48.6 million doses have been administered (79.52%). So far, only 1.12% of the African population has been fully vaccinated. Most of those supplies were received in March & April this year through the WHO co-sponsored COVAX vaccine facility – before COVAX supplies produced by the Serum Institute of India dried up as a result of India’s COVID infection spike. “Cases are outpacing vaccination, leaving more people exposed. Now we need international solidarity and innovation to increase our supply,” Moeti said. Nkengasong agreed: “What we need is rapid access to vaccines to member states. It is extremely frightening to look at the graphs from some African countries. We just really need vaccines to get into people’s arms very quickly.” Without any intentional actions to speed up vaccine dose supply to Africa, Nkengasong said member states may have to wait until August when doses are expected to start becoming available through African Union’s COVID-19 Africa Vaccine Acquisition Task Team (AVATT). Delta Variant Spreading Across Africa WHO and Africa CDC also called attention to the rapid spread of the Delta variant of the virus that was first reported in India, across the African continent. The Delta variant, has already been reported in 14 countries in Africa, rapidly catching up with other variants, Moeti said. “In the Democratic Republic of the Congo and Uganda that are experiencing COVID-19 resurgence, the Delta variant has been detected in most samples sequenced in the past month,” she noted. “We have seen that variant really aggressively taking over from other variants, not just in Uganda, but in other countries like the DRC,” Nkengasong added. In addition, the Beta variant which was first identified in South Africa, has since been reported in 29 African countries. And the Alpha variant that was first reported in the UK and is now being reported in 30 African countries, according to the Africa CDC. WHO said it is taking steps towards expanding the capabilities of various African countries to track the spread and evolution of the virus in order to guide epidemiological decisions. “We are supporting South Africa-based regional laboratories to monitor variants of concern,” Moeti said. “WHO is also boosting innovative technological support to other laboratories in the region without sequencing capacities to better monitor the evolution of the virus. In the next six months, WHO is aiming for an eight- to ten-fold increase in the samples sequenced each month in Southern African countries.” Leading Researchers Highlight the Impact of COVID-19 on Global Liver Disease 24/06/2021 Chandre Prince Dr Rifaat Safadi, director of the Liver Unit at Hadassah Hebrew University Medical Center, in Jerusalem, Israel. Patients who had liver transplants or those with advanced liver fibrosis may not be adequately protected against COVID-19 after two doses of the Pfizer-BioNTech vaccine, in light of the findings of a new study presented Wednesday on the opening day of the International Liver Congress(ILC) 2021. Presenting abstracts from the soon-to-be-released study on Wednesday, Dr Rifaat Safadi, director of the Liver Unit at Hadassah Hebrew University Medical Center, in Jerusalem, Israel, said the study suggests that such patients with low levels of antibodies to the SARS-CoV-2 virus should get a third booster Pfizer shot to increase their chances of protection against the virus. The global virtual conference, convened by the European Association for the Study of the Liver (EASL), is taking place Wednesday – Saturday. This year’s conference brings together leading liver disease researchers from around the world to explore new science around the prevention and treatment of liver disease caused by Hepatitis C, alcohol abuse and other risk factors, as well as the impact of the COVID-19 pandemic on people living with liver diseases and on liver disease medications. This year’s conference proceedings are highlighting the extreme vulnerability of people with liver disease to COVID – with one new study finding the chronic liver disease increased the odds of COVID-19 death by 80%. On the more positive side, another study however, found that the antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B. Research on the impact of COVID-19 on alcohol-related liver disease is also being showcased at this year’s conference session, along with new or improved treatments for people suffering from HCV. “We are beginning to understand more clearly just how disproportionately COVID-19 is impacting on people living with liver-related diseases and the studies presented at ILC 2021 advance our knowledge on multiple fronts, knowledge that can potentially help inform policy responses to the pandemic going forward,” said Philip Newsome, General Secretary of EASL and Director of the Centre for Liver Research at the University of Birmingham in the UK, at Wednesday’s opening session. Pfizer-BioNTech Vaccine Offers Low Immunity for People with Advanced Liver Disease Data from an Israeli study found that patients with advanced liver fibrosis may not be adequately protected against COVID-19 after two doses of the Pfizer-BioNTech vaccine. With regards to the Pfizer vaccine on patients with liver disease, Safadi, who will present the full results of the Israeli study on Saturday, explained that “older age”, advanced fibrosis and decreased steatosis appear to be risk factors for lower vaccine response among people with related forms of liver disease. The study analysed data from 88 patients living with hepatic fibrosis who had tested positive for COVID-19 and who had received both doses of Pfizer’s-BioNTech vaccine. It found that elderly patients with advanced liver fibrosis had a lower response to Pfizer’s vaccine, with Safadi suggesting that those patients may need a third booster shot. “Therefore, we have to think about the booster vaccination… we are thinking now about boosting the third shot, especially those with high risk for non responsiveness or lower response,” said Safadi. The study’s recommendation, however, goes beyond current US Food and Drug Administration (FDA) recommendations. The FDA has so far not recommended the use of antibody tests to check the effectiveness of vaccination against the virus, nor has it approved a three-dose regimen or booster of any SARS-CoV-2 vaccine. Tenofovir Reduces Severity of COVID-19 in Patients with Chronic Hepatitis B Encouraging data from another new study found that antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B. A study conducted in Spain found that antiretrovira drug tenofovir reduced the severity of COVID-19 in patients with chronic Hepatitis B. Beatriz Mateos Muñoz, PhD Specialist in Gastroenterology and Hepatology at the Hospital Universitario Ramón in Spain, said the study analysed data from 4736 patients from 28 Spanish hospitals. Of the 117 COVID-19 positive patients who were identified, 67 were taking tenofovir and 50 were on entecavir, an antiviral drug in the treatment of hepatitis B virus infection. Muñoz said the incidence of COVID-19 in patients on tenofovir or entecavir were similar, but that patients on entecavir “more often had severe COVID-19, required ICU, ventilatory support, had longer hospitalization or died”. The study found that tenofovir seemed to offer some protection in patients with chronic hepatitis B infected by COVID-19. “In multivariate logistic regression adjusted by age, sex, obesity, comorbidities and fibrosis stage, tenofovir reduced by 6-fold the risk of severe COVID-19. Patients with chronic hepatitis B on tenofovir have a lower risk of severe COVID-19 infection than those on entecavir.” COVID-19 Related Alcohol Sales May Have Increased Alcohol-related Liver Disease Abdel-Aziz Shaheen, assistant professor at the Gastroenterology and Hepatology at the University of Calgary in Canada, said a large population-based study found a significant increase in the number of patients with alcoholic hepatitis who were hospitalised last year in Alberta, Canada last year, with the highest admission rate recorded in April 2020. Shaheen said a significant increase in alcohol sales across Europe and North America during the early months of the pandemic had alarming consequences for patients with alcoholic hepatitis. He said most of the newer patients with alcoholic hepatitis were younger and mainly from rural areas. “There was a significant 9% increase in alcoholic hepatitis admissions per month between March and September and the average rate of alcoholic hepatitis hospitalizations compared to overall hospitalizations rate doubled from 11.6/ 10,000 general hospitalizations to 22.1/ 10,000 general hospitalizations for the same period,” said Shaheen. More worrying, said Shaheen was that: “Our results show that the increase in alcohol sales post pandemic will significantly impact the natural history of alcoholic liver disease in Canada”. Chronic Liver Disease Increased the Odds of Covid-19 Death by 80% Vincent Mallet, Managing Senior Physician and Professor, Hepatology Unit, Cochin University Another study that used the French National Hospital Discharge database for patients who were hospitalised for COVID-19 found that chronic liver disease increased the odds of COVID-19 death by 80%. Vincent Mallet, Managing Senior Physician and Professor, Hepatology Unit, Cochin University said the hospital records showed that 3, 943 of the 16,338 patients diagnosed with chronic liver disease who were admitted for Covid-19 in France in 2020 died, including 2518 after liver-related complications. He said liver complications and alcohol use disorders may have contributed to the COVID-19 deaths of patients with chronic liver disease. People with Obesity & Diabetes Related Fatty Liver Disease Also at Higher Risk from COVID-19 Similarly, a small study in Mexico of 348 patients found that people living with Metabolic Associated Fatty Liver Disease (MAFLD) were five times more likely to die during hospitalization for COVID-19 than people without these factors. The patients studied were admitted with the SARS-COV-2 infection to a number of tertiary referral hospitals between 4 April and 24 June 2020, said Martin Uriel Vázquez Medina, Researcher at the Laboratory of Biomathematical and Biostatistical Modelling for Health Escuela Superior de Medicina, México. Major risk factors for the chronic conditions are obesity and type-2 diabetes, common conditions in many parts of Latin America, also closely associated with unhealthy diets, including high sugar consumption, and lack of physical activity. Medina added: “We also want to show with this result that [patients in] Latin American countries that have this overhead problem of obesity, diabetes, and pre-diabetes, could also be associated with increased risk from COVID-19”. The ILC continues until Saturday. Six More African Countries Needed to Ratify Treaty Creating the First Continent-Wide Medicines Regulator 23/06/2021 Paul Adepoju The African Medicines Agency’s framework would help combat falsified products and by ensuring harmonized drug standards and approvals, ease access to more affordable medicines and vaccines for people throughout the continent. Michel Sidibé, Special Envoy of the African Union and Minister of Health of Mali has high hopes that 15 African countries will have finally ratified the African Medicines Agency (AMA) Treaty in time for the 35th African Union (AU) Summit, scheduled for early 2022. Fifteen is the magic number of countries that must ratify the treaty creating the AMA – in order to birth the agency into operational existence. By the time of the summit, Sidibé also predicts that 30 or more countries will also have signed the framework agreement on the creation of the agency – an agreement that was first approved by the African Union in February 2019. He was speaking at a virtual session on Tuesday, From civil society to the pharma industry, establishment of the continent-wide AMA is regarded as an important step forward that would help improve the functioning of national medicines regulatory agencies – combating fake medicines and streamlining approval of new medicines and vaccines. That, in turn, should also help reduce prices and boost access for people throughout the continent, observers predict. Snail Speed Pace of Ratification So Far However, snail-speed ratification of the treaty by the legislatures and parliaments of the AU’s 54 member states has become a major hurdle to actually opening the doors of the new agency. This is despite the strong support displayed by global health actors actors ranging from the World Health Organization, Africa Centres for Disease Control, as well as other regional drug regulatory agencies such as the European Medicines Authority. However, Sidibé said he is confident the new agency, once it finally begins operations, can build upon the continent’s existing expertise in pharmacovigilance – developed by national agencies such as the Moroccan agency for medicines and the Nigerian Agency for Foods, Drugs Administration and Control (NAFDAC). As for concerns regarding the slow pace of country approvals of the framework agreement and formal ratification, Sidibé said the plan has been to first target a balance of countries in diverse African regions as “low-hanging fruit” – followed by others. In fact, so far most of the countries signing and then ratifying the agreemeht have been West African and/or Francophone. But as the critical mass of ratifications is approached, momentum elsewhere is also building. “Our strategy was to go for different regional balances… , to make sure that we can have a low hanging fruit so we can get quickly the 15 countries,” he said. “Now we are almost there. I am sure by the next meeting of the African Union, we can come and present to the leaders that we managed to have 15 countries,” he said, adding that the priority is to ensure that all African countries are soon on board. Getting buy-in from all African countries will involve actively engaging with governments that are yet to sign and/or ratify the treaty, one by one. Top countries earmarked now for the next stage include north and west African regional leaders such as Ethiopia and Nigeria, as well as the Democratic Republic of Congo. “We are learning from different experiences and ensuring that we are not losing time. We are making sure we bring different partners together to implement the agenda quickly,” Sidibé added. The Long Road to Ratification In October 2020 Health Policy Watch reported that only 18 of Africa’s 55 countries had signed the framework agreement to establish the agency, while only 5 countries – Rwanda, Mali, Burkina Faso, Ghana and Seychelles – had actually ratified the agreement. At the time, Africa CDC Director John Nkengasong, told Health Policy Watch the delay in the treaty ratification was due to the COVID-19 pandemic. “I don’t think it is because countries do not want to sign on. I think it is because of the process that is required to make them sign that treaty, and the countries are currently focusing more on COVID-19,” said Nkengasong. “I think it’s a much needed institution. If we had the AMA, it would be working very closely with the WHO and other bodies to facilitate regulatory issues on drugs to help control the COVID-19 pandemic.” Since then, Zimbabwe and the Seychelles have signed the AMA framework treaty, raising the total number of signatories to 20. Guinea, Namibia and Sierra Leone have ratified the treaty, followed by Algeria this month, raising the number of countries that have fully completed the two-step approval process to nine. In order to get across the finish line, a new African Medicines Agency Treaty Alliance (AMATA) has also recently been created, said Kawaldip Sehmi of the International Alliance of Patients Organizations (IAPO), at Tuesday’s session. The Alliance, led by IAPO and including patient groups, researchers and academics, and industry, will advocate for rapid AMA ratification continent wide. It will also work to establish meaningful engagement with patients, industry and other relevant parties once the Agency becomes operational. The WHO is also actively supporting the emergence of the AMA, with its Director-General, Dr Tedros Adhanom Ghebreyesus describing the lack of strong national regulatory systems as “one of the biggest obstacles to improving access to medical products in Africa”. WHO Regional Director in Africa, Dr Matshidiso Moeti, has also reiterated the importance of the agency, telling Health Policy Watch: “AMA is a very important platform for medicines to be available and affordable equitably, and to be of good quality so that we have both good outcomes for the money that people and countries are spending, and that we prevent problems.” Other Benefits – International Partnerships and Support for Local Production The AMA will also help strengthen global collaborations, including participation of African researchers and patients in clinical research trials of new medicines, especially in the area of cancer, said Emer Cooke, Executive Director of the European Medicines Agency, speaking at Tuesday’s event. “We’re already collaborating with a number of initiatives on clinical trials with African regulators, particularly in the context of the African Vaccines Regulatory Forum. We can use forums such as this to build on the collaborative activities that take place to share our experiences and to help us to work on training and capacity building initiatives,” Cooke said. “I think we should be heartened by the fact that there’s already good discussion and collaboration in the context of clinical trials.” Fighting Fake Medicines Meanwhile, Lotfi Benbahmed, minister of the pharmaceutical industry of Algeria, said the AMA can help improve the reliability of Africa’s medicines — a feat that he said requires the existence of a regional framework to fight fake drugs. “So what we need to do is to harmonise rules and regulations, and enable countries to fight the illegal markets, and the informal markets,” Benbahmed said, who spoke alongside other African ministers of health from Algeria, the Democratic Republic of Congo, Egypt and Cape Verde. . According to him, a similar framework can be deployed to tackle the challenge of low quality drugs on the continent from the point of production, including setting up measures to inspect and control equipment in laboratories. At the same time, delays being encountered in the finalisation of the agency are “understandable”, said Dr Margareth Ndomondo-Sigonda, African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD), who highlighted the extensive harmonisation processes that needs to be undertaken between national governments to birth the new agency. “It takes time to get to the point where you’ve achieved regulatory harmonisation of African medicines and harmonization of regulatory standards. You have to make sure that through harmonization of these technical requirements, you know the quality standards and practice and you build trust,” Ndomondo-Sigonda said. She was however hopeful that once AMA comes into force, it will be able to deal with many outstanding issues regarding the harmonisation of Africa’s medicines landscape. Image Credits: Marco Verch/Flickr. Urgent Government Action and Investment Needed Against Antimicrobial Resistance, Says New Report 23/06/2021 Raisa Santos Launch of the AMR Preparedness Index Panel – left to right – James Anderson, Susan Schwarz, Neil Clancy, Anand Anandkumar, Christine Ardal, Mike Hodin, Norio Ohmagari, Tiemo Wolken Government action against the threat of “superbugs” in most of the world’s leading economies gets a score of less than 50%, according to a new AMR Preparedness Index, released today by a global coalition committed to fighting current trends. Great Britain, the United States, Germany and France rated highest on a score of 1-100 in an assessment of responses in 11 of the world’s leading economies to antimicrobial resistance (AMR) threats. Meanwhile, emerging economies such as Brazil, China, and India scored the worst in the assessment that looked at national strategy; awareness and prevention; innovation; access; appropriate and responsible use; AMR and the environment; and collaborative engagement. The index was launched today by the Global Coalition on Aging (GCOA) and the Infectious Diseases Society of America (IDSA), to shine more light on how the governments are living up to their commitments to address antimicrobial resistance (AMR). “We need health systems and policymakers to really step up and advocate that federal, state, and local governments prioritize AMR,” said Neil Clancy of the AMR Committee, Infectious Disease Society of America, during an event Wednesday launching the Index. “Without significant national and global coordination and multi-party interventions in this area, our efforts are not going to succeed.” The AMR Preparedness Index ranked 11 countries across 7 categories in a 1-100 point scale. UN Report Warns That AMR Could Cause As Many as 10 Million Deaths/ Year Livestock applications of antibiotics in metric tons/year, among countries reporting use. (The Antibiotic Footprint) An estimated 700,000 people already die each year from drug-resistant infections and the lack of antimicrobials to treat them. A 2019 UN report warned that if trends are ignored, AMR could cause as many as 10 million deaths per year, and GDP losses of more than US $100 trillion by 2050. The report assigns scores to each of the 11 countries across seven categories for needed and achievable policy action. Although the assessment considered national policies on “AMR and the Environment” it was unclear how heavily weighted that issue was in the overall index. Per capita, the US agricultural industry is one of the heaviest users of antibiotics in the world. COVID-19 Is a Warning Light to Act Preemptively on AMR The cost of AMR action pales in comparison to the future costs of inaction, participants underlined, drawing comparisons with the COVID-19 pandemic. Delays in responding to urgent public health crises have deadly consequences. “If the pandemic has taught us one thing, it is that we are not well-prepared to combat the serious threat that emerging infectious diseases can pose to human health and our economies,” said Tiemo Wölken, member of the European Parliament, Germany. In Europe, AMR causes the annual death of 33,000 people and costs 1.5 billion Euros in regards to healthcare costs and productivity losses. COVID-19 has highlighted the need for increased monitoring tools, more improved detection, prevention, and control practices, said Wölken. “The time to act is now. COVID already put our healthcare systems under extreme pressure, and this could only be a foretaste of what we could expect from a world where antibiotic microbials are no longer effective.” All Countries Fail in Awareness & Prevention of AMR Testing for antimicrobial resistance at the Liverpool School of Tropical Science. The analysis identified critical opportunities for all governments to act upon to slow the growth of drug resistant bugs. “Despite the progress that’s being made and despite the good work being done in countries throughout the world, we need to do more,” said Clancy. Several trends have emerged from an analysis of the different indices that went into the combined score. All countries performed insufficiently with regards to awareness and prevention of AMR, with India lagging furthest behind. More developed countries tended to fare better in the appropriate and responsible use of existing antibiotics and other antimicrobial agents – as compared to developing country counterparts. Outside of the UK and US, most other countries performed poorly in assessments of the quality of national strategies, innovations, and collaboration. Innovation Important Training on standardized and harmonized surveillance methods for antimicrobial resistance in food animals in Southeast Asia Innovation is another area that requires more significant action going forward, said James Anderson, Executive Director of Global Health at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). “We do need to really drive pipelines. We do need investments in AMR.” In the fight against the borderless threat of drug resistance, the Index included key insights and guidance for governments to immediately prioritize in order to fulfill their commitments on AMR. Overall, the top-level priorities identified in the Index were to: Strengthen and fully implement national AMR strategies; and raise awareness of AMR and its consequences. Along with that, other key priorities were to: Bolster surveillance and leverage data across AMR efforts; Enable a restructured antimicrobial marketplace to stimulate innovation; Promote responsible and appropriate use of antibiotics; Enable reliable and consistent access to needed and novel antimicrobials; More effectively integrate the One Health Approach, including environmental concerns, into national strategies; Better engage with other governments, third-party organizations, and advocacy groups Despite AMR being one of the top five global health challenges, as cited by the WHO, a large majority of the public remains unaware of their role. Local, national, and international efforts are needed in raising awareness and investment in AMR. “All of us have a stake in preserving antibiotics and assuring the development of new antibiotics,” said Clancy. Vaccinating Older Groups Against COVID – Can Help Fight AMR 93-year-old Lebanese actor Salah Tizani, who falls into the elderly priority group, receives his first vaccine dose against COVID-19 in Beirut on Feb. 14, 2021. In terms of the battle against COVID and AMR, the report underlines how vaccinating older adults can help fight overuse of antibiotics during the pandemic. That is because people who become seriously ill with COVID, are often given antibiotics preventively in order to ward off secondary infections. Adequately vaccinating older populations against other infections such as pneumococcal pneumonia and tuberculosis, and even infections like influenza is also critical step to combatting AMR. In other ways, too, older adults have a key stake in fighting AMR, because they tend to be major consumers of health services, and also may be more vulnerable to drug resistant bacteria and viruses overall. “We are at a time now when the megatrend of aging is at the top of our agenda, not just the public health agenda but the economic and social agenda as well,” said GCOA CEO Michael Hodin. As the UN Decade of Healthy Aging was launched in January, AMR needs to be a central part of this initiative, applied not only to older people but to all of us for a healthy and active aging, Hodin added. Coordination and Collaboration Across Low- and Middle-income Countries and High-Income Countries Most countries examined in the report are not making adequate investments to combat the AMR threat, with the lack of commitment felt globally. Huge disparities in total public AMR research funding remains an issue across high, middle, and low-income countries. “We cannot afford to be only US-centric, or only LMIC centric. It takes a very globalized approach,” said Anand Anandkumar, Founder and CEO of Bugworks Research, India. Greater support and collaboration is necessary to increase capacity for AMR initiatives, such as monitoring and surveillance in many low and middle-income countries (LMICs). Consequently, high income countries must collect and provide more complete data to increase the robustness of international, regional, and domestic efforts. “Access and equity are global challenges and the central tilt to competitive AMR,” said Clancy. “[We need to ensure] that we get antibiotics and access to these drugs in an equitable fashion. We’re all at risk from AMR.” Image Credits: USAID Asia/Flickr, GC, antibioticfootprint.net, Flickr – UK Department for International Development, World Bank: Mohamed Azakir. COVAX Shortcomings Under Microscope Ahead of Gavi, Vaccine Alliance Board Meeting 22/06/2021 Elaine Ruth Fletcher & Svĕt Lustig Vijay COVAX vaccine deliveries in Africa – a much trumpeted solution to vaccine inequalities in troubled waters. As the board of Gavi, The Vaccine Alliance is set to meet this Wednesday and Thursday, the COVAX global vaccine facility – a cornerstone of the global health sector response on vaccine access – is coming under increased fire for its shortcomings. A bitter opinion piece by Médecins Sans Frontières, published today, has called for a “drastic change of model” in the global procurement mechanism “that was supposed to deliver COVID-19 vaccine equity.” Co-launched by a range of partners, including WHO, the COVAX facility is legally administered by GAVI. What started out with a much-trumpeted bang of vaccine distributions across African nations has fizzled after the primary vaccine supplier, the Serum Institute of India, began redirecting its available COVID doses to domestic vaccine needs. Massive commitments by rich countries for further vaccine sharing, made at the recent G-7 meeting, are supposed to be funnelled through COVAX. Yet most of those donations will likely only be realized in the latter part of 2021 or early 2022, leaving the current shortfalls over the summer, as Africa faces yet another COVID wave. “COVAX is currently grossly behind on achieving its goals,” said MSF’s Katie Elder, senior vaccines policy advisor. “COVAX had aimed to provide 2 billion doses by the end of 2021, but so far has only distributed 88 million (the goal by the end of June was to distribute around 337 million). Less than half of one percent of total populations of COVAX countries have received at least a first dose of vaccine through COVAX.” She blames the fundamental model of the facility – in which it has been forced to compete on the open market for COVID vaccines – which were still often subsidized by public and government players – for the failings. AstraZeneca vaccine doses are unloaded at Bole International Airport in Addis Ababa, Ethiopia. Not Set Up to Succeed “COVAX was not set up to succeed,” she said. “It was constructed to work within the current parameters of the pharmaceutical market, where you see how much money you can raise and then see what you can negotiate with industry for it. “Loud calls early in the pandemic to depart from a business as usual approach were ignored—pharmaceutical corporations developing vaccines received billions in government money without any strings attached, so were free to charge prices they chose and to sell to the highest bidder. Unsurprisingly, this led to the very same governments that had touted the importance of equity …. and the governments that Gavi spent so much time courting to join the COVAX Facility – ultimately pursuing national interests and securing the bulk of future promised vaccines. “COVAX was left behind as wealthy governments secured their doses through bilateral deals with an industry that acted as expected: selling doses first to the buyers who could afford to pay the most.” The net result now leaves the Gavi Board struggling with how to continue the participation of upper income countries in the facility at all. “The fact that Gavi’s board is now reviewing the way in which wealthier countries (so called ‘Self-financing participants’) can continue to participate in the facility is in part a recognition that the set up does not work,” she added. “Allowing wealthy countries so much flexibility to decide how they join COVAX and how many vaccines they procure, has caused delays and undermined its objectives. A more equitable model would have encouraged regional leadership with decentralized methods of procurement at their core. In the future, we must support these regional initiatives that aim for self-sufficiency and self-determination.” A Beautiful idea: How the COVAX has Fallen Short To date, COVAX has distributed over 20 million doses to rich countries and 80 million doses to poorer countries. The result has been an awkward legal situation for the facility which is still required to provide 20% of its doses for higher income countries – even though most have now met their vaccine needs and hoarded even more, notably Canada, which bought enough vaccine doses to cover its population four times over. “The failure to entice wealthy countries to join COVAX in large numbers has left the managers of the facility in an awkward situation,” said global health journalist Ann Aanaiya Usher in a critique published by The Lancet. “On one hand, not enough self-financing participants joined COVAX to give it the massive buying power that was hoped. On the other, even though COVAX is desperately short of vaccines, the facility is now contractually obliged to reserve one in five doses for a few rich countries, she said, adding that so far, COVAX has distributed 80 million doses to LMICs and over 20 million doses to high-income countries (HICs), including the UK and Canada. She slams the COVAX facility for its “naive” set-up that failed to anticipate widespread vaccine nationalism that has locked up most of the vaccine doses that are available. “It was a beautiful idea, born out of solidarity”, Duke University’s Gavin Yamey was quoted as saying. “Unfortunately, it didn’t happen…Rich countries behaved worse than anyone’s worst nightmares.” COVAX should have also diversified its portfolio earlier on, in anticipation of supply shortages that crippled the facility after India’s Serum Institute halted vaccine exports to fend off a tragic second wave on the subcontinent that has claimed the lives of almost 400,000 people. “Supply shortages should have been anticipated and ramping up supplies should have been baked into the design of COVAX from the start,” observed Georgetown University’s Lawrence Gostin. He added, however, that it would be “literally impossible” to ramp up vaccine supplies without greater investments in manufacturing hubs in lower-income countries, as well as broad waiver on intellectual property rights to vaccine know-how. In its struggle to get rich countries to sign up, the COVAX facility’s offer to allow rich countries to choose which vaccines they would receive has also drawn widespread criticism for leading to “double standards” – which seemingly defy the very purpose of the facility, critics have said. A beautiful idea: how COVAX has fallen short https://t.co/QpG6o5zbqt This is the most complete & readable analysis of COVAX I have seen. The title says it all. COVAX was a beautiful idea & we must make it better & permanent — Lawrence Gostin (@LawrenceGostin) June 18, 2021 Facility Needs Equity Funds to Compete in the Marketplace Even Gavi, the Vaccine Alliance, has acknowledged that its slow mobilization of resources has hampered its ability to quickly procure, and thus deliver as many doses as possible to those who need them most. “If we had secured financing earlier, then we could have locked in doses earlier, as opposed to the second half of this year when COVAX’s volume will start ramping up,” a Gavi spokesperson said. The spokesperson was referring to the fact that most of the funds to procure and distribute vaccines for the 92 low- and middle-income countries (LMICs) that signed up for the scheme were pledged in late December or early 2021 – after high-income countries had already snapped up large vaccine pre-orders. That is a point of view shared by some independent observers as well as industry leaders, who maintain that the facility needs fine-tuning for the next pandemic. “Had COVAX had sufficient and readily available early funding it would have been better able to secure enough immediate supply to meet its aim,” said the Independent Panel for Pandemic Preparedness said, which reviewed the global pandemic response, under a mandate from the World Health Organization. Going forward, what COVAX needs is a “pot of money” to be able to pre-order vaccine doses earlier on in a global health emergency, said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations, in a recent Q&A with Health Policy Watch. That, he maintains, would allow the global facility to compete on a more equal footing with rich countries in the vaccines marketplace. Added Peter Hotez, a prominent vaccine scientist and dean at Baylor College of Medicine in Texas: “I think it’s important that we don’t sell COVAX short. It still has a lot going for it, and is innovative in its design. But it needs more vaccines to share,” Asked for comment by Health Policy Watch, GAVI did not respond. Image Credits: UNICEF, WHO, WHO. 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.
Frontline Health Workers Critical to Improving Mental Health Response During and After COVID-19 Pandemic 25/06/2021 Raisa Santos Nurses celebrate Nurses Appreciation Week in New York City, 2020, at the height of the COVID pandemic. Healthcare professionals, and particularly community health workers who have been the backbone of local and national health systems during the COVID crisis, are also unsung ‘first responders’ to the massive mental health fallout from the pandemic, now and going forward. That is the central theme of a webinar panel on ‘COVID-19 and Frontline Workers’, Wednesday, 30th June, 13:00 – 15:00 CET, which featuring COVID response and mental health experts from the World Health Organization, the International Council of Nurses and consumer groups. The panel is sponsored by the Geneva-based Global Self-Care Federation with Health Policy Watch serving as media partners for the event. Protecting Healthcare Workers’ Wellbeing Through Inclusive Mental Health Care While the tireless work of nurses and healthcare professionals has been championed and celebrated throughout the pandemic, those workers have, for the most part, been ‘largely absent from the mental health discourse’, said Judy Stenmark, Director-General of GSCF, in a recent blog post on mental health. Stenmark calls for a more ‘more inclusive approach that brings all stakeholders into the equation’ to both consider the mental health needs of health workers during the pandemic period – as well as optimising their contribution to community-based mental health response. “Without healthcare workers, there’s no chance we will see this pandemic through. Therefore, a greater consideration of self-care for healthcare workers is essential as we learn more about the consequences of the pandemic on healthcare systems,” she said in her blog, adding: “Unless we take proactive measures to ensure staff are safe at work and have sustainable working conditions – we’re at risk of losing the means that make healthcare possible.” WHO Action Plan Extension Receives Wide Support During WHA The Maldives’ delegate at the 74th World Health Assembly on Monday. Those messages also echo ones heard during last month’s 74th World Health Assembly, in which WHO Director General Dr Tedros Adhanom Ghebreyesus called for a rethinking of mental health treatment and delivery: “One day this pandemic will be over – but many of the psychological scars linked to the pandemic will stay with us for a long, long time,” he stated, at the Assembly, in which a special session saw WHO officials and member states acknowledging how the ‘mass trauma’ of COVID-19 has worsened mental health worldwide. A draft decision endorsing an updated version of WHO’s Mental Health Action Plan also was adopted during the 74th WHA. The updated WHO Action Plan will include a greater forums on suicide prevention, workplace mental health, universal health coverage, mental health of children, mental health across the life course, and the involvement of people with lived experience of mental health conditions. “It is crucial to prioritize the actions to minimize mental health consequences of the pandemic and incorporate these actions into emergency and disaster risk management strategies,” said Asim Ahmed, Permanent Representative at the Permanent Mission of the Maldives to the UN in Geneva, during the 74th WHA. Incorporating Mental Health into COVID-19 Response Plans Mental health services for children and adolescents have been disrupted due to COVID-19 During the pandemic, WHO and its Member States have also worked to incorporate mental health and psychosocial support into COVID-19 response plans. That has included WHO’s development of a wide range of resources in collaboration with partners, including: a stress management guide for the general public; a guide for COVID-19 responders on basic psychosocial skills; and a toolkit to help older adults maintain mental well-being. “Doing What Matters in Times of Stress: An Illustrated Guide” is a stress management guide aimed at equipping people with practical skills to help cope with stress, especially in the early stages of the pandemic. The Inter-Agency Standing Committee Reference Group on Mental Health and Psychosocial Support in Emergency Settings, co-chaired by the WHO and the International Federation of Red Cross and Red Crescent Societies, has created an illustrated guide aimed at building basic psychosocial skills among all essential workers responding to COVID-19. The group has also produced a storybook for children, “My Hero is You, how kids can fight COVID-19”, to help children of 6-11 years learn how to protect themselves, their families and friends from coronavirus, and how to manage difficult emotions during the pandemic. A sequel that addresses the concerns of children during the current stage of the pandemic is planned for the third quarter of 2021. New WHO Guidance on Community-Based Mental Health Alternatives A lay counsellor on the Friendship Bench in Zimbabwe – part of an innovative community-based mental health programme rolled out in the country. With community-based services the backbone of better mental health services, WHO has recently highlighted successful examples of person-centered and rights-based community mental health services from across the world in a new report, released on 10 June. The report, ‘Guidance on community mental health service: promoting person-centered and rights-based approaches’, offers over two-dozen peer-reviewed examples of mental health services around the world that demonstrated good practices that are non-coercive, incorporate the community, and respect people’s agency, or their right to make decisions about their treatment and life. These include examples of cost-effective initiatives in low- and middle-income countries that promote frontline health workers, social workers, trained lay experts, and guided self-care networks as a backbone of service delivery to people in need. Examples include initiatives such as the Friendship Bench in Zimbabwe, Atmiyata in India, as well as self-help groups, such as Kenya’s Users and Survivors of Psychiatry (USP-Kenya). These services also feature alternative methods of treatment that ireduce compulsory hospitalization, over-prescription of anti-psychotic drugs – and critically, incorporate the voices of those with their own experiences with mental health conditions and psychosocial disabilities through peer-support groups. “[The value of peer-support groups] has been about restoring power, voice, and choice to persons with psychosocial disabilities,” said USP-Kenya CEO Michael Njenga. Nurses and healthcare workers are the frontline of the health workforce Image Credits: R Santos, Raisa Santos , WHO, WHO/NOOR/Sebastian Liste, Tim Kubacki/Flick. WHO, World Trade Organization & World Intellectual Property Organization Map Out Joint Approach to COVID Pandemic 24/06/2021 Elaine Ruth Fletcher Directors-General of WIPO (far left) WHO (back center) and WTO (far right) discuss stepped up cooperation on combatting COVID-19 pandemic In a first-ever tripartite meeting this year, the heads of the World Health Organization, the World Trade Organization (WTO) and the World Intellectual Property Organization (WIPO), have agreed to step up their collaboration on tools and resources for fighting the COVID-19 pandemic. The meeting was the first formal tripartite meeting since Ngozi Okonjo-Iweala was elected as head of WTO earlier this spring, following the election of Daren Tang as the new head of WIPO late last year. In a joint statement issued after the meeting the three heads of agencies, including WHO’s Director General Dr Tedros Adhanom Ghebreyesus, pledged to collaborate more closely on a joint platform for tripartite technical assistance to member governments relating to their needs for medical technologies as well as a series of workshops – to augment capacity and information flow. In a joint statement issued following their meeting 15 June, the three agency heads stated that they would ramp up cooperation focusing first on “the organization of practical, capacity-building workshops to enhance the flow of updated information on current developments in the pandemic and responses to achieve equitable access to COVID-19 health technologies. “The aim of these workshops is to strengthen the capacity of policymakers and experts in member governments to address the pandemic accordingly. “The first workshop in the series will be a workshop on technology transfer and licensing, scheduled for September. The workshop will help our members update their knowledge and understanding of how intellectual property, know-how and technology transfer work in actuality. This would be in the context of medical technologies and related products and services. This first workshop will be followed by others on related practical themes.” A second prong of the joint initiative, will be the joint platform for technical assistance, that aims to provide “a one-stop shop that will makae available the full range of expertise on access, IP and trade matters provided by our organizations, and other partners, in a coordinated and systematic manner.” The platform will focus, in particular, on: supporting countries to assess and prioritize unmet needs for COVID-19 vaccines, medicines and related technologies, and; providing “timely and tailored technical assistance in making full use of all available options to access vaccines, medicines and technologies, including through coordination between members facing similar challenges to facilitate collective responses.” The effort would also include “periodical update” of baseline resources maintained by the three organizations, mapped in the joint publication: “Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade”, the statemnt said. The initiative appears to bring WIPO closer into the circle that has already been established by WTO and WHO on pandemic response – following last year’s change of administration in the agency that maintains a critical repository of data on intellectual property on health products for manufacturers worldwide – but has been too often accused of remaining outside of the loop of practical advice on IP use to low- and middle-income countries. Image Credits: World Trade Organization . Third COVID Wave Racing Across Africa — New Case Rates in South Africa & Tunisia Outstrip United Kingdom 24/06/2021 Paul Adepoju A quiet street in Cape Town, South Africa, during one of the hard lockdown periods of 2020, which helped curb the spread of COVID-19 last year. A “terrible third wave” of the COVID-19 pandemic is now hitting Africa in full force – with about 20 of the continent’s 54 countries experiencing particularly sharp rises in new infections, African Centers for Disease Control director, John Nkengasong told Health Policy Watch at a press briefing on Thursday. Per-capita rates of new SARS-CoV2 cases in South Africa and Tunisia now outstrip those in the United Kingdom – and spiralling 5-6 times higher than those in the United States and India. Although the continent-wide average is still only about 27 new cases per million, below the current US average, (34/million), the increases seen are prompting worries that Africa could even become a new global epicentre for the pandemic. That after nearly a year when it managed to maintain comparatively low case counts. Daily new cases per million people in Tunisia and South Africa are now running at nearly 200 infections/million. In comparison, in the United Kingdom new cases now stand at 149/million and in hard-hit India at 40 per million, over the last week. The new wave has already stretched several health systems on the continent beyond their limits, Nkengasong said. “This is the first time that we are seeing countries report that their health systems are completely overwhelmed,” he said. Zambia, Uganda & DRC In Zambia, daily new infections are averaging 138/million the highest ever recorded since the pandemic was declared. That, in turn, is biting health systems hard, Nkengasong said. According to the latest figures, on June 23, the country reported 3,367 new cases of COVID-19 over the past 24 hours – the highest number of daily reported cases yet in the country. It was also nearly double the number of cases (1,796) reported on 16 January 2021 when the country reached the peak of its second wave. Nkengasong revealed that aside from the already dispatched commodities, Africa CDC will also be sending a team of experts to Zambia to help the country cope with the third wave. “They are completely overwhelmed,” he said. The health systems of Uganda and the Democratic Republic of Congo are facing similar crises, he added. In conflict-ridden DRC, meanwhile, the lack of strong systems for COVID testing and case reporting may also be keeping the numbers artificially low, inside observers told Health Policy Watch. DRC has also been one of the most vaccine hesitant countries – turning back a large shipment of COVAX vaccines that it received to Africa CDC in April because it did not have the means to administer the doses. Even among the country’s large presence of UN forces and support teams, who have ready access to dedicated vaccine donations from India, vaccinations have progressed at painfully slow rates, observers told Health Policy Watch. Steepest COVID-19 Surge Yet — WHO WHO Regional Director for Africa Dr Matshidiso Moeti believes Afric can still blunt the impact of the currently fast-rising infection wave if precaution is taken against transmitting the virus. At a separate WHO briefing, WHO Regional Director for Africa Matshidiso Moeti described the third wave as the pandemic’s steepest surge yet continent-wide. According to WHO’s data, the number of cases have risen for five consecutive weeks since 3 May. As of 20 June—day 48 into the new wave—Africa had recorded around 474 000 new cases—a 21% higher rate as compared with the first 48 days of the second wave. At the current rate of infections, the ongoing surge is set to surpass the previous one by early July, WHO stated. “With rapidly rising case numbers and increasing reports of serious illness, the latest surge threatens to be Africa’s worst yet,” Moeti warned. But even though the window of opportunity may be closing, she noted that Africa can still blunt the impact of the currently fast-rising infections. “Everyone everywhere can do their bit by taking precautions to prevent transmission,” she said. For instance, after Uganda slapped on new restrictions last week, new cases there appeared to be plateauing. Vaccine Supplies May Not Arrive In Time Africa CDC director Dr John Nkengasong Despite promises of hundreds of millions of doses from different partners, including the United States government, the timeline for the delivery of the doses may not see their arrival in time to really help African countries combat the third wave, both WHO and Africa CDC officials warned. Globally, of the 2.7 billion vaccine doses administered, under 1.5% have been in the arms of Africans. According to the Africa CDC, 61.4 million COVID-19 vaccine doses have been received so far by 51 African member states out of which 48.6 million doses have been administered (79.52%). So far, only 1.12% of the African population has been fully vaccinated. Most of those supplies were received in March & April this year through the WHO co-sponsored COVAX vaccine facility – before COVAX supplies produced by the Serum Institute of India dried up as a result of India’s COVID infection spike. “Cases are outpacing vaccination, leaving more people exposed. Now we need international solidarity and innovation to increase our supply,” Moeti said. Nkengasong agreed: “What we need is rapid access to vaccines to member states. It is extremely frightening to look at the graphs from some African countries. We just really need vaccines to get into people’s arms very quickly.” Without any intentional actions to speed up vaccine dose supply to Africa, Nkengasong said member states may have to wait until August when doses are expected to start becoming available through African Union’s COVID-19 Africa Vaccine Acquisition Task Team (AVATT). Delta Variant Spreading Across Africa WHO and Africa CDC also called attention to the rapid spread of the Delta variant of the virus that was first reported in India, across the African continent. The Delta variant, has already been reported in 14 countries in Africa, rapidly catching up with other variants, Moeti said. “In the Democratic Republic of the Congo and Uganda that are experiencing COVID-19 resurgence, the Delta variant has been detected in most samples sequenced in the past month,” she noted. “We have seen that variant really aggressively taking over from other variants, not just in Uganda, but in other countries like the DRC,” Nkengasong added. In addition, the Beta variant which was first identified in South Africa, has since been reported in 29 African countries. And the Alpha variant that was first reported in the UK and is now being reported in 30 African countries, according to the Africa CDC. WHO said it is taking steps towards expanding the capabilities of various African countries to track the spread and evolution of the virus in order to guide epidemiological decisions. “We are supporting South Africa-based regional laboratories to monitor variants of concern,” Moeti said. “WHO is also boosting innovative technological support to other laboratories in the region without sequencing capacities to better monitor the evolution of the virus. In the next six months, WHO is aiming for an eight- to ten-fold increase in the samples sequenced each month in Southern African countries.” Leading Researchers Highlight the Impact of COVID-19 on Global Liver Disease 24/06/2021 Chandre Prince Dr Rifaat Safadi, director of the Liver Unit at Hadassah Hebrew University Medical Center, in Jerusalem, Israel. Patients who had liver transplants or those with advanced liver fibrosis may not be adequately protected against COVID-19 after two doses of the Pfizer-BioNTech vaccine, in light of the findings of a new study presented Wednesday on the opening day of the International Liver Congress(ILC) 2021. Presenting abstracts from the soon-to-be-released study on Wednesday, Dr Rifaat Safadi, director of the Liver Unit at Hadassah Hebrew University Medical Center, in Jerusalem, Israel, said the study suggests that such patients with low levels of antibodies to the SARS-CoV-2 virus should get a third booster Pfizer shot to increase their chances of protection against the virus. The global virtual conference, convened by the European Association for the Study of the Liver (EASL), is taking place Wednesday – Saturday. This year’s conference brings together leading liver disease researchers from around the world to explore new science around the prevention and treatment of liver disease caused by Hepatitis C, alcohol abuse and other risk factors, as well as the impact of the COVID-19 pandemic on people living with liver diseases and on liver disease medications. This year’s conference proceedings are highlighting the extreme vulnerability of people with liver disease to COVID – with one new study finding the chronic liver disease increased the odds of COVID-19 death by 80%. On the more positive side, another study however, found that the antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B. Research on the impact of COVID-19 on alcohol-related liver disease is also being showcased at this year’s conference session, along with new or improved treatments for people suffering from HCV. “We are beginning to understand more clearly just how disproportionately COVID-19 is impacting on people living with liver-related diseases and the studies presented at ILC 2021 advance our knowledge on multiple fronts, knowledge that can potentially help inform policy responses to the pandemic going forward,” said Philip Newsome, General Secretary of EASL and Director of the Centre for Liver Research at the University of Birmingham in the UK, at Wednesday’s opening session. Pfizer-BioNTech Vaccine Offers Low Immunity for People with Advanced Liver Disease Data from an Israeli study found that patients with advanced liver fibrosis may not be adequately protected against COVID-19 after two doses of the Pfizer-BioNTech vaccine. With regards to the Pfizer vaccine on patients with liver disease, Safadi, who will present the full results of the Israeli study on Saturday, explained that “older age”, advanced fibrosis and decreased steatosis appear to be risk factors for lower vaccine response among people with related forms of liver disease. The study analysed data from 88 patients living with hepatic fibrosis who had tested positive for COVID-19 and who had received both doses of Pfizer’s-BioNTech vaccine. It found that elderly patients with advanced liver fibrosis had a lower response to Pfizer’s vaccine, with Safadi suggesting that those patients may need a third booster shot. “Therefore, we have to think about the booster vaccination… we are thinking now about boosting the third shot, especially those with high risk for non responsiveness or lower response,” said Safadi. The study’s recommendation, however, goes beyond current US Food and Drug Administration (FDA) recommendations. The FDA has so far not recommended the use of antibody tests to check the effectiveness of vaccination against the virus, nor has it approved a three-dose regimen or booster of any SARS-CoV-2 vaccine. Tenofovir Reduces Severity of COVID-19 in Patients with Chronic Hepatitis B Encouraging data from another new study found that antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B. A study conducted in Spain found that antiretrovira drug tenofovir reduced the severity of COVID-19 in patients with chronic Hepatitis B. Beatriz Mateos Muñoz, PhD Specialist in Gastroenterology and Hepatology at the Hospital Universitario Ramón in Spain, said the study analysed data from 4736 patients from 28 Spanish hospitals. Of the 117 COVID-19 positive patients who were identified, 67 were taking tenofovir and 50 were on entecavir, an antiviral drug in the treatment of hepatitis B virus infection. Muñoz said the incidence of COVID-19 in patients on tenofovir or entecavir were similar, but that patients on entecavir “more often had severe COVID-19, required ICU, ventilatory support, had longer hospitalization or died”. The study found that tenofovir seemed to offer some protection in patients with chronic hepatitis B infected by COVID-19. “In multivariate logistic regression adjusted by age, sex, obesity, comorbidities and fibrosis stage, tenofovir reduced by 6-fold the risk of severe COVID-19. Patients with chronic hepatitis B on tenofovir have a lower risk of severe COVID-19 infection than those on entecavir.” COVID-19 Related Alcohol Sales May Have Increased Alcohol-related Liver Disease Abdel-Aziz Shaheen, assistant professor at the Gastroenterology and Hepatology at the University of Calgary in Canada, said a large population-based study found a significant increase in the number of patients with alcoholic hepatitis who were hospitalised last year in Alberta, Canada last year, with the highest admission rate recorded in April 2020. Shaheen said a significant increase in alcohol sales across Europe and North America during the early months of the pandemic had alarming consequences for patients with alcoholic hepatitis. He said most of the newer patients with alcoholic hepatitis were younger and mainly from rural areas. “There was a significant 9% increase in alcoholic hepatitis admissions per month between March and September and the average rate of alcoholic hepatitis hospitalizations compared to overall hospitalizations rate doubled from 11.6/ 10,000 general hospitalizations to 22.1/ 10,000 general hospitalizations for the same period,” said Shaheen. More worrying, said Shaheen was that: “Our results show that the increase in alcohol sales post pandemic will significantly impact the natural history of alcoholic liver disease in Canada”. Chronic Liver Disease Increased the Odds of Covid-19 Death by 80% Vincent Mallet, Managing Senior Physician and Professor, Hepatology Unit, Cochin University Another study that used the French National Hospital Discharge database for patients who were hospitalised for COVID-19 found that chronic liver disease increased the odds of COVID-19 death by 80%. Vincent Mallet, Managing Senior Physician and Professor, Hepatology Unit, Cochin University said the hospital records showed that 3, 943 of the 16,338 patients diagnosed with chronic liver disease who were admitted for Covid-19 in France in 2020 died, including 2518 after liver-related complications. He said liver complications and alcohol use disorders may have contributed to the COVID-19 deaths of patients with chronic liver disease. People with Obesity & Diabetes Related Fatty Liver Disease Also at Higher Risk from COVID-19 Similarly, a small study in Mexico of 348 patients found that people living with Metabolic Associated Fatty Liver Disease (MAFLD) were five times more likely to die during hospitalization for COVID-19 than people without these factors. The patients studied were admitted with the SARS-COV-2 infection to a number of tertiary referral hospitals between 4 April and 24 June 2020, said Martin Uriel Vázquez Medina, Researcher at the Laboratory of Biomathematical and Biostatistical Modelling for Health Escuela Superior de Medicina, México. Major risk factors for the chronic conditions are obesity and type-2 diabetes, common conditions in many parts of Latin America, also closely associated with unhealthy diets, including high sugar consumption, and lack of physical activity. Medina added: “We also want to show with this result that [patients in] Latin American countries that have this overhead problem of obesity, diabetes, and pre-diabetes, could also be associated with increased risk from COVID-19”. The ILC continues until Saturday. Six More African Countries Needed to Ratify Treaty Creating the First Continent-Wide Medicines Regulator 23/06/2021 Paul Adepoju The African Medicines Agency’s framework would help combat falsified products and by ensuring harmonized drug standards and approvals, ease access to more affordable medicines and vaccines for people throughout the continent. Michel Sidibé, Special Envoy of the African Union and Minister of Health of Mali has high hopes that 15 African countries will have finally ratified the African Medicines Agency (AMA) Treaty in time for the 35th African Union (AU) Summit, scheduled for early 2022. Fifteen is the magic number of countries that must ratify the treaty creating the AMA – in order to birth the agency into operational existence. By the time of the summit, Sidibé also predicts that 30 or more countries will also have signed the framework agreement on the creation of the agency – an agreement that was first approved by the African Union in February 2019. He was speaking at a virtual session on Tuesday, From civil society to the pharma industry, establishment of the continent-wide AMA is regarded as an important step forward that would help improve the functioning of national medicines regulatory agencies – combating fake medicines and streamlining approval of new medicines and vaccines. That, in turn, should also help reduce prices and boost access for people throughout the continent, observers predict. Snail Speed Pace of Ratification So Far However, snail-speed ratification of the treaty by the legislatures and parliaments of the AU’s 54 member states has become a major hurdle to actually opening the doors of the new agency. This is despite the strong support displayed by global health actors actors ranging from the World Health Organization, Africa Centres for Disease Control, as well as other regional drug regulatory agencies such as the European Medicines Authority. However, Sidibé said he is confident the new agency, once it finally begins operations, can build upon the continent’s existing expertise in pharmacovigilance – developed by national agencies such as the Moroccan agency for medicines and the Nigerian Agency for Foods, Drugs Administration and Control (NAFDAC). As for concerns regarding the slow pace of country approvals of the framework agreement and formal ratification, Sidibé said the plan has been to first target a balance of countries in diverse African regions as “low-hanging fruit” – followed by others. In fact, so far most of the countries signing and then ratifying the agreemeht have been West African and/or Francophone. But as the critical mass of ratifications is approached, momentum elsewhere is also building. “Our strategy was to go for different regional balances… , to make sure that we can have a low hanging fruit so we can get quickly the 15 countries,” he said. “Now we are almost there. I am sure by the next meeting of the African Union, we can come and present to the leaders that we managed to have 15 countries,” he said, adding that the priority is to ensure that all African countries are soon on board. Getting buy-in from all African countries will involve actively engaging with governments that are yet to sign and/or ratify the treaty, one by one. Top countries earmarked now for the next stage include north and west African regional leaders such as Ethiopia and Nigeria, as well as the Democratic Republic of Congo. “We are learning from different experiences and ensuring that we are not losing time. We are making sure we bring different partners together to implement the agenda quickly,” Sidibé added. The Long Road to Ratification In October 2020 Health Policy Watch reported that only 18 of Africa’s 55 countries had signed the framework agreement to establish the agency, while only 5 countries – Rwanda, Mali, Burkina Faso, Ghana and Seychelles – had actually ratified the agreement. At the time, Africa CDC Director John Nkengasong, told Health Policy Watch the delay in the treaty ratification was due to the COVID-19 pandemic. “I don’t think it is because countries do not want to sign on. I think it is because of the process that is required to make them sign that treaty, and the countries are currently focusing more on COVID-19,” said Nkengasong. “I think it’s a much needed institution. If we had the AMA, it would be working very closely with the WHO and other bodies to facilitate regulatory issues on drugs to help control the COVID-19 pandemic.” Since then, Zimbabwe and the Seychelles have signed the AMA framework treaty, raising the total number of signatories to 20. Guinea, Namibia and Sierra Leone have ratified the treaty, followed by Algeria this month, raising the number of countries that have fully completed the two-step approval process to nine. In order to get across the finish line, a new African Medicines Agency Treaty Alliance (AMATA) has also recently been created, said Kawaldip Sehmi of the International Alliance of Patients Organizations (IAPO), at Tuesday’s session. The Alliance, led by IAPO and including patient groups, researchers and academics, and industry, will advocate for rapid AMA ratification continent wide. It will also work to establish meaningful engagement with patients, industry and other relevant parties once the Agency becomes operational. The WHO is also actively supporting the emergence of the AMA, with its Director-General, Dr Tedros Adhanom Ghebreyesus describing the lack of strong national regulatory systems as “one of the biggest obstacles to improving access to medical products in Africa”. WHO Regional Director in Africa, Dr Matshidiso Moeti, has also reiterated the importance of the agency, telling Health Policy Watch: “AMA is a very important platform for medicines to be available and affordable equitably, and to be of good quality so that we have both good outcomes for the money that people and countries are spending, and that we prevent problems.” Other Benefits – International Partnerships and Support for Local Production The AMA will also help strengthen global collaborations, including participation of African researchers and patients in clinical research trials of new medicines, especially in the area of cancer, said Emer Cooke, Executive Director of the European Medicines Agency, speaking at Tuesday’s event. “We’re already collaborating with a number of initiatives on clinical trials with African regulators, particularly in the context of the African Vaccines Regulatory Forum. We can use forums such as this to build on the collaborative activities that take place to share our experiences and to help us to work on training and capacity building initiatives,” Cooke said. “I think we should be heartened by the fact that there’s already good discussion and collaboration in the context of clinical trials.” Fighting Fake Medicines Meanwhile, Lotfi Benbahmed, minister of the pharmaceutical industry of Algeria, said the AMA can help improve the reliability of Africa’s medicines — a feat that he said requires the existence of a regional framework to fight fake drugs. “So what we need to do is to harmonise rules and regulations, and enable countries to fight the illegal markets, and the informal markets,” Benbahmed said, who spoke alongside other African ministers of health from Algeria, the Democratic Republic of Congo, Egypt and Cape Verde. . According to him, a similar framework can be deployed to tackle the challenge of low quality drugs on the continent from the point of production, including setting up measures to inspect and control equipment in laboratories. At the same time, delays being encountered in the finalisation of the agency are “understandable”, said Dr Margareth Ndomondo-Sigonda, African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD), who highlighted the extensive harmonisation processes that needs to be undertaken between national governments to birth the new agency. “It takes time to get to the point where you’ve achieved regulatory harmonisation of African medicines and harmonization of regulatory standards. You have to make sure that through harmonization of these technical requirements, you know the quality standards and practice and you build trust,” Ndomondo-Sigonda said. She was however hopeful that once AMA comes into force, it will be able to deal with many outstanding issues regarding the harmonisation of Africa’s medicines landscape. Image Credits: Marco Verch/Flickr. Urgent Government Action and Investment Needed Against Antimicrobial Resistance, Says New Report 23/06/2021 Raisa Santos Launch of the AMR Preparedness Index Panel – left to right – James Anderson, Susan Schwarz, Neil Clancy, Anand Anandkumar, Christine Ardal, Mike Hodin, Norio Ohmagari, Tiemo Wolken Government action against the threat of “superbugs” in most of the world’s leading economies gets a score of less than 50%, according to a new AMR Preparedness Index, released today by a global coalition committed to fighting current trends. Great Britain, the United States, Germany and France rated highest on a score of 1-100 in an assessment of responses in 11 of the world’s leading economies to antimicrobial resistance (AMR) threats. Meanwhile, emerging economies such as Brazil, China, and India scored the worst in the assessment that looked at national strategy; awareness and prevention; innovation; access; appropriate and responsible use; AMR and the environment; and collaborative engagement. The index was launched today by the Global Coalition on Aging (GCOA) and the Infectious Diseases Society of America (IDSA), to shine more light on how the governments are living up to their commitments to address antimicrobial resistance (AMR). “We need health systems and policymakers to really step up and advocate that federal, state, and local governments prioritize AMR,” said Neil Clancy of the AMR Committee, Infectious Disease Society of America, during an event Wednesday launching the Index. “Without significant national and global coordination and multi-party interventions in this area, our efforts are not going to succeed.” The AMR Preparedness Index ranked 11 countries across 7 categories in a 1-100 point scale. UN Report Warns That AMR Could Cause As Many as 10 Million Deaths/ Year Livestock applications of antibiotics in metric tons/year, among countries reporting use. (The Antibiotic Footprint) An estimated 700,000 people already die each year from drug-resistant infections and the lack of antimicrobials to treat them. A 2019 UN report warned that if trends are ignored, AMR could cause as many as 10 million deaths per year, and GDP losses of more than US $100 trillion by 2050. The report assigns scores to each of the 11 countries across seven categories for needed and achievable policy action. Although the assessment considered national policies on “AMR and the Environment” it was unclear how heavily weighted that issue was in the overall index. Per capita, the US agricultural industry is one of the heaviest users of antibiotics in the world. COVID-19 Is a Warning Light to Act Preemptively on AMR The cost of AMR action pales in comparison to the future costs of inaction, participants underlined, drawing comparisons with the COVID-19 pandemic. Delays in responding to urgent public health crises have deadly consequences. “If the pandemic has taught us one thing, it is that we are not well-prepared to combat the serious threat that emerging infectious diseases can pose to human health and our economies,” said Tiemo Wölken, member of the European Parliament, Germany. In Europe, AMR causes the annual death of 33,000 people and costs 1.5 billion Euros in regards to healthcare costs and productivity losses. COVID-19 has highlighted the need for increased monitoring tools, more improved detection, prevention, and control practices, said Wölken. “The time to act is now. COVID already put our healthcare systems under extreme pressure, and this could only be a foretaste of what we could expect from a world where antibiotic microbials are no longer effective.” All Countries Fail in Awareness & Prevention of AMR Testing for antimicrobial resistance at the Liverpool School of Tropical Science. The analysis identified critical opportunities for all governments to act upon to slow the growth of drug resistant bugs. “Despite the progress that’s being made and despite the good work being done in countries throughout the world, we need to do more,” said Clancy. Several trends have emerged from an analysis of the different indices that went into the combined score. All countries performed insufficiently with regards to awareness and prevention of AMR, with India lagging furthest behind. More developed countries tended to fare better in the appropriate and responsible use of existing antibiotics and other antimicrobial agents – as compared to developing country counterparts. Outside of the UK and US, most other countries performed poorly in assessments of the quality of national strategies, innovations, and collaboration. Innovation Important Training on standardized and harmonized surveillance methods for antimicrobial resistance in food animals in Southeast Asia Innovation is another area that requires more significant action going forward, said James Anderson, Executive Director of Global Health at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). “We do need to really drive pipelines. We do need investments in AMR.” In the fight against the borderless threat of drug resistance, the Index included key insights and guidance for governments to immediately prioritize in order to fulfill their commitments on AMR. Overall, the top-level priorities identified in the Index were to: Strengthen and fully implement national AMR strategies; and raise awareness of AMR and its consequences. Along with that, other key priorities were to: Bolster surveillance and leverage data across AMR efforts; Enable a restructured antimicrobial marketplace to stimulate innovation; Promote responsible and appropriate use of antibiotics; Enable reliable and consistent access to needed and novel antimicrobials; More effectively integrate the One Health Approach, including environmental concerns, into national strategies; Better engage with other governments, third-party organizations, and advocacy groups Despite AMR being one of the top five global health challenges, as cited by the WHO, a large majority of the public remains unaware of their role. Local, national, and international efforts are needed in raising awareness and investment in AMR. “All of us have a stake in preserving antibiotics and assuring the development of new antibiotics,” said Clancy. Vaccinating Older Groups Against COVID – Can Help Fight AMR 93-year-old Lebanese actor Salah Tizani, who falls into the elderly priority group, receives his first vaccine dose against COVID-19 in Beirut on Feb. 14, 2021. In terms of the battle against COVID and AMR, the report underlines how vaccinating older adults can help fight overuse of antibiotics during the pandemic. That is because people who become seriously ill with COVID, are often given antibiotics preventively in order to ward off secondary infections. Adequately vaccinating older populations against other infections such as pneumococcal pneumonia and tuberculosis, and even infections like influenza is also critical step to combatting AMR. In other ways, too, older adults have a key stake in fighting AMR, because they tend to be major consumers of health services, and also may be more vulnerable to drug resistant bacteria and viruses overall. “We are at a time now when the megatrend of aging is at the top of our agenda, not just the public health agenda but the economic and social agenda as well,” said GCOA CEO Michael Hodin. As the UN Decade of Healthy Aging was launched in January, AMR needs to be a central part of this initiative, applied not only to older people but to all of us for a healthy and active aging, Hodin added. Coordination and Collaboration Across Low- and Middle-income Countries and High-Income Countries Most countries examined in the report are not making adequate investments to combat the AMR threat, with the lack of commitment felt globally. Huge disparities in total public AMR research funding remains an issue across high, middle, and low-income countries. “We cannot afford to be only US-centric, or only LMIC centric. It takes a very globalized approach,” said Anand Anandkumar, Founder and CEO of Bugworks Research, India. Greater support and collaboration is necessary to increase capacity for AMR initiatives, such as monitoring and surveillance in many low and middle-income countries (LMICs). Consequently, high income countries must collect and provide more complete data to increase the robustness of international, regional, and domestic efforts. “Access and equity are global challenges and the central tilt to competitive AMR,” said Clancy. “[We need to ensure] that we get antibiotics and access to these drugs in an equitable fashion. We’re all at risk from AMR.” Image Credits: USAID Asia/Flickr, GC, antibioticfootprint.net, Flickr – UK Department for International Development, World Bank: Mohamed Azakir. COVAX Shortcomings Under Microscope Ahead of Gavi, Vaccine Alliance Board Meeting 22/06/2021 Elaine Ruth Fletcher & Svĕt Lustig Vijay COVAX vaccine deliveries in Africa – a much trumpeted solution to vaccine inequalities in troubled waters. As the board of Gavi, The Vaccine Alliance is set to meet this Wednesday and Thursday, the COVAX global vaccine facility – a cornerstone of the global health sector response on vaccine access – is coming under increased fire for its shortcomings. A bitter opinion piece by Médecins Sans Frontières, published today, has called for a “drastic change of model” in the global procurement mechanism “that was supposed to deliver COVID-19 vaccine equity.” Co-launched by a range of partners, including WHO, the COVAX facility is legally administered by GAVI. What started out with a much-trumpeted bang of vaccine distributions across African nations has fizzled after the primary vaccine supplier, the Serum Institute of India, began redirecting its available COVID doses to domestic vaccine needs. Massive commitments by rich countries for further vaccine sharing, made at the recent G-7 meeting, are supposed to be funnelled through COVAX. Yet most of those donations will likely only be realized in the latter part of 2021 or early 2022, leaving the current shortfalls over the summer, as Africa faces yet another COVID wave. “COVAX is currently grossly behind on achieving its goals,” said MSF’s Katie Elder, senior vaccines policy advisor. “COVAX had aimed to provide 2 billion doses by the end of 2021, but so far has only distributed 88 million (the goal by the end of June was to distribute around 337 million). Less than half of one percent of total populations of COVAX countries have received at least a first dose of vaccine through COVAX.” She blames the fundamental model of the facility – in which it has been forced to compete on the open market for COVID vaccines – which were still often subsidized by public and government players – for the failings. AstraZeneca vaccine doses are unloaded at Bole International Airport in Addis Ababa, Ethiopia. Not Set Up to Succeed “COVAX was not set up to succeed,” she said. “It was constructed to work within the current parameters of the pharmaceutical market, where you see how much money you can raise and then see what you can negotiate with industry for it. “Loud calls early in the pandemic to depart from a business as usual approach were ignored—pharmaceutical corporations developing vaccines received billions in government money without any strings attached, so were free to charge prices they chose and to sell to the highest bidder. Unsurprisingly, this led to the very same governments that had touted the importance of equity …. and the governments that Gavi spent so much time courting to join the COVAX Facility – ultimately pursuing national interests and securing the bulk of future promised vaccines. “COVAX was left behind as wealthy governments secured their doses through bilateral deals with an industry that acted as expected: selling doses first to the buyers who could afford to pay the most.” The net result now leaves the Gavi Board struggling with how to continue the participation of upper income countries in the facility at all. “The fact that Gavi’s board is now reviewing the way in which wealthier countries (so called ‘Self-financing participants’) can continue to participate in the facility is in part a recognition that the set up does not work,” she added. “Allowing wealthy countries so much flexibility to decide how they join COVAX and how many vaccines they procure, has caused delays and undermined its objectives. A more equitable model would have encouraged regional leadership with decentralized methods of procurement at their core. In the future, we must support these regional initiatives that aim for self-sufficiency and self-determination.” A Beautiful idea: How the COVAX has Fallen Short To date, COVAX has distributed over 20 million doses to rich countries and 80 million doses to poorer countries. The result has been an awkward legal situation for the facility which is still required to provide 20% of its doses for higher income countries – even though most have now met their vaccine needs and hoarded even more, notably Canada, which bought enough vaccine doses to cover its population four times over. “The failure to entice wealthy countries to join COVAX in large numbers has left the managers of the facility in an awkward situation,” said global health journalist Ann Aanaiya Usher in a critique published by The Lancet. “On one hand, not enough self-financing participants joined COVAX to give it the massive buying power that was hoped. On the other, even though COVAX is desperately short of vaccines, the facility is now contractually obliged to reserve one in five doses for a few rich countries, she said, adding that so far, COVAX has distributed 80 million doses to LMICs and over 20 million doses to high-income countries (HICs), including the UK and Canada. She slams the COVAX facility for its “naive” set-up that failed to anticipate widespread vaccine nationalism that has locked up most of the vaccine doses that are available. “It was a beautiful idea, born out of solidarity”, Duke University’s Gavin Yamey was quoted as saying. “Unfortunately, it didn’t happen…Rich countries behaved worse than anyone’s worst nightmares.” COVAX should have also diversified its portfolio earlier on, in anticipation of supply shortages that crippled the facility after India’s Serum Institute halted vaccine exports to fend off a tragic second wave on the subcontinent that has claimed the lives of almost 400,000 people. “Supply shortages should have been anticipated and ramping up supplies should have been baked into the design of COVAX from the start,” observed Georgetown University’s Lawrence Gostin. He added, however, that it would be “literally impossible” to ramp up vaccine supplies without greater investments in manufacturing hubs in lower-income countries, as well as broad waiver on intellectual property rights to vaccine know-how. In its struggle to get rich countries to sign up, the COVAX facility’s offer to allow rich countries to choose which vaccines they would receive has also drawn widespread criticism for leading to “double standards” – which seemingly defy the very purpose of the facility, critics have said. A beautiful idea: how COVAX has fallen short https://t.co/QpG6o5zbqt This is the most complete & readable analysis of COVAX I have seen. The title says it all. COVAX was a beautiful idea & we must make it better & permanent — Lawrence Gostin (@LawrenceGostin) June 18, 2021 Facility Needs Equity Funds to Compete in the Marketplace Even Gavi, the Vaccine Alliance, has acknowledged that its slow mobilization of resources has hampered its ability to quickly procure, and thus deliver as many doses as possible to those who need them most. “If we had secured financing earlier, then we could have locked in doses earlier, as opposed to the second half of this year when COVAX’s volume will start ramping up,” a Gavi spokesperson said. The spokesperson was referring to the fact that most of the funds to procure and distribute vaccines for the 92 low- and middle-income countries (LMICs) that signed up for the scheme were pledged in late December or early 2021 – after high-income countries had already snapped up large vaccine pre-orders. That is a point of view shared by some independent observers as well as industry leaders, who maintain that the facility needs fine-tuning for the next pandemic. “Had COVAX had sufficient and readily available early funding it would have been better able to secure enough immediate supply to meet its aim,” said the Independent Panel for Pandemic Preparedness said, which reviewed the global pandemic response, under a mandate from the World Health Organization. Going forward, what COVAX needs is a “pot of money” to be able to pre-order vaccine doses earlier on in a global health emergency, said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations, in a recent Q&A with Health Policy Watch. That, he maintains, would allow the global facility to compete on a more equal footing with rich countries in the vaccines marketplace. Added Peter Hotez, a prominent vaccine scientist and dean at Baylor College of Medicine in Texas: “I think it’s important that we don’t sell COVAX short. It still has a lot going for it, and is innovative in its design. But it needs more vaccines to share,” Asked for comment by Health Policy Watch, GAVI did not respond. Image Credits: UNICEF, WHO, WHO. 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, World Trade Organization & World Intellectual Property Organization Map Out Joint Approach to COVID Pandemic 24/06/2021 Elaine Ruth Fletcher Directors-General of WIPO (far left) WHO (back center) and WTO (far right) discuss stepped up cooperation on combatting COVID-19 pandemic In a first-ever tripartite meeting this year, the heads of the World Health Organization, the World Trade Organization (WTO) and the World Intellectual Property Organization (WIPO), have agreed to step up their collaboration on tools and resources for fighting the COVID-19 pandemic. The meeting was the first formal tripartite meeting since Ngozi Okonjo-Iweala was elected as head of WTO earlier this spring, following the election of Daren Tang as the new head of WIPO late last year. In a joint statement issued after the meeting the three heads of agencies, including WHO’s Director General Dr Tedros Adhanom Ghebreyesus, pledged to collaborate more closely on a joint platform for tripartite technical assistance to member governments relating to their needs for medical technologies as well as a series of workshops – to augment capacity and information flow. In a joint statement issued following their meeting 15 June, the three agency heads stated that they would ramp up cooperation focusing first on “the organization of practical, capacity-building workshops to enhance the flow of updated information on current developments in the pandemic and responses to achieve equitable access to COVID-19 health technologies. “The aim of these workshops is to strengthen the capacity of policymakers and experts in member governments to address the pandemic accordingly. “The first workshop in the series will be a workshop on technology transfer and licensing, scheduled for September. The workshop will help our members update their knowledge and understanding of how intellectual property, know-how and technology transfer work in actuality. This would be in the context of medical technologies and related products and services. This first workshop will be followed by others on related practical themes.” A second prong of the joint initiative, will be the joint platform for technical assistance, that aims to provide “a one-stop shop that will makae available the full range of expertise on access, IP and trade matters provided by our organizations, and other partners, in a coordinated and systematic manner.” The platform will focus, in particular, on: supporting countries to assess and prioritize unmet needs for COVID-19 vaccines, medicines and related technologies, and; providing “timely and tailored technical assistance in making full use of all available options to access vaccines, medicines and technologies, including through coordination between members facing similar challenges to facilitate collective responses.” The effort would also include “periodical update” of baseline resources maintained by the three organizations, mapped in the joint publication: “Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade”, the statemnt said. The initiative appears to bring WIPO closer into the circle that has already been established by WTO and WHO on pandemic response – following last year’s change of administration in the agency that maintains a critical repository of data on intellectual property on health products for manufacturers worldwide – but has been too often accused of remaining outside of the loop of practical advice on IP use to low- and middle-income countries. Image Credits: World Trade Organization . Third COVID Wave Racing Across Africa — New Case Rates in South Africa & Tunisia Outstrip United Kingdom 24/06/2021 Paul Adepoju A quiet street in Cape Town, South Africa, during one of the hard lockdown periods of 2020, which helped curb the spread of COVID-19 last year. A “terrible third wave” of the COVID-19 pandemic is now hitting Africa in full force – with about 20 of the continent’s 54 countries experiencing particularly sharp rises in new infections, African Centers for Disease Control director, John Nkengasong told Health Policy Watch at a press briefing on Thursday. Per-capita rates of new SARS-CoV2 cases in South Africa and Tunisia now outstrip those in the United Kingdom – and spiralling 5-6 times higher than those in the United States and India. Although the continent-wide average is still only about 27 new cases per million, below the current US average, (34/million), the increases seen are prompting worries that Africa could even become a new global epicentre for the pandemic. That after nearly a year when it managed to maintain comparatively low case counts. Daily new cases per million people in Tunisia and South Africa are now running at nearly 200 infections/million. In comparison, in the United Kingdom new cases now stand at 149/million and in hard-hit India at 40 per million, over the last week. The new wave has already stretched several health systems on the continent beyond their limits, Nkengasong said. “This is the first time that we are seeing countries report that their health systems are completely overwhelmed,” he said. Zambia, Uganda & DRC In Zambia, daily new infections are averaging 138/million the highest ever recorded since the pandemic was declared. That, in turn, is biting health systems hard, Nkengasong said. According to the latest figures, on June 23, the country reported 3,367 new cases of COVID-19 over the past 24 hours – the highest number of daily reported cases yet in the country. It was also nearly double the number of cases (1,796) reported on 16 January 2021 when the country reached the peak of its second wave. Nkengasong revealed that aside from the already dispatched commodities, Africa CDC will also be sending a team of experts to Zambia to help the country cope with the third wave. “They are completely overwhelmed,” he said. The health systems of Uganda and the Democratic Republic of Congo are facing similar crises, he added. In conflict-ridden DRC, meanwhile, the lack of strong systems for COVID testing and case reporting may also be keeping the numbers artificially low, inside observers told Health Policy Watch. DRC has also been one of the most vaccine hesitant countries – turning back a large shipment of COVAX vaccines that it received to Africa CDC in April because it did not have the means to administer the doses. Even among the country’s large presence of UN forces and support teams, who have ready access to dedicated vaccine donations from India, vaccinations have progressed at painfully slow rates, observers told Health Policy Watch. Steepest COVID-19 Surge Yet — WHO WHO Regional Director for Africa Dr Matshidiso Moeti believes Afric can still blunt the impact of the currently fast-rising infection wave if precaution is taken against transmitting the virus. At a separate WHO briefing, WHO Regional Director for Africa Matshidiso Moeti described the third wave as the pandemic’s steepest surge yet continent-wide. According to WHO’s data, the number of cases have risen for five consecutive weeks since 3 May. As of 20 June—day 48 into the new wave—Africa had recorded around 474 000 new cases—a 21% higher rate as compared with the first 48 days of the second wave. At the current rate of infections, the ongoing surge is set to surpass the previous one by early July, WHO stated. “With rapidly rising case numbers and increasing reports of serious illness, the latest surge threatens to be Africa’s worst yet,” Moeti warned. But even though the window of opportunity may be closing, she noted that Africa can still blunt the impact of the currently fast-rising infections. “Everyone everywhere can do their bit by taking precautions to prevent transmission,” she said. For instance, after Uganda slapped on new restrictions last week, new cases there appeared to be plateauing. Vaccine Supplies May Not Arrive In Time Africa CDC director Dr John Nkengasong Despite promises of hundreds of millions of doses from different partners, including the United States government, the timeline for the delivery of the doses may not see their arrival in time to really help African countries combat the third wave, both WHO and Africa CDC officials warned. Globally, of the 2.7 billion vaccine doses administered, under 1.5% have been in the arms of Africans. According to the Africa CDC, 61.4 million COVID-19 vaccine doses have been received so far by 51 African member states out of which 48.6 million doses have been administered (79.52%). So far, only 1.12% of the African population has been fully vaccinated. Most of those supplies were received in March & April this year through the WHO co-sponsored COVAX vaccine facility – before COVAX supplies produced by the Serum Institute of India dried up as a result of India’s COVID infection spike. “Cases are outpacing vaccination, leaving more people exposed. Now we need international solidarity and innovation to increase our supply,” Moeti said. Nkengasong agreed: “What we need is rapid access to vaccines to member states. It is extremely frightening to look at the graphs from some African countries. We just really need vaccines to get into people’s arms very quickly.” Without any intentional actions to speed up vaccine dose supply to Africa, Nkengasong said member states may have to wait until August when doses are expected to start becoming available through African Union’s COVID-19 Africa Vaccine Acquisition Task Team (AVATT). Delta Variant Spreading Across Africa WHO and Africa CDC also called attention to the rapid spread of the Delta variant of the virus that was first reported in India, across the African continent. The Delta variant, has already been reported in 14 countries in Africa, rapidly catching up with other variants, Moeti said. “In the Democratic Republic of the Congo and Uganda that are experiencing COVID-19 resurgence, the Delta variant has been detected in most samples sequenced in the past month,” she noted. “We have seen that variant really aggressively taking over from other variants, not just in Uganda, but in other countries like the DRC,” Nkengasong added. In addition, the Beta variant which was first identified in South Africa, has since been reported in 29 African countries. And the Alpha variant that was first reported in the UK and is now being reported in 30 African countries, according to the Africa CDC. WHO said it is taking steps towards expanding the capabilities of various African countries to track the spread and evolution of the virus in order to guide epidemiological decisions. “We are supporting South Africa-based regional laboratories to monitor variants of concern,” Moeti said. “WHO is also boosting innovative technological support to other laboratories in the region without sequencing capacities to better monitor the evolution of the virus. In the next six months, WHO is aiming for an eight- to ten-fold increase in the samples sequenced each month in Southern African countries.” Leading Researchers Highlight the Impact of COVID-19 on Global Liver Disease 24/06/2021 Chandre Prince Dr Rifaat Safadi, director of the Liver Unit at Hadassah Hebrew University Medical Center, in Jerusalem, Israel. Patients who had liver transplants or those with advanced liver fibrosis may not be adequately protected against COVID-19 after two doses of the Pfizer-BioNTech vaccine, in light of the findings of a new study presented Wednesday on the opening day of the International Liver Congress(ILC) 2021. Presenting abstracts from the soon-to-be-released study on Wednesday, Dr Rifaat Safadi, director of the Liver Unit at Hadassah Hebrew University Medical Center, in Jerusalem, Israel, said the study suggests that such patients with low levels of antibodies to the SARS-CoV-2 virus should get a third booster Pfizer shot to increase their chances of protection against the virus. The global virtual conference, convened by the European Association for the Study of the Liver (EASL), is taking place Wednesday – Saturday. This year’s conference brings together leading liver disease researchers from around the world to explore new science around the prevention and treatment of liver disease caused by Hepatitis C, alcohol abuse and other risk factors, as well as the impact of the COVID-19 pandemic on people living with liver diseases and on liver disease medications. This year’s conference proceedings are highlighting the extreme vulnerability of people with liver disease to COVID – with one new study finding the chronic liver disease increased the odds of COVID-19 death by 80%. On the more positive side, another study however, found that the antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B. Research on the impact of COVID-19 on alcohol-related liver disease is also being showcased at this year’s conference session, along with new or improved treatments for people suffering from HCV. “We are beginning to understand more clearly just how disproportionately COVID-19 is impacting on people living with liver-related diseases and the studies presented at ILC 2021 advance our knowledge on multiple fronts, knowledge that can potentially help inform policy responses to the pandemic going forward,” said Philip Newsome, General Secretary of EASL and Director of the Centre for Liver Research at the University of Birmingham in the UK, at Wednesday’s opening session. Pfizer-BioNTech Vaccine Offers Low Immunity for People with Advanced Liver Disease Data from an Israeli study found that patients with advanced liver fibrosis may not be adequately protected against COVID-19 after two doses of the Pfizer-BioNTech vaccine. With regards to the Pfizer vaccine on patients with liver disease, Safadi, who will present the full results of the Israeli study on Saturday, explained that “older age”, advanced fibrosis and decreased steatosis appear to be risk factors for lower vaccine response among people with related forms of liver disease. The study analysed data from 88 patients living with hepatic fibrosis who had tested positive for COVID-19 and who had received both doses of Pfizer’s-BioNTech vaccine. It found that elderly patients with advanced liver fibrosis had a lower response to Pfizer’s vaccine, with Safadi suggesting that those patients may need a third booster shot. “Therefore, we have to think about the booster vaccination… we are thinking now about boosting the third shot, especially those with high risk for non responsiveness or lower response,” said Safadi. The study’s recommendation, however, goes beyond current US Food and Drug Administration (FDA) recommendations. The FDA has so far not recommended the use of antibody tests to check the effectiveness of vaccination against the virus, nor has it approved a three-dose regimen or booster of any SARS-CoV-2 vaccine. Tenofovir Reduces Severity of COVID-19 in Patients with Chronic Hepatitis B Encouraging data from another new study found that antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B. A study conducted in Spain found that antiretrovira drug tenofovir reduced the severity of COVID-19 in patients with chronic Hepatitis B. Beatriz Mateos Muñoz, PhD Specialist in Gastroenterology and Hepatology at the Hospital Universitario Ramón in Spain, said the study analysed data from 4736 patients from 28 Spanish hospitals. Of the 117 COVID-19 positive patients who were identified, 67 were taking tenofovir and 50 were on entecavir, an antiviral drug in the treatment of hepatitis B virus infection. Muñoz said the incidence of COVID-19 in patients on tenofovir or entecavir were similar, but that patients on entecavir “more often had severe COVID-19, required ICU, ventilatory support, had longer hospitalization or died”. The study found that tenofovir seemed to offer some protection in patients with chronic hepatitis B infected by COVID-19. “In multivariate logistic regression adjusted by age, sex, obesity, comorbidities and fibrosis stage, tenofovir reduced by 6-fold the risk of severe COVID-19. Patients with chronic hepatitis B on tenofovir have a lower risk of severe COVID-19 infection than those on entecavir.” COVID-19 Related Alcohol Sales May Have Increased Alcohol-related Liver Disease Abdel-Aziz Shaheen, assistant professor at the Gastroenterology and Hepatology at the University of Calgary in Canada, said a large population-based study found a significant increase in the number of patients with alcoholic hepatitis who were hospitalised last year in Alberta, Canada last year, with the highest admission rate recorded in April 2020. Shaheen said a significant increase in alcohol sales across Europe and North America during the early months of the pandemic had alarming consequences for patients with alcoholic hepatitis. He said most of the newer patients with alcoholic hepatitis were younger and mainly from rural areas. “There was a significant 9% increase in alcoholic hepatitis admissions per month between March and September and the average rate of alcoholic hepatitis hospitalizations compared to overall hospitalizations rate doubled from 11.6/ 10,000 general hospitalizations to 22.1/ 10,000 general hospitalizations for the same period,” said Shaheen. More worrying, said Shaheen was that: “Our results show that the increase in alcohol sales post pandemic will significantly impact the natural history of alcoholic liver disease in Canada”. Chronic Liver Disease Increased the Odds of Covid-19 Death by 80% Vincent Mallet, Managing Senior Physician and Professor, Hepatology Unit, Cochin University Another study that used the French National Hospital Discharge database for patients who were hospitalised for COVID-19 found that chronic liver disease increased the odds of COVID-19 death by 80%. Vincent Mallet, Managing Senior Physician and Professor, Hepatology Unit, Cochin University said the hospital records showed that 3, 943 of the 16,338 patients diagnosed with chronic liver disease who were admitted for Covid-19 in France in 2020 died, including 2518 after liver-related complications. He said liver complications and alcohol use disorders may have contributed to the COVID-19 deaths of patients with chronic liver disease. People with Obesity & Diabetes Related Fatty Liver Disease Also at Higher Risk from COVID-19 Similarly, a small study in Mexico of 348 patients found that people living with Metabolic Associated Fatty Liver Disease (MAFLD) were five times more likely to die during hospitalization for COVID-19 than people without these factors. The patients studied were admitted with the SARS-COV-2 infection to a number of tertiary referral hospitals between 4 April and 24 June 2020, said Martin Uriel Vázquez Medina, Researcher at the Laboratory of Biomathematical and Biostatistical Modelling for Health Escuela Superior de Medicina, México. Major risk factors for the chronic conditions are obesity and type-2 diabetes, common conditions in many parts of Latin America, also closely associated with unhealthy diets, including high sugar consumption, and lack of physical activity. Medina added: “We also want to show with this result that [patients in] Latin American countries that have this overhead problem of obesity, diabetes, and pre-diabetes, could also be associated with increased risk from COVID-19”. The ILC continues until Saturday. Six More African Countries Needed to Ratify Treaty Creating the First Continent-Wide Medicines Regulator 23/06/2021 Paul Adepoju The African Medicines Agency’s framework would help combat falsified products and by ensuring harmonized drug standards and approvals, ease access to more affordable medicines and vaccines for people throughout the continent. Michel Sidibé, Special Envoy of the African Union and Minister of Health of Mali has high hopes that 15 African countries will have finally ratified the African Medicines Agency (AMA) Treaty in time for the 35th African Union (AU) Summit, scheduled for early 2022. Fifteen is the magic number of countries that must ratify the treaty creating the AMA – in order to birth the agency into operational existence. By the time of the summit, Sidibé also predicts that 30 or more countries will also have signed the framework agreement on the creation of the agency – an agreement that was first approved by the African Union in February 2019. He was speaking at a virtual session on Tuesday, From civil society to the pharma industry, establishment of the continent-wide AMA is regarded as an important step forward that would help improve the functioning of national medicines regulatory agencies – combating fake medicines and streamlining approval of new medicines and vaccines. That, in turn, should also help reduce prices and boost access for people throughout the continent, observers predict. Snail Speed Pace of Ratification So Far However, snail-speed ratification of the treaty by the legislatures and parliaments of the AU’s 54 member states has become a major hurdle to actually opening the doors of the new agency. This is despite the strong support displayed by global health actors actors ranging from the World Health Organization, Africa Centres for Disease Control, as well as other regional drug regulatory agencies such as the European Medicines Authority. However, Sidibé said he is confident the new agency, once it finally begins operations, can build upon the continent’s existing expertise in pharmacovigilance – developed by national agencies such as the Moroccan agency for medicines and the Nigerian Agency for Foods, Drugs Administration and Control (NAFDAC). As for concerns regarding the slow pace of country approvals of the framework agreement and formal ratification, Sidibé said the plan has been to first target a balance of countries in diverse African regions as “low-hanging fruit” – followed by others. In fact, so far most of the countries signing and then ratifying the agreemeht have been West African and/or Francophone. But as the critical mass of ratifications is approached, momentum elsewhere is also building. “Our strategy was to go for different regional balances… , to make sure that we can have a low hanging fruit so we can get quickly the 15 countries,” he said. “Now we are almost there. I am sure by the next meeting of the African Union, we can come and present to the leaders that we managed to have 15 countries,” he said, adding that the priority is to ensure that all African countries are soon on board. Getting buy-in from all African countries will involve actively engaging with governments that are yet to sign and/or ratify the treaty, one by one. Top countries earmarked now for the next stage include north and west African regional leaders such as Ethiopia and Nigeria, as well as the Democratic Republic of Congo. “We are learning from different experiences and ensuring that we are not losing time. We are making sure we bring different partners together to implement the agenda quickly,” Sidibé added. The Long Road to Ratification In October 2020 Health Policy Watch reported that only 18 of Africa’s 55 countries had signed the framework agreement to establish the agency, while only 5 countries – Rwanda, Mali, Burkina Faso, Ghana and Seychelles – had actually ratified the agreement. At the time, Africa CDC Director John Nkengasong, told Health Policy Watch the delay in the treaty ratification was due to the COVID-19 pandemic. “I don’t think it is because countries do not want to sign on. I think it is because of the process that is required to make them sign that treaty, and the countries are currently focusing more on COVID-19,” said Nkengasong. “I think it’s a much needed institution. If we had the AMA, it would be working very closely with the WHO and other bodies to facilitate regulatory issues on drugs to help control the COVID-19 pandemic.” Since then, Zimbabwe and the Seychelles have signed the AMA framework treaty, raising the total number of signatories to 20. Guinea, Namibia and Sierra Leone have ratified the treaty, followed by Algeria this month, raising the number of countries that have fully completed the two-step approval process to nine. In order to get across the finish line, a new African Medicines Agency Treaty Alliance (AMATA) has also recently been created, said Kawaldip Sehmi of the International Alliance of Patients Organizations (IAPO), at Tuesday’s session. The Alliance, led by IAPO and including patient groups, researchers and academics, and industry, will advocate for rapid AMA ratification continent wide. It will also work to establish meaningful engagement with patients, industry and other relevant parties once the Agency becomes operational. The WHO is also actively supporting the emergence of the AMA, with its Director-General, Dr Tedros Adhanom Ghebreyesus describing the lack of strong national regulatory systems as “one of the biggest obstacles to improving access to medical products in Africa”. WHO Regional Director in Africa, Dr Matshidiso Moeti, has also reiterated the importance of the agency, telling Health Policy Watch: “AMA is a very important platform for medicines to be available and affordable equitably, and to be of good quality so that we have both good outcomes for the money that people and countries are spending, and that we prevent problems.” Other Benefits – International Partnerships and Support for Local Production The AMA will also help strengthen global collaborations, including participation of African researchers and patients in clinical research trials of new medicines, especially in the area of cancer, said Emer Cooke, Executive Director of the European Medicines Agency, speaking at Tuesday’s event. “We’re already collaborating with a number of initiatives on clinical trials with African regulators, particularly in the context of the African Vaccines Regulatory Forum. We can use forums such as this to build on the collaborative activities that take place to share our experiences and to help us to work on training and capacity building initiatives,” Cooke said. “I think we should be heartened by the fact that there’s already good discussion and collaboration in the context of clinical trials.” Fighting Fake Medicines Meanwhile, Lotfi Benbahmed, minister of the pharmaceutical industry of Algeria, said the AMA can help improve the reliability of Africa’s medicines — a feat that he said requires the existence of a regional framework to fight fake drugs. “So what we need to do is to harmonise rules and regulations, and enable countries to fight the illegal markets, and the informal markets,” Benbahmed said, who spoke alongside other African ministers of health from Algeria, the Democratic Republic of Congo, Egypt and Cape Verde. . According to him, a similar framework can be deployed to tackle the challenge of low quality drugs on the continent from the point of production, including setting up measures to inspect and control equipment in laboratories. At the same time, delays being encountered in the finalisation of the agency are “understandable”, said Dr Margareth Ndomondo-Sigonda, African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD), who highlighted the extensive harmonisation processes that needs to be undertaken between national governments to birth the new agency. “It takes time to get to the point where you’ve achieved regulatory harmonisation of African medicines and harmonization of regulatory standards. You have to make sure that through harmonization of these technical requirements, you know the quality standards and practice and you build trust,” Ndomondo-Sigonda said. She was however hopeful that once AMA comes into force, it will be able to deal with many outstanding issues regarding the harmonisation of Africa’s medicines landscape. Image Credits: Marco Verch/Flickr. Urgent Government Action and Investment Needed Against Antimicrobial Resistance, Says New Report 23/06/2021 Raisa Santos Launch of the AMR Preparedness Index Panel – left to right – James Anderson, Susan Schwarz, Neil Clancy, Anand Anandkumar, Christine Ardal, Mike Hodin, Norio Ohmagari, Tiemo Wolken Government action against the threat of “superbugs” in most of the world’s leading economies gets a score of less than 50%, according to a new AMR Preparedness Index, released today by a global coalition committed to fighting current trends. Great Britain, the United States, Germany and France rated highest on a score of 1-100 in an assessment of responses in 11 of the world’s leading economies to antimicrobial resistance (AMR) threats. Meanwhile, emerging economies such as Brazil, China, and India scored the worst in the assessment that looked at national strategy; awareness and prevention; innovation; access; appropriate and responsible use; AMR and the environment; and collaborative engagement. The index was launched today by the Global Coalition on Aging (GCOA) and the Infectious Diseases Society of America (IDSA), to shine more light on how the governments are living up to their commitments to address antimicrobial resistance (AMR). “We need health systems and policymakers to really step up and advocate that federal, state, and local governments prioritize AMR,” said Neil Clancy of the AMR Committee, Infectious Disease Society of America, during an event Wednesday launching the Index. “Without significant national and global coordination and multi-party interventions in this area, our efforts are not going to succeed.” The AMR Preparedness Index ranked 11 countries across 7 categories in a 1-100 point scale. UN Report Warns That AMR Could Cause As Many as 10 Million Deaths/ Year Livestock applications of antibiotics in metric tons/year, among countries reporting use. (The Antibiotic Footprint) An estimated 700,000 people already die each year from drug-resistant infections and the lack of antimicrobials to treat them. A 2019 UN report warned that if trends are ignored, AMR could cause as many as 10 million deaths per year, and GDP losses of more than US $100 trillion by 2050. The report assigns scores to each of the 11 countries across seven categories for needed and achievable policy action. Although the assessment considered national policies on “AMR and the Environment” it was unclear how heavily weighted that issue was in the overall index. Per capita, the US agricultural industry is one of the heaviest users of antibiotics in the world. COVID-19 Is a Warning Light to Act Preemptively on AMR The cost of AMR action pales in comparison to the future costs of inaction, participants underlined, drawing comparisons with the COVID-19 pandemic. Delays in responding to urgent public health crises have deadly consequences. “If the pandemic has taught us one thing, it is that we are not well-prepared to combat the serious threat that emerging infectious diseases can pose to human health and our economies,” said Tiemo Wölken, member of the European Parliament, Germany. In Europe, AMR causes the annual death of 33,000 people and costs 1.5 billion Euros in regards to healthcare costs and productivity losses. COVID-19 has highlighted the need for increased monitoring tools, more improved detection, prevention, and control practices, said Wölken. “The time to act is now. COVID already put our healthcare systems under extreme pressure, and this could only be a foretaste of what we could expect from a world where antibiotic microbials are no longer effective.” All Countries Fail in Awareness & Prevention of AMR Testing for antimicrobial resistance at the Liverpool School of Tropical Science. The analysis identified critical opportunities for all governments to act upon to slow the growth of drug resistant bugs. “Despite the progress that’s being made and despite the good work being done in countries throughout the world, we need to do more,” said Clancy. Several trends have emerged from an analysis of the different indices that went into the combined score. All countries performed insufficiently with regards to awareness and prevention of AMR, with India lagging furthest behind. More developed countries tended to fare better in the appropriate and responsible use of existing antibiotics and other antimicrobial agents – as compared to developing country counterparts. Outside of the UK and US, most other countries performed poorly in assessments of the quality of national strategies, innovations, and collaboration. Innovation Important Training on standardized and harmonized surveillance methods for antimicrobial resistance in food animals in Southeast Asia Innovation is another area that requires more significant action going forward, said James Anderson, Executive Director of Global Health at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). “We do need to really drive pipelines. We do need investments in AMR.” In the fight against the borderless threat of drug resistance, the Index included key insights and guidance for governments to immediately prioritize in order to fulfill their commitments on AMR. Overall, the top-level priorities identified in the Index were to: Strengthen and fully implement national AMR strategies; and raise awareness of AMR and its consequences. Along with that, other key priorities were to: Bolster surveillance and leverage data across AMR efforts; Enable a restructured antimicrobial marketplace to stimulate innovation; Promote responsible and appropriate use of antibiotics; Enable reliable and consistent access to needed and novel antimicrobials; More effectively integrate the One Health Approach, including environmental concerns, into national strategies; Better engage with other governments, third-party organizations, and advocacy groups Despite AMR being one of the top five global health challenges, as cited by the WHO, a large majority of the public remains unaware of their role. Local, national, and international efforts are needed in raising awareness and investment in AMR. “All of us have a stake in preserving antibiotics and assuring the development of new antibiotics,” said Clancy. Vaccinating Older Groups Against COVID – Can Help Fight AMR 93-year-old Lebanese actor Salah Tizani, who falls into the elderly priority group, receives his first vaccine dose against COVID-19 in Beirut on Feb. 14, 2021. In terms of the battle against COVID and AMR, the report underlines how vaccinating older adults can help fight overuse of antibiotics during the pandemic. That is because people who become seriously ill with COVID, are often given antibiotics preventively in order to ward off secondary infections. Adequately vaccinating older populations against other infections such as pneumococcal pneumonia and tuberculosis, and even infections like influenza is also critical step to combatting AMR. In other ways, too, older adults have a key stake in fighting AMR, because they tend to be major consumers of health services, and also may be more vulnerable to drug resistant bacteria and viruses overall. “We are at a time now when the megatrend of aging is at the top of our agenda, not just the public health agenda but the economic and social agenda as well,” said GCOA CEO Michael Hodin. As the UN Decade of Healthy Aging was launched in January, AMR needs to be a central part of this initiative, applied not only to older people but to all of us for a healthy and active aging, Hodin added. Coordination and Collaboration Across Low- and Middle-income Countries and High-Income Countries Most countries examined in the report are not making adequate investments to combat the AMR threat, with the lack of commitment felt globally. Huge disparities in total public AMR research funding remains an issue across high, middle, and low-income countries. “We cannot afford to be only US-centric, or only LMIC centric. It takes a very globalized approach,” said Anand Anandkumar, Founder and CEO of Bugworks Research, India. Greater support and collaboration is necessary to increase capacity for AMR initiatives, such as monitoring and surveillance in many low and middle-income countries (LMICs). Consequently, high income countries must collect and provide more complete data to increase the robustness of international, regional, and domestic efforts. “Access and equity are global challenges and the central tilt to competitive AMR,” said Clancy. “[We need to ensure] that we get antibiotics and access to these drugs in an equitable fashion. We’re all at risk from AMR.” Image Credits: USAID Asia/Flickr, GC, antibioticfootprint.net, Flickr – UK Department for International Development, World Bank: Mohamed Azakir. COVAX Shortcomings Under Microscope Ahead of Gavi, Vaccine Alliance Board Meeting 22/06/2021 Elaine Ruth Fletcher & Svĕt Lustig Vijay COVAX vaccine deliveries in Africa – a much trumpeted solution to vaccine inequalities in troubled waters. As the board of Gavi, The Vaccine Alliance is set to meet this Wednesday and Thursday, the COVAX global vaccine facility – a cornerstone of the global health sector response on vaccine access – is coming under increased fire for its shortcomings. A bitter opinion piece by Médecins Sans Frontières, published today, has called for a “drastic change of model” in the global procurement mechanism “that was supposed to deliver COVID-19 vaccine equity.” Co-launched by a range of partners, including WHO, the COVAX facility is legally administered by GAVI. What started out with a much-trumpeted bang of vaccine distributions across African nations has fizzled after the primary vaccine supplier, the Serum Institute of India, began redirecting its available COVID doses to domestic vaccine needs. Massive commitments by rich countries for further vaccine sharing, made at the recent G-7 meeting, are supposed to be funnelled through COVAX. Yet most of those donations will likely only be realized in the latter part of 2021 or early 2022, leaving the current shortfalls over the summer, as Africa faces yet another COVID wave. “COVAX is currently grossly behind on achieving its goals,” said MSF’s Katie Elder, senior vaccines policy advisor. “COVAX had aimed to provide 2 billion doses by the end of 2021, but so far has only distributed 88 million (the goal by the end of June was to distribute around 337 million). Less than half of one percent of total populations of COVAX countries have received at least a first dose of vaccine through COVAX.” She blames the fundamental model of the facility – in which it has been forced to compete on the open market for COVID vaccines – which were still often subsidized by public and government players – for the failings. AstraZeneca vaccine doses are unloaded at Bole International Airport in Addis Ababa, Ethiopia. Not Set Up to Succeed “COVAX was not set up to succeed,” she said. “It was constructed to work within the current parameters of the pharmaceutical market, where you see how much money you can raise and then see what you can negotiate with industry for it. “Loud calls early in the pandemic to depart from a business as usual approach were ignored—pharmaceutical corporations developing vaccines received billions in government money without any strings attached, so were free to charge prices they chose and to sell to the highest bidder. Unsurprisingly, this led to the very same governments that had touted the importance of equity …. and the governments that Gavi spent so much time courting to join the COVAX Facility – ultimately pursuing national interests and securing the bulk of future promised vaccines. “COVAX was left behind as wealthy governments secured their doses through bilateral deals with an industry that acted as expected: selling doses first to the buyers who could afford to pay the most.” The net result now leaves the Gavi Board struggling with how to continue the participation of upper income countries in the facility at all. “The fact that Gavi’s board is now reviewing the way in which wealthier countries (so called ‘Self-financing participants’) can continue to participate in the facility is in part a recognition that the set up does not work,” she added. “Allowing wealthy countries so much flexibility to decide how they join COVAX and how many vaccines they procure, has caused delays and undermined its objectives. A more equitable model would have encouraged regional leadership with decentralized methods of procurement at their core. In the future, we must support these regional initiatives that aim for self-sufficiency and self-determination.” A Beautiful idea: How the COVAX has Fallen Short To date, COVAX has distributed over 20 million doses to rich countries and 80 million doses to poorer countries. The result has been an awkward legal situation for the facility which is still required to provide 20% of its doses for higher income countries – even though most have now met their vaccine needs and hoarded even more, notably Canada, which bought enough vaccine doses to cover its population four times over. “The failure to entice wealthy countries to join COVAX in large numbers has left the managers of the facility in an awkward situation,” said global health journalist Ann Aanaiya Usher in a critique published by The Lancet. “On one hand, not enough self-financing participants joined COVAX to give it the massive buying power that was hoped. On the other, even though COVAX is desperately short of vaccines, the facility is now contractually obliged to reserve one in five doses for a few rich countries, she said, adding that so far, COVAX has distributed 80 million doses to LMICs and over 20 million doses to high-income countries (HICs), including the UK and Canada. She slams the COVAX facility for its “naive” set-up that failed to anticipate widespread vaccine nationalism that has locked up most of the vaccine doses that are available. “It was a beautiful idea, born out of solidarity”, Duke University’s Gavin Yamey was quoted as saying. “Unfortunately, it didn’t happen…Rich countries behaved worse than anyone’s worst nightmares.” COVAX should have also diversified its portfolio earlier on, in anticipation of supply shortages that crippled the facility after India’s Serum Institute halted vaccine exports to fend off a tragic second wave on the subcontinent that has claimed the lives of almost 400,000 people. “Supply shortages should have been anticipated and ramping up supplies should have been baked into the design of COVAX from the start,” observed Georgetown University’s Lawrence Gostin. He added, however, that it would be “literally impossible” to ramp up vaccine supplies without greater investments in manufacturing hubs in lower-income countries, as well as broad waiver on intellectual property rights to vaccine know-how. In its struggle to get rich countries to sign up, the COVAX facility’s offer to allow rich countries to choose which vaccines they would receive has also drawn widespread criticism for leading to “double standards” – which seemingly defy the very purpose of the facility, critics have said. A beautiful idea: how COVAX has fallen short https://t.co/QpG6o5zbqt This is the most complete & readable analysis of COVAX I have seen. The title says it all. COVAX was a beautiful idea & we must make it better & permanent — Lawrence Gostin (@LawrenceGostin) June 18, 2021 Facility Needs Equity Funds to Compete in the Marketplace Even Gavi, the Vaccine Alliance, has acknowledged that its slow mobilization of resources has hampered its ability to quickly procure, and thus deliver as many doses as possible to those who need them most. “If we had secured financing earlier, then we could have locked in doses earlier, as opposed to the second half of this year when COVAX’s volume will start ramping up,” a Gavi spokesperson said. The spokesperson was referring to the fact that most of the funds to procure and distribute vaccines for the 92 low- and middle-income countries (LMICs) that signed up for the scheme were pledged in late December or early 2021 – after high-income countries had already snapped up large vaccine pre-orders. That is a point of view shared by some independent observers as well as industry leaders, who maintain that the facility needs fine-tuning for the next pandemic. “Had COVAX had sufficient and readily available early funding it would have been better able to secure enough immediate supply to meet its aim,” said the Independent Panel for Pandemic Preparedness said, which reviewed the global pandemic response, under a mandate from the World Health Organization. Going forward, what COVAX needs is a “pot of money” to be able to pre-order vaccine doses earlier on in a global health emergency, said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations, in a recent Q&A with Health Policy Watch. That, he maintains, would allow the global facility to compete on a more equal footing with rich countries in the vaccines marketplace. Added Peter Hotez, a prominent vaccine scientist and dean at Baylor College of Medicine in Texas: “I think it’s important that we don’t sell COVAX short. It still has a lot going for it, and is innovative in its design. But it needs more vaccines to share,” Asked for comment by Health Policy Watch, GAVI did not respond. Image Credits: UNICEF, WHO, WHO. 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.
Third COVID Wave Racing Across Africa — New Case Rates in South Africa & Tunisia Outstrip United Kingdom 24/06/2021 Paul Adepoju A quiet street in Cape Town, South Africa, during one of the hard lockdown periods of 2020, which helped curb the spread of COVID-19 last year. A “terrible third wave” of the COVID-19 pandemic is now hitting Africa in full force – with about 20 of the continent’s 54 countries experiencing particularly sharp rises in new infections, African Centers for Disease Control director, John Nkengasong told Health Policy Watch at a press briefing on Thursday. Per-capita rates of new SARS-CoV2 cases in South Africa and Tunisia now outstrip those in the United Kingdom – and spiralling 5-6 times higher than those in the United States and India. Although the continent-wide average is still only about 27 new cases per million, below the current US average, (34/million), the increases seen are prompting worries that Africa could even become a new global epicentre for the pandemic. That after nearly a year when it managed to maintain comparatively low case counts. Daily new cases per million people in Tunisia and South Africa are now running at nearly 200 infections/million. In comparison, in the United Kingdom new cases now stand at 149/million and in hard-hit India at 40 per million, over the last week. The new wave has already stretched several health systems on the continent beyond their limits, Nkengasong said. “This is the first time that we are seeing countries report that their health systems are completely overwhelmed,” he said. Zambia, Uganda & DRC In Zambia, daily new infections are averaging 138/million the highest ever recorded since the pandemic was declared. That, in turn, is biting health systems hard, Nkengasong said. According to the latest figures, on June 23, the country reported 3,367 new cases of COVID-19 over the past 24 hours – the highest number of daily reported cases yet in the country. It was also nearly double the number of cases (1,796) reported on 16 January 2021 when the country reached the peak of its second wave. Nkengasong revealed that aside from the already dispatched commodities, Africa CDC will also be sending a team of experts to Zambia to help the country cope with the third wave. “They are completely overwhelmed,” he said. The health systems of Uganda and the Democratic Republic of Congo are facing similar crises, he added. In conflict-ridden DRC, meanwhile, the lack of strong systems for COVID testing and case reporting may also be keeping the numbers artificially low, inside observers told Health Policy Watch. DRC has also been one of the most vaccine hesitant countries – turning back a large shipment of COVAX vaccines that it received to Africa CDC in April because it did not have the means to administer the doses. Even among the country’s large presence of UN forces and support teams, who have ready access to dedicated vaccine donations from India, vaccinations have progressed at painfully slow rates, observers told Health Policy Watch. Steepest COVID-19 Surge Yet — WHO WHO Regional Director for Africa Dr Matshidiso Moeti believes Afric can still blunt the impact of the currently fast-rising infection wave if precaution is taken against transmitting the virus. At a separate WHO briefing, WHO Regional Director for Africa Matshidiso Moeti described the third wave as the pandemic’s steepest surge yet continent-wide. According to WHO’s data, the number of cases have risen for five consecutive weeks since 3 May. As of 20 June—day 48 into the new wave—Africa had recorded around 474 000 new cases—a 21% higher rate as compared with the first 48 days of the second wave. At the current rate of infections, the ongoing surge is set to surpass the previous one by early July, WHO stated. “With rapidly rising case numbers and increasing reports of serious illness, the latest surge threatens to be Africa’s worst yet,” Moeti warned. But even though the window of opportunity may be closing, she noted that Africa can still blunt the impact of the currently fast-rising infections. “Everyone everywhere can do their bit by taking precautions to prevent transmission,” she said. For instance, after Uganda slapped on new restrictions last week, new cases there appeared to be plateauing. Vaccine Supplies May Not Arrive In Time Africa CDC director Dr John Nkengasong Despite promises of hundreds of millions of doses from different partners, including the United States government, the timeline for the delivery of the doses may not see their arrival in time to really help African countries combat the third wave, both WHO and Africa CDC officials warned. Globally, of the 2.7 billion vaccine doses administered, under 1.5% have been in the arms of Africans. According to the Africa CDC, 61.4 million COVID-19 vaccine doses have been received so far by 51 African member states out of which 48.6 million doses have been administered (79.52%). So far, only 1.12% of the African population has been fully vaccinated. Most of those supplies were received in March & April this year through the WHO co-sponsored COVAX vaccine facility – before COVAX supplies produced by the Serum Institute of India dried up as a result of India’s COVID infection spike. “Cases are outpacing vaccination, leaving more people exposed. Now we need international solidarity and innovation to increase our supply,” Moeti said. Nkengasong agreed: “What we need is rapid access to vaccines to member states. It is extremely frightening to look at the graphs from some African countries. We just really need vaccines to get into people’s arms very quickly.” Without any intentional actions to speed up vaccine dose supply to Africa, Nkengasong said member states may have to wait until August when doses are expected to start becoming available through African Union’s COVID-19 Africa Vaccine Acquisition Task Team (AVATT). Delta Variant Spreading Across Africa WHO and Africa CDC also called attention to the rapid spread of the Delta variant of the virus that was first reported in India, across the African continent. The Delta variant, has already been reported in 14 countries in Africa, rapidly catching up with other variants, Moeti said. “In the Democratic Republic of the Congo and Uganda that are experiencing COVID-19 resurgence, the Delta variant has been detected in most samples sequenced in the past month,” she noted. “We have seen that variant really aggressively taking over from other variants, not just in Uganda, but in other countries like the DRC,” Nkengasong added. In addition, the Beta variant which was first identified in South Africa, has since been reported in 29 African countries. And the Alpha variant that was first reported in the UK and is now being reported in 30 African countries, according to the Africa CDC. WHO said it is taking steps towards expanding the capabilities of various African countries to track the spread and evolution of the virus in order to guide epidemiological decisions. “We are supporting South Africa-based regional laboratories to monitor variants of concern,” Moeti said. “WHO is also boosting innovative technological support to other laboratories in the region without sequencing capacities to better monitor the evolution of the virus. In the next six months, WHO is aiming for an eight- to ten-fold increase in the samples sequenced each month in Southern African countries.” Leading Researchers Highlight the Impact of COVID-19 on Global Liver Disease 24/06/2021 Chandre Prince Dr Rifaat Safadi, director of the Liver Unit at Hadassah Hebrew University Medical Center, in Jerusalem, Israel. Patients who had liver transplants or those with advanced liver fibrosis may not be adequately protected against COVID-19 after two doses of the Pfizer-BioNTech vaccine, in light of the findings of a new study presented Wednesday on the opening day of the International Liver Congress(ILC) 2021. Presenting abstracts from the soon-to-be-released study on Wednesday, Dr Rifaat Safadi, director of the Liver Unit at Hadassah Hebrew University Medical Center, in Jerusalem, Israel, said the study suggests that such patients with low levels of antibodies to the SARS-CoV-2 virus should get a third booster Pfizer shot to increase their chances of protection against the virus. The global virtual conference, convened by the European Association for the Study of the Liver (EASL), is taking place Wednesday – Saturday. This year’s conference brings together leading liver disease researchers from around the world to explore new science around the prevention and treatment of liver disease caused by Hepatitis C, alcohol abuse and other risk factors, as well as the impact of the COVID-19 pandemic on people living with liver diseases and on liver disease medications. This year’s conference proceedings are highlighting the extreme vulnerability of people with liver disease to COVID – with one new study finding the chronic liver disease increased the odds of COVID-19 death by 80%. On the more positive side, another study however, found that the antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B. Research on the impact of COVID-19 on alcohol-related liver disease is also being showcased at this year’s conference session, along with new or improved treatments for people suffering from HCV. “We are beginning to understand more clearly just how disproportionately COVID-19 is impacting on people living with liver-related diseases and the studies presented at ILC 2021 advance our knowledge on multiple fronts, knowledge that can potentially help inform policy responses to the pandemic going forward,” said Philip Newsome, General Secretary of EASL and Director of the Centre for Liver Research at the University of Birmingham in the UK, at Wednesday’s opening session. Pfizer-BioNTech Vaccine Offers Low Immunity for People with Advanced Liver Disease Data from an Israeli study found that patients with advanced liver fibrosis may not be adequately protected against COVID-19 after two doses of the Pfizer-BioNTech vaccine. With regards to the Pfizer vaccine on patients with liver disease, Safadi, who will present the full results of the Israeli study on Saturday, explained that “older age”, advanced fibrosis and decreased steatosis appear to be risk factors for lower vaccine response among people with related forms of liver disease. The study analysed data from 88 patients living with hepatic fibrosis who had tested positive for COVID-19 and who had received both doses of Pfizer’s-BioNTech vaccine. It found that elderly patients with advanced liver fibrosis had a lower response to Pfizer’s vaccine, with Safadi suggesting that those patients may need a third booster shot. “Therefore, we have to think about the booster vaccination… we are thinking now about boosting the third shot, especially those with high risk for non responsiveness or lower response,” said Safadi. The study’s recommendation, however, goes beyond current US Food and Drug Administration (FDA) recommendations. The FDA has so far not recommended the use of antibody tests to check the effectiveness of vaccination against the virus, nor has it approved a three-dose regimen or booster of any SARS-CoV-2 vaccine. Tenofovir Reduces Severity of COVID-19 in Patients with Chronic Hepatitis B Encouraging data from another new study found that antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B. A study conducted in Spain found that antiretrovira drug tenofovir reduced the severity of COVID-19 in patients with chronic Hepatitis B. Beatriz Mateos Muñoz, PhD Specialist in Gastroenterology and Hepatology at the Hospital Universitario Ramón in Spain, said the study analysed data from 4736 patients from 28 Spanish hospitals. Of the 117 COVID-19 positive patients who were identified, 67 were taking tenofovir and 50 were on entecavir, an antiviral drug in the treatment of hepatitis B virus infection. Muñoz said the incidence of COVID-19 in patients on tenofovir or entecavir were similar, but that patients on entecavir “more often had severe COVID-19, required ICU, ventilatory support, had longer hospitalization or died”. The study found that tenofovir seemed to offer some protection in patients with chronic hepatitis B infected by COVID-19. “In multivariate logistic regression adjusted by age, sex, obesity, comorbidities and fibrosis stage, tenofovir reduced by 6-fold the risk of severe COVID-19. Patients with chronic hepatitis B on tenofovir have a lower risk of severe COVID-19 infection than those on entecavir.” COVID-19 Related Alcohol Sales May Have Increased Alcohol-related Liver Disease Abdel-Aziz Shaheen, assistant professor at the Gastroenterology and Hepatology at the University of Calgary in Canada, said a large population-based study found a significant increase in the number of patients with alcoholic hepatitis who were hospitalised last year in Alberta, Canada last year, with the highest admission rate recorded in April 2020. Shaheen said a significant increase in alcohol sales across Europe and North America during the early months of the pandemic had alarming consequences for patients with alcoholic hepatitis. He said most of the newer patients with alcoholic hepatitis were younger and mainly from rural areas. “There was a significant 9% increase in alcoholic hepatitis admissions per month between March and September and the average rate of alcoholic hepatitis hospitalizations compared to overall hospitalizations rate doubled from 11.6/ 10,000 general hospitalizations to 22.1/ 10,000 general hospitalizations for the same period,” said Shaheen. More worrying, said Shaheen was that: “Our results show that the increase in alcohol sales post pandemic will significantly impact the natural history of alcoholic liver disease in Canada”. Chronic Liver Disease Increased the Odds of Covid-19 Death by 80% Vincent Mallet, Managing Senior Physician and Professor, Hepatology Unit, Cochin University Another study that used the French National Hospital Discharge database for patients who were hospitalised for COVID-19 found that chronic liver disease increased the odds of COVID-19 death by 80%. Vincent Mallet, Managing Senior Physician and Professor, Hepatology Unit, Cochin University said the hospital records showed that 3, 943 of the 16,338 patients diagnosed with chronic liver disease who were admitted for Covid-19 in France in 2020 died, including 2518 after liver-related complications. He said liver complications and alcohol use disorders may have contributed to the COVID-19 deaths of patients with chronic liver disease. People with Obesity & Diabetes Related Fatty Liver Disease Also at Higher Risk from COVID-19 Similarly, a small study in Mexico of 348 patients found that people living with Metabolic Associated Fatty Liver Disease (MAFLD) were five times more likely to die during hospitalization for COVID-19 than people without these factors. The patients studied were admitted with the SARS-COV-2 infection to a number of tertiary referral hospitals between 4 April and 24 June 2020, said Martin Uriel Vázquez Medina, Researcher at the Laboratory of Biomathematical and Biostatistical Modelling for Health Escuela Superior de Medicina, México. Major risk factors for the chronic conditions are obesity and type-2 diabetes, common conditions in many parts of Latin America, also closely associated with unhealthy diets, including high sugar consumption, and lack of physical activity. Medina added: “We also want to show with this result that [patients in] Latin American countries that have this overhead problem of obesity, diabetes, and pre-diabetes, could also be associated with increased risk from COVID-19”. The ILC continues until Saturday. Six More African Countries Needed to Ratify Treaty Creating the First Continent-Wide Medicines Regulator 23/06/2021 Paul Adepoju The African Medicines Agency’s framework would help combat falsified products and by ensuring harmonized drug standards and approvals, ease access to more affordable medicines and vaccines for people throughout the continent. Michel Sidibé, Special Envoy of the African Union and Minister of Health of Mali has high hopes that 15 African countries will have finally ratified the African Medicines Agency (AMA) Treaty in time for the 35th African Union (AU) Summit, scheduled for early 2022. Fifteen is the magic number of countries that must ratify the treaty creating the AMA – in order to birth the agency into operational existence. By the time of the summit, Sidibé also predicts that 30 or more countries will also have signed the framework agreement on the creation of the agency – an agreement that was first approved by the African Union in February 2019. He was speaking at a virtual session on Tuesday, From civil society to the pharma industry, establishment of the continent-wide AMA is regarded as an important step forward that would help improve the functioning of national medicines regulatory agencies – combating fake medicines and streamlining approval of new medicines and vaccines. That, in turn, should also help reduce prices and boost access for people throughout the continent, observers predict. Snail Speed Pace of Ratification So Far However, snail-speed ratification of the treaty by the legislatures and parliaments of the AU’s 54 member states has become a major hurdle to actually opening the doors of the new agency. This is despite the strong support displayed by global health actors actors ranging from the World Health Organization, Africa Centres for Disease Control, as well as other regional drug regulatory agencies such as the European Medicines Authority. However, Sidibé said he is confident the new agency, once it finally begins operations, can build upon the continent’s existing expertise in pharmacovigilance – developed by national agencies such as the Moroccan agency for medicines and the Nigerian Agency for Foods, Drugs Administration and Control (NAFDAC). As for concerns regarding the slow pace of country approvals of the framework agreement and formal ratification, Sidibé said the plan has been to first target a balance of countries in diverse African regions as “low-hanging fruit” – followed by others. In fact, so far most of the countries signing and then ratifying the agreemeht have been West African and/or Francophone. But as the critical mass of ratifications is approached, momentum elsewhere is also building. “Our strategy was to go for different regional balances… , to make sure that we can have a low hanging fruit so we can get quickly the 15 countries,” he said. “Now we are almost there. I am sure by the next meeting of the African Union, we can come and present to the leaders that we managed to have 15 countries,” he said, adding that the priority is to ensure that all African countries are soon on board. Getting buy-in from all African countries will involve actively engaging with governments that are yet to sign and/or ratify the treaty, one by one. Top countries earmarked now for the next stage include north and west African regional leaders such as Ethiopia and Nigeria, as well as the Democratic Republic of Congo. “We are learning from different experiences and ensuring that we are not losing time. We are making sure we bring different partners together to implement the agenda quickly,” Sidibé added. The Long Road to Ratification In October 2020 Health Policy Watch reported that only 18 of Africa’s 55 countries had signed the framework agreement to establish the agency, while only 5 countries – Rwanda, Mali, Burkina Faso, Ghana and Seychelles – had actually ratified the agreement. At the time, Africa CDC Director John Nkengasong, told Health Policy Watch the delay in the treaty ratification was due to the COVID-19 pandemic. “I don’t think it is because countries do not want to sign on. I think it is because of the process that is required to make them sign that treaty, and the countries are currently focusing more on COVID-19,” said Nkengasong. “I think it’s a much needed institution. If we had the AMA, it would be working very closely with the WHO and other bodies to facilitate regulatory issues on drugs to help control the COVID-19 pandemic.” Since then, Zimbabwe and the Seychelles have signed the AMA framework treaty, raising the total number of signatories to 20. Guinea, Namibia and Sierra Leone have ratified the treaty, followed by Algeria this month, raising the number of countries that have fully completed the two-step approval process to nine. In order to get across the finish line, a new African Medicines Agency Treaty Alliance (AMATA) has also recently been created, said Kawaldip Sehmi of the International Alliance of Patients Organizations (IAPO), at Tuesday’s session. The Alliance, led by IAPO and including patient groups, researchers and academics, and industry, will advocate for rapid AMA ratification continent wide. It will also work to establish meaningful engagement with patients, industry and other relevant parties once the Agency becomes operational. The WHO is also actively supporting the emergence of the AMA, with its Director-General, Dr Tedros Adhanom Ghebreyesus describing the lack of strong national regulatory systems as “one of the biggest obstacles to improving access to medical products in Africa”. WHO Regional Director in Africa, Dr Matshidiso Moeti, has also reiterated the importance of the agency, telling Health Policy Watch: “AMA is a very important platform for medicines to be available and affordable equitably, and to be of good quality so that we have both good outcomes for the money that people and countries are spending, and that we prevent problems.” Other Benefits – International Partnerships and Support for Local Production The AMA will also help strengthen global collaborations, including participation of African researchers and patients in clinical research trials of new medicines, especially in the area of cancer, said Emer Cooke, Executive Director of the European Medicines Agency, speaking at Tuesday’s event. “We’re already collaborating with a number of initiatives on clinical trials with African regulators, particularly in the context of the African Vaccines Regulatory Forum. We can use forums such as this to build on the collaborative activities that take place to share our experiences and to help us to work on training and capacity building initiatives,” Cooke said. “I think we should be heartened by the fact that there’s already good discussion and collaboration in the context of clinical trials.” Fighting Fake Medicines Meanwhile, Lotfi Benbahmed, minister of the pharmaceutical industry of Algeria, said the AMA can help improve the reliability of Africa’s medicines — a feat that he said requires the existence of a regional framework to fight fake drugs. “So what we need to do is to harmonise rules and regulations, and enable countries to fight the illegal markets, and the informal markets,” Benbahmed said, who spoke alongside other African ministers of health from Algeria, the Democratic Republic of Congo, Egypt and Cape Verde. . According to him, a similar framework can be deployed to tackle the challenge of low quality drugs on the continent from the point of production, including setting up measures to inspect and control equipment in laboratories. At the same time, delays being encountered in the finalisation of the agency are “understandable”, said Dr Margareth Ndomondo-Sigonda, African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD), who highlighted the extensive harmonisation processes that needs to be undertaken between national governments to birth the new agency. “It takes time to get to the point where you’ve achieved regulatory harmonisation of African medicines and harmonization of regulatory standards. You have to make sure that through harmonization of these technical requirements, you know the quality standards and practice and you build trust,” Ndomondo-Sigonda said. She was however hopeful that once AMA comes into force, it will be able to deal with many outstanding issues regarding the harmonisation of Africa’s medicines landscape. Image Credits: Marco Verch/Flickr. Urgent Government Action and Investment Needed Against Antimicrobial Resistance, Says New Report 23/06/2021 Raisa Santos Launch of the AMR Preparedness Index Panel – left to right – James Anderson, Susan Schwarz, Neil Clancy, Anand Anandkumar, Christine Ardal, Mike Hodin, Norio Ohmagari, Tiemo Wolken Government action against the threat of “superbugs” in most of the world’s leading economies gets a score of less than 50%, according to a new AMR Preparedness Index, released today by a global coalition committed to fighting current trends. Great Britain, the United States, Germany and France rated highest on a score of 1-100 in an assessment of responses in 11 of the world’s leading economies to antimicrobial resistance (AMR) threats. Meanwhile, emerging economies such as Brazil, China, and India scored the worst in the assessment that looked at national strategy; awareness and prevention; innovation; access; appropriate and responsible use; AMR and the environment; and collaborative engagement. The index was launched today by the Global Coalition on Aging (GCOA) and the Infectious Diseases Society of America (IDSA), to shine more light on how the governments are living up to their commitments to address antimicrobial resistance (AMR). “We need health systems and policymakers to really step up and advocate that federal, state, and local governments prioritize AMR,” said Neil Clancy of the AMR Committee, Infectious Disease Society of America, during an event Wednesday launching the Index. “Without significant national and global coordination and multi-party interventions in this area, our efforts are not going to succeed.” The AMR Preparedness Index ranked 11 countries across 7 categories in a 1-100 point scale. UN Report Warns That AMR Could Cause As Many as 10 Million Deaths/ Year Livestock applications of antibiotics in metric tons/year, among countries reporting use. (The Antibiotic Footprint) An estimated 700,000 people already die each year from drug-resistant infections and the lack of antimicrobials to treat them. A 2019 UN report warned that if trends are ignored, AMR could cause as many as 10 million deaths per year, and GDP losses of more than US $100 trillion by 2050. The report assigns scores to each of the 11 countries across seven categories for needed and achievable policy action. Although the assessment considered national policies on “AMR and the Environment” it was unclear how heavily weighted that issue was in the overall index. Per capita, the US agricultural industry is one of the heaviest users of antibiotics in the world. COVID-19 Is a Warning Light to Act Preemptively on AMR The cost of AMR action pales in comparison to the future costs of inaction, participants underlined, drawing comparisons with the COVID-19 pandemic. Delays in responding to urgent public health crises have deadly consequences. “If the pandemic has taught us one thing, it is that we are not well-prepared to combat the serious threat that emerging infectious diseases can pose to human health and our economies,” said Tiemo Wölken, member of the European Parliament, Germany. In Europe, AMR causes the annual death of 33,000 people and costs 1.5 billion Euros in regards to healthcare costs and productivity losses. COVID-19 has highlighted the need for increased monitoring tools, more improved detection, prevention, and control practices, said Wölken. “The time to act is now. COVID already put our healthcare systems under extreme pressure, and this could only be a foretaste of what we could expect from a world where antibiotic microbials are no longer effective.” All Countries Fail in Awareness & Prevention of AMR Testing for antimicrobial resistance at the Liverpool School of Tropical Science. The analysis identified critical opportunities for all governments to act upon to slow the growth of drug resistant bugs. “Despite the progress that’s being made and despite the good work being done in countries throughout the world, we need to do more,” said Clancy. Several trends have emerged from an analysis of the different indices that went into the combined score. All countries performed insufficiently with regards to awareness and prevention of AMR, with India lagging furthest behind. More developed countries tended to fare better in the appropriate and responsible use of existing antibiotics and other antimicrobial agents – as compared to developing country counterparts. Outside of the UK and US, most other countries performed poorly in assessments of the quality of national strategies, innovations, and collaboration. Innovation Important Training on standardized and harmonized surveillance methods for antimicrobial resistance in food animals in Southeast Asia Innovation is another area that requires more significant action going forward, said James Anderson, Executive Director of Global Health at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). “We do need to really drive pipelines. We do need investments in AMR.” In the fight against the borderless threat of drug resistance, the Index included key insights and guidance for governments to immediately prioritize in order to fulfill their commitments on AMR. Overall, the top-level priorities identified in the Index were to: Strengthen and fully implement national AMR strategies; and raise awareness of AMR and its consequences. Along with that, other key priorities were to: Bolster surveillance and leverage data across AMR efforts; Enable a restructured antimicrobial marketplace to stimulate innovation; Promote responsible and appropriate use of antibiotics; Enable reliable and consistent access to needed and novel antimicrobials; More effectively integrate the One Health Approach, including environmental concerns, into national strategies; Better engage with other governments, third-party organizations, and advocacy groups Despite AMR being one of the top five global health challenges, as cited by the WHO, a large majority of the public remains unaware of their role. Local, national, and international efforts are needed in raising awareness and investment in AMR. “All of us have a stake in preserving antibiotics and assuring the development of new antibiotics,” said Clancy. Vaccinating Older Groups Against COVID – Can Help Fight AMR 93-year-old Lebanese actor Salah Tizani, who falls into the elderly priority group, receives his first vaccine dose against COVID-19 in Beirut on Feb. 14, 2021. In terms of the battle against COVID and AMR, the report underlines how vaccinating older adults can help fight overuse of antibiotics during the pandemic. That is because people who become seriously ill with COVID, are often given antibiotics preventively in order to ward off secondary infections. Adequately vaccinating older populations against other infections such as pneumococcal pneumonia and tuberculosis, and even infections like influenza is also critical step to combatting AMR. In other ways, too, older adults have a key stake in fighting AMR, because they tend to be major consumers of health services, and also may be more vulnerable to drug resistant bacteria and viruses overall. “We are at a time now when the megatrend of aging is at the top of our agenda, not just the public health agenda but the economic and social agenda as well,” said GCOA CEO Michael Hodin. As the UN Decade of Healthy Aging was launched in January, AMR needs to be a central part of this initiative, applied not only to older people but to all of us for a healthy and active aging, Hodin added. Coordination and Collaboration Across Low- and Middle-income Countries and High-Income Countries Most countries examined in the report are not making adequate investments to combat the AMR threat, with the lack of commitment felt globally. Huge disparities in total public AMR research funding remains an issue across high, middle, and low-income countries. “We cannot afford to be only US-centric, or only LMIC centric. It takes a very globalized approach,” said Anand Anandkumar, Founder and CEO of Bugworks Research, India. Greater support and collaboration is necessary to increase capacity for AMR initiatives, such as monitoring and surveillance in many low and middle-income countries (LMICs). Consequently, high income countries must collect and provide more complete data to increase the robustness of international, regional, and domestic efforts. “Access and equity are global challenges and the central tilt to competitive AMR,” said Clancy. “[We need to ensure] that we get antibiotics and access to these drugs in an equitable fashion. We’re all at risk from AMR.” Image Credits: USAID Asia/Flickr, GC, antibioticfootprint.net, Flickr – UK Department for International Development, World Bank: Mohamed Azakir. COVAX Shortcomings Under Microscope Ahead of Gavi, Vaccine Alliance Board Meeting 22/06/2021 Elaine Ruth Fletcher & Svĕt Lustig Vijay COVAX vaccine deliveries in Africa – a much trumpeted solution to vaccine inequalities in troubled waters. As the board of Gavi, The Vaccine Alliance is set to meet this Wednesday and Thursday, the COVAX global vaccine facility – a cornerstone of the global health sector response on vaccine access – is coming under increased fire for its shortcomings. A bitter opinion piece by Médecins Sans Frontières, published today, has called for a “drastic change of model” in the global procurement mechanism “that was supposed to deliver COVID-19 vaccine equity.” Co-launched by a range of partners, including WHO, the COVAX facility is legally administered by GAVI. What started out with a much-trumpeted bang of vaccine distributions across African nations has fizzled after the primary vaccine supplier, the Serum Institute of India, began redirecting its available COVID doses to domestic vaccine needs. Massive commitments by rich countries for further vaccine sharing, made at the recent G-7 meeting, are supposed to be funnelled through COVAX. Yet most of those donations will likely only be realized in the latter part of 2021 or early 2022, leaving the current shortfalls over the summer, as Africa faces yet another COVID wave. “COVAX is currently grossly behind on achieving its goals,” said MSF’s Katie Elder, senior vaccines policy advisor. “COVAX had aimed to provide 2 billion doses by the end of 2021, but so far has only distributed 88 million (the goal by the end of June was to distribute around 337 million). Less than half of one percent of total populations of COVAX countries have received at least a first dose of vaccine through COVAX.” She blames the fundamental model of the facility – in which it has been forced to compete on the open market for COVID vaccines – which were still often subsidized by public and government players – for the failings. AstraZeneca vaccine doses are unloaded at Bole International Airport in Addis Ababa, Ethiopia. Not Set Up to Succeed “COVAX was not set up to succeed,” she said. “It was constructed to work within the current parameters of the pharmaceutical market, where you see how much money you can raise and then see what you can negotiate with industry for it. “Loud calls early in the pandemic to depart from a business as usual approach were ignored—pharmaceutical corporations developing vaccines received billions in government money without any strings attached, so were free to charge prices they chose and to sell to the highest bidder. Unsurprisingly, this led to the very same governments that had touted the importance of equity …. and the governments that Gavi spent so much time courting to join the COVAX Facility – ultimately pursuing national interests and securing the bulk of future promised vaccines. “COVAX was left behind as wealthy governments secured their doses through bilateral deals with an industry that acted as expected: selling doses first to the buyers who could afford to pay the most.” The net result now leaves the Gavi Board struggling with how to continue the participation of upper income countries in the facility at all. “The fact that Gavi’s board is now reviewing the way in which wealthier countries (so called ‘Self-financing participants’) can continue to participate in the facility is in part a recognition that the set up does not work,” she added. “Allowing wealthy countries so much flexibility to decide how they join COVAX and how many vaccines they procure, has caused delays and undermined its objectives. A more equitable model would have encouraged regional leadership with decentralized methods of procurement at their core. In the future, we must support these regional initiatives that aim for self-sufficiency and self-determination.” A Beautiful idea: How the COVAX has Fallen Short To date, COVAX has distributed over 20 million doses to rich countries and 80 million doses to poorer countries. The result has been an awkward legal situation for the facility which is still required to provide 20% of its doses for higher income countries – even though most have now met their vaccine needs and hoarded even more, notably Canada, which bought enough vaccine doses to cover its population four times over. “The failure to entice wealthy countries to join COVAX in large numbers has left the managers of the facility in an awkward situation,” said global health journalist Ann Aanaiya Usher in a critique published by The Lancet. “On one hand, not enough self-financing participants joined COVAX to give it the massive buying power that was hoped. On the other, even though COVAX is desperately short of vaccines, the facility is now contractually obliged to reserve one in five doses for a few rich countries, she said, adding that so far, COVAX has distributed 80 million doses to LMICs and over 20 million doses to high-income countries (HICs), including the UK and Canada. She slams the COVAX facility for its “naive” set-up that failed to anticipate widespread vaccine nationalism that has locked up most of the vaccine doses that are available. “It was a beautiful idea, born out of solidarity”, Duke University’s Gavin Yamey was quoted as saying. “Unfortunately, it didn’t happen…Rich countries behaved worse than anyone’s worst nightmares.” COVAX should have also diversified its portfolio earlier on, in anticipation of supply shortages that crippled the facility after India’s Serum Institute halted vaccine exports to fend off a tragic second wave on the subcontinent that has claimed the lives of almost 400,000 people. “Supply shortages should have been anticipated and ramping up supplies should have been baked into the design of COVAX from the start,” observed Georgetown University’s Lawrence Gostin. He added, however, that it would be “literally impossible” to ramp up vaccine supplies without greater investments in manufacturing hubs in lower-income countries, as well as broad waiver on intellectual property rights to vaccine know-how. In its struggle to get rich countries to sign up, the COVAX facility’s offer to allow rich countries to choose which vaccines they would receive has also drawn widespread criticism for leading to “double standards” – which seemingly defy the very purpose of the facility, critics have said. A beautiful idea: how COVAX has fallen short https://t.co/QpG6o5zbqt This is the most complete & readable analysis of COVAX I have seen. The title says it all. COVAX was a beautiful idea & we must make it better & permanent — Lawrence Gostin (@LawrenceGostin) June 18, 2021 Facility Needs Equity Funds to Compete in the Marketplace Even Gavi, the Vaccine Alliance, has acknowledged that its slow mobilization of resources has hampered its ability to quickly procure, and thus deliver as many doses as possible to those who need them most. “If we had secured financing earlier, then we could have locked in doses earlier, as opposed to the second half of this year when COVAX’s volume will start ramping up,” a Gavi spokesperson said. The spokesperson was referring to the fact that most of the funds to procure and distribute vaccines for the 92 low- and middle-income countries (LMICs) that signed up for the scheme were pledged in late December or early 2021 – after high-income countries had already snapped up large vaccine pre-orders. That is a point of view shared by some independent observers as well as industry leaders, who maintain that the facility needs fine-tuning for the next pandemic. “Had COVAX had sufficient and readily available early funding it would have been better able to secure enough immediate supply to meet its aim,” said the Independent Panel for Pandemic Preparedness said, which reviewed the global pandemic response, under a mandate from the World Health Organization. Going forward, what COVAX needs is a “pot of money” to be able to pre-order vaccine doses earlier on in a global health emergency, said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations, in a recent Q&A with Health Policy Watch. That, he maintains, would allow the global facility to compete on a more equal footing with rich countries in the vaccines marketplace. Added Peter Hotez, a prominent vaccine scientist and dean at Baylor College of Medicine in Texas: “I think it’s important that we don’t sell COVAX short. It still has a lot going for it, and is innovative in its design. But it needs more vaccines to share,” Asked for comment by Health Policy Watch, GAVI did not respond. Image Credits: UNICEF, WHO, WHO. 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.
Leading Researchers Highlight the Impact of COVID-19 on Global Liver Disease 24/06/2021 Chandre Prince Dr Rifaat Safadi, director of the Liver Unit at Hadassah Hebrew University Medical Center, in Jerusalem, Israel. Patients who had liver transplants or those with advanced liver fibrosis may not be adequately protected against COVID-19 after two doses of the Pfizer-BioNTech vaccine, in light of the findings of a new study presented Wednesday on the opening day of the International Liver Congress(ILC) 2021. Presenting abstracts from the soon-to-be-released study on Wednesday, Dr Rifaat Safadi, director of the Liver Unit at Hadassah Hebrew University Medical Center, in Jerusalem, Israel, said the study suggests that such patients with low levels of antibodies to the SARS-CoV-2 virus should get a third booster Pfizer shot to increase their chances of protection against the virus. The global virtual conference, convened by the European Association for the Study of the Liver (EASL), is taking place Wednesday – Saturday. This year’s conference brings together leading liver disease researchers from around the world to explore new science around the prevention and treatment of liver disease caused by Hepatitis C, alcohol abuse and other risk factors, as well as the impact of the COVID-19 pandemic on people living with liver diseases and on liver disease medications. This year’s conference proceedings are highlighting the extreme vulnerability of people with liver disease to COVID – with one new study finding the chronic liver disease increased the odds of COVID-19 death by 80%. On the more positive side, another study however, found that the antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B. Research on the impact of COVID-19 on alcohol-related liver disease is also being showcased at this year’s conference session, along with new or improved treatments for people suffering from HCV. “We are beginning to understand more clearly just how disproportionately COVID-19 is impacting on people living with liver-related diseases and the studies presented at ILC 2021 advance our knowledge on multiple fronts, knowledge that can potentially help inform policy responses to the pandemic going forward,” said Philip Newsome, General Secretary of EASL and Director of the Centre for Liver Research at the University of Birmingham in the UK, at Wednesday’s opening session. Pfizer-BioNTech Vaccine Offers Low Immunity for People with Advanced Liver Disease Data from an Israeli study found that patients with advanced liver fibrosis may not be adequately protected against COVID-19 after two doses of the Pfizer-BioNTech vaccine. With regards to the Pfizer vaccine on patients with liver disease, Safadi, who will present the full results of the Israeli study on Saturday, explained that “older age”, advanced fibrosis and decreased steatosis appear to be risk factors for lower vaccine response among people with related forms of liver disease. The study analysed data from 88 patients living with hepatic fibrosis who had tested positive for COVID-19 and who had received both doses of Pfizer’s-BioNTech vaccine. It found that elderly patients with advanced liver fibrosis had a lower response to Pfizer’s vaccine, with Safadi suggesting that those patients may need a third booster shot. “Therefore, we have to think about the booster vaccination… we are thinking now about boosting the third shot, especially those with high risk for non responsiveness or lower response,” said Safadi. The study’s recommendation, however, goes beyond current US Food and Drug Administration (FDA) recommendations. The FDA has so far not recommended the use of antibody tests to check the effectiveness of vaccination against the virus, nor has it approved a three-dose regimen or booster of any SARS-CoV-2 vaccine. Tenofovir Reduces Severity of COVID-19 in Patients with Chronic Hepatitis B Encouraging data from another new study found that antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B. A study conducted in Spain found that antiretrovira drug tenofovir reduced the severity of COVID-19 in patients with chronic Hepatitis B. Beatriz Mateos Muñoz, PhD Specialist in Gastroenterology and Hepatology at the Hospital Universitario Ramón in Spain, said the study analysed data from 4736 patients from 28 Spanish hospitals. Of the 117 COVID-19 positive patients who were identified, 67 were taking tenofovir and 50 were on entecavir, an antiviral drug in the treatment of hepatitis B virus infection. Muñoz said the incidence of COVID-19 in patients on tenofovir or entecavir were similar, but that patients on entecavir “more often had severe COVID-19, required ICU, ventilatory support, had longer hospitalization or died”. The study found that tenofovir seemed to offer some protection in patients with chronic hepatitis B infected by COVID-19. “In multivariate logistic regression adjusted by age, sex, obesity, comorbidities and fibrosis stage, tenofovir reduced by 6-fold the risk of severe COVID-19. Patients with chronic hepatitis B on tenofovir have a lower risk of severe COVID-19 infection than those on entecavir.” COVID-19 Related Alcohol Sales May Have Increased Alcohol-related Liver Disease Abdel-Aziz Shaheen, assistant professor at the Gastroenterology and Hepatology at the University of Calgary in Canada, said a large population-based study found a significant increase in the number of patients with alcoholic hepatitis who were hospitalised last year in Alberta, Canada last year, with the highest admission rate recorded in April 2020. Shaheen said a significant increase in alcohol sales across Europe and North America during the early months of the pandemic had alarming consequences for patients with alcoholic hepatitis. He said most of the newer patients with alcoholic hepatitis were younger and mainly from rural areas. “There was a significant 9% increase in alcoholic hepatitis admissions per month between March and September and the average rate of alcoholic hepatitis hospitalizations compared to overall hospitalizations rate doubled from 11.6/ 10,000 general hospitalizations to 22.1/ 10,000 general hospitalizations for the same period,” said Shaheen. More worrying, said Shaheen was that: “Our results show that the increase in alcohol sales post pandemic will significantly impact the natural history of alcoholic liver disease in Canada”. Chronic Liver Disease Increased the Odds of Covid-19 Death by 80% Vincent Mallet, Managing Senior Physician and Professor, Hepatology Unit, Cochin University Another study that used the French National Hospital Discharge database for patients who were hospitalised for COVID-19 found that chronic liver disease increased the odds of COVID-19 death by 80%. Vincent Mallet, Managing Senior Physician and Professor, Hepatology Unit, Cochin University said the hospital records showed that 3, 943 of the 16,338 patients diagnosed with chronic liver disease who were admitted for Covid-19 in France in 2020 died, including 2518 after liver-related complications. He said liver complications and alcohol use disorders may have contributed to the COVID-19 deaths of patients with chronic liver disease. People with Obesity & Diabetes Related Fatty Liver Disease Also at Higher Risk from COVID-19 Similarly, a small study in Mexico of 348 patients found that people living with Metabolic Associated Fatty Liver Disease (MAFLD) were five times more likely to die during hospitalization for COVID-19 than people without these factors. The patients studied were admitted with the SARS-COV-2 infection to a number of tertiary referral hospitals between 4 April and 24 June 2020, said Martin Uriel Vázquez Medina, Researcher at the Laboratory of Biomathematical and Biostatistical Modelling for Health Escuela Superior de Medicina, México. Major risk factors for the chronic conditions are obesity and type-2 diabetes, common conditions in many parts of Latin America, also closely associated with unhealthy diets, including high sugar consumption, and lack of physical activity. Medina added: “We also want to show with this result that [patients in] Latin American countries that have this overhead problem of obesity, diabetes, and pre-diabetes, could also be associated with increased risk from COVID-19”. The ILC continues until Saturday. Six More African Countries Needed to Ratify Treaty Creating the First Continent-Wide Medicines Regulator 23/06/2021 Paul Adepoju The African Medicines Agency’s framework would help combat falsified products and by ensuring harmonized drug standards and approvals, ease access to more affordable medicines and vaccines for people throughout the continent. Michel Sidibé, Special Envoy of the African Union and Minister of Health of Mali has high hopes that 15 African countries will have finally ratified the African Medicines Agency (AMA) Treaty in time for the 35th African Union (AU) Summit, scheduled for early 2022. Fifteen is the magic number of countries that must ratify the treaty creating the AMA – in order to birth the agency into operational existence. By the time of the summit, Sidibé also predicts that 30 or more countries will also have signed the framework agreement on the creation of the agency – an agreement that was first approved by the African Union in February 2019. He was speaking at a virtual session on Tuesday, From civil society to the pharma industry, establishment of the continent-wide AMA is regarded as an important step forward that would help improve the functioning of national medicines regulatory agencies – combating fake medicines and streamlining approval of new medicines and vaccines. That, in turn, should also help reduce prices and boost access for people throughout the continent, observers predict. Snail Speed Pace of Ratification So Far However, snail-speed ratification of the treaty by the legislatures and parliaments of the AU’s 54 member states has become a major hurdle to actually opening the doors of the new agency. This is despite the strong support displayed by global health actors actors ranging from the World Health Organization, Africa Centres for Disease Control, as well as other regional drug regulatory agencies such as the European Medicines Authority. However, Sidibé said he is confident the new agency, once it finally begins operations, can build upon the continent’s existing expertise in pharmacovigilance – developed by national agencies such as the Moroccan agency for medicines and the Nigerian Agency for Foods, Drugs Administration and Control (NAFDAC). As for concerns regarding the slow pace of country approvals of the framework agreement and formal ratification, Sidibé said the plan has been to first target a balance of countries in diverse African regions as “low-hanging fruit” – followed by others. In fact, so far most of the countries signing and then ratifying the agreemeht have been West African and/or Francophone. But as the critical mass of ratifications is approached, momentum elsewhere is also building. “Our strategy was to go for different regional balances… , to make sure that we can have a low hanging fruit so we can get quickly the 15 countries,” he said. “Now we are almost there. I am sure by the next meeting of the African Union, we can come and present to the leaders that we managed to have 15 countries,” he said, adding that the priority is to ensure that all African countries are soon on board. Getting buy-in from all African countries will involve actively engaging with governments that are yet to sign and/or ratify the treaty, one by one. Top countries earmarked now for the next stage include north and west African regional leaders such as Ethiopia and Nigeria, as well as the Democratic Republic of Congo. “We are learning from different experiences and ensuring that we are not losing time. We are making sure we bring different partners together to implement the agenda quickly,” Sidibé added. The Long Road to Ratification In October 2020 Health Policy Watch reported that only 18 of Africa’s 55 countries had signed the framework agreement to establish the agency, while only 5 countries – Rwanda, Mali, Burkina Faso, Ghana and Seychelles – had actually ratified the agreement. At the time, Africa CDC Director John Nkengasong, told Health Policy Watch the delay in the treaty ratification was due to the COVID-19 pandemic. “I don’t think it is because countries do not want to sign on. I think it is because of the process that is required to make them sign that treaty, and the countries are currently focusing more on COVID-19,” said Nkengasong. “I think it’s a much needed institution. If we had the AMA, it would be working very closely with the WHO and other bodies to facilitate regulatory issues on drugs to help control the COVID-19 pandemic.” Since then, Zimbabwe and the Seychelles have signed the AMA framework treaty, raising the total number of signatories to 20. Guinea, Namibia and Sierra Leone have ratified the treaty, followed by Algeria this month, raising the number of countries that have fully completed the two-step approval process to nine. In order to get across the finish line, a new African Medicines Agency Treaty Alliance (AMATA) has also recently been created, said Kawaldip Sehmi of the International Alliance of Patients Organizations (IAPO), at Tuesday’s session. The Alliance, led by IAPO and including patient groups, researchers and academics, and industry, will advocate for rapid AMA ratification continent wide. It will also work to establish meaningful engagement with patients, industry and other relevant parties once the Agency becomes operational. The WHO is also actively supporting the emergence of the AMA, with its Director-General, Dr Tedros Adhanom Ghebreyesus describing the lack of strong national regulatory systems as “one of the biggest obstacles to improving access to medical products in Africa”. WHO Regional Director in Africa, Dr Matshidiso Moeti, has also reiterated the importance of the agency, telling Health Policy Watch: “AMA is a very important platform for medicines to be available and affordable equitably, and to be of good quality so that we have both good outcomes for the money that people and countries are spending, and that we prevent problems.” Other Benefits – International Partnerships and Support for Local Production The AMA will also help strengthen global collaborations, including participation of African researchers and patients in clinical research trials of new medicines, especially in the area of cancer, said Emer Cooke, Executive Director of the European Medicines Agency, speaking at Tuesday’s event. “We’re already collaborating with a number of initiatives on clinical trials with African regulators, particularly in the context of the African Vaccines Regulatory Forum. We can use forums such as this to build on the collaborative activities that take place to share our experiences and to help us to work on training and capacity building initiatives,” Cooke said. “I think we should be heartened by the fact that there’s already good discussion and collaboration in the context of clinical trials.” Fighting Fake Medicines Meanwhile, Lotfi Benbahmed, minister of the pharmaceutical industry of Algeria, said the AMA can help improve the reliability of Africa’s medicines — a feat that he said requires the existence of a regional framework to fight fake drugs. “So what we need to do is to harmonise rules and regulations, and enable countries to fight the illegal markets, and the informal markets,” Benbahmed said, who spoke alongside other African ministers of health from Algeria, the Democratic Republic of Congo, Egypt and Cape Verde. . According to him, a similar framework can be deployed to tackle the challenge of low quality drugs on the continent from the point of production, including setting up measures to inspect and control equipment in laboratories. At the same time, delays being encountered in the finalisation of the agency are “understandable”, said Dr Margareth Ndomondo-Sigonda, African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD), who highlighted the extensive harmonisation processes that needs to be undertaken between national governments to birth the new agency. “It takes time to get to the point where you’ve achieved regulatory harmonisation of African medicines and harmonization of regulatory standards. You have to make sure that through harmonization of these technical requirements, you know the quality standards and practice and you build trust,” Ndomondo-Sigonda said. She was however hopeful that once AMA comes into force, it will be able to deal with many outstanding issues regarding the harmonisation of Africa’s medicines landscape. Image Credits: Marco Verch/Flickr. Urgent Government Action and Investment Needed Against Antimicrobial Resistance, Says New Report 23/06/2021 Raisa Santos Launch of the AMR Preparedness Index Panel – left to right – James Anderson, Susan Schwarz, Neil Clancy, Anand Anandkumar, Christine Ardal, Mike Hodin, Norio Ohmagari, Tiemo Wolken Government action against the threat of “superbugs” in most of the world’s leading economies gets a score of less than 50%, according to a new AMR Preparedness Index, released today by a global coalition committed to fighting current trends. Great Britain, the United States, Germany and France rated highest on a score of 1-100 in an assessment of responses in 11 of the world’s leading economies to antimicrobial resistance (AMR) threats. Meanwhile, emerging economies such as Brazil, China, and India scored the worst in the assessment that looked at national strategy; awareness and prevention; innovation; access; appropriate and responsible use; AMR and the environment; and collaborative engagement. The index was launched today by the Global Coalition on Aging (GCOA) and the Infectious Diseases Society of America (IDSA), to shine more light on how the governments are living up to their commitments to address antimicrobial resistance (AMR). “We need health systems and policymakers to really step up and advocate that federal, state, and local governments prioritize AMR,” said Neil Clancy of the AMR Committee, Infectious Disease Society of America, during an event Wednesday launching the Index. “Without significant national and global coordination and multi-party interventions in this area, our efforts are not going to succeed.” The AMR Preparedness Index ranked 11 countries across 7 categories in a 1-100 point scale. UN Report Warns That AMR Could Cause As Many as 10 Million Deaths/ Year Livestock applications of antibiotics in metric tons/year, among countries reporting use. (The Antibiotic Footprint) An estimated 700,000 people already die each year from drug-resistant infections and the lack of antimicrobials to treat them. A 2019 UN report warned that if trends are ignored, AMR could cause as many as 10 million deaths per year, and GDP losses of more than US $100 trillion by 2050. The report assigns scores to each of the 11 countries across seven categories for needed and achievable policy action. Although the assessment considered national policies on “AMR and the Environment” it was unclear how heavily weighted that issue was in the overall index. Per capita, the US agricultural industry is one of the heaviest users of antibiotics in the world. COVID-19 Is a Warning Light to Act Preemptively on AMR The cost of AMR action pales in comparison to the future costs of inaction, participants underlined, drawing comparisons with the COVID-19 pandemic. Delays in responding to urgent public health crises have deadly consequences. “If the pandemic has taught us one thing, it is that we are not well-prepared to combat the serious threat that emerging infectious diseases can pose to human health and our economies,” said Tiemo Wölken, member of the European Parliament, Germany. In Europe, AMR causes the annual death of 33,000 people and costs 1.5 billion Euros in regards to healthcare costs and productivity losses. COVID-19 has highlighted the need for increased monitoring tools, more improved detection, prevention, and control practices, said Wölken. “The time to act is now. COVID already put our healthcare systems under extreme pressure, and this could only be a foretaste of what we could expect from a world where antibiotic microbials are no longer effective.” All Countries Fail in Awareness & Prevention of AMR Testing for antimicrobial resistance at the Liverpool School of Tropical Science. The analysis identified critical opportunities for all governments to act upon to slow the growth of drug resistant bugs. “Despite the progress that’s being made and despite the good work being done in countries throughout the world, we need to do more,” said Clancy. Several trends have emerged from an analysis of the different indices that went into the combined score. All countries performed insufficiently with regards to awareness and prevention of AMR, with India lagging furthest behind. More developed countries tended to fare better in the appropriate and responsible use of existing antibiotics and other antimicrobial agents – as compared to developing country counterparts. Outside of the UK and US, most other countries performed poorly in assessments of the quality of national strategies, innovations, and collaboration. Innovation Important Training on standardized and harmonized surveillance methods for antimicrobial resistance in food animals in Southeast Asia Innovation is another area that requires more significant action going forward, said James Anderson, Executive Director of Global Health at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). “We do need to really drive pipelines. We do need investments in AMR.” In the fight against the borderless threat of drug resistance, the Index included key insights and guidance for governments to immediately prioritize in order to fulfill their commitments on AMR. Overall, the top-level priorities identified in the Index were to: Strengthen and fully implement national AMR strategies; and raise awareness of AMR and its consequences. Along with that, other key priorities were to: Bolster surveillance and leverage data across AMR efforts; Enable a restructured antimicrobial marketplace to stimulate innovation; Promote responsible and appropriate use of antibiotics; Enable reliable and consistent access to needed and novel antimicrobials; More effectively integrate the One Health Approach, including environmental concerns, into national strategies; Better engage with other governments, third-party organizations, and advocacy groups Despite AMR being one of the top five global health challenges, as cited by the WHO, a large majority of the public remains unaware of their role. Local, national, and international efforts are needed in raising awareness and investment in AMR. “All of us have a stake in preserving antibiotics and assuring the development of new antibiotics,” said Clancy. Vaccinating Older Groups Against COVID – Can Help Fight AMR 93-year-old Lebanese actor Salah Tizani, who falls into the elderly priority group, receives his first vaccine dose against COVID-19 in Beirut on Feb. 14, 2021. In terms of the battle against COVID and AMR, the report underlines how vaccinating older adults can help fight overuse of antibiotics during the pandemic. That is because people who become seriously ill with COVID, are often given antibiotics preventively in order to ward off secondary infections. Adequately vaccinating older populations against other infections such as pneumococcal pneumonia and tuberculosis, and even infections like influenza is also critical step to combatting AMR. In other ways, too, older adults have a key stake in fighting AMR, because they tend to be major consumers of health services, and also may be more vulnerable to drug resistant bacteria and viruses overall. “We are at a time now when the megatrend of aging is at the top of our agenda, not just the public health agenda but the economic and social agenda as well,” said GCOA CEO Michael Hodin. As the UN Decade of Healthy Aging was launched in January, AMR needs to be a central part of this initiative, applied not only to older people but to all of us for a healthy and active aging, Hodin added. Coordination and Collaboration Across Low- and Middle-income Countries and High-Income Countries Most countries examined in the report are not making adequate investments to combat the AMR threat, with the lack of commitment felt globally. Huge disparities in total public AMR research funding remains an issue across high, middle, and low-income countries. “We cannot afford to be only US-centric, or only LMIC centric. It takes a very globalized approach,” said Anand Anandkumar, Founder and CEO of Bugworks Research, India. Greater support and collaboration is necessary to increase capacity for AMR initiatives, such as monitoring and surveillance in many low and middle-income countries (LMICs). Consequently, high income countries must collect and provide more complete data to increase the robustness of international, regional, and domestic efforts. “Access and equity are global challenges and the central tilt to competitive AMR,” said Clancy. “[We need to ensure] that we get antibiotics and access to these drugs in an equitable fashion. We’re all at risk from AMR.” Image Credits: USAID Asia/Flickr, GC, antibioticfootprint.net, Flickr – UK Department for International Development, World Bank: Mohamed Azakir. COVAX Shortcomings Under Microscope Ahead of Gavi, Vaccine Alliance Board Meeting 22/06/2021 Elaine Ruth Fletcher & Svĕt Lustig Vijay COVAX vaccine deliveries in Africa – a much trumpeted solution to vaccine inequalities in troubled waters. As the board of Gavi, The Vaccine Alliance is set to meet this Wednesday and Thursday, the COVAX global vaccine facility – a cornerstone of the global health sector response on vaccine access – is coming under increased fire for its shortcomings. A bitter opinion piece by Médecins Sans Frontières, published today, has called for a “drastic change of model” in the global procurement mechanism “that was supposed to deliver COVID-19 vaccine equity.” Co-launched by a range of partners, including WHO, the COVAX facility is legally administered by GAVI. What started out with a much-trumpeted bang of vaccine distributions across African nations has fizzled after the primary vaccine supplier, the Serum Institute of India, began redirecting its available COVID doses to domestic vaccine needs. Massive commitments by rich countries for further vaccine sharing, made at the recent G-7 meeting, are supposed to be funnelled through COVAX. Yet most of those donations will likely only be realized in the latter part of 2021 or early 2022, leaving the current shortfalls over the summer, as Africa faces yet another COVID wave. “COVAX is currently grossly behind on achieving its goals,” said MSF’s Katie Elder, senior vaccines policy advisor. “COVAX had aimed to provide 2 billion doses by the end of 2021, but so far has only distributed 88 million (the goal by the end of June was to distribute around 337 million). Less than half of one percent of total populations of COVAX countries have received at least a first dose of vaccine through COVAX.” She blames the fundamental model of the facility – in which it has been forced to compete on the open market for COVID vaccines – which were still often subsidized by public and government players – for the failings. AstraZeneca vaccine doses are unloaded at Bole International Airport in Addis Ababa, Ethiopia. Not Set Up to Succeed “COVAX was not set up to succeed,” she said. “It was constructed to work within the current parameters of the pharmaceutical market, where you see how much money you can raise and then see what you can negotiate with industry for it. “Loud calls early in the pandemic to depart from a business as usual approach were ignored—pharmaceutical corporations developing vaccines received billions in government money without any strings attached, so were free to charge prices they chose and to sell to the highest bidder. Unsurprisingly, this led to the very same governments that had touted the importance of equity …. and the governments that Gavi spent so much time courting to join the COVAX Facility – ultimately pursuing national interests and securing the bulk of future promised vaccines. “COVAX was left behind as wealthy governments secured their doses through bilateral deals with an industry that acted as expected: selling doses first to the buyers who could afford to pay the most.” The net result now leaves the Gavi Board struggling with how to continue the participation of upper income countries in the facility at all. “The fact that Gavi’s board is now reviewing the way in which wealthier countries (so called ‘Self-financing participants’) can continue to participate in the facility is in part a recognition that the set up does not work,” she added. “Allowing wealthy countries so much flexibility to decide how they join COVAX and how many vaccines they procure, has caused delays and undermined its objectives. A more equitable model would have encouraged regional leadership with decentralized methods of procurement at their core. In the future, we must support these regional initiatives that aim for self-sufficiency and self-determination.” A Beautiful idea: How the COVAX has Fallen Short To date, COVAX has distributed over 20 million doses to rich countries and 80 million doses to poorer countries. The result has been an awkward legal situation for the facility which is still required to provide 20% of its doses for higher income countries – even though most have now met their vaccine needs and hoarded even more, notably Canada, which bought enough vaccine doses to cover its population four times over. “The failure to entice wealthy countries to join COVAX in large numbers has left the managers of the facility in an awkward situation,” said global health journalist Ann Aanaiya Usher in a critique published by The Lancet. “On one hand, not enough self-financing participants joined COVAX to give it the massive buying power that was hoped. On the other, even though COVAX is desperately short of vaccines, the facility is now contractually obliged to reserve one in five doses for a few rich countries, she said, adding that so far, COVAX has distributed 80 million doses to LMICs and over 20 million doses to high-income countries (HICs), including the UK and Canada. She slams the COVAX facility for its “naive” set-up that failed to anticipate widespread vaccine nationalism that has locked up most of the vaccine doses that are available. “It was a beautiful idea, born out of solidarity”, Duke University’s Gavin Yamey was quoted as saying. “Unfortunately, it didn’t happen…Rich countries behaved worse than anyone’s worst nightmares.” COVAX should have also diversified its portfolio earlier on, in anticipation of supply shortages that crippled the facility after India’s Serum Institute halted vaccine exports to fend off a tragic second wave on the subcontinent that has claimed the lives of almost 400,000 people. “Supply shortages should have been anticipated and ramping up supplies should have been baked into the design of COVAX from the start,” observed Georgetown University’s Lawrence Gostin. He added, however, that it would be “literally impossible” to ramp up vaccine supplies without greater investments in manufacturing hubs in lower-income countries, as well as broad waiver on intellectual property rights to vaccine know-how. In its struggle to get rich countries to sign up, the COVAX facility’s offer to allow rich countries to choose which vaccines they would receive has also drawn widespread criticism for leading to “double standards” – which seemingly defy the very purpose of the facility, critics have said. A beautiful idea: how COVAX has fallen short https://t.co/QpG6o5zbqt This is the most complete & readable analysis of COVAX I have seen. The title says it all. COVAX was a beautiful idea & we must make it better & permanent — Lawrence Gostin (@LawrenceGostin) June 18, 2021 Facility Needs Equity Funds to Compete in the Marketplace Even Gavi, the Vaccine Alliance, has acknowledged that its slow mobilization of resources has hampered its ability to quickly procure, and thus deliver as many doses as possible to those who need them most. “If we had secured financing earlier, then we could have locked in doses earlier, as opposed to the second half of this year when COVAX’s volume will start ramping up,” a Gavi spokesperson said. The spokesperson was referring to the fact that most of the funds to procure and distribute vaccines for the 92 low- and middle-income countries (LMICs) that signed up for the scheme were pledged in late December or early 2021 – after high-income countries had already snapped up large vaccine pre-orders. That is a point of view shared by some independent observers as well as industry leaders, who maintain that the facility needs fine-tuning for the next pandemic. “Had COVAX had sufficient and readily available early funding it would have been better able to secure enough immediate supply to meet its aim,” said the Independent Panel for Pandemic Preparedness said, which reviewed the global pandemic response, under a mandate from the World Health Organization. Going forward, what COVAX needs is a “pot of money” to be able to pre-order vaccine doses earlier on in a global health emergency, said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations, in a recent Q&A with Health Policy Watch. That, he maintains, would allow the global facility to compete on a more equal footing with rich countries in the vaccines marketplace. Added Peter Hotez, a prominent vaccine scientist and dean at Baylor College of Medicine in Texas: “I think it’s important that we don’t sell COVAX short. It still has a lot going for it, and is innovative in its design. But it needs more vaccines to share,” Asked for comment by Health Policy Watch, GAVI did not respond. Image Credits: UNICEF, WHO, WHO. 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.
Six More African Countries Needed to Ratify Treaty Creating the First Continent-Wide Medicines Regulator 23/06/2021 Paul Adepoju The African Medicines Agency’s framework would help combat falsified products and by ensuring harmonized drug standards and approvals, ease access to more affordable medicines and vaccines for people throughout the continent. Michel Sidibé, Special Envoy of the African Union and Minister of Health of Mali has high hopes that 15 African countries will have finally ratified the African Medicines Agency (AMA) Treaty in time for the 35th African Union (AU) Summit, scheduled for early 2022. Fifteen is the magic number of countries that must ratify the treaty creating the AMA – in order to birth the agency into operational existence. By the time of the summit, Sidibé also predicts that 30 or more countries will also have signed the framework agreement on the creation of the agency – an agreement that was first approved by the African Union in February 2019. He was speaking at a virtual session on Tuesday, From civil society to the pharma industry, establishment of the continent-wide AMA is regarded as an important step forward that would help improve the functioning of national medicines regulatory agencies – combating fake medicines and streamlining approval of new medicines and vaccines. That, in turn, should also help reduce prices and boost access for people throughout the continent, observers predict. Snail Speed Pace of Ratification So Far However, snail-speed ratification of the treaty by the legislatures and parliaments of the AU’s 54 member states has become a major hurdle to actually opening the doors of the new agency. This is despite the strong support displayed by global health actors actors ranging from the World Health Organization, Africa Centres for Disease Control, as well as other regional drug regulatory agencies such as the European Medicines Authority. However, Sidibé said he is confident the new agency, once it finally begins operations, can build upon the continent’s existing expertise in pharmacovigilance – developed by national agencies such as the Moroccan agency for medicines and the Nigerian Agency for Foods, Drugs Administration and Control (NAFDAC). As for concerns regarding the slow pace of country approvals of the framework agreement and formal ratification, Sidibé said the plan has been to first target a balance of countries in diverse African regions as “low-hanging fruit” – followed by others. In fact, so far most of the countries signing and then ratifying the agreemeht have been West African and/or Francophone. But as the critical mass of ratifications is approached, momentum elsewhere is also building. “Our strategy was to go for different regional balances… , to make sure that we can have a low hanging fruit so we can get quickly the 15 countries,” he said. “Now we are almost there. I am sure by the next meeting of the African Union, we can come and present to the leaders that we managed to have 15 countries,” he said, adding that the priority is to ensure that all African countries are soon on board. Getting buy-in from all African countries will involve actively engaging with governments that are yet to sign and/or ratify the treaty, one by one. Top countries earmarked now for the next stage include north and west African regional leaders such as Ethiopia and Nigeria, as well as the Democratic Republic of Congo. “We are learning from different experiences and ensuring that we are not losing time. We are making sure we bring different partners together to implement the agenda quickly,” Sidibé added. The Long Road to Ratification In October 2020 Health Policy Watch reported that only 18 of Africa’s 55 countries had signed the framework agreement to establish the agency, while only 5 countries – Rwanda, Mali, Burkina Faso, Ghana and Seychelles – had actually ratified the agreement. At the time, Africa CDC Director John Nkengasong, told Health Policy Watch the delay in the treaty ratification was due to the COVID-19 pandemic. “I don’t think it is because countries do not want to sign on. I think it is because of the process that is required to make them sign that treaty, and the countries are currently focusing more on COVID-19,” said Nkengasong. “I think it’s a much needed institution. If we had the AMA, it would be working very closely with the WHO and other bodies to facilitate regulatory issues on drugs to help control the COVID-19 pandemic.” Since then, Zimbabwe and the Seychelles have signed the AMA framework treaty, raising the total number of signatories to 20. Guinea, Namibia and Sierra Leone have ratified the treaty, followed by Algeria this month, raising the number of countries that have fully completed the two-step approval process to nine. In order to get across the finish line, a new African Medicines Agency Treaty Alliance (AMATA) has also recently been created, said Kawaldip Sehmi of the International Alliance of Patients Organizations (IAPO), at Tuesday’s session. The Alliance, led by IAPO and including patient groups, researchers and academics, and industry, will advocate for rapid AMA ratification continent wide. It will also work to establish meaningful engagement with patients, industry and other relevant parties once the Agency becomes operational. The WHO is also actively supporting the emergence of the AMA, with its Director-General, Dr Tedros Adhanom Ghebreyesus describing the lack of strong national regulatory systems as “one of the biggest obstacles to improving access to medical products in Africa”. WHO Regional Director in Africa, Dr Matshidiso Moeti, has also reiterated the importance of the agency, telling Health Policy Watch: “AMA is a very important platform for medicines to be available and affordable equitably, and to be of good quality so that we have both good outcomes for the money that people and countries are spending, and that we prevent problems.” Other Benefits – International Partnerships and Support for Local Production The AMA will also help strengthen global collaborations, including participation of African researchers and patients in clinical research trials of new medicines, especially in the area of cancer, said Emer Cooke, Executive Director of the European Medicines Agency, speaking at Tuesday’s event. “We’re already collaborating with a number of initiatives on clinical trials with African regulators, particularly in the context of the African Vaccines Regulatory Forum. We can use forums such as this to build on the collaborative activities that take place to share our experiences and to help us to work on training and capacity building initiatives,” Cooke said. “I think we should be heartened by the fact that there’s already good discussion and collaboration in the context of clinical trials.” Fighting Fake Medicines Meanwhile, Lotfi Benbahmed, minister of the pharmaceutical industry of Algeria, said the AMA can help improve the reliability of Africa’s medicines — a feat that he said requires the existence of a regional framework to fight fake drugs. “So what we need to do is to harmonise rules and regulations, and enable countries to fight the illegal markets, and the informal markets,” Benbahmed said, who spoke alongside other African ministers of health from Algeria, the Democratic Republic of Congo, Egypt and Cape Verde. . According to him, a similar framework can be deployed to tackle the challenge of low quality drugs on the continent from the point of production, including setting up measures to inspect and control equipment in laboratories. At the same time, delays being encountered in the finalisation of the agency are “understandable”, said Dr Margareth Ndomondo-Sigonda, African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD), who highlighted the extensive harmonisation processes that needs to be undertaken between national governments to birth the new agency. “It takes time to get to the point where you’ve achieved regulatory harmonisation of African medicines and harmonization of regulatory standards. You have to make sure that through harmonization of these technical requirements, you know the quality standards and practice and you build trust,” Ndomondo-Sigonda said. She was however hopeful that once AMA comes into force, it will be able to deal with many outstanding issues regarding the harmonisation of Africa’s medicines landscape. Image Credits: Marco Verch/Flickr. Urgent Government Action and Investment Needed Against Antimicrobial Resistance, Says New Report 23/06/2021 Raisa Santos Launch of the AMR Preparedness Index Panel – left to right – James Anderson, Susan Schwarz, Neil Clancy, Anand Anandkumar, Christine Ardal, Mike Hodin, Norio Ohmagari, Tiemo Wolken Government action against the threat of “superbugs” in most of the world’s leading economies gets a score of less than 50%, according to a new AMR Preparedness Index, released today by a global coalition committed to fighting current trends. Great Britain, the United States, Germany and France rated highest on a score of 1-100 in an assessment of responses in 11 of the world’s leading economies to antimicrobial resistance (AMR) threats. Meanwhile, emerging economies such as Brazil, China, and India scored the worst in the assessment that looked at national strategy; awareness and prevention; innovation; access; appropriate and responsible use; AMR and the environment; and collaborative engagement. The index was launched today by the Global Coalition on Aging (GCOA) and the Infectious Diseases Society of America (IDSA), to shine more light on how the governments are living up to their commitments to address antimicrobial resistance (AMR). “We need health systems and policymakers to really step up and advocate that federal, state, and local governments prioritize AMR,” said Neil Clancy of the AMR Committee, Infectious Disease Society of America, during an event Wednesday launching the Index. “Without significant national and global coordination and multi-party interventions in this area, our efforts are not going to succeed.” The AMR Preparedness Index ranked 11 countries across 7 categories in a 1-100 point scale. UN Report Warns That AMR Could Cause As Many as 10 Million Deaths/ Year Livestock applications of antibiotics in metric tons/year, among countries reporting use. (The Antibiotic Footprint) An estimated 700,000 people already die each year from drug-resistant infections and the lack of antimicrobials to treat them. A 2019 UN report warned that if trends are ignored, AMR could cause as many as 10 million deaths per year, and GDP losses of more than US $100 trillion by 2050. The report assigns scores to each of the 11 countries across seven categories for needed and achievable policy action. Although the assessment considered national policies on “AMR and the Environment” it was unclear how heavily weighted that issue was in the overall index. Per capita, the US agricultural industry is one of the heaviest users of antibiotics in the world. COVID-19 Is a Warning Light to Act Preemptively on AMR The cost of AMR action pales in comparison to the future costs of inaction, participants underlined, drawing comparisons with the COVID-19 pandemic. Delays in responding to urgent public health crises have deadly consequences. “If the pandemic has taught us one thing, it is that we are not well-prepared to combat the serious threat that emerging infectious diseases can pose to human health and our economies,” said Tiemo Wölken, member of the European Parliament, Germany. In Europe, AMR causes the annual death of 33,000 people and costs 1.5 billion Euros in regards to healthcare costs and productivity losses. COVID-19 has highlighted the need for increased monitoring tools, more improved detection, prevention, and control practices, said Wölken. “The time to act is now. COVID already put our healthcare systems under extreme pressure, and this could only be a foretaste of what we could expect from a world where antibiotic microbials are no longer effective.” All Countries Fail in Awareness & Prevention of AMR Testing for antimicrobial resistance at the Liverpool School of Tropical Science. The analysis identified critical opportunities for all governments to act upon to slow the growth of drug resistant bugs. “Despite the progress that’s being made and despite the good work being done in countries throughout the world, we need to do more,” said Clancy. Several trends have emerged from an analysis of the different indices that went into the combined score. All countries performed insufficiently with regards to awareness and prevention of AMR, with India lagging furthest behind. More developed countries tended to fare better in the appropriate and responsible use of existing antibiotics and other antimicrobial agents – as compared to developing country counterparts. Outside of the UK and US, most other countries performed poorly in assessments of the quality of national strategies, innovations, and collaboration. Innovation Important Training on standardized and harmonized surveillance methods for antimicrobial resistance in food animals in Southeast Asia Innovation is another area that requires more significant action going forward, said James Anderson, Executive Director of Global Health at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). “We do need to really drive pipelines. We do need investments in AMR.” In the fight against the borderless threat of drug resistance, the Index included key insights and guidance for governments to immediately prioritize in order to fulfill their commitments on AMR. Overall, the top-level priorities identified in the Index were to: Strengthen and fully implement national AMR strategies; and raise awareness of AMR and its consequences. Along with that, other key priorities were to: Bolster surveillance and leverage data across AMR efforts; Enable a restructured antimicrobial marketplace to stimulate innovation; Promote responsible and appropriate use of antibiotics; Enable reliable and consistent access to needed and novel antimicrobials; More effectively integrate the One Health Approach, including environmental concerns, into national strategies; Better engage with other governments, third-party organizations, and advocacy groups Despite AMR being one of the top five global health challenges, as cited by the WHO, a large majority of the public remains unaware of their role. Local, national, and international efforts are needed in raising awareness and investment in AMR. “All of us have a stake in preserving antibiotics and assuring the development of new antibiotics,” said Clancy. Vaccinating Older Groups Against COVID – Can Help Fight AMR 93-year-old Lebanese actor Salah Tizani, who falls into the elderly priority group, receives his first vaccine dose against COVID-19 in Beirut on Feb. 14, 2021. In terms of the battle against COVID and AMR, the report underlines how vaccinating older adults can help fight overuse of antibiotics during the pandemic. That is because people who become seriously ill with COVID, are often given antibiotics preventively in order to ward off secondary infections. Adequately vaccinating older populations against other infections such as pneumococcal pneumonia and tuberculosis, and even infections like influenza is also critical step to combatting AMR. In other ways, too, older adults have a key stake in fighting AMR, because they tend to be major consumers of health services, and also may be more vulnerable to drug resistant bacteria and viruses overall. “We are at a time now when the megatrend of aging is at the top of our agenda, not just the public health agenda but the economic and social agenda as well,” said GCOA CEO Michael Hodin. As the UN Decade of Healthy Aging was launched in January, AMR needs to be a central part of this initiative, applied not only to older people but to all of us for a healthy and active aging, Hodin added. Coordination and Collaboration Across Low- and Middle-income Countries and High-Income Countries Most countries examined in the report are not making adequate investments to combat the AMR threat, with the lack of commitment felt globally. Huge disparities in total public AMR research funding remains an issue across high, middle, and low-income countries. “We cannot afford to be only US-centric, or only LMIC centric. It takes a very globalized approach,” said Anand Anandkumar, Founder and CEO of Bugworks Research, India. Greater support and collaboration is necessary to increase capacity for AMR initiatives, such as monitoring and surveillance in many low and middle-income countries (LMICs). Consequently, high income countries must collect and provide more complete data to increase the robustness of international, regional, and domestic efforts. “Access and equity are global challenges and the central tilt to competitive AMR,” said Clancy. “[We need to ensure] that we get antibiotics and access to these drugs in an equitable fashion. We’re all at risk from AMR.” Image Credits: USAID Asia/Flickr, GC, antibioticfootprint.net, Flickr – UK Department for International Development, World Bank: Mohamed Azakir. COVAX Shortcomings Under Microscope Ahead of Gavi, Vaccine Alliance Board Meeting 22/06/2021 Elaine Ruth Fletcher & Svĕt Lustig Vijay COVAX vaccine deliveries in Africa – a much trumpeted solution to vaccine inequalities in troubled waters. As the board of Gavi, The Vaccine Alliance is set to meet this Wednesday and Thursday, the COVAX global vaccine facility – a cornerstone of the global health sector response on vaccine access – is coming under increased fire for its shortcomings. A bitter opinion piece by Médecins Sans Frontières, published today, has called for a “drastic change of model” in the global procurement mechanism “that was supposed to deliver COVID-19 vaccine equity.” Co-launched by a range of partners, including WHO, the COVAX facility is legally administered by GAVI. What started out with a much-trumpeted bang of vaccine distributions across African nations has fizzled after the primary vaccine supplier, the Serum Institute of India, began redirecting its available COVID doses to domestic vaccine needs. Massive commitments by rich countries for further vaccine sharing, made at the recent G-7 meeting, are supposed to be funnelled through COVAX. Yet most of those donations will likely only be realized in the latter part of 2021 or early 2022, leaving the current shortfalls over the summer, as Africa faces yet another COVID wave. “COVAX is currently grossly behind on achieving its goals,” said MSF’s Katie Elder, senior vaccines policy advisor. “COVAX had aimed to provide 2 billion doses by the end of 2021, but so far has only distributed 88 million (the goal by the end of June was to distribute around 337 million). Less than half of one percent of total populations of COVAX countries have received at least a first dose of vaccine through COVAX.” She blames the fundamental model of the facility – in which it has been forced to compete on the open market for COVID vaccines – which were still often subsidized by public and government players – for the failings. AstraZeneca vaccine doses are unloaded at Bole International Airport in Addis Ababa, Ethiopia. Not Set Up to Succeed “COVAX was not set up to succeed,” she said. “It was constructed to work within the current parameters of the pharmaceutical market, where you see how much money you can raise and then see what you can negotiate with industry for it. “Loud calls early in the pandemic to depart from a business as usual approach were ignored—pharmaceutical corporations developing vaccines received billions in government money without any strings attached, so were free to charge prices they chose and to sell to the highest bidder. Unsurprisingly, this led to the very same governments that had touted the importance of equity …. and the governments that Gavi spent so much time courting to join the COVAX Facility – ultimately pursuing national interests and securing the bulk of future promised vaccines. “COVAX was left behind as wealthy governments secured their doses through bilateral deals with an industry that acted as expected: selling doses first to the buyers who could afford to pay the most.” The net result now leaves the Gavi Board struggling with how to continue the participation of upper income countries in the facility at all. “The fact that Gavi’s board is now reviewing the way in which wealthier countries (so called ‘Self-financing participants’) can continue to participate in the facility is in part a recognition that the set up does not work,” she added. “Allowing wealthy countries so much flexibility to decide how they join COVAX and how many vaccines they procure, has caused delays and undermined its objectives. A more equitable model would have encouraged regional leadership with decentralized methods of procurement at their core. In the future, we must support these regional initiatives that aim for self-sufficiency and self-determination.” A Beautiful idea: How the COVAX has Fallen Short To date, COVAX has distributed over 20 million doses to rich countries and 80 million doses to poorer countries. The result has been an awkward legal situation for the facility which is still required to provide 20% of its doses for higher income countries – even though most have now met their vaccine needs and hoarded even more, notably Canada, which bought enough vaccine doses to cover its population four times over. “The failure to entice wealthy countries to join COVAX in large numbers has left the managers of the facility in an awkward situation,” said global health journalist Ann Aanaiya Usher in a critique published by The Lancet. “On one hand, not enough self-financing participants joined COVAX to give it the massive buying power that was hoped. On the other, even though COVAX is desperately short of vaccines, the facility is now contractually obliged to reserve one in five doses for a few rich countries, she said, adding that so far, COVAX has distributed 80 million doses to LMICs and over 20 million doses to high-income countries (HICs), including the UK and Canada. She slams the COVAX facility for its “naive” set-up that failed to anticipate widespread vaccine nationalism that has locked up most of the vaccine doses that are available. “It was a beautiful idea, born out of solidarity”, Duke University’s Gavin Yamey was quoted as saying. “Unfortunately, it didn’t happen…Rich countries behaved worse than anyone’s worst nightmares.” COVAX should have also diversified its portfolio earlier on, in anticipation of supply shortages that crippled the facility after India’s Serum Institute halted vaccine exports to fend off a tragic second wave on the subcontinent that has claimed the lives of almost 400,000 people. “Supply shortages should have been anticipated and ramping up supplies should have been baked into the design of COVAX from the start,” observed Georgetown University’s Lawrence Gostin. He added, however, that it would be “literally impossible” to ramp up vaccine supplies without greater investments in manufacturing hubs in lower-income countries, as well as broad waiver on intellectual property rights to vaccine know-how. In its struggle to get rich countries to sign up, the COVAX facility’s offer to allow rich countries to choose which vaccines they would receive has also drawn widespread criticism for leading to “double standards” – which seemingly defy the very purpose of the facility, critics have said. A beautiful idea: how COVAX has fallen short https://t.co/QpG6o5zbqt This is the most complete & readable analysis of COVAX I have seen. The title says it all. COVAX was a beautiful idea & we must make it better & permanent — Lawrence Gostin (@LawrenceGostin) June 18, 2021 Facility Needs Equity Funds to Compete in the Marketplace Even Gavi, the Vaccine Alliance, has acknowledged that its slow mobilization of resources has hampered its ability to quickly procure, and thus deliver as many doses as possible to those who need them most. “If we had secured financing earlier, then we could have locked in doses earlier, as opposed to the second half of this year when COVAX’s volume will start ramping up,” a Gavi spokesperson said. The spokesperson was referring to the fact that most of the funds to procure and distribute vaccines for the 92 low- and middle-income countries (LMICs) that signed up for the scheme were pledged in late December or early 2021 – after high-income countries had already snapped up large vaccine pre-orders. That is a point of view shared by some independent observers as well as industry leaders, who maintain that the facility needs fine-tuning for the next pandemic. “Had COVAX had sufficient and readily available early funding it would have been better able to secure enough immediate supply to meet its aim,” said the Independent Panel for Pandemic Preparedness said, which reviewed the global pandemic response, under a mandate from the World Health Organization. Going forward, what COVAX needs is a “pot of money” to be able to pre-order vaccine doses earlier on in a global health emergency, said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations, in a recent Q&A with Health Policy Watch. That, he maintains, would allow the global facility to compete on a more equal footing with rich countries in the vaccines marketplace. Added Peter Hotez, a prominent vaccine scientist and dean at Baylor College of Medicine in Texas: “I think it’s important that we don’t sell COVAX short. It still has a lot going for it, and is innovative in its design. But it needs more vaccines to share,” Asked for comment by Health Policy Watch, GAVI did not respond. Image Credits: UNICEF, WHO, WHO. 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.
Urgent Government Action and Investment Needed Against Antimicrobial Resistance, Says New Report 23/06/2021 Raisa Santos Launch of the AMR Preparedness Index Panel – left to right – James Anderson, Susan Schwarz, Neil Clancy, Anand Anandkumar, Christine Ardal, Mike Hodin, Norio Ohmagari, Tiemo Wolken Government action against the threat of “superbugs” in most of the world’s leading economies gets a score of less than 50%, according to a new AMR Preparedness Index, released today by a global coalition committed to fighting current trends. Great Britain, the United States, Germany and France rated highest on a score of 1-100 in an assessment of responses in 11 of the world’s leading economies to antimicrobial resistance (AMR) threats. Meanwhile, emerging economies such as Brazil, China, and India scored the worst in the assessment that looked at national strategy; awareness and prevention; innovation; access; appropriate and responsible use; AMR and the environment; and collaborative engagement. The index was launched today by the Global Coalition on Aging (GCOA) and the Infectious Diseases Society of America (IDSA), to shine more light on how the governments are living up to their commitments to address antimicrobial resistance (AMR). “We need health systems and policymakers to really step up and advocate that federal, state, and local governments prioritize AMR,” said Neil Clancy of the AMR Committee, Infectious Disease Society of America, during an event Wednesday launching the Index. “Without significant national and global coordination and multi-party interventions in this area, our efforts are not going to succeed.” The AMR Preparedness Index ranked 11 countries across 7 categories in a 1-100 point scale. UN Report Warns That AMR Could Cause As Many as 10 Million Deaths/ Year Livestock applications of antibiotics in metric tons/year, among countries reporting use. (The Antibiotic Footprint) An estimated 700,000 people already die each year from drug-resistant infections and the lack of antimicrobials to treat them. A 2019 UN report warned that if trends are ignored, AMR could cause as many as 10 million deaths per year, and GDP losses of more than US $100 trillion by 2050. The report assigns scores to each of the 11 countries across seven categories for needed and achievable policy action. Although the assessment considered national policies on “AMR and the Environment” it was unclear how heavily weighted that issue was in the overall index. Per capita, the US agricultural industry is one of the heaviest users of antibiotics in the world. COVID-19 Is a Warning Light to Act Preemptively on AMR The cost of AMR action pales in comparison to the future costs of inaction, participants underlined, drawing comparisons with the COVID-19 pandemic. Delays in responding to urgent public health crises have deadly consequences. “If the pandemic has taught us one thing, it is that we are not well-prepared to combat the serious threat that emerging infectious diseases can pose to human health and our economies,” said Tiemo Wölken, member of the European Parliament, Germany. In Europe, AMR causes the annual death of 33,000 people and costs 1.5 billion Euros in regards to healthcare costs and productivity losses. COVID-19 has highlighted the need for increased monitoring tools, more improved detection, prevention, and control practices, said Wölken. “The time to act is now. COVID already put our healthcare systems under extreme pressure, and this could only be a foretaste of what we could expect from a world where antibiotic microbials are no longer effective.” All Countries Fail in Awareness & Prevention of AMR Testing for antimicrobial resistance at the Liverpool School of Tropical Science. The analysis identified critical opportunities for all governments to act upon to slow the growth of drug resistant bugs. “Despite the progress that’s being made and despite the good work being done in countries throughout the world, we need to do more,” said Clancy. Several trends have emerged from an analysis of the different indices that went into the combined score. All countries performed insufficiently with regards to awareness and prevention of AMR, with India lagging furthest behind. More developed countries tended to fare better in the appropriate and responsible use of existing antibiotics and other antimicrobial agents – as compared to developing country counterparts. Outside of the UK and US, most other countries performed poorly in assessments of the quality of national strategies, innovations, and collaboration. Innovation Important Training on standardized and harmonized surveillance methods for antimicrobial resistance in food animals in Southeast Asia Innovation is another area that requires more significant action going forward, said James Anderson, Executive Director of Global Health at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). “We do need to really drive pipelines. We do need investments in AMR.” In the fight against the borderless threat of drug resistance, the Index included key insights and guidance for governments to immediately prioritize in order to fulfill their commitments on AMR. Overall, the top-level priorities identified in the Index were to: Strengthen and fully implement national AMR strategies; and raise awareness of AMR and its consequences. Along with that, other key priorities were to: Bolster surveillance and leverage data across AMR efforts; Enable a restructured antimicrobial marketplace to stimulate innovation; Promote responsible and appropriate use of antibiotics; Enable reliable and consistent access to needed and novel antimicrobials; More effectively integrate the One Health Approach, including environmental concerns, into national strategies; Better engage with other governments, third-party organizations, and advocacy groups Despite AMR being one of the top five global health challenges, as cited by the WHO, a large majority of the public remains unaware of their role. Local, national, and international efforts are needed in raising awareness and investment in AMR. “All of us have a stake in preserving antibiotics and assuring the development of new antibiotics,” said Clancy. Vaccinating Older Groups Against COVID – Can Help Fight AMR 93-year-old Lebanese actor Salah Tizani, who falls into the elderly priority group, receives his first vaccine dose against COVID-19 in Beirut on Feb. 14, 2021. In terms of the battle against COVID and AMR, the report underlines how vaccinating older adults can help fight overuse of antibiotics during the pandemic. That is because people who become seriously ill with COVID, are often given antibiotics preventively in order to ward off secondary infections. Adequately vaccinating older populations against other infections such as pneumococcal pneumonia and tuberculosis, and even infections like influenza is also critical step to combatting AMR. In other ways, too, older adults have a key stake in fighting AMR, because they tend to be major consumers of health services, and also may be more vulnerable to drug resistant bacteria and viruses overall. “We are at a time now when the megatrend of aging is at the top of our agenda, not just the public health agenda but the economic and social agenda as well,” said GCOA CEO Michael Hodin. As the UN Decade of Healthy Aging was launched in January, AMR needs to be a central part of this initiative, applied not only to older people but to all of us for a healthy and active aging, Hodin added. Coordination and Collaboration Across Low- and Middle-income Countries and High-Income Countries Most countries examined in the report are not making adequate investments to combat the AMR threat, with the lack of commitment felt globally. Huge disparities in total public AMR research funding remains an issue across high, middle, and low-income countries. “We cannot afford to be only US-centric, or only LMIC centric. It takes a very globalized approach,” said Anand Anandkumar, Founder and CEO of Bugworks Research, India. Greater support and collaboration is necessary to increase capacity for AMR initiatives, such as monitoring and surveillance in many low and middle-income countries (LMICs). Consequently, high income countries must collect and provide more complete data to increase the robustness of international, regional, and domestic efforts. “Access and equity are global challenges and the central tilt to competitive AMR,” said Clancy. “[We need to ensure] that we get antibiotics and access to these drugs in an equitable fashion. We’re all at risk from AMR.” Image Credits: USAID Asia/Flickr, GC, antibioticfootprint.net, Flickr – UK Department for International Development, World Bank: Mohamed Azakir. COVAX Shortcomings Under Microscope Ahead of Gavi, Vaccine Alliance Board Meeting 22/06/2021 Elaine Ruth Fletcher & Svĕt Lustig Vijay COVAX vaccine deliveries in Africa – a much trumpeted solution to vaccine inequalities in troubled waters. As the board of Gavi, The Vaccine Alliance is set to meet this Wednesday and Thursday, the COVAX global vaccine facility – a cornerstone of the global health sector response on vaccine access – is coming under increased fire for its shortcomings. A bitter opinion piece by Médecins Sans Frontières, published today, has called for a “drastic change of model” in the global procurement mechanism “that was supposed to deliver COVID-19 vaccine equity.” Co-launched by a range of partners, including WHO, the COVAX facility is legally administered by GAVI. What started out with a much-trumpeted bang of vaccine distributions across African nations has fizzled after the primary vaccine supplier, the Serum Institute of India, began redirecting its available COVID doses to domestic vaccine needs. Massive commitments by rich countries for further vaccine sharing, made at the recent G-7 meeting, are supposed to be funnelled through COVAX. Yet most of those donations will likely only be realized in the latter part of 2021 or early 2022, leaving the current shortfalls over the summer, as Africa faces yet another COVID wave. “COVAX is currently grossly behind on achieving its goals,” said MSF’s Katie Elder, senior vaccines policy advisor. “COVAX had aimed to provide 2 billion doses by the end of 2021, but so far has only distributed 88 million (the goal by the end of June was to distribute around 337 million). Less than half of one percent of total populations of COVAX countries have received at least a first dose of vaccine through COVAX.” She blames the fundamental model of the facility – in which it has been forced to compete on the open market for COVID vaccines – which were still often subsidized by public and government players – for the failings. AstraZeneca vaccine doses are unloaded at Bole International Airport in Addis Ababa, Ethiopia. Not Set Up to Succeed “COVAX was not set up to succeed,” she said. “It was constructed to work within the current parameters of the pharmaceutical market, where you see how much money you can raise and then see what you can negotiate with industry for it. “Loud calls early in the pandemic to depart from a business as usual approach were ignored—pharmaceutical corporations developing vaccines received billions in government money without any strings attached, so were free to charge prices they chose and to sell to the highest bidder. Unsurprisingly, this led to the very same governments that had touted the importance of equity …. and the governments that Gavi spent so much time courting to join the COVAX Facility – ultimately pursuing national interests and securing the bulk of future promised vaccines. “COVAX was left behind as wealthy governments secured their doses through bilateral deals with an industry that acted as expected: selling doses first to the buyers who could afford to pay the most.” The net result now leaves the Gavi Board struggling with how to continue the participation of upper income countries in the facility at all. “The fact that Gavi’s board is now reviewing the way in which wealthier countries (so called ‘Self-financing participants’) can continue to participate in the facility is in part a recognition that the set up does not work,” she added. “Allowing wealthy countries so much flexibility to decide how they join COVAX and how many vaccines they procure, has caused delays and undermined its objectives. A more equitable model would have encouraged regional leadership with decentralized methods of procurement at their core. In the future, we must support these regional initiatives that aim for self-sufficiency and self-determination.” A Beautiful idea: How the COVAX has Fallen Short To date, COVAX has distributed over 20 million doses to rich countries and 80 million doses to poorer countries. The result has been an awkward legal situation for the facility which is still required to provide 20% of its doses for higher income countries – even though most have now met their vaccine needs and hoarded even more, notably Canada, which bought enough vaccine doses to cover its population four times over. “The failure to entice wealthy countries to join COVAX in large numbers has left the managers of the facility in an awkward situation,” said global health journalist Ann Aanaiya Usher in a critique published by The Lancet. “On one hand, not enough self-financing participants joined COVAX to give it the massive buying power that was hoped. On the other, even though COVAX is desperately short of vaccines, the facility is now contractually obliged to reserve one in five doses for a few rich countries, she said, adding that so far, COVAX has distributed 80 million doses to LMICs and over 20 million doses to high-income countries (HICs), including the UK and Canada. She slams the COVAX facility for its “naive” set-up that failed to anticipate widespread vaccine nationalism that has locked up most of the vaccine doses that are available. “It was a beautiful idea, born out of solidarity”, Duke University’s Gavin Yamey was quoted as saying. “Unfortunately, it didn’t happen…Rich countries behaved worse than anyone’s worst nightmares.” COVAX should have also diversified its portfolio earlier on, in anticipation of supply shortages that crippled the facility after India’s Serum Institute halted vaccine exports to fend off a tragic second wave on the subcontinent that has claimed the lives of almost 400,000 people. “Supply shortages should have been anticipated and ramping up supplies should have been baked into the design of COVAX from the start,” observed Georgetown University’s Lawrence Gostin. He added, however, that it would be “literally impossible” to ramp up vaccine supplies without greater investments in manufacturing hubs in lower-income countries, as well as broad waiver on intellectual property rights to vaccine know-how. In its struggle to get rich countries to sign up, the COVAX facility’s offer to allow rich countries to choose which vaccines they would receive has also drawn widespread criticism for leading to “double standards” – which seemingly defy the very purpose of the facility, critics have said. A beautiful idea: how COVAX has fallen short https://t.co/QpG6o5zbqt This is the most complete & readable analysis of COVAX I have seen. The title says it all. COVAX was a beautiful idea & we must make it better & permanent — Lawrence Gostin (@LawrenceGostin) June 18, 2021 Facility Needs Equity Funds to Compete in the Marketplace Even Gavi, the Vaccine Alliance, has acknowledged that its slow mobilization of resources has hampered its ability to quickly procure, and thus deliver as many doses as possible to those who need them most. “If we had secured financing earlier, then we could have locked in doses earlier, as opposed to the second half of this year when COVAX’s volume will start ramping up,” a Gavi spokesperson said. The spokesperson was referring to the fact that most of the funds to procure and distribute vaccines for the 92 low- and middle-income countries (LMICs) that signed up for the scheme were pledged in late December or early 2021 – after high-income countries had already snapped up large vaccine pre-orders. That is a point of view shared by some independent observers as well as industry leaders, who maintain that the facility needs fine-tuning for the next pandemic. “Had COVAX had sufficient and readily available early funding it would have been better able to secure enough immediate supply to meet its aim,” said the Independent Panel for Pandemic Preparedness said, which reviewed the global pandemic response, under a mandate from the World Health Organization. Going forward, what COVAX needs is a “pot of money” to be able to pre-order vaccine doses earlier on in a global health emergency, said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations, in a recent Q&A with Health Policy Watch. That, he maintains, would allow the global facility to compete on a more equal footing with rich countries in the vaccines marketplace. Added Peter Hotez, a prominent vaccine scientist and dean at Baylor College of Medicine in Texas: “I think it’s important that we don’t sell COVAX short. It still has a lot going for it, and is innovative in its design. But it needs more vaccines to share,” Asked for comment by Health Policy Watch, GAVI did not respond. Image Credits: UNICEF, WHO, WHO. 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
COVAX Shortcomings Under Microscope Ahead of Gavi, Vaccine Alliance Board Meeting 22/06/2021 Elaine Ruth Fletcher & Svĕt Lustig Vijay COVAX vaccine deliveries in Africa – a much trumpeted solution to vaccine inequalities in troubled waters. As the board of Gavi, The Vaccine Alliance is set to meet this Wednesday and Thursday, the COVAX global vaccine facility – a cornerstone of the global health sector response on vaccine access – is coming under increased fire for its shortcomings. A bitter opinion piece by Médecins Sans Frontières, published today, has called for a “drastic change of model” in the global procurement mechanism “that was supposed to deliver COVID-19 vaccine equity.” Co-launched by a range of partners, including WHO, the COVAX facility is legally administered by GAVI. What started out with a much-trumpeted bang of vaccine distributions across African nations has fizzled after the primary vaccine supplier, the Serum Institute of India, began redirecting its available COVID doses to domestic vaccine needs. Massive commitments by rich countries for further vaccine sharing, made at the recent G-7 meeting, are supposed to be funnelled through COVAX. Yet most of those donations will likely only be realized in the latter part of 2021 or early 2022, leaving the current shortfalls over the summer, as Africa faces yet another COVID wave. “COVAX is currently grossly behind on achieving its goals,” said MSF’s Katie Elder, senior vaccines policy advisor. “COVAX had aimed to provide 2 billion doses by the end of 2021, but so far has only distributed 88 million (the goal by the end of June was to distribute around 337 million). Less than half of one percent of total populations of COVAX countries have received at least a first dose of vaccine through COVAX.” She blames the fundamental model of the facility – in which it has been forced to compete on the open market for COVID vaccines – which were still often subsidized by public and government players – for the failings. AstraZeneca vaccine doses are unloaded at Bole International Airport in Addis Ababa, Ethiopia. Not Set Up to Succeed “COVAX was not set up to succeed,” she said. “It was constructed to work within the current parameters of the pharmaceutical market, where you see how much money you can raise and then see what you can negotiate with industry for it. “Loud calls early in the pandemic to depart from a business as usual approach were ignored—pharmaceutical corporations developing vaccines received billions in government money without any strings attached, so were free to charge prices they chose and to sell to the highest bidder. Unsurprisingly, this led to the very same governments that had touted the importance of equity …. and the governments that Gavi spent so much time courting to join the COVAX Facility – ultimately pursuing national interests and securing the bulk of future promised vaccines. “COVAX was left behind as wealthy governments secured their doses through bilateral deals with an industry that acted as expected: selling doses first to the buyers who could afford to pay the most.” The net result now leaves the Gavi Board struggling with how to continue the participation of upper income countries in the facility at all. “The fact that Gavi’s board is now reviewing the way in which wealthier countries (so called ‘Self-financing participants’) can continue to participate in the facility is in part a recognition that the set up does not work,” she added. “Allowing wealthy countries so much flexibility to decide how they join COVAX and how many vaccines they procure, has caused delays and undermined its objectives. A more equitable model would have encouraged regional leadership with decentralized methods of procurement at their core. In the future, we must support these regional initiatives that aim for self-sufficiency and self-determination.” A Beautiful idea: How the COVAX has Fallen Short To date, COVAX has distributed over 20 million doses to rich countries and 80 million doses to poorer countries. The result has been an awkward legal situation for the facility which is still required to provide 20% of its doses for higher income countries – even though most have now met their vaccine needs and hoarded even more, notably Canada, which bought enough vaccine doses to cover its population four times over. “The failure to entice wealthy countries to join COVAX in large numbers has left the managers of the facility in an awkward situation,” said global health journalist Ann Aanaiya Usher in a critique published by The Lancet. “On one hand, not enough self-financing participants joined COVAX to give it the massive buying power that was hoped. On the other, even though COVAX is desperately short of vaccines, the facility is now contractually obliged to reserve one in five doses for a few rich countries, she said, adding that so far, COVAX has distributed 80 million doses to LMICs and over 20 million doses to high-income countries (HICs), including the UK and Canada. She slams the COVAX facility for its “naive” set-up that failed to anticipate widespread vaccine nationalism that has locked up most of the vaccine doses that are available. “It was a beautiful idea, born out of solidarity”, Duke University’s Gavin Yamey was quoted as saying. “Unfortunately, it didn’t happen…Rich countries behaved worse than anyone’s worst nightmares.” COVAX should have also diversified its portfolio earlier on, in anticipation of supply shortages that crippled the facility after India’s Serum Institute halted vaccine exports to fend off a tragic second wave on the subcontinent that has claimed the lives of almost 400,000 people. “Supply shortages should have been anticipated and ramping up supplies should have been baked into the design of COVAX from the start,” observed Georgetown University’s Lawrence Gostin. He added, however, that it would be “literally impossible” to ramp up vaccine supplies without greater investments in manufacturing hubs in lower-income countries, as well as broad waiver on intellectual property rights to vaccine know-how. In its struggle to get rich countries to sign up, the COVAX facility’s offer to allow rich countries to choose which vaccines they would receive has also drawn widespread criticism for leading to “double standards” – which seemingly defy the very purpose of the facility, critics have said. A beautiful idea: how COVAX has fallen short https://t.co/QpG6o5zbqt This is the most complete & readable analysis of COVAX I have seen. The title says it all. COVAX was a beautiful idea & we must make it better & permanent — Lawrence Gostin (@LawrenceGostin) June 18, 2021 Facility Needs Equity Funds to Compete in the Marketplace Even Gavi, the Vaccine Alliance, has acknowledged that its slow mobilization of resources has hampered its ability to quickly procure, and thus deliver as many doses as possible to those who need them most. “If we had secured financing earlier, then we could have locked in doses earlier, as opposed to the second half of this year when COVAX’s volume will start ramping up,” a Gavi spokesperson said. The spokesperson was referring to the fact that most of the funds to procure and distribute vaccines for the 92 low- and middle-income countries (LMICs) that signed up for the scheme were pledged in late December or early 2021 – after high-income countries had already snapped up large vaccine pre-orders. That is a point of view shared by some independent observers as well as industry leaders, who maintain that the facility needs fine-tuning for the next pandemic. “Had COVAX had sufficient and readily available early funding it would have been better able to secure enough immediate supply to meet its aim,” said the Independent Panel for Pandemic Preparedness said, which reviewed the global pandemic response, under a mandate from the World Health Organization. Going forward, what COVAX needs is a “pot of money” to be able to pre-order vaccine doses earlier on in a global health emergency, said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations, in a recent Q&A with Health Policy Watch. That, he maintains, would allow the global facility to compete on a more equal footing with rich countries in the vaccines marketplace. Added Peter Hotez, a prominent vaccine scientist and dean at Baylor College of Medicine in Texas: “I think it’s important that we don’t sell COVAX short. It still has a lot going for it, and is innovative in its design. But it needs more vaccines to share,” Asked for comment by Health Policy Watch, GAVI did not respond. Image Credits: UNICEF, WHO, WHO. Posts navigation Older postsNewer posts