Two Billion Doses Secured For COVAX Vaccine Facility – Distribution Will Begin in First Quarter 2021 To High Risk Groups in Low- And Middle-Income Countries Medicines & Vaccines 18/12/2020 • Elaine Ruth Fletcher Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) At least 1.3 billion of the 2 billion donor-funded vaccine doses secured will be distributed in the poorest economies. The WHO-led COVAX Facility announced Friday that it has now secured some 2 billion vaccine doses and distribution of vaccines will begin in the first quarter of 2021 – ensuring that at least some vaccines will begin to reach the 92 low-income countries that are largely dependent on global philanthropy to access sufficient vaccine supplies. That would be roughly enough vaccines to immunize a little more than one-eighth of the global population: most of the vaccines procured so far require two doses. At least 1.3 billion of the 2 billion donor-funded doses secured will be distributed in the poorest economies, said the heads of Gavi, the Vaccine Alliance and the World Health Organization (WHO) at a press conference on Friday. They said that the COVAX facility – co-sponsored by WHO and GAVI – would push ahead to acquire more doses, so that all countries worldwide could reach 20% population coverage of the highest risk groups by the end of next year. “We have secured access to the first 2 billion vaccines and these will be delivered in the first quarter of next year,” said Seth Berkley, head of Gavi, The Vaccine Alliance, at the press conference on Friday. “This is fantastic news and a milestone in global health,” WHO’s Dr Tedros Adhanom Ghebreyesus, at the event. “Images of people receiving vaccines are giving us hope, but it must be hope for all, not hope for some.” The announcement was made jointly with leading pharma companies that had just sealed deals with COVAX. Paul Stoffels, head of Johnson & Johnson, said the firm had signed a memorandum of understanding (MOU) to market some 500 million courses of its one-dose vaccine candidate through the facility, if the vaccine wins regulatory approval. “We are reaching the end point in a large clinical trial, likely by the end of January,” Stoffels said in the briefing. “Following regulatory approvals, we hope to be delivering vaccines in the course of the next year.” Dr Paul Stoffels, head of Johnson & Johnson. In addition, Pascal Soriot of AstraZeneca, announced a deal with the COVAX facility for some 170 million doses of the AstraZeneca/Oxford vaccine. The new deals come in addition to previously announced pre-purchase agreements with India’s Serum Institute, which has signed agreements with COVAX to provide at least 200 million doses – with options for up to 900 million doses more – of either the AstraZeneca/Oxford or Novavax candidates. This is as well as an agreement, in principle, for 200 million doses of another vaccine candidate by Sanofi/GSK. AstraZeneca’s Soriot said that the company hopes to be geared up to produce up to 3 billion doses of its vaccine, following approval. As one of the cheapest and most durable, it is expected to play a major role in immunization drives in lower-income countries. US$ 2.4 Million More in Donations – Vaccine Sharing Plans Also Unveiled The purchases will be funded by US$2.4 billion in donor funds made available over the past two weeks, WHO said in a press release. This includes new pledges from Norway, Canada, Kuwait, Denmark, New Zealand, the Netherlands, Singapore and Estonia. But the biggest influx of funds has been in the form of a combined European Commission grant and European Investment bank loan totaling €500 million. At the press conference, Canada’s Minister of International Development, Karina Gould, and France’s Stephanie Seydoux, also said that their countries would consider making donations from their pre-reserved vaccine stockpiles to the COVAX facility, for use in low- and middle-income countries (LMICs). With pre-orders for around 10 vaccine doses per capita, Canada has one of the largest stockpiles of pre-orders: far more than it can use domestically. Karina Gould, Canada’s Minister of International Development. “The idea [is] to be ready to start sharing vaccines as early as possible, that is what we are considering … in conformity with the sharing principles that COVAX and WHO issued today,” said Seydoux. Their announcement coincided with the release of a WHO paper on Principles for Dose-Sharing. Under this, higher-income economies could donate surplus doses they have procured through direct deals with manufacturers to the COVAX facility’s low-income countries. The framework “opens another potential source of vaccines – supporting the overall goal of equitable access”, WHO said in a press release. “France will rely on this framework to consider sharing doses, as early as possible to enable vaccination against COVID-19 low priority populations,” said Seydoux, encouraging countries belonging to the G7 and G20 to follow suit. It remains to be seen if other countries will indeed choose to donate surpluses to the global COVAX initiative – or share directly with other close neighbors and allies. For instance, New Zealand, an ostensibly strong supporter of the COVAX initiative, announced a plan this week to share its vaccines with its Pacific region partners using any surplus that it acquires. At the same time, it also committed NZD 10 million this week to the COVAX global scheme this week. Pfizer and Moderna Vaccines Noticeably Absent on Stage The Pfizer and Moderna vaccines – which have been the first to secure regulatory approvals in the United Kingdom and by the United States Food and Drug Administration (US FDA) – do not appear in the COVAX vaccine portfolio. Moderna’s absence is even more striking, since it received funding for Phase 3 of its clinical trials from the Oslo-based Coalition for Epidemic Preparedness Initiative (CEPI), which is funded by a number of governments as well as philanthropies and other public partners. Moderna’s mRNA vaccine received overwhelming approval from an advisory panel to the US FDA, on the same day as the COVAX announcement. Since these vaccines are also going to be the first to reach markets – it also means that high income countries in North America, Europe and elsewhere, will inevitably be the first to have their high-risk populations immunized en masse. This process has already begun in the UK and US. Other countries, such as Israel, begin next week with immunizations. While there are some objective reasons why the Pfizer vaccine would be difficult to deploy – namely, its ultra-cold -70 C temperatures required for storage – Moderna’s vaccine, with its -2C to -8C storage, is much easier to handle. CEPI’s CEO Richard Hatchet made no mention of the absence, saying only at the briefing: “Science has given us the tools to fight the pandemic. But equitable access is what will enable us to win in the pandemic” COVAX Dose Distribution To Be Pro-rated by Population In terms of the COVAX organized rollout, WHO’s Chief Scientist Soumya Swaminathan said that a pro-rated number of doses would be distributed to countries based on their population. It would remain up to the countries to prioritize the distribution, but she said that she expected most to go along with WHO guidelines calling for health workers, older people and other high-risk groups to be vaccinated first. “In the first year, when we have limited supplies, we would distribute them by tranches, based on the country’s population, understanding that most countries are prioritizing their health care workers and vulnerable workers,” said Swaminathan. Dr Soumya Swaminathan, WHO’s Chief Scientist, WHO. Executing the initiative will still be a massive logistical task, however, and global health leaders at the briefing said that helping health systems prepare to receive the vaccines would be the next step. To support its plan to transport 850 tonnes of vaccines a month, UNICEF’s Henrietta Fore said that the organization is aiming to install 70,000 cold chains fridges fridges in lower-income countries by the end of 2021, almost half of which will be solar powered. “As we’ve learned with routine immunisation vaccines don’t save lives, vaccination does,“ said Dr Kwaku Agyeman Manu, Minister of Health for Ghana said in a statement. “This means we need the health infrastructure in place – from supply chain and logistics to well- trained health workers – to ensure the effective and streamlined distribution of vaccines. “For this we call on governments, manufacturers and the private sector to make urgent and necessary investments in COVAX so that no one is left behind.“ While COVAX was designed as a vaccine pool for countries at all income levels, with a self-financing arm as well as an arm for donations, as more and more high- and middle-income countries make bilateral deals, the focus of the facility has shifted to supplying shots to the world’s 92 LMICs that traditionally rely on donor aid for other vaccine campaigns. That has left COVAX heavily reliant on voluntary donations to make the system work. Currently, 86 of the 92 LMICs eligible for COVAX have submitted vaccine requests. On Friday 11 December, WHO director-general Dr Tedros Adhanom Ghebreyesus issued a plea to world leaders to “honour their pledges” to fund the scheme. Regulations and Readiness: Plans for a 2021 Rollout With Health Workers In Mind A press release by GAVI said that the first wave of doses, expected to be delivered in the first half of 2021, should be enough to protect health and social care workers. Prioritising health workers should help these countries keep infection rates low and health systems functioning in the interim period between production waves. Healthcare staff have constituted about 15% of the global COVID-19 case toll: they account for only 3% of the world’s population. As the rollout continues beyond this initial group, COVAX will aim to support the immunization of up to 20% of a given country’s population. But a successful global campaign such as this is also dependent upon national regulatory approvals, cautioned Swaminathan. She said that WHO has been working with LMICs to ease the process in countries outside of the European Union and other developed regions. World Trade Organization IP Waiver For COVID Health Products – Opponents Ask Countries To Explore What Are the Barriers In Use Of Current Rules Meanwhile, WTO spokesperson Keith Rockwell said that the debate over a South African and Indian proposal to issue a WTO “waiver” for IP related to COVID medicines, vaccines and other tools would be continued in January 2021, following the impasse reached in the meetings held over the past two months. He spoke at a press briefing just as the WTO’s General Council was wrapping up two days of meetings in Geneva on Friday that had examined the issue – after the WTO TRIPS Council (Agreement on Trade-Related Aspects of Intellectual Property Rights) had failed to come to any agreement over the far-reaching proposal. WTO spokesperson Keith Rockwell said the discussion surrounding the WTO IP waiver will resume in January. “There was no decision in the offing. This conversation is going to continue,” said Rockwell, speaking after the discussion in the General Council. “I would say it was a very important conversation, and it was not a conversation that was vitriolic or acerbic. “The conversation will continue in January. In the TRIPS Council … there was support for continuing the conversation,” he said. He said that while all WTO members agreed that it was important for low- and middle-income countries to be able to acquire essential health technologies, opponents of the waiver say that existing TRIPS flexibilities for health emergencies already allow governments to take unilateral measures to produce essential drugs and other health products – through measures such as “compulsory licensing” to domestic producers for the manufacture of patented products. Rockwell suggested that among the countries that oppose the waiver, “there was a strong view expressed by many of them to try to use these discussions to identify where there may be imperfections in the TRIPS agreement that do not make it easy for the members to access these flexibilities, particularly as they pertain to compulsory licensing”. In the General Council discussions, the UK’s WTO Ambassador Julian Braithwaite, along with Singapore’s Tan Hung San, both said that the recent agreements between India’s Serum Institute and AstraZeneca and South Africa’s Aspen Corporation had indicated and existing flexibilities are working, in terms of vaccine distribution. On the other hand, proponents of the waiver say that “the flexibilities that are available are cumbersome and difficult to implement.” Rockwell said progress on this and other health related WTO disputes have suffered from the lack of a new WTO Director General. This follows the impasse over the final appointment of the leading candidate, Nigeria’s Ngozi Okonjo-Iweala, which was opposed in October by one sole WTO member, the United States. So far “a consensus remains elusive” on the new DG appointment, said Rockwell. While there is now a possibility that the incoming US administration of Joe Biden may withdraw its opposition to Iweala clearing the way for her appointment early next year, Walker made no reference to the pending change in the US administration in Washington, saying only: “It has not been an easy year. We need to do all we can to get a director general here. This is something that really has to be taken care of, hopefully soon. At the end of a long and difficult year for everyone around the planet, we will use the break to pause and reflect and see what the best way forward will be when we come back.” Image Credits: CDC Global/Flickr, World Economic Forum, UNICEF Ethiopia, Moderna, World Health Summit, APEC 2013. 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