Pfizer/BioNTech Join Global COVAX Vaccine Facility – In Game-Changer For WHO Plan To Roll Out Vaccines More Equitably Medicines & Vaccines 22/01/2021 • 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) Manufacturing Pfizer/BioNTech’s COVID-19 vaccine Pfizer/BioNTech will join the WHO-co-sponsored COVAX vaccine facility, providing up to 40 million vaccines at cost to the Facility for use in low-income countries around the world – in what signals a breakthrough for the facility that only a week ago appeared to be teetering on the verse of irrelevance – as more low- and middle-income countries raced to sign bilateral contracts with pharma manufacturers for vaccine supplies. The joint announcement by Pfizer CEO Albert Bourla and WHO’s Dr Tedros Adhanom Ghebreyesus at a WHO press conference on Friday evening puts a bookend on a week of good-news developments for the WHO and its global health partners in COVAX – following on from moves by the new US administration of President Joe Biden to rejoin WHO and join the COVAX facility as well. Albert Bourla, CEO Pfizer, announces vaccine procurement deal with COVAX, Friday 22 January 2021 Psychological Turning Point For COVAX While 40 million doses is still a relatively a small initial amount, to begin with, it is also psychologically important to COVAX. It makes a statement that the even the most expensive, cutting edge mRNA vaccine technologies will be a part of the global vaccine pool made available to low and middle-income countries – which has already stocked up pre-orders for 2 billion doses of cheaper, and more conventional COVID vaccines. Together with the AstraZeneca vaccine, the commitment by Pfizer also ensures that at least some vaccine supplies will be ready to roll out almost immediately; other vaccines in the COVAX portfolio include products by Johnson & Johnson, Novavax and Sanofi – which are still in Phase 3 trials and thus haven’t yet been approved by any regulatory agency. The Pfizer move is also important because it provides a signal to other vaccine developers that COVAX has a broad base of industry support. This now leaves Moderna, the other producer of an already-approved mRNA vaccine, as the COVAX “outsider”. Moderna was among the first pharma companies to declare that it would not enforce its patent rights on its vaccine technology during the pandemic. But it has not signed a contract with COVAX – yet. “Pfizer and BioNTech have reached an advance purchase agreement with the COVAX facility for up to 40 million initial doses of our COVAX vaccine,” said Bourla, in annoucing the agreement at the WHO briefing. “We expect that the first doses will be delivered in the first quarter of this year, once we finalize agreements with UNICEF … we are coordinating procurement to support the delivery of these vaccines. UNICEF is mounting the COVAX logistics effort on the back of its enormous existing global infrastructure in transport, logistics and cold chain management – which distributes and administers childhood vaccines worldwide every year. GAVI, The Vaccine Alliance, and the other key COVAX partner, is mediating the contractual arrangements with vaccine manufacturers as well as COVAX members, including 92 low-income countries that regularly receive vaccines free or at preferential prices through a donor supported “Advance Market Commitment” scheme. WHO Director General Dr Tedros Adhanom Ghebreyesus announces COVAX vaccine procurement deal with Pfizer/BioNTech Friday 22 January “Since the very beginning of our vaccine development program Pfizer and BioNTech have been firmly committed to working toward equitable and affordable access of COVID-19 vaccines for people around the world,” added Bourla. “We fully support, and we are in alignment with the guiding principles of the COVAX facility “GAVI’s coordination of the COVAX Advanced Market Commitment that supports the participation of 92, lower-middle and low-income economies, is an important tool that will help ensure developing countries have the same access to vaccines as the rest of the world,” said Bourla. “And we will provide the vaccine coverage for these countries, not for profit,” said Bourla.” Bourla said that the doses would “support COVAX efforts to vaccinate healthcare works at high risk of exposure, and other vulnerable communities.” He added, “this is just one step in our commitment to support developing countries. As we work to deliver these doses, we are also bringing resources and expertise that will help to strengthen the global health infrastructure, building on our recent innovations in packaging and cold chain requirements, and ensuring that solid systems are in place. “Establishing the infrastructure needed to deliver breakthrough mRNA vaccine in ow income countries will not also will not only help us fight the pandemic, but make us more prepared for the next pandemic,” Bourla said. “We believe that this is a collective responsibility that calls for highly coordinated and collaborative actions by public and private stakeholders.” COVAX Deals with Pfizer and AstraZeneca Mean Facility is Ready To Rollout Supplies Pfizer COVID-19 vaccine delivery – in ultra-cold chain storage in special containers designed by the company. Some 150 million doses of the AstraZeneca vaccine will also be available in the first quarter of 2021, said Dr Tedros, speaking at the press briefing. Those doses are primed and ready to go, pending only WHO review and approval of the safety and efficacy of the AstraZeneca vaccine and its production facilities at the Serum Institute in India and in the Republic of Korea. “Together, these announcements mean COVAX could begin delivering doses in February, provided that we can finalize a supply agreement for the Pfizer biotech vaccine and emergency use listing for the AstraZeneca Oxford vaccine,” he said. “This agreement also opens the door for countries who are willing to share doses of the Pfizer BioNTech vaccine, to donate doses to COVAX and support rapid rollout,” the WHO Director General said. A handful of high income countries have purchased or pre-ordered even more COVID19 vaccine doses than they have people to immunize – with Canada topping the list with pre-orders or purchases of multiple vaccines per capita. UNICEF’s Executive Director Henrietta Fore, said that her organization was in the process of securing logistics and supply chain arrangements for the new contract with Pfizer/BioNTech as well as for others in the COVAX pipeline. Those are arrangements will be particularly sensitive because the Pfizer vaccine requires -70C storage conditions – although innovative new packaging developed by the company can help keep the vaccine cold for at leat a week without an electricity supply. “In the coming weeks UNICEF will begin transporting vaccines, together with syringes and safety boxes to countries around the world. And we are working with airlines and freight and logistics providers to ensure safe and timely delivery,” said Fore at the briefing. “UNICEF and our partners are working with governments around the clock to ensure that countries are ready to receive the vaccines that there is appropriate cold chain equipment in place, and that health workers are trained to dispense them,” said Fore, adding that UNICEF is also playing a lead role in efforts to foster trust in the vaccine, tracking and addressing vaccine misinformation.” United States Expected to Play Critical Role in COVAX Global Vaccine Rollout The fact that the United States has rejoined WHO and is also playing an active role in COVAX, will also help ensure the kind of global solidarity needed to ensure success in the vaccine rollout effort, said Bourla and all three agency heads at the briefing. “Last year, we saw a truly unique human ingenuity at work to successfully develop effective and safe vaccines in record time. This year, we turn to the biggest logistical challenge the world has ever seen. And we need all hands on deck,” said Fore. “With that in mind, I join everyone to say how pleased I am that the United States is has joined the COVAX facility, and confident that with its expertise and resources, the United States will give this global effort, and UNICEF’s role in it, a major boost.” Her comments referred to the leading role the US has played as a funder and supporter of the UN agency whose main mission is the children’s and adolescent health in the world’s poorest countries. Tedros, for his part, said he spoke with Vice-President Kamala Harris by phone on what was her first full day in office: “The United States has long played a vital role in global health. The US was a founding member of WHO, and has been a leader in the fight against many diseases from smallpox to polio, and malaria to HIV. The US contributes an enormous amount to global health, but it also benefits from WHO’s work on a range of both infectious and non communicable diseases,” he added, noting that a healthier, safer world is a healthier, safer America.” Added Bourla, whose company is headquartered in the United States: “I couldn’t avoid the temptation to say that I’m very glad this press conference is happening the day that the United States is rejoining the WHO organization. I think it is a symbolic great day for us. Global Vaccine Capacity Increasing Seth Berkley, CEO GAVI, The Vaccine Alliance Seth Berkley, CEO of GAVI, said that with the rapid approval of new vaccines, the world could be positioned to roll out as much as 6 or 7 million vaccine doses in 2021. While Dr Tedros said that the COVAX was on track to rollout out at least 2 billion doses this year, Berkley said that the number could rise to 2.3 billion doses – “with the right level of funding in place” “This would equate to close to 1.8 billion doses for the 92 lower income counties in the COVAX advanced market commitment, or AMC,” said Berkley. “That’s enough to protect about 27% of the population in those low and lower-middle income countries, which is in excess of the initial tartlets we laid out to protect those at highest risks. And we have the prospect of more doses to come through other deals and sharing principles that we announced in December.” While initial deliveries “will be small, but they will grow quickly,” Berkley promised. Pfizer, for its park had initially only projected the production of 1.3 billion vaccine doses this year, but that has now increased to 2 billion Bourla said, adding that he feels “confident” about that projection. Reduce Virus Transmission to Preserve Vaccine Efficiency But Decision on 2021 Olympics Is Japan’s – WHO Says WHO’s Katherine O’Brien speaking at press briefing 22 January In a wide-ranging press briefing that covered a week packed with the WHO Executive Board meeting, WHO’s Executive Director of Health Emergencies, Mike Ryan, said that the higher rate of serious COVID19 cases now being observed in the United Kingdom doesn’t necesarily mean that the mutated SARSCoV virus variants are necessarily more deadly/. More infectious also generate more serious hospital cases, overloading hospitals and reducing their response capacity, he pointed out. So the dynamics of health system response have to be looked at in addition to the dynamics of the infections as such. Katherine O’Brien, WHO’s director of Immunization, Vaccines and Biologicals, underlined that as vaccine rollouts get underway, it is more important than ever for societies to use social distancing and other measures to rein in the virus. “The risk of virus variants relative to vacccines is even greater when transmission is very high in communities – because of the possiblility of additional [resistant] variants emerging under the pressure of vaccines,” she explaining, stressing “the importance of really crushing transmission.” In terms of queries over whether it would be safe to hold the 2021 Olympics, which the Japanese government is still planning to host this July – even though public opinion is more negative, Ryan said that WHO would provide advice about risk management of mass gatherings – but it doesn’t provide advice on whether to hold a mass gathering or not. He added: “we all hope for the Olympics but we all recognize that everyone is a little afraid as we enter the new year with some uncertainties. I believe the Japanese overnment will always act in the best interest, and according to the will of its people.” Investigation of SARS-CoV2 Virus Origins Will “Follow the Science” With regards to Beijing’s recent media campaign suggesting that the virus may have originated somewhere other than China – just as a WHO-led team begins work in Wuhan to look for virus tracks in the city where the first clusters of infection were reported, Ryan said that it was mistaken to “start any process where the conclusions are at the start, and then we look for the evidence to support them – we’re dealing with a lot of that in the last few days.” But Ryan declined to say whether the international team of independent experts would visit the Wuhan Virology Institute that had been conducting research into coronaviruses before the pandemic began. There has been some speculation that the virus could have escaped accidentally from the facility. Leading experts have noted that the virus that caused the pandemic shares 96% of its genetic makeup with coronavirus variants that circulate naturally among bat populations living in caves in Yunnan Province, about 1800 kilometers southwest of Wuhan near the borders of Laos and Myanmar. But there has been no suggestion that the team would visit the Yunnan cave region either – an area in Yunnan’s Tongguan district, from which roving BBC media team was recently barred. In terms of where the quest for the virus origins might lead, Ryan added that, “all hypotheses are on the table, and it is definitely to early to come to a conclusion, this is a big jigsaw puzzle, you’re entitled to your opinion… but that doesn’t make you right. So let’s step back and follow the science. “Our WHO team on the ground are having a good experience working with our Chinese colleagues, working through the data; the data will lead us to the next phase, where we need to go next to look at the origins of the SARS-CoV2 virus.” Image Credits: Flickr – Province of British Columbia, Pfizer, Flickr – Province of British Columbia. 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) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.