Procure And Supply Vaccines Through COVAX And Not Bilateral Deals – WHO Plea To Countries & Pharma Medicines & Vaccines 08/01/2021 • Elaine Ruth Fletcher, James Hacker & Madeleine Hoecklin 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) A doctor preparing the Moderna COVID-19 vaccine at the Naval Hospital in Bremerton, Washington, US. Some 42 countries around the world are now rolling out brand new COVID-19 vaccines to their populations. But 36 of those are high-income countries, 6 are middle-income countries, and none at all are low-income countries, said WHO’s Director General Dr Tedros Adhanom Ghebreyesus at a WHO press briefing on Friday. He and other WHO officials at the briefing called upon pharma manufacturers and countries to stop arranging bilateral deals on vaccine supplies – and channel new vaccine procurement through the WHO co-sponsored COVAX facility – In what seemed at times like an almost quixotic vision, in terms of how the real-world rollout is actually proceeding. Dr Tedros Adhanom Ghebreyesus, WHO Director General, at the press briefing on Friday. Although the COVAX facility has indeed secured funding and deals to provide at least 2 billion vaccine doses to countries around the world in 2021 – the fact that high and middle income countries, including South Africa and India most recently, are now organizing huge vaccine purchases outside the framework of the global procurement initiative, is a signal of the lack of leverage that the global facility wields to see that vaccines are distributed equitably. As more and more countries race ahead with their own deals, WHO officials clearly are concerned that COVAX could languish in the backwaters as a kind of “poor persons” fund supplying some vaccines to the 92 countries that cannot afford to pay on their own – but in limited quantities and at higher prices to boot. “The governments and health systems are on standby for global vaccine rollout. We are ready, COVAX is ready, countries are ready. The time to deliver vaccines equitably is now,” Dr Tedros said. COVID-19 vaccine doses administered as of 8 January 2021, since 14 December 2020. But rather than channel vaccine purchases through the global procurement system, bilateral deals are becoming the norm, he protested, saying: “Both high and middle income countries that are part of COVAX [are] making additional bilateral deals. This potentially bumps up the price for everyone and means high risk people in the poorest and most marginalized countries don’t get the vaccine,” said Tedros. “I want to see manufacturers prioritize supply and rollout through COVAX. “I urge countries and manufacturers to stop making bilateral deals at the expense of COVAX. No country is exceptional and should cut the queue and vaccinate all their population while some remain with no supply of the vaccine,” said Tedros, adding. “Science has delivered, let’s not waste an opportunity to protect the lives of those most at risk and ensure all economies have a fair shot at recovery. Vaccine nationalism hurts us all and is self defeating.” On the flip side, he added that “vaccinating equitably would not only save lives and stabilize health systems, but also “lead to a truly global economic recovery that stimulates job creation. “Importantly it would also help us limit the virus opportunities to mutate,” he added, referring to evidence that the more SARS-CoV2 infections spread, then the more potential dangerous virus mutations occur, which can make the virus more dangerous, more infectious, or more elusive to vaccines. The WHO Director General also urged countries to turn over surplus vaccines to the facility, saying: “I urge countries that have contracted more vaccines than they will need, and are controlling the global supply to also donate and release them to COVAX immediately, which is ready today to roll them out quickly. Appeal To Pharma – Provide WHO With Data on Safety And Efficacy To Facilitate WHO Global Vaccine Approvals Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. At the briefing, WHO officials also appealed to Pharma manufacturers to supply them with more up-to-date data on the safety and efficacy of vaccines recently approved by national regulatory authorities – or in the final stages of clinical trials, so that WHO can make informed recommendations on vaccines that countries may choose to use. WHO’s own “pre-qualification” and “emergency use” approval processes – can help support and expedite approvals in countries where regulatory authorities are weak – as well as paving the way for acquisition of more vaccines by COVAX. “Some companies and countries have not submitted critical data, which we need to issue emergency use listings [and] which blocks the whole system of procurement and delivery,” said Tedros. Added Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products, WHO has received at least 13 valid proposals for vaccine approvals since October. However so far, WHO has only received complete data from one vaccine manufacturer, Pfizer, which it recently approved for emergency use. Transparent access to such trial data is necessary as many countries rely on WHO’s assessment prior to authorizing a medical product, such as a COVID-19 vaccine, for emergency use, she underlined: “It helps international procurers, like UNICEF and others, to procure the vaccines that have been assessed by the region.” Added Bruce Aylward, senior advisor to the Director General: “We are not in a position to provide a perspective on vaccines that are in use that we’ve not seen the data on. And at this point as I say the vaccine that we have seen is the Pfizer vaccine.” WHO Received Data From Chinese Sinopharm Phase 3 Trial – Russia’s Sputnik Data Expected Soon In the case of Chinese and Russian vaccines, which are already being administered in some countries, both products “are currently being assessed by WHO,” Simão confirmed. WHO had obtained finalized data from the Chinese Sinopharm candidate’s Phase 3 trial, she said. More data is expected by the end of this month on the results of trials of Russian Sputnik V vaccine, developed by the Gamalaya Research Institute. That is significant since WHO review and recommendations on Chinese and Russian vaccines could help build confidence in, and speed to market, the more affordable vaccine products being produced by both countries. Moreover, neither vaccine has been subjected to a transparent review by an independent regulatory agency. Call For Countries & Companies To Transparently Report On Vaccine Procurement Deals Being Concluded Kate O’Brien, WHO’s head of Immunization, Vaccines and Biologicals, at the Friday press briefing. In a related issue, the WHO officials said that when vaccine deals are concluded bilaterally, then countries and companies should report on those deals – in order to facilitate tracking that would also ensure more equitable distribution of other available vaccine doses. Said Kate O’Brien, WHO’s head of Vaccines, Immunologics and Biologicals, “Our understanding of…what deals are being made is extremely important in order to help with this whole process of equitable allocation and equitable access to vaccines; “We’re calling on countries and manufacturers to be clear and transparent about where vaccine deals are being done, the doses that are being arranged for use in various countries, and their actual rollout. “Having this information over time is really important for WHO and for the world to respond to this crisis in a way that will have its maximum impact,” she said. Said Aylward: “This is where we need the manufacturers working with us and we need…the donor countries and others working with us and working together. If a company does not submit the data that we need, it is slowing equitable access to vaccines around the world. If a company doesn’t sign and work the deals through us and if we don’t have the financing to do it, they’re slowing equitable access.” Aylward highlighted Tedros’ call to action for “access to the data on all of these products in real time as it is coming out, so that we can ensure that we can provide a perspective on these products as rapidly as possible and get them out equitably around the world.” COVAX Provides Flexibility Bruce Aylward, Senior Advisor to the Director General of the WHO, at the press briefing on Friday. Despite the lackluster role played by COVAX so far in the initial stages of vaccine rollout, the officials also tried to sound upbeat about the advantages that COVAX could still offer to countries – giving them more flexible access to a wider range of vaccines. “The importance of having a portfolio of vaccines that serve different needs of different countries and especially serving the different needs of delivery situations. We know from the different products that we have some that require an ultra cold chain…some require refrigeration, so we have a lot of variability of the products in terms of a range of their characteristics,” said O’Brien. “The range of needs of countries and choices of countries is served by having this portfolio of vaccines, where there can be matching of vaccines to the delivery needs and the characteristics that countries have for the access to those vaccines,” she added. “One of the beauties of the COVAX facility, the way we set it up is we’ve got a very broad portfolio of products. We know we have a broad range of clients that we’re working with,” said Aylward. “It’s one of the reasons [why] this facility is such an important part of the global solution to equitable access and rollout,” Aylward added. “We’re going to work with [countries] to get that right balance of products.” Image Credits: Flickr – Official US Navy, WHO, Our World in Data. 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