64 High-Income Countries Make Binding Commitments To Buy COVID-19 Vaccines From New Global Facility – Billions Of Dollars Needed For Low-Income Nations Medicines & Vaccines 21/09/2020 • Grace Ren 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 print (Opens in new window) Seth Berkley, Gavi CEO, speaks at the Sept 20 WHO press briefing Some 64 higher income countries have now made binding financial commitments to a precedent-setting COVID-19 global vaccine pool that aims to equitably distribute future vaccines to halt the pandemic raging now. Another 38 countries are expected to commit over the next week, said CEO Berkley, in a WHO press conference Monday that disclosed the landmark agreement formally establishing the COVAX Advance Market Commitments (AMC) mechanism, the first to involve rich as well as poor countries in vaccine pooling. The COVAX vaccine pooling initiative is led by Gavi, in partnership with the World Health Organization and the Oslo-based Coalition for Epidemic Preparedness Innovations. Another 92 lower income countries that qualify for development assistance will be eligible to benefit from subsidized prices that the COVAX Facility will offer, Berkley said. This could mean that a total of 156 countries may be poised to join the initiative, making it the largest pooled procurement mechanism for a vaccine in history. However, some US $35 billion is still urgently needed to finance the manufacture and distribution of vaccines to low-income countries that join the COVAX pool, as well as treatments and tests needed to combat COVID-19 even more immediately, said WHO Director General Dr Tedros Adhanom Ghebreyesus at the press conference. He said that US$15 billion is “immediately needed” to “maintain momentum and stay on track for our ambitious timelines… We are at a critical point, and we need a significant increase in countries’ political and financial commitment. Only US $3 billion has been invested so far into financing vaccines for the COVAX faciliaty as well as the other pillars of the broader ACT Accelerator initiative, which aims to scale up development and distribution of COVID-19 treatments and diagnostics, said Dr Tedros. COVAX Announcement Widely Applauded – But Major Questions about Equitable Distribution to Most Vulnerable Groups Still Remain Despite the huge gap in financing, the fact that high income countries have begun to make firm commitments from a brand-new global pool to purchase COVID-19 vaccines that haven’t even yet been approved, was seen in global health circles as a major step forward in the drive to ensure that future COVID vaccines that do make it to market can be quickly scaled up and distributed in volume to people worldwide. With the Commitment Agreements secured, the COVAX Facility can now start signing formal agreements with vaccine manufacturers and developers, which are partners in the COVAX effort, to secure the 2 billion doses that it aims to distribute in 2021, WHO said in a statement. This is in addition to an ongoing effort to raise funding for both R&D and for the procurement of vaccines for lower-income countries via the Gavi COVAX AMC. Through the COVAX mechanism, countries can initially secure vaccine doses for up to 3% of their population most at risk rising to 20% in a second phase – in order to rationalize supplies, according to a “Fair Allocation Mechanism“, published by WHO on Monday. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which counts among its members most of the major pharma firms now racing to develop vaccines against the SARS-CoV-2 virus, applauded the COVAX agreement. “It is very encouraging to see so many countries move from talk to full commitment,” said Thomas Cueni, Director General of the IFPMA. “The Facility can only work, and equitable access can only be achieved, if there is solidarity between rich and poorer countries. Today, marks a significant step forward, and is a historic mark of solidarity which has the power to bring the acute phase of this pandemic to an end; and we are proud to be part of this unique endeavour to leave no one behind.” The pooling agreement will help accelerate future vaccine manufacture and distribution, said Jeremy Farrar, director of The Wellcome Trust, which has been a major funder of vaccine R&D, and of the Oslo-based CEPI coalition. But Farrar cautioned that major questions still remain about how to quickly get what are sure to be initially limited vaccine supplies to those most at risk: “It’s great to see a large number of countries signing up to COVAX and agreeing to secure vaccines not just for themselves, but for the world. The speed and scale of vaccine development have been remarkable but we still do not know yet which candidates might be successful or the most effective, and not all vaccines will be suitable for all who are at risk. Shared global investments in a range of vaccines that use diverse technologies and which can then be available for priority populations worldwide is critical. The investments today mean that COVAX can now start doing manufacturing deals, which is vital,” Farrar said. But he also cautioned against the currents of vaccine nationalism that have also been starkly evident during the pandemic, saying that worldwide distribution to those most vulnerable is essential to put the brakes on the pandemic: “Questions remain… on the detail of how the first vaccines – which will be in limited supply – will reach those who need them most in every country. Vaccinating high-risk people in every country first is not only the right thing to do, it’s in every country’s best interest. Unless every country has access to COVID-19 vaccines, tests and treatments the whole world is at risk. Countries cannot, and do not at this stage need access for every citizen. Countries should only buy doses for those in greatest need – healthcare and essential workers and those at highest risk. Any oversupply secured through bilateral deals must be donated for global supply. Clear and detailed commitments on this are urgently needed from governments now.” Notably, the United States has been among those countries taking a go-it-alone approach, refusing to participate in COVAX due to its disapproval of the World Health Organization for allegedly failing to act more decisively against the pandemic and catering to political pressure. China, on the other hand, has expressed interest in engaging with the Facility, but has so far not made any binding commitments, according to Berkley. WHO Comments On Pharma Blueprints for COVID-19 Vaccine Trials Soumya Swaminathan describes WHO’s minimum criteria for a COVID-19 vaccine’s safety and efficacy Meanwhile WHO Chief Scientist said that a vaccine candidate should be at least 30% effective in order to receive regulatory approval for widespread public use. “A vaccine with less than 30% efficacy is probably not going to have a big public health impact,” said Soumya Swaminathan, speaking at the same Monday press conference. She added that vaccine trials should also continue even beyond initial proof of efficacy to determine that vaccines coming on market are truly safe for widespread use: “On the safety side, we would like to see several months of follow-up to assess the potential adverse reactions, particularly since we have so many platforms that are being tried for the first time, such as the mRNA and even the adenovirus vectors are not being used at scale,” she added. “The benefit-risk ratio has to be very very strong.” Swaminathan’s comments come after three leading firms developing COVID-19 vaccine candidates, Pfizer, Moderna, and AstraZeneca released detailed blueprints of their vaccine development timelines over the weekend in an unprecedented move. The companies bowed to public pressure to increase transparency. The AstraZeneca Phase 3 trial had been paused previously to investigate two cases of neurological illnesses in patients, potentially associated with the vaccine. While the trial resumed in the United Kingdom after review by a UK data safety board, the US Food and Drug Administration has not yet allowed AstraZeneca to resume its US arms of the trial. Vaccine Efficacy Goals Vary by Pharma Firm – From 50-60% AstraZeneca’s plan revealed that the company was seeking to make a vaccine that was at least 50% effective. Moderna is aiming for a vaccine with 60% efficacy, and Pfizer is aiming for at least 52.3% efficacy in its final analysis. The AstraZeneca trial currently has 18,000 people enrolled. Once 150 people enrolled in the trial’s control and intervention arms became sick with COVID-19, protectiveness of the vaccine against COVID-19 infection could then be determined – by comparing infection rates among those who received the vaccine and those who did not. However, the Astra Zeneca plan allows for researchers to conduct an interim analysis of the effectiveness of the vaccine after 75 people get sick with coronavirus, and possibly pause the trial if results of the interim analysis are positive. Similarly, Moderna and Pfizer’s plans allow for two and four such interim analyses. Moderna has enrolled more than 25,000 people so far in its trial, and Pfizer has enrolled more than 10,000. But stopping trials early could increase the risk of missing potential rare side effects, and too many interim analyses increases the chances of researchers finding results that may be positively biased, Eric Topol, a clinical trials expert at Scripps College told the New York Times. The trials also include mild COVID-19 cases in the analysis criteria for stopping the trials early, which could prevent researchers from determining how effective the vaccine may be against preventing more severe disease, says Topol. And it’s unclear how closely the protocols really align up with a pledge signed by the CEOs of nine investigational COVID-19 vaccine developers, including AstraZeneca’s CEO, that asserted companies would not seek regulatory approval until the vaccine was proven safe and effective in Phase 3 clinical trials. Still, despite those questions, all three of the leaders in the race to develop the first COVID-19 vaccine are following a timeline similar to the one US Centers for Disease Control Director Robert Redfield outlined in his testimony last week before the US Congress. In that testimony, Redfield predicted that a vaccine would only be approved for wider use in the general public by mid-2021 or even the autumn. And he warned that until that point, measures such as universal use of masks, would continue to be even more important in combatting the pandemic than a vaccine. Redfield’s timeline was sharply criticized later by US President Donald Trump, who had been telling reporters that a vaccine may become available by the end of October, just ahead of the November 6th US presidential election. Madeleine Hoecklin contributed to this story. -Updated 22 September, 2020 Image Credits: NIAID. 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 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.