COVAX Is Ready To Deliver Vaccines, WHO Officials Tell WHO Executive Board – But Regulatory Approvals Still Lagging For Key COVAX Products Medicines & Vaccines 19/01/2021 • Kerry Cullinan 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) The vaccine developed by Oxford University and AstraZeneca is the only one to have both been secured by COVAX and already approved by a national regulatory authority (the United Kingdom) in a transparent review process. The World Health Organization’s (WHO) COVID-19 vaccine access platform, COVAX, is geared up to deliver vaccines to “far more” than 20% of member states’ populations beyond 2021, Dr Kate O’Brien, the body’s director of vaccines, told its Executive Board meeting on Tuesday. She was responding to concerns and criticisms expressed by member states at the EB’s opening session on Monday about the ability of COVAX to deliver vaccines to member states that have not been able to purchase them on their own. As Austria’s Dr Clemens Martin Auer, told the meeting: “COVAX is slow. It has not closed a crucial number of contracts, and therefore, substantial numbers of vaccines are not being timely delivered to member states.” Distribution datelines for COVAX delivery of 2 billion vaccine doses in 2021, based on data available on 7 January 2021. Auer, who is also the co-chair of the EU’s vaccine procurement group’s board, said that the EU group had been meeting up to three times a week since June to put together a broad portfolio of vaccines, but the management of COVAX lacked transparency about its procurement programme. “We did do our homework within the EU to secure the needs for 450 million EU citizens to have access to urgently needed vaccines. We were sceptical that GAVI had the means and the capabilities to fulfill its tasks to negotiate the necessary contracts and to secure the needs of our citizens. “The proposals that GAVI negotiated side-by-side with the EU with the producers was rejected by the management of GAVI COVAX. So I would like to express the clear statement that the EU and its member states are exercising their global solidarity and we are the single largest donor when it comes to supporting GAVI COVAX facility.” Auer also asked why the COVAX management had initially decided to exclude the mRNA vaccines being produced by Pfizer and Moderna, which have been the first to receive European and American regulatory approvals; what COVAX’s delivery plans were and how many vaccine doses member states could expect? Dr Bruce Aylward, Senior Advisor to the Director-General, reported that GAVI has “145 million doses contracted for release during the first quarter of this year.” Bruce Aylward, WHO Senior Advisor to the Director General, at the Executive Board session on Tuesday. Timing depended on countries’ regulatory support, continued financing of COVAX and co-operation from countries and entities that have large bilateral vaccine deals “because choices have to be made as to which contracts get served in which order, and the dose sharing that we mentioned yesterday,” added Aylward, who represents the WHO at GAVI. “There is no question that we can achieve the Director General’s vision of all countries vaccinating their highest risk populations by World Health Day [7 April], which is only a couple of months away, but to achieve that ambition will require a new level of cooperation and coordination as we go forward,” said Aylward. “Any suggestion that COVAX is not operational has to be scrutinised, as the facility is operational,” stressed Aylward. WHO Now Examining Indian, Russian & Chinese Vaccines – While Moderna & Pfizer Hold Back One key holdup with COVAX, in fact, appears to lie in the mismatch between the vaccines for which COVAX has arranged pre-order deals – and those that have received approval so far by WHO or another strict regulatory authority as safe to use. Brand names of doses secured by COVAX that would be available for delivery – however only following WHO approval of AstraZeneca, Serum Institute of India and J&J vaccines. So far, the AstraZeneca/Oxford University vaccine is the only one to have both been secured by COVAX and already approved by national regulators. Another key COVAX product, a vaccine candidate by Johnson & Johnson has not yet received US or European regulatory approval. Yet a third, by Sanofi/GSK lags even further behind. Meanwhile, as Auer pointed out, COVAX has either been unable or unwilling to secure deals with the other two leading pharma companies that are rolling out millions of mRNA vaccine doses, Pfizer and Moderna. And Moderna has not yet even submitted a full dossier on its product for WHO review – despite the fact that it has been approved in Europe, the United Kingdom, the United States and Switzerland. In the interim, WHO is in the process of reviewing vaccine candidate submissions by Indian, Chinese and Russian counterparts – which are eager to get the Organization’s seal of approval – and market them independently to the dozens of countries that have already submitted pre-orders. In the case of the Indian vaccine, a generic version of the AstraZeneca/Oxford vaccine technology, WHO manufacturing approval would also clear the way for offering it through COVAX – where it comprises the largest single pre-order by the facility. “We have full dossiers from three other drug companies right now, Sinopharm, Sinovac, and the Serum Institute of India and they are under assessment,” said WHO’s Dr Mariangela Simao, Assistant Director-General for Access to Medicines, who said the real time status of WHO review and approval for all vaccines can be tracked on the WHO’s website. “We have a mission in China right now, to do the inspections in Sinopharm, in Sinovac,” she added. Mariângela Simão, WHO Assistant Director General of Access to Medicines and Health Products, at the morning session of the EB meeting on Tuesday. She added that she expects more information on Russia’s Sputnik vaccine next week following a meeting with the vaccines developers at the Gamaleya Research Institute. “For Russia, we are still waiting for additional information from Gamalaya, we have a meeting with the team next week.” She said that WHO is also awaiting further information from the Republic of Korea, where the firm SK Bio is set to produce the AstraZeneca vaccine under a generic license – using the core vaccine technology approved by the United Kingdom. Among all of the vaccines in late stage trials or already being rolled out, only the Pfizer vaccine has actually received the full and final WHO seal of approval – although so far there is no COVAX pre-purchase agreement with Pfizer – and the vaccine requires ultra cold storage conditions. Mixed Results from Chinese and Russian Phase 3 Trials So Far While WHO approvals would also be reassuring for the many countries that have already placed orders for the Chinese and Russian vaccines – there have been diverse reports so far about their efficacy. Sinovac’s results have generated the most concern. In the results of a Phase 3 trial in Turkey, released late in December, the company proudly announced an efficacy of 91.3%, but subsequent results in other countries have been much less impressive, showing 78% efficacy in one Brazil trial, 65.3% in Indonesia – and only 50.3% in the most recent Brazilian trial of 12,000 healthcare workers. That barely makes the 50% mark for the minimum efficiency standards set by WHO and the FDA – although Sinovac said that the trial of healthcare workers was biased because they would be more intensively exposed to the virus than the general public. The Sinopharm vaccine, co-developed by the Beijing Institute of Biological Products, has reportedly yielded an efficacy result of 79.3% in China and 86% in another Phase 3 trial in the United Arab Emirates – although again these have yet to be reviewed independently. Over 60,000 volunteers from 125 countries, including Morocco and Peru, are still taking part in late stage clinical trials, said Sinopharm. Of the three, the Russian Sputnik vaccine claims the highest overall efficacy rate of more than 90%, just trailing behind Pfizer’s and Moderna’s mRNA vaccines by a few percentage points, according to interim findings from late-stage trials in Russia. But once more, while the WHO review is still pending, the data has yet to be published in a peer-reviewed journal or reviewed transparently by a regulatory authority. Status of COVID-19 vaccines in the process of receiving WHO “Emergency Use Listing” approval, as of 14 January. –Svet Lustig Vijay contributed to this story Image Credits: John Cairns, WHO, WHO. 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.