The World Health Organization (WHO) plans to approve more COVID-19 vaccines from Western and Chinese manufacturers in the coming weeks and months, according to a document released Wednesday, as the global health agency aims to deliver vaccines quickly to poorer countries.
COVAX, a global system co-led by WHO, aims to deliver at least two billion doses of COVID-19 worldwide this year, with at least 1.3 billion going to poorer countries.
But the facility has so far struggled to get enough fire due to lack of funds, while rich nations have reserved large volumes of vaccines.
In the race to implement vaccines, regulatory approvals are essential to confirm the effectiveness and safety of vaccines and to increase production. But some poorer countries rely mainly on WHO permits because they have limited regulatory capacity.
As a result, WHO is “accelerating” emergency approvals, according to an internal COVAX document seen by the Reuters news agency.
The COVID-19 vaccine developed by AstraZeneca and manufactured by the Serum Institute of India (SII) could be authorized by the WHO in January or February, the document states.
The same vaccine produced in South Korea by SK Bioscience could be approved by the UN agency in the second half of February, at the earliest, according to a provisional timetable published by the WHO.
In addition to vaccines, regulators usually authorize their manufacturing processes in various factories.
SII chief executive Adar Poonawalla told Reuters last week that he expected WHO approval “in the next week or two”.
AstraZeneca did not respond to requests for comment, while SK Bioscience said it was not up to date with the WHO approval schedule.
The AstraZeneca vaccine, developed in conjunction with Oxford University, has already received emergency approval in the United Kingdom, while decisions in the European Union and the United States are close.
COVAX has supply contracts with AstraZeneca and SII for approximately 400 million doses and an option for many hundreds of millions more, although the delivery schedule is uncertain.
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The WHO authorized the vaccine developed by Pfizer and its German partner BioNTech at the end of December.
WHO officials say they are looking for a supply deal with the US pharmaceutical giant, which has already committed hundreds of millions of doses this year to several rich nations.
COVAX did not initially include Pfizer / BioNTech in its shortlist for advance purchases.
Pfizer did not respond to a request for comment on whether an agreement had been reached and whether it would involve only a limited number of doses this year.
The provisional approval schedule also shows that the WHO is expected to approve the Modern COVID-19 vaccine, which is based on the same RNA messenger (mRNA) technology as Pfizer, in late February.
Moderna, whose vaccine is already approved in many Western countries, including the United States and the European Union, had no immediate comment.
The Johnson & Johnson (J&J) vaccine, which has a non-binding agreement to supply COVAX with 500 million doses in an unspecified time, is expected to receive WHO approval in May or June at the earliest. in the WHO document.
J&J has not yet released the results of the phase III clinical trials of the vaccine, but the EU said it expects the company to seek approval as early as February.
A J&J spokesman did not respond to a request for comment.
China and Russia
The WHO is also considering possible rapid approvals for two Chinese vaccines, according to the provisional timetable.
Sinopharm and Sinovac have submitted their applications to the WHO, which is examining them and could make decisions on both in March at the earliest, he says.
None of the vaccines have been selected by the WHO for possible advance purchase offers. WHO approval does not automatically lead to purchases by COVAX. It could also facilitate the release in poorer countries that purchase vaccines directly.
Sinopharm has applied for two COVID-19 vaccines, but the possible approval in March refers only to the one developed by its Beijing affiliate, Beijing Institute of Biological Products Co., Ltd (BIBP), which has already been widely used for vaccinations. from China.
Sinovac has not yet published the overall results of the phase III studies, but its vaccine has been approved for emergency use in countries such as Brazil, Indonesia and Turkey.
Sinopharm and Sinovac did not respond to requests for comment.
There is still no provisional timetable for the possible approval of the Sputnik V vaccine in Russia, despite its developers who have submitted the relevant documentation, the calendar shows.
The Russian direct investment fund (RDIF), the main financial support of Sputnik V, did not respond to a request for comment.