The World Health Organization (WHO) plans to approve several COVID-19 vaccines from Western and Chinese manufacturers in the coming weeks and months, according to a document released on Wednesday, as the World Health Agency aims for a rapid deployment of vaccines in the poorest countries.
COVAX, a global program co-led by the WHO, wants to administer at least 2 billion doses of COVID-19 worldwide this year, of which at least 1.3 billion are destined for the poorest countries.
But the facility has so far struggled to get enough vaccines due to a lack of funds, while rich countries have reserved large volumes of vaccines for themselves.
In the race to deploy vaccines, regulatory approvals are essential to confirm vaccine efficacy and safety and to increase production. But some poorer countries depend mainly on WHO approvals because they have their own limited regulatory capacities.
The WHO is therefore “accelerating” emergency approvals, according to an internal COVAX document seen by Reuters.
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 said.
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 schedule published by the WHO.
In addition to vaccines, regulators typically license their manufacturing processes in different factories.
SII chief executive Adar Poonawalla told Reuters last week he expected WHO approval “within the next week or two.”
AstraZeneca did not respond to requests for comment, while SK said she was not aware of the WHO approval timeline.
The AstraZeneca vaccine, developed with the University of Oxford, has already received emergency approval in the UK, while decisions in the EU and US are near.
COVAX has supply contracts with AstraZeneca and SII for approximately 400 million doses and an option for several hundred million, although the timing of deliveries is uncertain.
Other western plans
The WHO authorized the vaccine developed by Pfizer and its German partner BioNTech at the end of December.
WHO officials have said they are seeking a supply deal with the US pharmaceutical giant, which has already committed hundreds of millions of doses this year in several wealthy countries.
COVAX did not initially include the Pfizer / BioNTech shot in its shortlist for advance purchases.
Pfizer did not respond to a request for comment on reaching a deal and whether it would involve only a limited number of doses this year.
The tentative approval schedule also shows that the WHO is expected to approve Moderna’s COVID-19 vaccine, based on the same messenger RNA (mRNA) technology as Pfizer’s, at the end of February.
Moderna, whose vaccine is already approved in many Western countries including the United States and the European Union, did not comment immediately.
The vaccine developed by Johnson & Johnson (J&J), which has a non-binding agreement to provide COVAX with 500 million doses over an unspecified period, is expected to gain WHO approval in May or June at the earliest, the WHO document.
J&J has yet to release the results of its vaccine’s Phase III clinical trials, but the EU has said it expects the company to seek approval as early as February.
A spokesperson for J&J did not respond to a request for comment.
China and Russia
WHO is also considering possible early approvals for two Chinese vaccines, the tentative schedule says.
Sinopharm and Sinovac have filed their claims with the WHO, which is reviewing them and could make decisions on both in March at the earliest, he said.
Neither vaccine has been prequalified by WHO for possible advance purchase agreements. WHO approval does not automatically lead to purchases by COVAX. It could also facilitate deployment in poorer countries that directly procure vaccines.
Sinopharm has filed applications for two COVID-19 vaccines, but the possible March approval only concerns one developed by its Beijing-based subsidiary, Beijing Institute of Biological Products Co, Ltd (BIBP), which has already been widely used for vaccinations in China.
Sinovac has yet to release global results from its Phase III trials, but its vaccine has been approved for emergency use in countries like Brazil, Indonesia, and Turkey.
Sinopharm and Sinovac did not respond to requests for comment.
There is no tentative timeline yet for the eventual approval of Russia’s Sputnik V vaccine, although its developers have filed relevant documentation, the timeline says.
The Russian Direct Investment Fund (RDIF), Sputnik V’s main backer, did not respond to a request for comment.