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 published on Wednesday, as the global health agency aims for rapid vaccine releases in poorer countries.
COVAX, a global scheme co-led by the WHO, wants to deliver at least two billion COVID-19 doses across the world this year, with at least 1.3 billion going to poorer countries.
But the facility has so far struggled to secure enough shots due to a shortage of funds, while wealthy nations have booked large volumes of vaccines for themselves.
In the race to deploy vaccines, regulatory approvals are key to confirming the effectiveness and safety of vaccines and to boosting output. But some poorer countries rely mostly on WHO authorisations as they have limited regulatory capacity of their own.
The WHO is therefore “expediting” emergency approvals, according to a COVAX internal 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 authorised by the WHO in January or February, the document says.
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 calendar published by the WHO.
As well as vaccines, regulators usually authorise their manufacturing processes in different plants.
SII chief executive Adar Poonawalla told Reuters last week 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 aware of the WHO’s approval timeline.
The AstraZeneca vaccine, developed with Oxford University, has already been given 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 about 400 million doses and an option for many more hundreds of millions, although the timing of deliveries is uncertain.
Other Western shots
The WHO authorised 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 to several wealthy nations.
COVAX had not initially included the Pfizer/BioNTech shot in its shortlist for advance purchases.
Pfizer did not respond to a request for comment on whether a deal was close and whether it would involve only a limited number of doses this year.
The provisional approval calendar also shows the WHO is expected to approve Moderna’s COVID-19 vaccine, which is 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 in the United States and the European Union, had no immediate comment.
The vaccine developed by Johnson & Johnson (J&J), which has a non-binding agreement to supply COVAX with 500 million doses over an unspecified timeframe, is expected to get WHO approval in May or June at the earliest, the WHO document says.
J&J has not yet published results of its vaccine’s Phase III clinical trials but the EU has said it expects the company to apply for 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 quick approvals for two Chinese vaccines, the provisional calendar shows.
Sinopharm and Sinovac have filed their applications with the WHO, which is reviewing them and could make decisions on both in March at the earliest, it says.
Neither vaccine was shortlisted by the WHO for possible advance purchase deals. WHO approval does not automatically lead to purchases by COVAX. It could also facilitate the release in poorer countries that acquire the vaccines directly.
Sinopharm has filed applications for two COVID-19 vaccines but the possible March approval concerns only the one developed by its Beijing-based affiliate, Beijing Institute of Biological Products Co, Ltd (BIBP), which has already been widely used for inoculations in China.
Sinovac has yet to release global results of its Phase III trials but its vaccine has been approved for emergency use in countries including Brazil, Indonesia and Turkey.
Sinopharm and Sinovac did not respond to requests for comment.
There is no provisional timetable yet for the possible approval of Russia’s Sputnik V vaccine, despite its developers having filed the relevant documentation, the timetable shows.
The Russian Direct Investment Fund (RDIF), the main financial backer of Sputnik V, did not respond to a request for comment.