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 at the rapid release of vaccines in poorer countries.
COVAX, a global scheme co-led by WHO, wants to deliver at least two billion doses of COVID-19 worldwide this year, with at least 1.3 billion going to the poorest countries.
But the facility has so far struggled to secure sufficient vaccines due to a lack of funds, while wealthy nations have reserved large volumes of vaccines for themselves.
In the race to deploy vaccines, regulatory approvals are critical to confirm vaccine effectiveness and safety and to increase production. But some poorer countries rely mainly on WHO authorizations, as they have limited regulatory capacity of their own.
WHO is therefore “accelerating” 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 authorized by 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 least, according to the provisional calendar published by WHO.
In addition to vaccines, regulators usually authorize their manufacturing processes in different factories.
SII Chief Executive Adar Poonawalla told Reuters last week that he expects WHO approval “in the next two weeks”.
AstraZeneca did not respond to requests for comment, while SK Bioscience said it was unaware of the WHO approval deadline.
The AstraZeneca vaccine, developed with the University of Oxford, has already obtained 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 around 400 million doses and an option for many hundreds of millions more, although the delivery time is uncertain.
Other western photos
WHO authorized the vaccine developed by Pfizer and its German partner BioNTech in late December.
WHO officials said they are seeking a supply agreement with the United States pharmaceutical giant, which has already allocated hundreds of millions of doses this year to several wealthy countries.
COVAX initially did not include the Pfizer / BioNTech photo in its list of options for advance purchases.
Pfizer did not respond to a request for comment on whether a deal was closed and would involve only a limited number of doses this year.
The provisional approval schedule also shows that WHO is expected to approve Moderna’s COVID-19 vaccine, which is based on the same messenger RNA (mRNA) technology from Pfizer, in late February.
Moderna, whose vaccine has already been approved in many Western countries, including the United States and the European Union, did not immediately comment.
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, must obtain WHO approval in May or June at least, says the WHO document .
J&J has yet to publish the results of Phase III clinical trials of its vaccine, but the EU 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
WHO is also considering possible rapid approvals for two Chinese vaccines, the provisional calendar shows.
Sinopharm and Sinovac filed their requirements with the WHO, which is analyzing them and could make decisions on both in March at the very least, he said.
None of the vaccines have been selected by WHO for possible advance purchase agreements. WHO approval does not automatically lead to purchases by COVAX. It could also facilitate delivery in poorer countries that purchase vaccines directly.
Sinopharm applied for two COVID-19 vaccines, but the possible approval in March concerns only that developed by its Beijing-based affiliate, the Beijing Institute of Biological Products Co, Ltd (BIBP), which has already been widely used for inoculations in China.
Sinovac has not yet released global results from its Phase III tests, 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 still no provisional timetable for the possible approval of the Russian Sputnik V vaccine, although its developers have filed the relevant documentation, the schedule shows.
The Russian Direct Investment Fund (RDIF), the main financier of Sputnik V, did not respond to a request for comment.