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 Wednesday, as the global health group aims to release quick vaccine alerts in poor countries.
COVAX, a global scheme co-led by the WHO, wants to deliver at least two billion doses of COVID-19 worldwide worldwide this year, with at least 1.3 billion going to poor countries.
But so far the facility has struggled to get enough beats due to a lack of funding, while rich countries have reserved many vaccines for themselves.
In the race to use vaccines, regulatory approval is crucial in determining the efficacy and safety of vaccines and promoting productivity. But some poor countries rely heavily on WHO authority because they have little regulatory capacity of their own.
The WHO is therefore “permitting” an emergency, 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 approved by the WHO in January or February, the document says.
The vaccine issued in South Korea by SK Bioscience could be approved by the DA group in the second half of February, at the earliest, according to a provisional calendar published by the WHO.
In addition to vaccines, regulators usually allow their manufacturing processes in different plants.
SII chief executive Adar Poonawalla told Reuters last week that he expected the WHO agreement “in the next week or two”.
AstraZeneca did not respond to requests for comment, although SK Bioscience said it was not aware of the WHO licensing timeline.
The AstraZeneca vaccine, developed by Oxford University, has already been approved 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 option for many more hundreds of millions, although delivery time is uncertain.
Other views West
The WHO developed the vaccine developed by Pfizer and its German partner BioNTech in late December.
WHO officials have said they are seeking a supply contract with the US pharmaceutical giant, which has pledged hundreds of millions of doses this year to several rich countries.
COVAX had not included the Pfizer / BioNTech photo to its shortlist for pre-purchase.
Pfizer did not respond to a request for comment on whether there was a close contract and whether it would include just a limited number of doses this year.
The provisional permit calendar also indicates that the WHO is expected to approve the Moderna COVID-19 vaccine, which is based on the same RNA messenger (mRNA) technology as Pfizer, at the end of February.
Moderna, whose vaccine has already been approved in many Western countries including the United States and the European Union, made no mention.
The vaccine developed by Johnson & Johnson (J&J), which has a non-binding agreement to administer 500 million doses of COVAX over an unspecified period, is expected to receive WHO approval in May or June at at the earliest, a WHO document states.
J&J has not released the results of the Phase III clinical trial of the vaccine but the EU has said it expects the company to apply for approval as early as February.
A J&J spokesperson did not respond to a request for comment.
China and Russia
The WHO is also considering possible quick licenses for two Chinese vaccines, the provisional calendar shows.
Sinopharm and Sinovac have submitted their bids with the WHO, which is reviewing them and could make decisions on both in March at the earliest, he says .
The second vaccine was not shortlisted by the WHO for prior purchase contracts. WHO approval does not automatically allow purchases with COVAX. It could also be released in poor countries that receive the vaccines directly.
Sinopharm has filed bids for two COVID-19 vaccines but the potential March agreement concerns the one developed by its cousin in Beijing, Institute of Biological Products Beijing Geological Co., Ltd. (BIBP), which has already been widely used for inoculations in China.
Sinovac has not yet released the global results of its Phase III tests 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 not yet a provisional timetable for obtaining permission for the Russian Sputnik V vaccine, despite the fact that the developers have submitted the relevant documents, the timetable shows.
The Russian Direct Investment Fund (RDIF), Sputnik V’s main financial backer, did not respond to a request for comment.