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 Wednesday, as the global health agency pushes for rapid vaccination in poorer countries.
COVAX, a global program co-led by the WHO, aims to deliver at least two billion COVID-19 doses around the world this year, of which at least 1.3 billion to poorer countries.
But the facility has so far struggled to get enough shots due to a shortage of funds, while rich countries have booked large amounts of vaccines for themselves.
In the race to deploy vaccines, regulatory approvals are essential to confirm vaccine effectiveness and safety, and boost output. But some poorer countries mainly rely on WHO authorizations because they themselves have limited regulatory capacity.
WHO is therefore “accelerating” emergency approvals, according to an internal COVAX document seen by Reuters news agency.
The COVID-19 vaccine, developed by AstraZeneca and manufactured by the Serum Institute of India (SII), could be approved by WHO in January or February, the document said.
The same vaccine produced by SK Bioscience in South Korea could not be approved by the UN agency until the second half of February at the earliest, according to a preliminary calendar published by the WHO.
In addition to vaccines, regulators usually allow their manufacturing processes in different factories.
SII chief Adar Poonawalla told Reuters last week that he expected WHO approval “in the next two weeks.”
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, co-developed with the University of Oxford, has already received emergency approval in the UK, while decisions are imminent in the European Union and the United States.
COVAX has supply contracts with AstraZeneca and SII for approximately 400 million doses and an option for many hundreds more millions, although the timing of deliveries is uncertain.
Other western shots
The WHO approved the vaccine developed by Pfizer and its German partner BioNTech at the end of December.
WHO officials have said they are seeking a supply agreement with the US pharmaceutical giant, which has already pledged hundreds of millions of doses to several wealthy countries this year.
COVAX initially did not include Pfizer / BioNTech’s shot in the pre-purchase shortlist.
Pfizer did not respond to a request for comment as to whether a deal was closed and whether it would involve only a limited number of doses this year.
The preliminary approval calendar also shows that WHO is expected to approve Moderna’s COVID-19 vaccine, which is based on the same messenger RNA (mRNA) technology as Pfizer’s, 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 deliver COVAX 500 million doses over an indefinite period of time, is expected to receive WHO approval at the earliest in May or June, it said. WHO document.
J&J has not yet published the results of the Phase III clinical trials of the vaccine, but the EU has said it expects the company to seek 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 early approvals for two Chinese vaccines, the preliminary calendar shows.
Sinopharm and Sinovac have submitted their applications to WHO, which is reviewing them and making a decision in March at the earliest, it says.
Neither vaccine was shortlisted by WHO for potential pre-purchase agreements. WHO approval does not automatically lead to purchases by COVAX. It could also facilitate introduction to poorer countries that obtain the vaccines directly.
Sinopharm has filed applications for two COVID-19 vaccines, but the possible approval in March only concerns the vaccine developed by the Beijing-based affiliate, Beijing Institute of Biological Products Co, Ltd (BIBP), which is already being widely used for vaccinations in China.
Sinovac has not yet released global results from its Phase III trials, but the 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 no preliminary timetable yet for the possible approval of the Russian Sputnik V vaccine, despite developers submitting the relevant documentation, the timetable shows.
The Russian Direct Investment Fund (RDIF), Sputnik V’s main financier, did not respond to a request for comment.