WHO plans slew of COVID-19 vaccine approvals for global rollout

Reuters 

The World Health Organization (WHO) plans to approve several COVID-19 vaccines from Western and Chinese manufacturers in coming weeks and months, a document published on Wednesday shows, as it aims for rapid rollouts in poorer countries.

COVAX, a global procurement pool co-led by the WHO, wants to deliver at least 2 billion COVID-19 doses across the world this year, with at least 1.3 billion going to poorer countries.

But it 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 shots, regulatory approvals are key to confirming the effectiveness and safety of vaccines, and to boosting output. But some poorer countries rely mostly on WHO authorizations as they have limited regulatory capacity.

The WHO is therefore “expediting” emergency approvals, according to a COVAX internal 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 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, a provisional calendar published by the WHO on Wednesday shows.

As well as vaccines, regulators usually authorize their manufacturing processes in different plants.

SII chief executive Adar Poonawalla told Reuters last week that he expected WHO approval “in the next week or two.”

AstraZeneca did not respond to requests for comment, while SK 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 Britain, 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 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 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 that the WHO is expected to approve Moderna’s COVID-19 vaccine, which is based on the same messenger RNA 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 nonbinding agreement to supply COVAX with 500 million doses over an unspecified time frame, 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 3 clinical trials, but the European Union 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.

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