China’s Covid-19 vaccines reach final stage of WHO approval process

Josephine Ma
·4-min read

The World Health Organization’s review of two Chinese Covid-19 vaccines for emergency use licensing - a prerequisite for their inclusion in the Covax Facility global vaccine distribution programme - is proceeding as scheduled.

Kate O’Brien, director of the WHO’s immunisation department, said on Thursday meetings to discuss Sinopharm and Sinovac were planned for Monday and May 3, respectively.

“We are pleased that we are at a point that these review meetings can be scheduled and we are looking forward to … the formal review meeting of the [emergency licensing] process,” O’Brien said. “The WHO has been in constant touch with the two companies to prepare for the official review meeting.”

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The scheduling of the meetings means the reviewers have the required information and could finish their report before these dates.

“The meetings are planned based on the expectations that reports from all the reviewers will be completed in time for that meeting,” O’Brien said. “Occasionally, unexpected things happen but the meeting is expected to take place as the dates have been shared.”

According to past practice, the emergency use licensing (EUL) will be granted shortly after the reviewers’ recommendation at the formal meeting, opening the way for the Sinopharm and Sinovac vaccines to be included in the Covax programme led by the global health agency.

A WHO endorsement would also boost confidence in the two Chinese vaccines, which have faced pressure over a lack of transparency and confusing data. They have been administered to hundreds of millions of Chinese people. More than 100 million doses have been exported to developing countries, although Sinopharm has yet to give details about its late-stage clinical trials.

China’s CanSino distances itself from blood clot fears

In late March, a meeting of the WHO’s Strategic Advisory Group of Experts, which decides how vaccines should be used, said data from the two Chinese companies indicated that both vaccines met the minimum requirement of 50 per cent efficacy. But the advisory group also said more data was required about the vaccines’ performance on the elderly and people with underlying conditions.

O’Brien said the group would meet on Thursday to discuss Sinopharm and Sinovac.

No detailed efficacy data on Sinopharm’s vaccine has been released, although the Chinese government said it was 79.34 per cent effective in preventing people from developing Covid-19. Studies in Brazil, Turkey and Indonesia showed Sinovac’s vaccine to have efficacy ratings of between 50.65 per cent and 83.5 per cent.

There are four vaccines approved in China. In addition to the two under advanced consideration, an application for EUL has been submitted for another vaccine developed by Sinopharm with the Wuhan Institute of Biological Products, although no information has yet been provided to the WHO. The fourth is an adenovirus vaccine by CanSino, which has started providing rolling data to the agency.

Anhui Zhifei Longcom has also started applying for emergency use licensing, but the WHO said the company needed to supply more information. Zhifei has yet to release its late stage trial for a protein subunit vaccine.

The Covax programme, whose goal is to immunise 20 per cent of its members’ populations, has three vaccines in its portfolio: the mRNA vaccine developed by Pfizer/BioNTech, and those from Oxford/AstraZeneca and Johnson & Johnson.

O’Brien said despite the cases of rare blood clots, the two latter vaccines remained safe and would continue to be deployed by Covax. Still unknown, however, is the need for a booster shot and the vaccines’ protection against new variants, she said, adding that the agency is still collecting data.

Gian Gandhi, Covax coordinator for supply, said a current challenge was the amount of Oxford vaccines produced by the Serum Institute in India because of the country’s rising domestic demand.

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