The World Health Organisation said on Tuesday it would take the final decision next week on whether to grant Covaxin, India’s homegrown Covid-19 vaccine, emergency use listing (EUL) its stamp of approval expected to boost the vaccine’s acceptability.
The WHO and an independent group of experts “are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant emergency use listing to Covaxin”, the international health agency tweeted on Tuesday night.
“Covaxin’s manufacturer, Bharat Biotech, has submitted data to the WHO on a rolling basis and submitted additional information at WHO’s request on September 27,” the agency tweeted. “WHO experts are currently reviewing this info and it if addresses all questions raised, WHO assessment will be finalised next week.”
The EUL process conducted by the WHO and a technical advisory group of independent experts is centred on determining if a manufactured product such as a vaccine is “quality-assured, safe and effective,” it said.
India’s drug regulatory authority had approved Covaxin and Covishield, the AstraZeneca vaccine produced in India by the Serum Institute of India, in early January. But while Covishield received WHO’s EUL listing on February 15 this year, WHO’s decision on Covaxin is awaited.
The delay has prompted sections of Indian researchers to contrast the speed at which India’s drug regulatory authority had approved Covaxin — even before Bharat Biotech had made public the results of its vaccine’s efficacy trials — and the diligence they say is evident in the WHO’s process.
Bharat Biotech had published a paper describing the efficacy trial results in early July on an archive for research preprints, but some scientists have expressed concern that the paper had not been published in a peer-reviewed medical journal until early October.
India’s Covid-19 vaccination campaign currently relies primarily on Covishield and Covaxin. But among the 920 million vaccine doses administered till Tuesday, around 820 million are Covishield and about 100 million are Covaxin.
An EUL from the WHO is expected to ease restrictions on international travel for recipients of Covaxin in the country.
