Covaxin nod: WHO seeks more data

Millions of Indians have taken Covaxin shot produced by Bharat Biotech but many have been unable to travel pending the WHO approval. (Source: The Hindu)

The World Health Organisation’s technical advisory group on Tuesday sought “additional clarifications” from Bharat Biotech for its COVID-19 vaccine Covaxin to conduct a final “risk-benefit assessment” for Emergency Use Listing of the vaccine.

The technical advisory group will now meet on November 3 for a final assessment.

Hyderabad-based Bharat Biotech had submitted an EOI (Expression of Interest) to the WHO on April 19 for Emergency Use Listing (EUL) of Covaxin.

The technical advisory group met on Tuesday to review data. “The TAG met today (26 October 2021) and decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine,” the WHO said in an email response.

“The TAG expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, 3 November,” it added.

The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that provides recommendations to WHO on whether a Covid 19 vaccine can be listed for emergency use under the EUL procedure.

Earlier Tuesday, WHO spokesperson Dr Margaret Harris had said that on COVAXIN, the technical advisory group that reviews all the data for a potential emergency use listing was reviewing that data.

"Now if all is in place, and all goes well, and if the committee is satisfied, we would expect a recommendation within the next 24 hours or so,” she had said during a press briefing.