Covaxin approval: WHO seeks additional clarification from Bharat Biotech, decision likely on November 3

The technical advisory group met on October 26 to review data on Covaxin for the emergency use listing of indigenously-made vaccine (File image of a vial of Covaxin vaccine)

The technical advisory group of the World Health Organisation on October 26 sought "additional clarifications" from Bharat Biotech to conduct a final "risk-benefit assessment" for Emergency Use Listing of its COVID-19 vaccine.

The statement came hours after WHO official Dr Margaret Harris had said that a recommendation was expected within the next 24 hours.

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

Read | 'If all goes well' Covaxin to get WHO nod within 24 hours

The technical advisory group met on October 26 to review data on Covaxin for the emergency use listing of indigenously-made vaccine.

"The WHO independent TAG met today & asked for additional clarifications from the manufacturer BharatBiotech to conduct a final EUL risk-benefit assessment for global use of Covaxin. It will reconvene for the final assessment on Wednesday, 3 November if data is received soon," WHO Chief Scientist Soumya Swaminathan tweeted.

Update: The @WHO independent TAG met today & asked for addnl clarifications from the manufacturer @BharatBiotech to conduct a final EUL risk-benefit assessment for global use of #Covaxin. It will reconvene for the final assessment on Wednesday, 3 November if data received soon

— Soumya Swaminathan (@doctorsoumya) October 26, 2021

Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted EOI (Expression of Interest) to the WHO on April 19 for the vaccine's Emergency Use Listing (EUL).

Earlier in the day, 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.

The Covaxin has demonstrated 77.8 percent effectiveness against symptomatic cases and 65.2 percent protection against the new Delta variant.

Last week, the WHO had said it is expecting one additional piece of information from Bharat Biotech regarding Covaxin and emphasised that it has to thoroughly evaluate to ensure vaccines are safe and “cannot cut corners” before recommending a vaccine for emergency use.