WHO seeks 'additional clarifications' from Bharat Biotech for Covaxin to conduct final 'risk-benefit assessment'

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

The technical advisory group met on Tuesday to review data on Covaxin for the emergency use listing of India’s indigenously-made vaccine.

Also read: Vaccinated but stuck: Indians await WHO nod for Covaxin to travel abroad

"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 to a question by PTI on the decision regarding the Emergency Use Listing of Covaxin.

"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.

The Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic Covid-19 and 65.2 per cent protection against the new Delta variant. In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.

Bharat Biotech's Covaxin and AstraZeneca and Oxford University's Covishield are the two widely used vaccines in India.

The WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use.

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.

WHO has said the timeframe for its Emergency Use Listing procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for WHO to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries.

"When the information provided addresses all questions raised, WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation whether to grant Emergency Use Listing to the vaccine,” it has said.

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