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WHO seeks ‘additional clarifications’ from Bharat Biotech to approve Covaxin

Bharat Biotech has been submitting data to WHO on a rolling basis and submitted additional information at the UN health body's request on September 27.

WHO seeks additional clarifications from Bharat Biotech to approve Covaxin-dnm
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Hyderabad, First Published Oct 27, 2021, 9:16 AM IST
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Bharat Biotech will have to wait for some more time before getting the Emergency Use approval from the World Health Organisation (WHO) for its Covid-19 vaccine Covaxin as the UN body has sought additional clarifications.

The WHO’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.

“The @WHO independent Technical Advisory Group (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 Dr Soumya Swaminathan said in a tweet.

Bharat Biotech has been submitting data to WHO on a rolling basis and submitted additional information at the UN health body's request on September 27.

"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.

Though a EUL is not required for countries to source the vaccines from the company, ratification of the vaccine by the WHO is vital when people travel abroad.

International travel presently requires people to get a vaccine that’s on the WHO’s approved list.

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.

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