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Covaxin yet to get EUL, WHO seeks 'additional clarifications' from Bharat Biotech

The Covaxin jab has been approved in 14 countries and 70 million doses have been distributed overseas, Bharat Biotech told World Health Organisation.

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Covaxin yet to get EUL, WHO seeks 'additional clarifications' from Bharat Biotech
(Image Source: Reuters)
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It seems that Hyderabad-based Bharat Biotech has to wait for some time more to get an Emergency Use Authorisation for its indigenously-made COVID-19 vaccine 'Covaxin' from the World Health Organisation (WHO). Once Covaxin gets a EUL the vaccine will be eligible for distribution to low and middle-income countries under the COVAX facility.

During its technical advisory group meeting on Tuesday to review data on Covaxin, WHO sought 'additional clarifications' from Bharat Biotech for a final 'risk-benefit assessment' before recommending the vaccine for emergency use.

The next meeting of the technical advisory group is scheduled for November 3 for a final assessment. Bharat Biotech had submitted EOI (Expression of Interest) to the WHO on April 19 for Covaxin's Emergency Use Listing (EUL).

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.

The World Health Organisation (WHO) said it expects to receive these clarifications from Bharat Biotech by the end of this week. Last week, the WHO had said it is expecting one 'additional piece' of information from Bharat Biotech regarding Covaxin.

The WHO said there needs to be a thorough evaluation to ensure vaccines are safe and 'cannot cut corners' before it is recommended for emergency use. India's first indigenous COVID-19 vaccine Covaxin made by Hyderabad-based Bharat Biotech demonstrated 77.8% efficacy in its Phase 3 clinical trial.

In June, Bharat Biotech said it concluded the final analysis of Covaxin efficacy from Phase 3 trials. The Covaxin jab has been approved in 14 countries and 70 million doses have been distributed overseas, Bharat Biotech told WHO.

(With Agency Inputs)

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