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WHO seeks clarifications from Bharat Biotech on Covaxin, to meet on Nov 3 for ‘final assessment’

WHO clearance is a crucial step in Covaxin being accepted by foreign governments. EUL is important to remove uncertainty around overseas travel by Indians inoculated with this vaccine.

Written by Kaunain Sheriff M | New Delhi |
Updated: October 27, 2021 12:01:42 pm
The Covaxin vaccine is developed by Bharat Biotech (File photo)

The World Health Organization (WHO) Tuesday said the Technical Advisory Group (TAG) for Emergency Use Listing (EUL) has decided that additional clarifications from Hyderabad-based Bharat Biotech are needed to conduct a final EUL risk-benefit assessment for global use of Covaxin.

In an e-mail response to The Indian Express on the outcome of the meeting that took place Tuesday on the grant of EUL to Covaxin, the WHO said 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”.

“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 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,” WHO told The Indian Express.

Last Monday, WHO had said it was expecting “one additional piece of information” from Bharat Biotech on Covaxin, which is being examined by WHO’s experts for grant of EUL.

In a series of tweets, the WHO said it could not “cut corners”, and that the timeframe for its Emergency Use Listing was dependent on how quickly vaccine manufacturers were able to provide the required data.

“We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the #COVID19 Emergency Use Listing, but we cannot cut corners — before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective,” the WHO had said.

WHO clearance is a crucial step in Covaxin being accepted by foreign governments. EUL is important to remove uncertainty around overseas travel by Indians inoculated with this vaccine. EUL is also a prerequisite for a vaccine to be supplied through COVAX.

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