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WHO panel seeks additional clarifications from Bharat Biotech for Covaxin approval

K V Kurmanath Hyderabad | Updated on October 27, 2021

The Technical Advisory Group to reconvene on November 3 for the final risk-benefit assessment.

Bharat Biotech will have to wait for some more time before getting the Emergency Use tag from the World Health Organisation (WHO) for its Covid-19 vaccine Covaxin.

The Technical Advisory Group for Emergency Use Listing (TAG-EUL), which met on Tuesday, has sought additional clarifications from the Hyderabad-based vaccine manufacturer.

“The TAG decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine,” a WHO statement said in response to a Business Line query on the outcome of the group’s discussions today.

The TAG expects to receive these clarifications from the manufacturer by the end of this week. “It will reconvene for the final risk-benefit assessment on November 3,” the WHO said in an email response.

The TAG 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.

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.

Published on October 27, 2021

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