No Nod for Covaxin Yet as WHO Seeks More Data, Final Assessment Likely on November 3

The World Health Organization (WHO) on Tuesday once again postponed granting approval to India’s indigenous Covid-19 vaccine Covaxin, seeking more technical details to conduct a final ‘risk-benefit assessment’.

The global body — which was reviewing data on India’s Covaxin shot against Covid-19 to grant Emergency Use Listing (EUL) — has sought additional information from Hyderabad-based Bharat Biotech to conduct a final “risk-benefit assessment” for approving the vaccine for global use.

The organisation expects to receive the information by the “end of this week” and plans to conduct the final assessment on November 3. Bharat Biotech had submitted the request for granting EUL to the WHO on April 19, 2021.

While the process has already taken more than six months so far, the WHO told News18.com in an emailed response that “duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on those data meeting WHO criteria.”

The WHO said that “the technical advisory group (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.”

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.

It further said that “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.”

On being asked the nature of technical query that WHO has sought from Bharat Biotech, WHO told News18.com that “Submissions to WHO for prequalification or listing under the emergency use procedure are confidential.”

It further added that “if a product submitted for assessment is found to meet the criteria for listing, WHO will publish the results widely.”

The approval of Covaxin holds importance for millions of Indians who have taken the vaccine but are unable to travel pending the WHO approval. WHO’s approval will help international travel for Indians, including students and businessmen, who plan to travel to countries where a vaccination certificate for WHO-approved vaccines is compulsory.

Till October 25, around 11.70 crores doses of Covaxin have been administered in India among different age groups above 18.

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