WHO seeks additional clarifications for Covaxin approval
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New Delhi: The World Health Organisation'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 WHO's Technical Advisory Group in a meeting on Tuesday agreed to conduct the final risk assessment after receiving additional data from the manufacturer.
"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.
Hyderabad based Bharat Biotech is expected to submit the data by this weekend. The Technical Advisory Group may meet for the final risk-benefit assessment on November 3. The company also submitted additional info at WHO's request on September 27.
The Technical Advisory Group for Emergency Use Listing (TAG-EUL) provides recommendations to WHO on whether a Covid 19 vaccine can be listed for emergency use under the EUL procedure.
