No approval for Covaxin yet, WHO says ‘additional clarifications’ needed from Bharat Biotech

The World Health Organization (WHO) on Tuesday said “extra explanations” are required from Bharat Biotech in regards to its Covid-19 immunization ‘Covaxin’ for a last “hazard advantage evaluation” prior to suggesting the antibody for crisis use.

“The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an autonomous warning gathering that gives proposals to WHO on whether a Covid 19 antibody can be recorded for crisis use under the EUL methodology,” the WHO proclamation report said. 

“The TAG met today (October 26, 2021) and concluded that extra explanations from the producer are expected to direct a last EUL hazard advantage appraisal for worldwide utilization of the immunization,” the WHO said. 

The WHO said it hopes to get these explanations from Bharat Biotech before the current week’s over. 

“The TAG hopes to get these explanations from the producer before the current week’s over, and expects to reconvene for the last danger advantage appraisal on Wednesday, November 3,” the WHO said. 

Last week, the WHO had said it is anticipating one “extra piece” of data from Bharat Biotech with respect to Covaxin. The WHO said there should be an exhaustive assessment to guarantee immunizations are protected and “can’t compromise” before it is suggested for crisis use.

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