Covaxin’s emergency approval push in US fails

Covaxin manufacturer Bharat Biotech, which is already drawing flak in India for the unusual delay in releasing its final phase 3 clinical trial results, got a fresh jolt as the US drug regulator declined emergency use authorisation for the vaccine in it’s country.

Indian authorities, however, claimed the US decision will have no bearing on the nation’s Covid vaccination drive, of which Covaxin apart from Covishield is a key element. The USFDA advised Bharat Biotech’s US partner Ocugen to take the biological license applications or full approval route instead for the approval.

Putting it in context, Bharat Biotech said the USFDA has already stopped issuing EUAs, since the country now has good herd immunity and a significant percentage of it’s population is vaccinated

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