US FDA Rejects Emergency Use Authorisation For Bharat Biotech's Covaxin

NEW DELHI: The US Food and Drug Administration (FDA) has rejected Bharat Biotech’s proposal for an emergency use authorization (EUA) of its Covid vaccine Covaxin.

Ocugen, Bharat Biotech's US partner, on June 10 said the company will now be seeking a full approval of Covaxin.

Earlier in June, Ocugen and Bharat Biotech announced that they have entered into an amendment to their co-development, supply, and commercialization agreement to expand Ocugen’s exclusive territory to commercialise Covaxin to now also include Canada.

Following US FDA's rejection, the US biopharmaceutical company announced that tit will pursue submission of a biologics license application (BLA) for its COVID-19 vaccine candidate and the Company will no longer pursue an Emergency Use Authorization (EUA) for Covaxin.(Inputs from Agencies)

 

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