US FDA REJECTS EMERGENCY NOD FOR COVAXIN, SEEKS MORE INFO

In setback that could potentially delay the launch of Bharat Biotech’s Covid-19 vaccine Covaxin in USA, the Food and Drug Administration there has “recommended” Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.

Bharat Biotech said the BLA path is for full approval instead of emergency use authorisation. “All applications have to follow the BLA process, which is the standard process for vaccines.”. The company said no vaccine manufactured or developed in India has ever received emergency use approval or full licensure from FDA.