FDA REJECTS NOD FOR EMERGENCY USE OF 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.

Ocugen in a statement on Thursday announced that as recommended by the FDA, it will pursue submission of a biologics licence application (BLA) for Covaxin. BLA is a “full approval” mechanism by the FDA for drugs and vaccines.

The development may delay the Covaxin launch in the US, Ocugen said. “The company will no longer pursue an Emergency Use Authorization (EUA) for Covaxin. The FDA provided feedback to Ocugen regarding the Master File. The company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data,” Ocugen said.

Talking about Covaxin rejection by USFDA, NITI Aayog member (Health) Dr V K told ANI, “It’s their decision, should be respected. Our regulator has endorsed licensure for this vaccine&there’s no impact on use of Covaxin in our national program...”