US FDA REJECTS EMERGENCY NOD FOR COVAXIN, SEEKS MORE INFO
NEW DELHI: 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.
HYDERABAD : 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...”
SATURDAY JUNE 12, 2021