In a 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 (EUA).

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. The 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 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.