FDA denies Bharat Bio’s US partner emergency approval for Covaxin vaccine

 US FDA has “recommended” Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application route with additional data, nixinghopes of Emergency Use Authorisation

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. Ocugen is in discussions with the FDA to understand the additional information required to support a BLA submission.

The company anticipates that data from an additional clinical trial will be required to support the submission. “Although we were close to finalising our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the US,” Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer and co-founder of Ocugen said.