FDA Has Rejected Covaxin’s Emergency Use In America; Here’s Why

In a big jolt to Bharat Biotech, the US Food and Drug Administration on Friday rejected its proposal for an emergency use authorization (EUA) of its Covid-19 vaccine Covaxin.

The drug regulator has “recommended” Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data instead of EUA (Emergency Use Authorisation) application for its vaccine candidate. According to a  statement issued Thursday, the biopharmaceutical company, which has inked a deal with Bharat Biotech for the supply of Covaxin to the US said that it will pursue submission of a biologics license application (BLA) for Covaxin as recommended by the FDA. Notably, BLA is a “full approval” mechanism by the FDA for drugs and vaccines.

“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 a EUA application for its vaccine candidate and requested additional information and data,” Ocugen said.

The development may delay the Covaxin launch in the US. “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. 

He added, “This differentiated vaccine is a critical tool to include in our national arsenal given its potential to address the SARS-CoV-2 variants, including the delta variant, and given the unknowns about what will be needed to protect US population in the long term.”

The rejection of emergency authorization was large because the company (Occugen) submitted partial data from the Covaxin trial only in March this year, but the USFDA had issued a revised guideline for covid vaccine approval last month that said it will no longer grant emergency authorization to new applications.

Ocugen in a statement provided the reason for the FDA’s rejection of Covaxin’s emergency use. “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 a EUA application for its vaccine candidate and requested additional information and data,” Ocugen informed NYSE in a statement.

With PTI inputs