Bharat Biotech's partner seeks full approval for Covaxin in US

Ocugen, the US partner for Bharat Biotech’s Covid-19 vaccine, said on Thursday that it will pursue submission of a biologics licence application (BLA) for Covaxin, instead of emergency-use authorisation (EUA) as originally planned.

This follows the recommendation of the USFDA and it means that, subject to regulatory approvals, it will take a longer time for Covaxin to be launched in the US. Submission of a BLA represents pursuit of full approval for the vaccine, rather than initial approval under an emergency-use authorization.

“Upon recommendation from the US Food and Drug Administration , it will pursue submission of a biologics licence application for its Covid-19 vaccine candidate, Covaxin. The company will no longer pursue an emergency use authorization for Covaxin,” it said.


The company said it anticipates that data from an additional clinical trial will be required to support the submission.

“Although we were close to finalizing 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,” Shankar Musunuri, chief executive officer of Ocugen said in a statement.

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

Ocugen recently said that it secured exclusive rights to market the vaccine in Canada and had initiated discussions with Health Canada for approval.