FDA Rejects Emergency Use for Covaxin, 'Suggests' Biologics Licence Application Route for US Approval

Hyderabad: In a setback to Bharat Biotech's COVID-19 vaccine Covaxin, the US Food and Drug Administration (FDA) 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.

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 an EUA application for its vaccine candidate and requested additional information and data," Ocugen said.

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

"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," he added.

Ocugen recently announced that it secured exclusive rights to commercialise Covaxin in Canada and has initiated discussions with Health Canada for regulatory approval.

The company will pursue expedited authorisation for the vaccine under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 in Canada.