Bharat Biotech's proposal for an emergency use authorisation (EUA) of its COVID-19 vaccine, Covaxin, has been rejected by the US Food and Drug Administration (FDA).
This has delayed the Indian drug maker's vaccine launch in America. Ocugen, the US partner of Bharat Biotech had applied for the EUA with FDA.
The company said on Thursday that it would no longer seek emergency approval for Covaxin, and would rather file for full approval of the anti-COVID shot.
Ocugen added that the decision was based on a recommendation put forth by the US FDA asking the company to launch an additional clinical trial so that it can file for a Biologics Licence Application (BLA), which is a full approval.
"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," said a statement from Ocugen to NYSE.
The company stated that it expects data from an additional clinical trial will be required to support the marketing application submission for Covaxin.
"While this will extend our timelines, we are committed to bringing COVAXIN to the US," Ocugen Chief Executive Officer Dr. Shankar Musunuri said.
The US-based biopharma player is co-developing Covaxin with Hyderabad-based Biotech for the US market.
Ocugen recently secured exclusive rights to market the vaccine in Canada and has started discussions with Health Canada for regulatory approval, it said.