The United States Food and Drug Administration (FDA) on June 11 rejected Bharat Biotech’s proposal for an emergency use authorisation (EUA) of its Covid-19 vaccine Covaxin, postponing the company’s vaccine launch in America.
The US partner for Bharat Biotech, Ocugen Inc., on June 10 said the company would now be seeking full approval for Covaxin. This is a result of the US FDA asking Ocugen to launch another trial to file for a Biologics License Application (BLA) for full approval.
“The company will no longer pursue an EUA for Covaxin,” stated Nguyen. “The FDA provided feedback on Ocugen regarding the Master File. The company earlier had submitted and recommended Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional data and information.”
The company is trying to understand what additional information could be required to support a BLA submission, and thus it is in discussion with the FDA. However, Ocugen speculates that additional trial data will be needed to back up the submission.
“Though we were close to finalising our EUA application for submission, we received a recommendation from the FDA to follow a BLA path,” said Dr Shankar Musunuri, Chairman of the Board, CEO and Co-founder of Ocugen. “While this will extend our timelines, we are committed to bringing Covaxin to the US.”
“This distinguished vaccine is a vital tool to include in our national arsenal given its potential to combat the SARS-CoV-2 variants, including the delta strain, and given the uncertainty about what will be required to protect the American population in the long term,” he added.
Ocugen Inc. recently announced its secured exclusive rights to commercialise Covaxin in Canada and has initiated a talk with Health Canada for regulatory approval. The company will seek expedited authorisation for the vaccine under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in link with Covid-19 in Canada.