Ocugen has announced plans to seek full approval from the US Food and Drug Administration (FDA) for Covid-19 vaccine candidate, Covaxin.
The company received feedback from the FDA on its previously submitted Master File.
The regulator recommended the company submit a biologics license application (BLA) instead of an Emergency Use Authorization (EUA) application for the vaccine candidate.
The FDA also requested additional information and data and Ocugen is in talks with the agency regarding the further information needed for a BLA submission.
The company expects that the data from an additional clinical trial will support the application.
Ocugen CEO, co-founder and board chairman Dr Shankar Musunuri said: “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.
“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.”
India-based Bharat Biotech developed Covaxin in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).
It is a purified and inactivated vaccine that is made using a vero cell manufacturing platform, which has an established safety record.
To date, the vaccine candidate has shown an efficacy rate of 78% overall efficacy and 100% in severe Covid-19 cases.
Recently, Ocugen also secured exclusive rights to market the vaccine candidate in Canada and has started talks with Health Canada for regulatory approval.