Biopharmaceutical Ocugen, who is the US partner of the Indian vaccine maker, said that the US Food and Drug administration has denied the emergency use approval (EUA) for Bharat Biotech’s Covaxin, and has also asked for additional data related to the vaccine.

US FDA had recommended that Ocugen should pursue a Biologics Licence Application (BLA) submission as an alternative for a EUA application and has requested the additional information and data related to it. Ocugen projected that the data from additional clinical trials will be required to support the submission. 

Ocugen’s Shankar Musunuri said that they are close to finalising their EUA application when they received FDA’s recommendation to follow a BLA path. This will extend the timelines, butthey are committed to bring Covaxin to the US.

Source: ET Healthworld