The US Food and Drug Administration (FDA) has recommended Ocugen, the US partner of Indian vaccine maker Bharat Biotech, to pursue a final approval for COVID-19 vaccine Covaxin instead of getting Emergency Use Authorisation (EUA).
Ocugen will now pursue submission of a biologics licence application (BLA) for Covaxin. The BLA is a full approval mechanism by the FDA for drugs and vaccines.
The pharma firm is in talks with the FDA regarding the additional documents and information required for the BLA submission to bring Covaxin to the US.
The US drug regulator had last month revised the guidelines for COVID-19 vaccine approvals and said that they will no longer grant EUAs to new vaccine applications.Watch the video for more.