In a major blow to the indigenous vaccine maker of India , Bharat-BioTech, United States Food and Drug Administration (USFDA) has rejected the company’s proposal to grant emergency use authorisation.
Ocugen, the US partner of Bharat Biotech, on Thursday said the company will now be seeking a full approval of Covaxin. This is a consequence of the US FDA asking the company to launch an additional trial so that the company can file for a Biologics Licence Application (BLA), which is a full approval.
This comes as the company has also failed to release its data of Phase III trials in India. Notably authorisation from USFDA, EU or WHO is necessary for vaccine makers to cross international borders.