FDA rejects emergency use of Bharat Biotech's Covaxin
New Delhi : The US Food and Drug Administration (FDA) on Thursday rejected Bharat Biotech's proposal for emergency use of its coronavirus vaccine - Covaxin, delaying its official launch in the country. Ocugen, the US partner of Bharat Biotech, on Thursday said the company will now be seeking a full approval of Covaxin.
The emergency use proposal was rejected as 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.
“The FDA provided feedback to Ocugen regarding the Master File the Company had previously submitted and recommended that Ocugen pursue a BLA submission instead of a EUA application for its vaccine candidate and requested additional information and data," said a statement from Ocugen to NYSE. Adding that the company is in discussions with the FDA on the additional documents required to clear its application. “While this will extend our timelines, we are committed to bringing Covaxin to the US," a report by Mint quoted Shankar Musuniri, chief executive of Ocugen.
The development comes at a time when Covaxin is under severe criticism for not sharing its data of Phase 3 trials even after six months of it being used for the country's immunization program.
No official comment has come so far from Bharat Biotech on the matter.