United States drug regulator has rejected the proposal for Covaxin to be used under emergency authorization.
Bharat Biotech's US arm Ocugen said that the FDA has asked the company to launch an additional trial so that it can file for for a full approval.Bharat Biotech’s US partner stated, “The FDA provided feedback and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data.” BLA is Biologics Licence Application which is a full approval.
Ocugen however remains committed to the aim of bringing the home grown Indian vaccine to the US markets even as Bharat Biotech faces flak in India for not sharing data from its phase 3 clinical trials almost six months after the company’s vaccine was included in the vaccination drive.