In a setback to the Hyderabad-based Bharat Biotech, the US FDA has rejected its proposal for an emergency use authorisation (EUA) of its Covid vaccine, delaying the company’s vaccine launch in that country. The Indian Government here, however, asserted that it will have no impact whatsoever on India’s vaccination programme.

Ocugen, the US partner of Bharat Biotech, had recently said the company will now be seeking a full approval of Covaxin. This is after the US FDA asked the company to launch an additional trial so that it 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 an EUA application for its vaccine candidate and requested additional information and data,” said a statement from Ocugen, 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,” said Shankar Musuniri, chief executive of Ocugen.

This development comes at a time when Bharat Biotech is under criticism in India for not sharing data from its phase 3 clinical trials almost six months after the company’s vaccine was included in India’s immunization programme.

Responding to a question on the denial to Covaxin, NITI Aayog member (Health) V K Paul said each country has its own regulatory system which India respects and hoped that the manufacturer will be able to comply with it by doing whatever requires to be done.

“Each country has its own regulatory system. Some parameters might be common while some might be different which we respect. Our country’s regulatory system also takes decisions in a similar manner. The scientific framework is the same but nuancing is in context... These are scientific considerations especially in those countries where science is strong and for us manufacturing is strong,” he said.

“We expect that our manufacturer will be able to comply with it by doing whatever requires to be done. It will have no impact whatsoever on our programme clearly. We are satisfied our regulator has approved it. We have so much data on safety and so much data on phase-3 trials that has been screened by them,” Paul added.

He further said that the phase 3 publication of Covaxin will also come in 7-8 days which is beyond data shared with DCGI.