Bharat Biotech to carry out clinical trials of Covaxin in the United States

COVID-19 vaccine manufacturer Bharat Biotech announced on Saturday that it will be conducting clinical trials in the United States to support the marketing application for Covaxin.

After the Hyderabad-based company hit a roadblock in securing Emergency Use Authorisation for its vaccine, the company’s US partner, Ocugen, said it would follow the biologics licence application (BLA) route to seek full licensure of Covaxin in the US.

Ocugen in a statement on Thursday announced that as recommended by the Food and Drug Administration, it will pursue submission of a biologics licence application (BLA) for Covaxin. BLA is a "full approval" mechanism by the FDA for drugs and vaccines.

“The company will no longer pursue an Emergency Use Authorization (EUA) for Covaxin. 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," Ocugen said.

V K Paul, member, health, NITI Aayog, said at a press briefing on Friday: “We respect their (USFDA’s) decision and we expect that our manufacturer will be able to comply with whatever is required to be done. Their decision has no bearing on our programme. Our regulator has approved it. We have so much data on safety.”

Covaxin gets emergency use authorisation from 14 countries

Covaxin has made a massive leap into the global market as it announced that it has obtained the Emergency Use Authorization (EUA) in 14 countries with more to follow. The EUA obtained in 14 countries which means that Covaxin could soon begin circulation in these countries. The Hyderabad-based pharma company last month had said that regulatory approval for its COVID-19 vaccine, developed in partnership with the ICMR, is under process in over 50 countries overall including Brazil, Hungary, and others. Till now, Covaxin is yet to secure entry to WHO Emergency Use Listing of COVID vaccines.