The US Food and Drug Administration (FDA) has disapproved Ocugen’s application for an emergency use authorization (EUA) of Bharat Biotech’s Covaxin.
The FDA rejection shows an indication of delay in Covaxin’s launch in the US. Bharat Biotech’s US partner Ocugen said it would no longer follow the emergency use authorization for Covaxin. Now, it will aim to file for a full US approval of the anti-COVID shot.
The FDA has requested additional information and data on Bharat Biotech’s vaccine. In addition, Covaxin has been facing denunciation in India for not sharing its Phase-3 trial data, despite being approved by India’s top drug regulator, the Drugs Controller General of India (DCGI), six months ago.
Revising its guidelines for emergency use authorization, the US FDA earlier had said that it would not please such new requests. Bharat Biotech is currently carrying out the Phase-3 trials for Covaxin. According to the sources, it will make all the data public by July.