Covaxin Clinical Trials: Bharat Biotech’s US Partner Ocugen Files Request With FDA

“We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population,” he added.

New Delhi: Bharat Biotech’s US partner for Covid-19 vaccine Covaxin, Ocugen, on Wednesday said it has submitted Investigational New Drug Application (IND) to the US Food and Drug Administration to conduct clinical trials.

“We are very excited to take this next step in the development of Covaxin, which we hope will bring us, closer to introducing a different type of COVID-19 vaccine to the American public,” said Dr Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen, PTI reported.

READ: WHO Seeks 'Additional Clarifications' From Covaxin Before Giving Nod To Emergency Use Listing

“We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population,” he added.

This comes a day after the World Health Organisation (WHO) sought more details from Bharat Biotech to consider its Covid-19 vaccine Covaxin for Emergency Use Listing.

 

The firm in a release said the Phase 3 trial, proposed in the IND, is designed to establish whether the immune response experienced by participants in a completed Phase 3 efficacy trial in India is similar to that observed in a demographically representative, healthy adult population in the US.

Earlier in June, the US drug regulator recommended Ocugen Inc to go for Biologics Licence Application (BLA) route with additional data instead of Emergency Use Authorisation (EUA).

Ocugen has already sought regulatory approval from Health Canada for Covaxin to be used in that country.