Bharat Biotech’s US partner Ocugen files request with FDA for Covaxin trials

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

The development comes a day after the World Health Organization (WHO) sought more details from Bharat Biotech to consider its COVID-19 vaccine Covaxin for Emergency Use Listing (EUL).

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

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

The proposed trial can be to people who either have not been vaccinated for COVID-19 or who already received two doses of an mRNA vaccine at least six months earlier in the USA.

“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. 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 US population, ” Dr Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and co-founder, Ocugen, said.

If the study is allowed to proceed, Ocugen’s phase-III immuno-bridging study, OCU-002, will seek to enroll several hundred healthy adults in the US Subjects will be randomised to receive either two doses of Covaxin or placebo, 28 days apart.

The phase-III study conducted in India by Ocugen’s business partner, Bharat Biotech, involved 25,798 participants receiving two doses of Covaxin or placebo, 28 days apart.

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