 "Bharat Biotech's US partner Ocugen files request to FDA for Covaxin trials")
Ocugen, Bharat Biotech's US partner for COVID-19 vaccine Covaxin, on Wednesday said it has submitted Investigational New Drug Application (IND) to the US Food and Drug Administration to conduct clinical trials.
The development comes a day after the World Health Organisation sought more details from Bharat Biotech to consider its COVID-19 vaccine Covaxin for Emergency Use Listing.
The US firm in a press 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 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 U.S. population, " Dr Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen said.
If the study is allowed to proceed, Ocugen's Phase 3 immuno-bridging study, OCU-002, will seek to enroll several hundred healthy adults in the U.S. Subjects will be randomized to receive either two doses of Covaxin or placebo, 28 days apart.
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The Phase 3 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.
Covaxin is a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades.
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