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Hyderabad: Ocugen, Bharat Biotech’s US partner for the COVID-19 vaccine Covaxin, on Wednesday said it has submitted an Investigational New Drug Application (IND) to the US Food and Drug Administration for conducting clinical trials.
The development comes a day after the World Health Organization asked Bharat Biotech for more details to consider its COVID-19 vaccine Covaxin for emergency use list.
The proposed phase 3 trial in India, the US firm said in a press release, is designed to establish whether the immune response experienced by participants in the completed phase 3 efficacy trial in India is demographically representative, similar to that observed in a healthy adult. Is. Population in the United States.
The US drug regulator had earlier in June “recommended” OcuGen Inc to go for the Biologics License Application (BLA) route with additional data instead of the Emergency Use Authorization (EUA).
The proposed trial could be for people who have either not been vaccinated for COVID-19 or who have received two doses of mRNA vaccine at least six months ago in the United States.
“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 hope that the study under IND, if allowed to proceed, will help demonstrate that the India data is applicable to the US population,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co. -Founder Okugain 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 US subjects, 28 days apart, to receive two doses of Covaxin or a placebo. to be randomised.
The Phase III study conducted in India by Ocugen’s business partner, Bharat Biotech, involved 25,798 participants who received either two doses of Covaxin or a placebo, spaced 28 days apart.
Ocugen has already sought regulatory approval from Health Canada for the use of Covaxin in that country.
Covaxin is a fully inactivated COVID-19 screening vaccine candidate that uses the same Vero cell manufacturing platform that has been used for decades in the production of the polio vaccine.
Read also: Bharat Biotech’s Covaxin may get WHO recommendation ‘within next 24 hours’
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