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Ocugen Inc., the US partner of Bharat Biotech International Ltd for its Covid-19 vaccine, Covaxin, has submitted an Investigational New Drug application (IND) with the US Food and Drug Administration (FDA) seeking approval to conduct phase 3 studies in the US.
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 who either have not been vaccinated for Covid-19 or who already received two doses of an mRNA vaccine at least six months earlier.
“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,” Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen said in a release.
“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,'' he added.
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 US Subjects will be randomized to receive either two doses of Covaxin or placebo, 28 days apart.
The primary endpoint will compare blood-based samples taken from US participants who received Covaxin with samples of the participants in the Phase 3 efficacy trial conducted in India. The secondary endpoint involves testing the vaccine’s immunogenic profile. The study will also evaluate safety and tolerability in the US population. Ocugen hopes to complete the study during H1 2022.
The Phase 3 study conducted in India by Hyderabad-based Bharat Biotech, involved 25,798 participants receiving two doses of Covaxin or placebo, 28 days apart.
Covaxin is now being administered as part of the public vaccination program along with Serum Institute's Covishield and Russian vaccine Sputnik V.
Ocugen had earlier submitted an application to FDA seeking Emergency Use License for Covaxin but was told by the US FDA to apply for a regular approval.
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