Ocugen files Covaxin IND application with USFDA, seeks nod for Phase-3 trial in US

HYDERABAD: Ocugen Inc, Bharat Biotech’s US and Canada partner for indigenously developed Covid-19 vaccine Covaxin, has submitted an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for Covaxin and has sought permission for conducting a Phase-3 trial in the US as part of the IND. Ocugen said that if approved, it expects to complete the study during the first half of 2022.
“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,” Ocugen said ion Wednesday.
If Ocugen gets a nod, the Phase 3 immuno-bridging study, OCU-002, will seek to enroll several hundred healthy adults in the US. The participants will be randomized to receive either two doses of Covaxin or placebo, 28 days apart, Ocugen said.
“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,” Ocugen said.
In the Indian Phase-3 trials, which was conducted on 25,798 participants, the whole virion inactivated vaccine demonstrated an overall efficacy of 77.8% against symptomatic Covid-19 disease and a 65.2% efficacy against the Delta variant. The vaccine also showed a 93.4% efficacy against severe Covid-19 and 63.6% efficacy against asymptomatic disease in the Indian 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. 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, CEO, and co-founder of Ocugen said.