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BusinessBharat Biotech's US partner Ocugen submits application with FDA for phase 3...

Bharat Biotech’s US partner Ocugen submits application with FDA for phase 3 Covaxin trial

Published: 27th Oct 2021 8:09 pm

Ocugen, the US partner of Bharat Biotech, has submitted an investigational new drug (IND) application with the US Food and Drug Administration (FDA) to evaluate the Covid-19 vaccine candidate, BBV152, known as Covaxin outside the United States.

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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 is taking this next step in the development of Covaxin, which it hopes will bring it closer to introducing a different type of Covid-19 vaccine to the American public, said Dr Shankar Musunuri, chairman of the Board, CEO & Co-founder of Ocugen.

“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,” Musunuri added.

Immuno-bridging study

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 randomised to receive either two doses of Covaxin or placebo, 28 days apart.

According to Ocugen, 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 the first half of 2022.

India trial

The phase 3 study conducted in India by Bharat Biotech, involved 25,798 participants receiving two doses of Covaxin or placebo, 28 days apart. The primary endpoint was preventing symptomatic Covid-19 occurring at least 14 days after the second dose.

Results of the trial found 93.4 per cent efficacy against severe Covid-19 disease, 77.8 per cent efficacy against symptomatic Covid-19 and 63.6 per cent efficacy against asymptomatic disease.

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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