Bharat Biotech US partner Ocugen files for clinical trials of Covaxin
Malvern: Ocugen, Inc., has announced that the company has submitted an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (USFDA) to evaluate the COVID-19 vaccine candidate, BBV152, known as COVAXIN outside the United States.
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.
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 U.S. 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," said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and 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 U.S. population."
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. The primary endpoint will compare blood-based samples taken from U.S. 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 U.S. population. Ocugen hopes to complete the study during H1 2022.
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. The primary endpoint was preventing symptomatic COVID-19 occurring at least 14 days after the second dose. Results of the trial found 93.4% efficacy against severe COVID-19 disease, 77.8% efficacy against symptomatic COVID-19 and 63.6% efficacy against asymptomatic disease. A sub-analysis of the Phase 3 study examined the presence of infections by variants of the original coronavirus strain. Overall, 90% of infections showed the presence of a variant, with 59% of those being the Delta variant. The sub-analysis revealed COVAXIN-treated patients experienced 65.2% efficacy against the Delta variant.
Read also: Give additional information on Covaxin: WHO tells Bharat Biotech
