Ocugen Files with U.S. FDA for Phase 3 Clinical Trial of COVID-19 Vaccine Candidate COVAXIN

 The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population

Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that it has submitted an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) 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.

https://finance.yahoo.com/news/ocugen-inc-announces-submission-investigational-103500850.html