India's COVID-19 Vaccine Remains Available and Effective

Ocugen Inc. announced positive results from the Phase 2/3, an observer-blind, immuno-bridging, and broadening the study of the COVID-19 vaccine, COVAXIN™.

Invented by Bharat Biotech in India, COVAXIN (BBV152) is a whole-virion inactivated COVID-19 vaccine that uses the same vero cell manufacturing platform used in the production of polio vaccines for decades.

This study enrolled 419 U.S. adult participants that were randomized 1:1 to receive two doses of COVAXIN™ or placebo, 28 days apart.

Approximately 24% of tested participants in the U.S. were vaccine-naïve.

COVAXIN was found to be well-tolerated in vaccine-naïve individuals and individuals previously vaccinated with mRNA vaccines in the U.S., with no vaccine-related serious adverse events, thrombotic events, or cases of myocarditis or pericarditis

Blinded safety data are also available for one month following vaccination.

There were no deaths related to potential immune-mediated medical conditions. 

“The successful completion of this study represents an important milestone to the ongoing management of COVID-19,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen, in a press release on January 9, 2023.

“Given that a portion of the public remains hesitant to receive mRNA vaccines, this COVID-19 vaccine ... may provide an important additional vaccine option.”

COVAXIN is currently approved for adults in India and authorized under emergency use in 25 countries, with more than 350 million doses administered to adults outside the U.S.

And COVAXIN is listed by the World Health Organization but not approved by the U.S. Food and Drug Administration as of January 10, 2023.