India-Produced COVID-19 Vaccine Booster Demonstrates Robust Immune Responses and Long-Term Safety

Pennsylvania-based Ocugen, Inc. announced on January 8, 2022, that its partner in India, Bharat Biotech, posted positive results from a Phase 2 analysis of the COVAXIN™ (BBV152) vaccine booster program.

Study participants ages 12-64, receiving a booster dose six months following a second dose, saw a significant increase in neutralizing titers, an important predictor of vaccine efficacy.

And, the booster dose analysis also found no serious adverse events, including hospitalization or death, were reported.

COVAXIN is an investigational vaccine candidate product in the U.S., but 180 million doses have been administered in 17 countries.

Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder, Ocugen, Inc., stated in a press release, "These booster data provide critical information about how COVAXIN™ can be used in the ongoing battle against COVID-19."

"We are encouraged by these results which continue to suggest that COVAXIN™ remains an important, broad-spectrum vaccine candidate with durability."

Additional data from the analysis found that more than 75% of all participants had a detectible neutralizing antibody response six months post their second dose of COVAXIN.

Wild-type neutralizing antibodies (PRNT50) GMTs at one month after a booster dose against Alpha, Beta, Delta, and Delta plus variants were increased ten ·9, 161·0, 264·7, and 174·2 fold from baseline at six months post the second dose, respectively.

"Based on emerging data, a third dose may be beneficial to maintain the highest levels of protection," commented Huma Qamar, MD, MPH, CMI, Associate Vice President, Clinical Development, Ocugen, Inc.

COVAXIN was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research - National Institute of Virology. COVAXIN is a highly purified and inactivated vaccine manufactured using a vero cell manufacturing platform.

Ocugen, Inc. is a biopharmaceutical company located in Malvern, PA, focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19.