Benzinga | Jan 8, 2022 07:30PM EST

Ocugen Announced Partner Bharat Biotech's COVAXIN Booster Dose Study Demonstrated Robust Immune Responses and Long-Term Safety; Participants Receiving Booster Dose Six months after Second Dose Saw >10-Fold Increase Across Alpha, Beta, Delta and Delta Plus Variants in Neutralizing Titers vs Baseline

Ocugen, Inc. (NASDAQ:OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that its partner, Bharat Biotech, posted positive results from a Phase 2 analysis of the vaccine candidate, COVAXIN(tm) (BBV152), in participants ages 12-64, receiving a booster dose six months following a second dose on the pre-print server, medRxiv. The analysis found that participants receiving a booster dose saw a significant increase in neutralizing titers, an important predictor of vaccine efficacy.

"As the COVID-19 virus continues to evolve, so does our understanding of the efficacy of vaccines and the critical role they play in protecting people from serious disease, hospitalization and death," said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen, Inc. "These booster data provide critical information about how COVAXIN(tm) can be used in the ongoing battle against COVID-19. We are encouraged by these results which continue to suggest that COVAXIN(tm) remains an important, broad-spectrum vaccine candidate with durability."

Additional data from the analysis found that more than 75 percent of all participants had a detectible neutralizing antibody response six months post their second dose of COVAXIN(tm). After receiving the booster, participants also saw an increase in antibody titers (at day 28) that were higher than those achieved after the two-dose primary series. Wild-type neutralizing antibodies (PRNT50) GMTs at one month after a booster dose against Alpha, Beta, Delta and Delta plus variants were increased 109, 1610, 2647, and 1742 fold from baseline at six months post second dose, respectively.

"Although protection against severe disease remains high six months following the second dose, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected and consistent with what we are seeing with other vaccines. Based on emerging data, a third dose may be beneficial to maintain the highest levels of protection," said Huma Qamar, MD, MPH, CMI, Associate Vice President, Clinical Development, Ocugen, Inc.

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