COVAXIN (BBV152) booster dose study shows promising results
The phase 2, double-blind, randomised controlled COVAXIN trial demonstrated long-term safety with no serious adverse events.
Hyderabad, January 8, 2022: Bharat Biotech, a global leader in vaccine innovation and developer of vaccines for infectious diseases, today announced the results from the highly anticipated trial studying the immunogenicity and safety of the COVAXIN (BBV152) a whole-virion inactivated COVID-19 vaccine as a booster dose.
This analysis re-emphasises Bharat Biotech’s continued efforts to stay ahead of COVID-19, and this update provides a comprehensive vaccine booster strategy. COVAXIN is the first vaccine (in India) to report safety and immunogenicity results from a booster clinical trial. The analysis showed, six months after a two-dose BBV152 vaccination series cell-mediated immunity and neutralising antibodies to both homologous (D614G) and heterologous strains (Alpha, Beta, Delta, and Delta plus) persisted above baseline, although the magnitude of the responses had declined.
Furthermore, Neutralising antibodies against homologous and heterologous SARS-CoV-2 variants increased 19 to 265 fold after a third vaccination. Booster BBV152 vaccination is safe and may be necessary to ensure persistent immunity to prevent breakthrough infections.
Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech, said, “These trial results provide a strong foundation towards our goal to provide COVAXIN as a booster dose. Our goals of developing a global vaccine against COVID-19 have been achieved. COVAXIN is now indicated for adults, children, 2 dose primary and booster doses. This enables the use of COVAXIN as an universal vaccine.”