The phase 2, double-blind, randomised controlled COVAXIN® trial demonstrated long-term safety with no serious adverse events
Bharat Biotech has announced the results from the highly anticipated trial studying the immunogenicity and safety of the COVAXIN® (BBV152) a wholevirion inactivated COVID-19 vaccine as a booster dose.
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 a universal vaccine.
As per the company statement, “We found the vaccine induces both memory B and T cells with a distinct CD4 and CD8 phenotype. Further, reactogenicity after vaccine and placebo was minimal and comparable, and no serious adverse events were reported. While protection against the severe disease remains high across the full 6 months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected. Based on emerging data, Bharat Biotech believes that a third dose may be beneficial to maintain the highest levels of protection.”