10 January 2022 | News
The phase 2, double-blind, randomised controlled COVAXIN trial demonstrated long-term safety with no serious adverse events
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Bharat Biotech has 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.
The 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.