Bharat Biotech International has announced that BBV152 (COVAXIN), its whole-virion inactivated COVID-19 vaccine, has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials. The study has been accepted and published in Nature Scientific Reports.

The comprehensive study has demonstrated multiple benefits of COVAXIN, such as long-term immune response, cell-mediated immunity, the safety of booster dose, immunogenicity against spike  protein, N protein and neutralising antibody responses against alpha, beta, delta, delta plus and omicron variants.  

The study was conducted on ~184 subjects, who were randomised 1:1 and received either a booster dose of BBV152 or a placebo, ~six months after the primary series of twp doses. Subjects were evaluated for safety, neutralising antibody responses against variants of concern, binding antibodies against spike protein, RBD, N proteins, and for memory T and B cell responses to demonstrate cell-mediated immunity.

Dr Krishna Ella, CMD, Bharat Biotech, said, “We have now achieved our goal of developing a safe and efficacious vaccine with long-term protection against a spectrum of variants.”

Bharat Biotech has a stockpile of more than 50 million doses of COVAXIN ready to be distributed as required.