Bharat Biotech today announced that Covaxin 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, a company statement said.
It also said that the study was conducted in approximately 184 subjects, who were randomised 1:1 and received either a booster dose of BBV152 or a placebo, approximately six months after the primary series of two 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, added the statement.
Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, said in the statement, “Our team has now demonstrated that Covaxin is a multi-epitope vaccine with antibodies against spike, RBD and N proteins. Post booster dose, it has proven neutralising antibody responses against variants of concern and long-term protection through memory T and B cell responses. We have now achieved our goal of developing a safe and efficacious vaccine with long-term protection against a spectrum of variants.”