Pharmaceutical major Bharat Biotech on Wednesday said its COVID-19 vaccine 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 high-impact factor journal.
A press release from the vaccine maker said the study was conducted on 184 subjects, who were randomized 1:1 and received either a booster dose of Covaxin or a placebo, six months after the primary series of two doses.
Subjects were evaluated for safety, neutralizing antibody responses against variants of concern, binding antibodies against spike protein, RBD, and N proteins, and for memory T and B cell responses to demonstrate cell-mediated immunity, it said.
Krishna Ella, chairman, and managing director, of Bharat Biotech, said the 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 neutralizing 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,'' Ella said.
Covaxin is formulated uniquely such that the same dosage can be administered to adults and children alike, for primary and booster doses, making it truly a universal vaccine, the company release said.
The jab is a ready-to-use liquid vaccine, stored at 2-8 degrees Celsius, with 12-month shelf life and a multi-dose vial policy.
Bharat Biotech has a stockpile of more than 50 million doses of Covaxin ready to be distributed as and when required.
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