Covaxin maker Bharat Biotech Said that the COVID-19 vaccine has been found to be safe, well-tolerated and immunogenic in subjects in controlled clinical trials. The results of the trial have been published by the respected Nature Scientific Reports journal.
In a statement, Bharat Biotech said a total of 184 subjects took part in the study and they were randomised 1:1. While one of the two groups received a booster dose of Covaxin, the other was given a placebo. Both the groups had completed their two-dose vaccination six months ago.
A Bharat Biotech press release stated that the 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.
Speaking on the study, the chairman and managing director of Bharat Biotech, Krishna Ella said that Covaxin has not been demonstrated to be 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,” Ella said.
The press release added that Covaxin has been formulated uniquely in such a manner that the same dosage can be administered to adults and children alike, for primary and booster doses. This, the release added, makes Covaxin a universal vaccine.
Covaxin is the only indigenously developed COVID-19 vaccine in India. It is administered in liquid form, is stored at 2-8 degrees Celsius, and has a 12-month shelf life. It is administered in two doses, with a boooster dose meant to provide additional protection.