Bharat Biotech International Limited (BBIL) has announced that its whole-virion inactivated COVID-19 vaccine, BBV152 (COVAXIN), has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials.
This study was undertaken in ~184 subjects, who were randomised 1:1 and received either a booster dose of the vaccine or a placebo, ~six months following the primary regimen of two doses.
The subjects were then analysed 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 show cell mediated immunity.
Bharat Biotech chairman and managing director Dr. Krishna Ella said, “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 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.”
COVAXIN is claimed to be formulated in a way that its same dosage can be administered to adults and children alike, for primary and booster doses, thereby making it a universal vaccine.
It is a ready to use liquid vaccine, stored at 2-8°C, with a shelf life of 12 months and multi dose vial policy.
According to the company, the whole virion inactivated vaccines have proven to be safe, tolerable with a safety track record of many decades.
Many paediatric vaccines made using this platform technology are utilised in regular immunisation for primary immunisation and booster doses. Many flu vaccines also make use of this manufacturing platform technology.
Bharat Biotech currently has a stockpile of over 50 million doses of COVAXIN ready to be distributed.