Bharat Biotech said on Wednesday that its vaccine against the Covid-19 virus, Covaxin, demonstrated immunity and works against emerging variants. Bharat Biotech said 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 high-impact factor journal.
Following the study, Bharat Biotech issued a press release and said the study was conducted in 184 subjects. The subjects were randomised 1:1 and they either received a booster dose of Covaxin or a placebo, six months after the primary series of two doses.
During the study, the 184 subjects were examined 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, it said.
Krishna Ella, chairman and managing directorn of Bharat Biotech, said 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," Ella said.
The Bharat Biotech press release said that Covaxin is formulated uniquely such that the same dosage can be administered to adults and children alike, for primary and booster doses.
It also said that administration of a third dose, after 6 months of two dose vaccination, dramatically increased neutralizing antibody responses against both homologous and heterologous strains (Alpha, Beta, Delta, Delta Plus and Omicron) and showed increased memory B cell response.
"Immune responses declined at 6 months but increased by 40 fold in subjects who received a booster dose," Bharat Biotech 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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