With this Corbevax becomes the first vaccine approved as a heterologous Covid-19 booster.
The vaccine can be administered after 6 months of administration of primary vaccination (two doses) of Covaxin or Covishield vaccines for restricted use in emergency situation, the company said.
“BE’s Corbevax is the first such vaccine in India to be approved as a heterologous Covid-19 booster,” it said.
BE had approached the drug regulator recently and submitted its clinical trials data to the DCGI who after a detailed evaluation and deliberations with Subject Experts Committee, granted their approval for administering Corbevax vaccine as a heterologous booster dose to people who have already taken two doses of either Covishield or Covaxin.
According to the company BE’s clinical trial data showed that Corbevax booster dose provided “significant enhancement” in immune response and “excellent safety profile” required for an effective booster.
Mahima Datla, Managing Director, Biological E. Limited, said, “We are very happy with this approval, which will address the need for Covid-19 booster doses in India. We have crossed yet another milestone in our Covid-19 vaccination journey. This approval reflects once again the sustained world class safety standards and high immunogenicity of CORBEVAX.”
The company conducted the study on 416 subjects aged 18 to 80 who took the second jab at least six month ago.
“The booster dose of Corbevax increased the neutralizing antibody titers in the Covishield and Covaxin groups significantly when compared to placebo,” the company said.
Currently, the precaution dose being given is of the same Covid-19 vaccine used for administering the first and second doses.
The company also evaluated neutralising antibodies against the Omicron variant.
“The Corbevax booster shot resulted in a significant increase in the nAb titers against the Omicron variant. After the booster dose of Corbevax, Omicron nAbs were observed in 91% and 75% of subjects who had received primary vaccination by Covishield and Covaxin respectively,” the company further said.
The company said that the booster shot was “well tolerated” and “safe”.
There were no severe or adverse events of interest for 3 months of follow-up after the booster dose was administered,” the company further said.
So far, 51.7 million doses of Corbevax have been administered to children across the country, including 17.4 million who have completed the two-dose regimen.
BE has supplied 100 million doses of Corbevax to the government so far.
(With inputs from health)