Corbevax
Corbevax vaccine approved by DCGI as heterologous Covid-19 booster dose
Hyderabad: Biological E. Limited (BE), a Hyderabad-based pharmaceutical and vaccines company, on Saturday announced that its Corbevax Covid-19 vaccine has been approved by the Drug Controller General of India (DCGI) as a heterologous COVID-19 booster dose to individuals aged 18 years and above after 6 months of administration of primary vaccination (two doses) of Covaxin or Covishiled vaccines for restricted use in emergency situation.
BE’s Corbevax is the first such vaccine in India to be approved as a heterologous COVID-19 booster, a company release here said.
Recently, BE has furnished 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.
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.
Speaking on the occasion,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," Datla said.
BE has conducted a multicentre Phase III placebo controlled heterologous booster clinical trial in 416 subjects from 18 to 80 years of age of persons who were previously vaccinated with two doses of either Covishield or Covaxin at least 6 months prior to the administration of Corbevax as a booster dose.
The booster dose of Corbevax increased the neutralizing antibody titers in the Covishield and Covaxin groups significantly when compared to placebo.
In a subset of subjects evaluated for nAb 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 per cent and 75 per cent of subjects who had received primary vaccination by Covishiled and Covaxin respectively.
The Corbevax vaccination slot can be booked through the Co-WIN app or Co-WIN portal. 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 of India, the release added.
(With UNI inputs)
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