Corbevax becomes first vaccine in India to get DCGI approval for heterologous COVID-19 booster shot

Hyderabad-based drugmaker Biological E's Corbevax has become the first vaccine in India to get the Drugs Controller General of India's (DCGI) approval for a heterologous COVID-19 booster shot.

According to Biological E, people who are 18 years and above as well as who have already taken two doses of either Covishield or Covaxin can now receive a dose of Corbevax.

Earlier, a government panel had also recommended granting emergency use authorisation for Corbevax for children in the five to 11 years age group.

“The Subject Expert Committee on COVID-19 of the CDSCO which deliberated on Biological E’s EUA application has recommended granting emergency use authorisation for use of Corbevax in the age group of five to 11 years,” a source told news agency PTI.

"The BE's Corbevax is the first such vaccine in India to be approved as a heterologous COVID-19 booster. Recently, BE has furnished its clinical trials data to the DCGI who after a detailed evaluation and deliberations with the Subject Experts Committee granted their approval for administering the Corbevax vaccine as a heterologous booster dose to people who have already taken two doses of either Covishield or Covaxin," a statement issued by pharmaceutical and vaccines company read.

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 statement further said, "Biological E has conducted a multicentre Phase III placebo-controlled heterologous booster clinical trial in 416 subjects from 18 to 80 years of age 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."

"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 pc and 75 pc of subjects who had received primary vaccination by Covishield and Covaxin respectively," said the statement.

India began administering precaution doses of vaccines to healthcare and frontline workers and those aged 60 and above with comorbidities from January 10.

(With inputs from agencies)

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