Hyderabad: Hyderabad-based Biological E Limited’s Corbevax has the distinction of becoming the first Covid-19 vaccine in India to be approved by the Drug Controller General of India (DCGI) as a heterologous Covid-19 booster dose. This means vaccinated adults with Covishield or Covaxin can take Corbevax as a booster shot.
The Corbevax booster can be given six months after the second dose of the vaccine.
Mahima Datla, Managing Director of Hyderabad-based pharmaceutical and vaccine company Biological E Ltd., said, “We are jubilant 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. “
Recently, Biological E Ltd. provided its clinical trial data to the DCGI, who, after a thorough assessment and discussions with the subject expert committee, decided to give their nod to administer the Corbevax vaccine as a heterologous booster dose to those who have taken two doses of either Covishield or Covaxin.
The clinical trial data showed that the Corbevax booster dose provided an enhancement in resistant response and was safe. The company conducted the trial on 416 subjects between 18 and 80 years of age.
So far, 51.7 million doses of Corbevax have been administered to children in India, including 17.4 million who have received both doses, Biological E Ltd said.
The company has supplied 100 million doses of the vaccine to the Center.