Biological E Limited on Saturday announced that its COVID-19 vaccine Corbevax has been approved by the Drug Controller General of India as a heterologous booster dose.
A press release from the vaccine maker said the Corbevax can be administered as a booster dose to individuals aged 18 years and above after six months of administration of primary vaccination (two doses) of Covaxin or Covishield 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 in the country, it said.
Recently, BE furnished its clinical trials data to the DCGI which after a detailed evaluation and deliberations with Subject Experts Committee, granted their approval for administering Corbevax as a heterologous booster dose to people who have been vaccinated.
BE's clinical trial data showed that its 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."
BE has conducted a multi-centre 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 six months prior to the administration of Corbevax as a booster, the release added.
Corbevax is entirely developed and manufactured by BE Limited in association with Texas Children's Hospital and Baylor College of Medicine as a recombinant protein sub-unit vaccine against COVID-19.
BE has supplied 100 million doses of the jab to the Central government so far.
