Corbevax cleared as Covid booster shot for adults

New Delhi, Jun 04: Corbevax, Biological E's COVID-19 vaccine has been cleared for booster dose for those 18 and above.

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 company said.

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.

Corbevax Vaccine is a "recombinant protein sub-unit" vaccine, developed from a component of the spike protein on the virus's surface, which helps the body build the immune response against the virus.

In April this year India's drug regulator had granted Emergency Use Authorisation (EUA) for Biological E's Corbevax for children in 5 to 12 years group along with Bharat Biotech's Covaxin for children in the age group of 6 to 12 years.

The Corbevax has been shown to prevent COVID-19 disease following 2 doses given at 4 weeks' interval. The duration of protection against COVID-19 disease is currently unknown. You may get protective immune response 4 weeks after the second dose of Corbevax.