Biological E seeks EUA for Corbevax as booster

NEW DELHI: Biological E has submitted an application to India's drug regulator seeking emergency use authorisation for its Covid vaccine Corbevax as a booster dose in adults fully vaccinated with Covishield or Covaxin, sources said on Wednesday.

The Drugs Controller General Of India (DCGI) had already approved Corbevax, India's first indigenously developed RBD protein subunit vaccine, for restricted use in emergency situations for those aged five and above. Currently, it is being used to inoculate children in the age group of 12 to 14 years.

According to the EUA application submitted to DCGI, Biological E in a phase-3 placebo-controlled clinical study, based on the drug regulator's nod, has evaluated the safety and immunogenicity of Corbevax as a single-dose booster in

Covid-negative adults fully vaccinated with either Covishield or Covaxin. The study was conducted on 416 subjects aged 18 to 80 who were vaccinated with two doses of either Covaxin or Covishield with the last jab administered at least six months prior to giving the booster dose of Corbevax.

"The results showed a significant boost in immunogenicity in terms of neutralizing antibodies after 28 days when compared with placebo cohort in both Covishield and Covaxin arms.

"The safety profile of Corbevax was found similar to that of the earlier clinical trials," an official source said quoting the Hyderabad-based firm as having mentioned in the EUA application.

As of now, the precaution dose is of the same COVID19 vaccine used for administering the first and second doses.