Vaccine maker Biological E. Ltd on April 26 announced that its COVID-19 vaccine Corbevax has received a nod from the Drugs Controller General of India (DCGI) for emergency use authorisation for the 5-12-year age group.

The approval comes after the Subject Expert Committee (SEC) recommendation based on the review of interim safety and immunogenicity data of Corbevax for this age bracket. This approval comes a month after Corbevax was given the nod for children between 12 and 15 years, Hyderabad-based BE said.

The company has developed India's first indigenous sub-unit COVID-19 against the novel coronavirus. It performed a multi-centric, Phase 2/3 clinical trial in 624 children aged between 5 and 18 in two age subsets, i.e., 12 to less than 18 years and 5 to less than 12 years. As a part of the trial, children were administered two doses of 0.5 ml each of the vaccine or placebo in a gap of 28 days.

BE submitted the interim safety data and immunogenicity data to regulatory agencies. For both the age subsets, the trial showed a significant increase in the anti-RBD IgG antibodies and neutralising antibodies (nAb) against ancestral strain and Delta variant.

The titers observed post-vaccination with Corbevax in the paediatric cohorts were comparable to the adult cohort evaluated in earlier clinical trials and the vaccine showed excellent safety for both age groups.

"This is a great opportunity to get back to some level of normalcy in our continuing fight against the prevalent pandemic situation as Corbevax is the first indigenous COVID-19 vaccine in the country that addresses the vaccination needs of all age groups from 5 years and above," said Mahima Datla, Managing Director, Biological E.

The company revealed that it has so far manufactured 30 crore doses of Corbevax and has already supplied nearly 10 crore doses to the government. Currently, over 3 crore doses of Corbevax have been administered to children between 12-and 15 years of age.

With approval for the 5-12 age group, this move will not only reduce the risks children face from the infectious disease but will also enable them to concentrate on their education and social development, which were severely impacted by the pandemic. Getting their kids vaccinated will also help ease parents' concerns while sending them to school, it added.