Biological E's Corbevax gets DCGI nod for emergency use in 5-12 year-olds
Hyderabad, April 26, 2022
Vaccine manufacturer Biological E. Limited (BE) today said that its COVID-19 vaccine Corbevax has received emergency use authorisation from the Drugs Controller General of India (DCGI) 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 group, a press release from the company said here.
The approval has come a month after Corbevax was given the nod for children between 12 and 15 years.
The release said BE had developed India’s first Indigenous sub-unit COVID-19 against the novel coronavirus.
The company performed a multi-centric, Phase 2/3 clinical trial in 624 children aged between 5 and 18 in two age sub-sets, 12 to 18 years and 5 to 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 sub-sets, the trial showed a significant increase in the anti-RBD IgG antibodies and neutralizing antibodies (nAb) against ancestral strain and Delta variant. The nAb titers observed post vaccination with Corbevax in the paediatric cohorts were comparable to the adult cohort evaluated in earlier clinical trial and the vaccine showed excellent safety for both age groups, the release said.
Mahima Datla, Managing Director, Biological E. Limited, said, “As many of us would be aware, the SEC had already given a positive recommendation for our vaccine’s use in the 5-12 age group. In continuation of the same, we were very happy to receive the formal approval from the DCGI making this an extremely safe and effective intervention available, particularly for the age groups 5 years onwards.
"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.”
To date, Biological E. Limited has manufactured 30 crore doses of Corbevax and have already supplied nearly 10 crore doses to the Government of India. Currently, over 3 crore doses of Corbevax have been administered in children between 12-15 years of age.
"And now, with the approval for the 5-12-year age group, this move will not only reduce the risks children face from the infectious disease, but it 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," the release added.
Biological E. Limited, a Hyderabad-based pharmaceuticals & biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India.
BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India and the USA, Europe. BE currently has eight WHO-prequalified vaccines in its portfolio and five USFDA approved Injectables.
In recent years, BE has embarked on new initiatives for organizational expansion such as developing specialty injectable products for global markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market, the release added.