The Drugs Controller General of India (DCGI) has given emergency use authorisation to Biological E’s COVID-19 vaccine Corbevax for those aged 5 to 12 years, the pharmaceutical company said on Tuesday.
The approval came a month after Corbevax was approved for children in the age group of 12-15.
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.
“BE has 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, i.e., >=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,” Biological E said in a statement.
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 pediatric cohorts were comparable to the adult cohort evaluated in earlier clinical trials and the vaccine showed excellent safety for both age groups.
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.
Datla further said that 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.
Biological E Limited has manufactured 30 crore doses of Corbevax and has already supplied nearly 10 crore doses to the Central Government.
Currently, over 3 crore doses of Corbevax have been administered to children between 12-15 years of age.
COVID-19 vaccination for minors in India started from January 3 onwards for those in the 15-18 age group with Bharat Biotech’s Covaxin. The drive later expanded on March 16 to include children aged above 12 for Corbevax. India is currently administering two COVID-19 vaccines for children above 12.
(With agency inputs)
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