The Drugs Controller General of India (DCGI) granted emergency use authorisation for Biological E’s Covid-19 vaccine Corbevax for children aged five to 12 years, and Bharat Biotech’s Covaxin for children in the age group of six to 12 years, on Tuesday.
The DCGI has also granted emergency use authorisation (EUA) to Cadila for its ZyCoV-D for an additional dose of 3 mg with a two-jab inoculation, 28 days apart, for those aged above 12 years.
The approval to expand coverage to children below 12 comes in the wake of rising cases among unvaccinated schoolchildren in Delhi and the emergence of the new Omicron sub-lineage BA.2.12. across the country. The country reported 2,483 new cases on Tuesday with a daily positivity rate of 0.55%.
The approval by the DCGI comes following recommendations by the Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO).
The SEC had last week reviewed the application of Biological E and Bharat Biotech, seeking emergency use authorisation for Corbevax and Covaxin for use in children of five to 12 years, and six to 12 years age group, respectively. It also reviewed Cadila’s application.
The Covid-19 vaccination drive going on in the country has covered children from 12 to 18 years, with 131 million doses of Covaxin and Corbevax being administered in this age group. The total vaccine coverage has crossed the 1.88-billion mark on Tuesday.
After getting regulatory nod to inoculate children, Bharat Biotech and Bilogical E have indicated that they had enough stocks of Covid-19 vaccine doses to vaccinate children in the 5-12 age group. Bharat Biotech said fresh stocks of Covaxin were available and ready for supplies. The company said it had readily available more than 50 million doses of Covaxin vials and more than 200 million doses as drug substance.
Krishna Ella, chairman and managing director, Bharat Biotech, said Covaxin has now proven data for safety and immunogenicity in children. Clinical trials in children documented seroconversion at 95-98%, four weeks after the second dose, indicating superior antibody responses in children when compared to adults.
Mahima Datla, managing director of Biological E, said Corbevax was an very safe and effective intervention available, particularly for the age groups five years onwards.