Bharat Biotech has received approval from the Drug Controller General of India (DGCI) for emergency use of Covaxin to inoculate children between the ages of 12 and 18 years against COVID-19, amid a recent spike in cases. The DGCI approval comes on the back of a recommendation by the Subject Expert Committee (SEC) to authorise emergency use of the vaccine for children.

“The recommendations of SEC experts were considered by this Directorate. Accordingly, based on the recommendations of SEC experts and submission of additional safety data, this Directorate has no objection at this stage for the additional indication of Whole Virion inactivated coronavirus vaccine for use in the age group of 12 to 18 years for restricted use in an emergency situation,” read DGCI’s letter to Bharat Biotech.

Bharat Biotech, in turn, released a statement saying, “Covaxin is formulated uniquely such that the same dosage can be administered to adults and children. It has established a proven record for safety and efficacy in adults for the original variant and subsequent variants.”

Bharat Biotech had earlier announced that it had submitted its data on clinical trials of Covaxin (BBV152) on children between ages 2 and 18 years to the Central Drugs Standard Control Organisation, (CDSCO) in October, and that it had received positive responses from the CDSCO and SEC after thorough review of the data.

Covaxin will be administered to children in two doses 28 days apart, as was the case for adults.

The approval makes Covaxin the second in India to be authorised for use on children, with Zydus Cadila’s three-dose jab being the other one. The Zydus Cadila vaccine received approval for use on both adults and children over the age of 12 in August.

There are other COVID-19 vaccines for children in the works. Last month, the DGCI gave approval to Serum Institute’s Novavax for clinical trials on children aged above 11 years. The DGCI has also cleared Biological E’s Corbevax for advanced trials in children above the age of five.