DCGI approves Covaxin shots for children above 12

Bharat Biotech had submitted data from clinical trials in the 2-18 years age group for Covaxin (BBV152) to Central Drugs Standard Control Organisation (CDSCO).

The Subject Expert Committee on COVID-19 of the CDSCO deliberated upon Bharat Biotech's EUA application on October 12.

CDSCO then granted emergency use approval to Covaxin for use in the 12-18 years age group subject to certain conditions.

Prime Minister Narendra Modi, in address to the nation tonight, said vaccination for children in the age group of 15 to 18 years will start from January 3.

"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," the DCGI letter to Bharat Biotech read.

Following the DCGI nod, Bharat Biotech, in an official statement, said, "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."

Covaxin is the second vaccine cleared for use on kids in India.

In August, Zydus Cadila's three-dose DNA jab was approved for use on adults and children over 12.

Serum Institute's Novavax and Biological E's Corbevax are two other vaccines in pipeline for the minor population.

DCGI has approved trials for Novavax for children between seven and 11 years and Biological E's Corbevax for children above five.

India is slowly turning its focus towards vaccinating children after administering over 100 crore doses to adults.