Covaxin Cleared For Children Above 12 By Drug Regulator

Bharat Biotech’s COVID-19 vaccine Covaxin has been approved for emergency use on children between the ages of 12 and 18 by the Drugs Controller General of India (DCGI). India will start rolling out vaccines for children in the age group of 15 to 18 years from January 3, PM Modi said in an address on Saturday.

Earlier, 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, after deliberating Bharat Biotech’s EUA application on October 12, had recommended granting emergency use approval to Covaxin for use in the 12-18 years age group with certain conditions.

“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 only the second vaccine cleared for use on kids in India; in August Zydus Cadila’s three-dose DNA jab was allowed to be used on adults and children over 12.

A third potential vaccine for kids is Serum Institute’s Novavax, for which the DCGI last month cleared trials for children between seven and 11 years. A fourth is Biological E’s Corbevax, which has been cleared to conduct advanced trials on children above five. In July, it had granted permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions.

India is slowly turning its focus towards vaccinating children against the coronavirus, having administered over 100 crore doses to adults.