After Zydus Cadila's ZyCoV-D, Covaxin Jab Cleared For Children Aged 12

The Drug Controller General of India (DCGI) on Saturday approved Bharat Biotech's COVID-19 vaccine Covaxin for emergency use on children between the ages of 12 and 18. The vaccine is not for children below 12 years. India will start rolling out vaccines for children in the age group of 15 to 18 years from January 3. Covaxin is the second vaccine cleared for use on children in India after Zydus Cadila's ZyCoV-D which is a three-dose DNA jab. Covaxin is a two-dose jab.

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

"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.

After getting 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."

The DCGI last month cleared trials for children between seven and 11 years for the third vaccine, Serum Institute's Novavax. Biological E's Corbevax, has been cleared to conduct advanced trials on children above five.

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