Expert committee approves Covaxin for kids aged 2-18

The Subject Expert Committee (SEC) on Tuesday has given a recommendation to DCGI (Drugs Controller General of India) for the use of Bharat Biotech’s Covaxin for kids aged 2 to 18, reported ANI quoting official sources

The Hyderabad-based Bharat Biotech, the maker of Covaxin, had completed Phase-2 and Phase-3 trials of the dose on children below 18 years of age in September and submitted the trial results to the Drugs and Comptroller General of India (DCGI) at the start of this month, PTI reported

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The Subject Expert Committee (SEC) on COVID-19 examined the data and deliberated on the EUA application on Monday.

“After detailed deliberation, the committee recommended grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations subject to the certain conditions,” a source quoted SEC as having stated in its recommendations.

The recommendations have been forwarded to the Drugs Controller General of India (DCGI) for final approval.

The approval will make Covaxin, the first Indian COVID-19 vaccine to be approved for kids aged below 12. Before this, Zydus Cadila’s ZyCoV-D received emergency authorisation to be administered to people aged 12 and above.

Covaxin, the first made in India vaccine will be administered in two doses, with a gap of 20 days between the first and second dose.

The emergency use authorisation, however, is subject to certain conditions.