Bharat Biotech said it had submitted data from the Phase 2/3 clinical trials in the 2-18 years age group for Covaxin (BBV152) to the Central Drugs Standard Control Organisation (CDSCO), that the data had been thoroughly reviewed by the CDSCO and SEC, and that they provided their positive recommendations.

The vaccine Subject Expert Committee (SEC) on Tuesday recommended granting of emergency use authorisation (EUA) for vaccine maker Bharat Biotech’s Covid-19-vaccine, Covaxin, for children in the 2-18 years age group. The SEC has recommended this to the Drugs Controller General of India (DCGI), which will approve the EUA. This is the second vaccine approved for children. Earlier, Zydus-Cadila had received EUA for administering their ZyCov-D Covid-19 vaccine for children in the 12 to 18 years group. Covaxin is the first vaccine in the country for children below 12 years.

Bharat Biotech said it had submitted data from the Phase 2/3 clinical trials in the 2-18 years age group for Covaxin (BBV152) to the Central Drugs Standard Control Organisation (CDSCO), that the data had been thoroughly reviewed by the CDSCO and SEC, and that they provided their positive recommendations. “We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for children,” a Bharat Biotech statement said.

This was one of the first approvals worldwide for Covid-19 vaccines for the 2-18 years age group. Bharat Biotech thanked the DCGI, SEC and CDSCO for expediting the review process. The company would be continuing the study, submit a risk management plan and provide data with analysis every 15 days.