Awaiting regulatory approvals to launch Covaxin for children-Bharat Biotech

PTI, Oct 12, 2021, 4:15 AM IST

Hyderabad: After getting approval from Subject Expert Committee (SEC) for Covaxin to be used for children in the 2 to 18 years age group with certain conditions, Bharat Biotech on Tuesday said they are awaiting further regulatory approvals from the Central Drugs Standard Control Organisation (CDSCO) to launch the product.

The expert panel of India’s Central Drug Authority has recommended granting emergency use authorisation to Bharat Biotech”s Covaxin for children in the 2 to 18 years age group with certain conditions.

“This represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group. Bharat Biotech sincerely thanks the DCGI, Subject Experts Committee, and CDSCO for their expedited review process. We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for children,” Bharat Biotech said in a statement.

Bharat Biotech has submitted data from clinical trials in the 2-18 years age group for Covaxin (BBV152) to CDSCO. The data has been thoroughly reviewed by the CDSCO and SEC and have provided their positive recommendations, the vaccine maker said.

The 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,” the SEC recommendations stated.

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