Awaiting regulatory approvals to launch Covaxin for children: Bharat Biotech

By Team Newsable | First Published Oct 12, 2021, 5:50 PM IST

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

Pharmaceutical company Bharat Biotech on Tuesday said they are awaiting further regulatory approvals from the Central Drugs Standard Control Organisation (CDSCO) to launch the product after the Subject Expert Committee approved Covaxin to be used for children in the 2 to 18 years age group.

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.

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“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 Subject Experts Committee (SEC) and have provided their positive recommendations," said Bharat Biotech in a statement.

“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.

While the office of Drugs Controller General of India (DCGI) confirmed the development, it also said the final approval from the drug regulator is still awaited.

“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.

(With inputs from agency)

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