Covaxin for children still under DCGI evaluation; final approval to take time: Reports

After a big win for Covaxin in the global arena, Bharat Biotech seeks India's drug controller’s nod for emergency use in children. As per ANI sources, the Drug Controller General of India (DCGI) said that the vaccine is being evaluated for children aged between 2-18 years, and they will take more time to evaluate and process the information and data. The final approval from the Drugs Controller General of India (DCGI) will take time as the officials continue to scrutinise the efficacy and safety of the vaccine for children below the age of 18 years. "It's a sensitive matter. Data evaluation is underway. More data has been submitted," sources informed ANI on Monday.

The Drugs Controller General of India (DCGI) has recently received a recommendation from the Subject Expert Committee (SEC) to approve Bharat Biotech's Covaxin COVID-19 vaccination for beneficiaries aged 2 to 18. Bharat Biotech has previously stated in an official statement that they are awaiting additional clearances from vaccine regulators.

"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," Hyderabad based pharmaceutical said in a statement.

Bharat Biotech had submitted data from COVAXIN (BBV152) clinical trials in children aged 2 to 18 years to the Central Drugs Standard Control Organization (CDSCO). According to the vaccine producers, the CDSCO and Subject Experts Committee (SEC) has thoroughly analysed the evidence and made favourable recommendations for Covaxin.

"After detailed deliberation, the committee recommended the grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation subject to the setting conditions," Bharat Biotech said.

WHO’s EUL approval of Covaxin

After India’s continued efforts and thorough analysis by WHO’s technical advisory group, Covaxin was granted the EUL approval on November 3, months after Bharat Biotech had submitted its application seeking the global health body’s approval. The EUL process, developed by the World Health Organization, evaluates the quality, safety, and efficacy of COVID-19 vaccines and is a requirement for Covaxin delivery. It also permits countries to speed their regulatory approval for COVID-19 vaccine import and administration.

With ANI inputs

Image: PTI