A day after a government panel recommended the usage of Covaxin for children as young as two, government sources have said that the final approval for 2-18 years old is under expert opinion and evaluation.
The Drugs Controller General of India (DCGI) will hold discussions with the health minister, PMO, and Bharat Biotech before granting EUA to Covaxin, sources added.
On Wednesday, an expert panel of the Central Drugs Standard Control Organisation (CDSCO) recommended granting emergency use authorization (EUA) for Bharat Biotech manufactured Covaxin for those aged 2 to 18. Reportedly, a Drugs Controller General of India (DCGI) official has confirmed the development, adding final approval is still awaited.
“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 CDSCO and subject experts committee (SEC), and they have provided their positive recommendations,” Bharat Biotech had said. “This represents one of the first approvals worldwide for covid-19 vaccines in the 2-18 age group. Bharat Biotech sincerely thanks DCGI, SEC, and CDSCO for their expedited review. We now await further regulatory approvals from CDSCO,” it added.