covaxin: Covaxin’s approval for children aged 2-18 years under experts’ opinion, evaluation: Sources | India News


NEW DELHI: Final approval for Bharat Biotechnology‘s Covaxin for children from 2 to 18 years old, it is under the opinion and evaluation of experts, government sources reported this Thursday.
Earlier Tuesday, official sources had said the Theme The Committee of Experts (SEC) has given a recommendation to the Comptroller General of Drugs of India (DCGI) for the use of Bharat BiotechCovid-19 vaccine, Covaxin, for beneficiaries between the ages of 2 and 18.
Sources had told ANI today that after evaluation of the data, the Comptroller General of Drugs of India (DCGI) will give final approval.
Bharat Biotech in an official statement said they are awaiting further approvals from drug regulators.
This is one of the first global approvals for Covid-19 vaccines for the group of beneficiaries between the ages of 2 and 18.
Bharat Biotech had submitted clinical trial data in the age group 2-18 years for Covaxin (BBV152) to CDSCO. The data has been thoroughly reviewed by the CDSCO and the Subject Matter Expert Committee (SEC) and has provided their positive recommendations, the vaccine manufacturer said.
The Covid-19 expert committee examined the data on Monday.

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