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Covaxin's approval for children aged 2-18 yrs under experts' opinion, evaluation: Sources
The final approval for Bharat Biotech's Covaxin for children aged 2-18 years is under experts opinion and evaluation, stated Government sources on Thursday.
Earlier on Tuesday, official sources had said that the Subject Expert Committee (SEC) has given a recommendation to the Drugs Controller General of India (DCGI) for the use of Bharat Biotech's COVID-19 vaccine, Covaxin, for the beneficiaries aged between 2-18 years.
Sources had told ANI today that after evaluation of the data, the final approval will be given by the Drug Controller General of India (DCGI).
Bharat Biotech in an official statement had said they are waiting for further approvals from drug regulators.
This is one of the first worldwide approval for COVID-19 vaccines for the age group of beneficiaries belonging to 2-18 years.
Bharat Biotech had 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, the vaccine maker said.
The Subject expert committee on COVID-19 examined the data on Monday. (ANI)