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Drugs Controller General of India (DCGI) will provide approval for Covaxin for children between 2 and18 years only after evaluation of data, official sources said.
After getting approval from Subject Experts Committee, the manufacturer of Covaxin Bharat Biotech has submitted data for clinical trials in the age group of 2-18 years to Central Drugs Standard Control Organisation (CDSCO).
The expert panel of India's Central Drug Authority has recommended granting emergency use authorisation to Covaxin for children in the 2 to 18 years age group with certain conditions.
The Hyderabad-based firm in a statement said, "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."
The firm 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 SEC and have provided their positive recommendations, the vaccine maker said in the statement.
The SEC on COVID-19 examined the data and deliberated on the EUA application on Monday. "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.
