Bharat Biotech’s Covaxin gets SEC nod for use in children aged 2-18 years, Health News, ET HealthWorld
New Delhi: Marking a major development for Bharat Biotech, the Subject Expert Committee (SEC) on Tuesday gave positive recommendation for use of Covaxin in the 2-18 years age group.
The decision comes after a thorough review of Bharat Biotech’s submitted data from clinical trials in the 2-18 years age group for COVAXIN (BBV152) to CDSCO.
Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of COVID vaccine Covaxin for use in children aged between 2 and 18 years, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab at the beginning of this month.
The Subject Expert Committee (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.
In a statement Bharat Biotech informed that this represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group.
“Bharat Biotech sincerely thank 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 company statement said.
It is said that the made in India vaccine will be administered in two doses, with a gap of 20 days between the first and second dose.