Bharat Biotech’s Covaxin for children in the 2-18 years age group has been granted emergency use approval by the Subject Expert Committee.
The vaccine will be administered in two doses, with a gap of 20 days between the first and second dose.
The Hyderabad based vaccine manufacturer had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September and submitted the trial data to the Drugs and Comptroller General of India (DCGI) at the start of this month.
“After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in emergency situation,” the subject expert panel said in a statement.
“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 vaccine developer said in a statement,
Meanwhile, the WHO is yet to grant emergency use authorisation to Covaxin. Bharat Biotech had reportedly submitted all documents required for the listing to the WHO by July 9, and the WHO review process, which takes close to six weeks, had commenced by July-end.