The Subject Expert Committee on Covid-19 has granted emergency use approval to Bharat Biotech’s Covaxin for children in the 2-18 years age group.
Hyderabad-based Bharat Biotech 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.
The made in India vaccine will be administered in two doses, with a gap of 20 days between the first and second dose.
In a statement, Bharat Biotech said the clinical trial data it had submitted was thoroughly reviewed by the Central Drugs Standard Control Organisation (CDSCO) and SEC, who provided their positive recommendations.
“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.