Wednesday, 13 October 2021 | PNS | New Delhi
The Subject Expert Committee (SEC) on Covid-19 has granted emergency use approval to Bharat Biotech’s Covaxin for children in the 2-18 years age group. Now it awaits the final approval from the Drugs and Controller General of India (DCGI).
The Hyderabad-based pharma 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 DCGI early this month.
“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 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.
Back in August, India had granted emergency use approval also to ZyCov-D’s Covid-19 vaccine for children between the ages of 12 and 18. The vaccine is developed by pharmaceutical firm Zydus Cadila and is the first DNA vaccine to be approved in the world.
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 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 vaccine developer said.