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.
Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age have been completed by Hyderabad-based Bharat Biotech in September. The reports of the study have been submitted to the Drugs and Comptroller General of India (DCGI) in the initial days 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 an emergency situation," the subject expert panel said in a statement.
Covaxin is the second COVID-19 vaccine to get approved for children in India. It was in the month of August when the DGCI had approved the ZyCoV-D vaccines for children aged 12 and above as well as adults.These vaccines which will be produced in India will be administered in two doses, with a gap of 20 days.
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 has thanked 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.
Covaxin is the second COVID-19 vaccine to get approved for children in India. It was in the month of August when the DGCI had approved the ZyCoV-D vaccines for children aged 12 and above as well as adults. However, its rollout has not yet begun.