The Drug Controller General of India (DGCI) gave Bharat Biotech approval for emergency use authorisation of the Covaxin COVID-19 vaccine for children in the 12-18 years age group on Saturday. This makes Covaxin the second vaccine cleared for use for children in India.
“Bharat Biotech has submitted data from clinical trials in the 2-18 years age group for COVAXIN (BBV152) to CDSCO. The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and have provided their positive recommendations,” Bharat Biotech said.
“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,” it added.
Before Covaxin, Zydus Cadila’s DNA vaccine was allowed to be used on adults and children over the age of 12 in August.
Covaxin will be given to children in two doses with a gap of 28 days between the first and second jab and as per the trial data submitted to the Union government, the gap and dosage of vaccine for adults and children will remain the same.
(With inputs from agencies)