Bharat Biotech's Covaxin recommended for use in children below 18 years
New Delhi/IBNS: An expert panel on Tuesday recommended Bharat Biotech's Covaxin to be administered on children between the ages of two and 18.
"Bharat Biotech has submitted data from clinical trials in the two - 18 age group for Covaxin to CDSCO (Central Drugs Standard Control Organisation). The data has been thoroughly reviewed by the Subject Expert Committee (SEC)... provided positive recommendations," the Hyderabad-based company said.
"This represents one of the first approvals worldwide for COVID-19 vaccines for the two - 18 age group... We now await further regulatory approvals prior to product launch and market availability of Covaxin for Children," the company said.
That final approval, which is more like a formality, will be given by the Drug Controller General of India.
Covaxin will be only the second vaccine against COVID-19 to be cleared for use on kids in India.
In August, Zydus Cadila's three-dose DNA jab was allowed to be used on adults and children over 12.