In a significant development, Bharat Biotech’s COVID-19 vaccine, Covaxin got DGCI’s approval on Tuesday for usage on kids aged 2-18.
This came after Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin in September on children below 18 years of age. The company had submitted the trial data to the Drugs and Comptroller General of India (DCGI) earlier this month.
The drug regulator said, “After detailed deliberation, the committee recommended for grant of market authorization” to children in age group of 2-18 years.
The DGCI added, “The emergency use authorisation, however, is subject to certain conditions. The developer of Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine the approved clinical trial protocol.”
Reacting to the authorisation, Bharat Biotech said, “This represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group.”
“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,” the Hyderabad-based company said.
The company further added, “We now await further regulatory approvals from the CDSCO prior to product launch and market availability of COVAXIN for Children.”