The Hyderabad-based pharma major Bharat Biotech’s Covaxin has got the emergency use approval for children in the age group of 2 to 18 years from the Drugs Controller General of India.
The subject expert committee on COVID-19 gave the approval for the emergency use in the children.
The expert panel said in a statement, “After detailed deliberation, the committee recommended for grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situation.”
Bharat Biotech had submitted the trial data of phase 2 and 3 of Covaxin on children in the beginning of this month to the apex body — DCGI. The vaccine will be administered in two doses with 20 days of interval.
However, Bharat Biotech needs to submit safety data with due analysis every 15 days for the first two months and monthly thereafter.
Remarkably, the global health body World Health Organisation has not granted the emergency use authorisation to Covaxin.
The World Health Organisation said last week that it will carry out the risk and benefit assessment next week with experts and take a final decision on the much-awaited EUL to Covaxin.
The WHO said in the last meeting, “WHO & an independent group of experts are scheduled to meet next week to carry out the risk/ benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin”