The Subject Expert Committee on Covid-19 has granted emergency use approval to Bharat Biotech's Covaxin for children in the 2-18 years age group, reports India Today.
"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," the expert panel said in a statement.
Notably, back in August, India had also granted emergency use approval to ZyCov-D's Covid-19 vaccine for children between the ages of 12 to 18.
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 at the start of this month. 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.
Meanwhile, the WHO is yet to grant 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 Covid vaccine 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".
With Agency Inputs