October 12
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 (DCGA).
Bharat Biotech had earlier submitted the Phase II & III trail data of Covaxin on Children to DCGI.
The Subject Expert Committee on Covid-19 gave the approval for the emergency use in the children.
The vaccine will be administered in two doses with 20 days of interval.
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 needs to submit safety data with due analysis every 15 days for the first two months and monthly thereafter.
