Covaxin for 2-18 age group approved
With subject committee approval for Covaxin, the age group between 2 to 19 will get two doses of vaccine for emergency use only. Drugs and Comptroller General of India has to give final approval for the same.
New Delhi: The Subject Expert Committee on Covid-19 has approved emergency use of Bharat Biotech's Covaxin for children in the 2-18 years age group.
Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September and it has submitted the trial data to the Drugs and Comptroller General of India to go ahead with production.
The committee recommended for grant of market authorization for the vaccine for the age group of 2, but only for emergency usage, the expert committee stated in a statement.
Covaxine will be two doses with a gap of 20 days between the first and second dose. The committee has authorized the vaccine by putting certain conditions. The Bharat Biotech will continue the study as per the whole virion, inactivated coronavirus vaccine the approved clinical trial protocol.
WHO is yet to grant emergency use authorisation to Covaxin. Bharat Biotech had reportedly submitted all documents required for the listing to the WHO by July 9, and the WHO review process, which takes close to six weeks, had commenced by July-end.
