Nagpur: The Subject Expert Committee (SEC) has approved Bharat Biotech’s Covaxin Covid-19 vaccine for emergency use for children in the age group of 2 to 18 years of age.
The Hyderabad-based firm completed phase two and phase three trials of Covaxin on children below 18 years of age in September and the trial data to the Drugs and Comptroller General of India (DCGI) at the starting of October.
The drug regulator body said that after detailed deliberation, the committee recommended grant of market authorisation to children in the age group of 2 to 18 years.
DCGI added, “The emergency use authorisation, however, is subject to certain conditions. The developer of Covaxin will continue the study as per Whole Virion, Inactivated Coronavirus Vaccine the approved clinical trial protocol.”
