New Delhi, May 13: The Drugs Controller General of India (DCGI), after careful examination has accorded permission to conduct the Phase II/III clinical trial of Covid-19 vaccines Covaxin in the age group 2 to 18 years to its manufacturer Bharat Biotech Ltd, informed the Ministry of Health and Family Welfare on Thursday.
The decision comes after the subject expert committee recommended permission in favour of Bharat Biotech.
The trial will be conducted in 525 healthy volunteers at AIIMS Delhi, AIIMS Patna and Meditrina Institute of Medical Sciences, Nagpur. In the trial, the vaccine will be given by intramuscular route in two doses in a gap of 28 days, said the Ministry.
"As a rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) (COVID-19) on 11.05.2021. The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II/III clinical trial to certain conditions," it said.
Bharat biotech, which developed Covaxin in association with the Indian Council of Medical Research, submitted the proposal of conducting trials on children early this year.