The Drugs Controller General of India (DCGI) after careful examination has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Bharat Biotech's Covaxin (COVID-19 vaccine) in the age group 2 to 18 years. 

Bharat Biotech International Ltd., Hyderabad (BBIL) had proposed to carry out Phase II/III clinical trials of Covaxin in the age group of 2 to 18 years. The trial will be conducted in 525 healthy volunteers. In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28. 

As a rapid regulatory response, the proposal was deliberated in the Subject Expert Committee (SEC) (COVID-19) on 11th May 2021. The committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II/III clinical trial on certain conditions