2-18 age group: DCGI approves Phase 3 clinical trial of COVAXIN
DCGI approves Phase II/III clinical trial of COVAXIN in the age group of 2 to 18 Years
New Delhi, May 13, 2021: 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 Covaxin (COVID vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on May 12.
M/s Bharat Biotech International Ltd., Hyderabad (BBIL) had proposed to carry out a Phase- II/III clinical trial 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 rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) (COVID-19) on May 11, 2021.
The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II/III clinical trial to certain conditions.
