DCGI approves phase II/III clinical trial of COVAXIN in 2-18 years age group
Hyderabad-based Bharat Biotech to conduct trials in 525 healthy volunteers
The national drug regulator Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of the 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.
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 a gap of 28 days.
As a rapid regulatory response, the proposal was deliberated in SEC on COVID-19 earlier this week. The committee, after detailed deliberation, recommended grant of permission to conduct proposed phase II/III clinical trials to certain conditions, the Ministry of Health and Family Welfare said.
Ministry of Health and Family Welfare
Drugs Controller General
bharat biotech ltd