DCGI approves clinical trial of Covaxin in 2 to 18-year age group
The trial will be conducted in 525 healthy volunteers
The national regulator, the Drugs Controller General of India (DCGI) has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II and III clinical trials of Covaxin (COVID vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on Wednesday.
According to the Ministry of Health and Family Welfare, Hyderabad-based Bharat Biotech had proposed to carry out a Phase II and III clinical trials of Covaxin in the age group of 2 to 18 years.
The trial will be conducted in 525 healthy volunteers, the statement released by the Ministry of Health and Family welfare on Thursday said.
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 May 11, 2021.
The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II and III clinical trials to certain conditions, the Ministry said.