The National Regulator of the country, the Drugs Controller General of India has granted permission to Bharat Biotech Ltd to conduct the phase II/III clinical trial of Covaxin (COVID vaccine) in the age group 2 to 18 years, a release issued by Health Ministry said on Thursday.
Hyderabad based M/s Bharat Biotech International Ltd. 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 on 525 healthy volunteers.
In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28, the release read.
As a rapid regulatory response, the proposal was deliberated in the Subject Expert Committee on May 11, it read.
After detailed deliberation, the Committee recommended for grant of permission to conduct the proposed Phase II/III clinical trial to certain conditions.