New Delhi: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.
