New Delhi: The Drugs Controller General of India (DCGI), the national regulator, 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 of 2 to 18 years, to its manufacturer Bharat Biotech Ltd.
The Hyderabad- based Pharmaceutical Company 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) meeting held on May 11.
The Committee, after a detailed deliberation in this regard, recommended for grant of permission to conduct proposed Phase II/III clinical trial to certain conditions.
This post was published on May 14, 2021 6:27 pm