DCGI green signal to COVAXIN’s Phase II/III clinical trial in 2-18 yrs age group

Hyderabad based Bharat Biotech to conduct clinical trials in 525 healthy volunteers

New Delhi: The 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 International Limited on 12th May, 2021.
Bharat Biotech 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.
During the course of trial, the vaccine will be given by intramuscular route in two doses on day 0 and day 28.
As a rapid regulatory response, the proposal was deliberated in the Subject Expert Committee (SEC) (COVID-19) on 11.05.2021. The Committee after detailed deliberation recommended for grant of permission to conduct the proposed Phase II/III clinical trial to certain conditions.