Phase II/III Clinical Trial of COVAXIN in Age Group of 2 to 18 Years Approved by DCGI

GG News Bureau

New Delhi, 13th May. After careful examination, the National Regulator of the country, the Drugs Controller General of India (DCGI), has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID vaccine) for the age group of 2 to 18 years, to its manufacturer Bharat Biotech Ltd on 12.05.2021.

Earlier, Bharat Biotech International Ltd., Hyderabad (BBIL) had proposed to carry out a Phase- II/III clinical trial of Covaxin in the age group of 2 to 18 years. The trial is going to be conducted in 525 healthy volunteers (2-18 years).

In the trial, the Covaxin 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 11.05.2021. The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II/III clinical trial to certain conditions.