India’s national regulator approves trial of Covaxin in 2-18 yr age group

at 12:03 pm
Vaccine Price

New Delhi (NVI): In a significant development, the Drugs Controller General of India (DCGI), country’s national regulator, has accorded permission for conduct of the Phase II/III clinical trials of Covid vaccine Covaxin in the age group of 2 to 18 years.

The approval was granted yesterday after “careful examination” of the recommendation of Subject Expert Committee (SEC), said a statement by the Ministry of Health and Family Welfare.

Covaxin manufacturer Bharat Biotech
had proposed to carry out Phase- II/III clinical trial of the vaccine in the age group of 2 to 18 years. The trial will be conducted in 525 healthy volunteers, it said.

In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28, the statement said.

“As rapid regulatory response, the proposal was deliberated in 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,” the ministry said.