Covaxin Phase 2, 3 trials for 2-18 age group cleared

The Drugs Controller General of India (DCGI) on Thursday cleared Covaxin trials on children from two to 18 years of age. This is the first time in India that a Covid vaccine will be tested on children. Covaxin maker Bharat Biotech said its phase 2 and 3 trials would be carried out on “525 healthy volunteers”.

The trial involves two vaccine doses injected at day 0 and day 28 and will take place at various sites.

New Delhi, May 13: India's apex drug regulator has granted permission for conducting the Phase 2/3 clinical trial of Bharat Biotech's Covaxin Covid-19 vaccine in the age group of 2 to 18 years, the Union health ministry said on Thursday. The trial will be conducted on 525 healthy volunteers.

"The National Regulator, the Drugs Controller General of India (DCGI), 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 2 to 18 years, to its manufacturer Bharat Biotech Ltd on May 12," the ministry said.

Hyderabad-based Bharat Biotech had proposed to carry out the clinical trial in the age group of 2 to 18 years.

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 SEC on meeting held on May 11. The committee, after detailed deliberation, recommended for grant of permission to conduct proposed Phase 2/3 clinical trial to certain conditions.