DCGI nod to Phase 2-3 clinical trials of Covaxin for 2-18 years
Hyderabad-based 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 in 525 healthy volunteers
- May 13, 2021,
- Updated May 13, 2021 11:31 AM IST
The national regulator Drugs Controller General of India (DCGI) has accepted the recommendation of the Subject Expert Committee (SEC) and given a nod to Bharat Biotech Ltd to conduct Phase II/III clinical trial of COVID-19 vaccine Covaxin in the age group 2 to 18 years.
Hyderabad-based 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 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 a rapid regulatory response, the proposal was deliberated in the SEC on May 11. The committee after detailed deliberation recommended for the grant of permission to conduct a proposed Phase II/III clinical trial to certain conditions.
The national regulator Drugs Controller General of India (DCGI) has accepted the recommendation of the Subject Expert Committee (SEC) and given a nod to Bharat Biotech Ltd to conduct Phase II/III clinical trial of COVID-19 vaccine Covaxin in the age group 2 to 18 years.
Hyderabad-based 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 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 a rapid regulatory response, the proposal was deliberated in the SEC on May 11. The committee after detailed deliberation recommended for the grant of permission to conduct a proposed Phase II/III clinical trial to certain conditions.