DCGI approves Phase II/III clinical trial of Covaxin in age group of 2-18 years
New Delhi, May 13, 2021
The Drugs Controller General of India (DCGI) has approved phase II and III clinical trials of Covaxin, the COVID-19 vaccine manufactured by Hyderabad-based Bharat Biotech International Limited (BBIL), in the age group of 2 to 18 years.
The Union Ministry of Health & Family Welfare (MoHFW) said the national regulator, after careful examination, has accepted the recommendation of the Subject Expert Committee (SEC) and accorded permission for the trials on May 12.
The trial will be conducted on 525 healthy volunteers, a press release from the Ministry said.
In the 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 May 11. The Committee after detailed deliberation recommended for grant of permission to conduct the proposed Phase II/III clinical trial, subject to certain conditions, the release added.