NEW DELHI: On Thursday, the Drugs Controller General of India (DCGI), the National Regulator of the country, after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II and III clinical trial of Covaxin vaccine in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on 12.05.2021.
Bharat Biotech International Ltd. Hyderabad (BBIL) had proposed to carry out a Phase II and 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 rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) (COVID-19) on May 11. The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II and III clinical trial to certain conditions.