New Delhi, May 13: Drugs Controller General of India (DCGI), the national drug regulator of the country, granted approval to vaccine maker Bharat Biotech 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 DCGI has taken the decision after careful examination, has accepted the recommendation of Subject Expert Committee (SEC). COVID-19 Vaccination in India: Bharat Biotech Commences Direct Supply of ‘Covaxin’ to 14 States.
The COVID-19 vaccine maker, Bharat Biotech International Ltd., Hyderabad (BBIL) 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 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.