The clinical trials of Bharat Biotech's Covaxin in the age group of 2-18 years will begin in next 10-12 days, the government said Tuesday. The development comes days after India's apex drugs regulator granted permission for conducting the phase II/III clinical trials on children.
"COVAXIN has been approved by the Drugs Controller General of India (DCGI), for Phase II/III clinical trials in the age group of 2 to 18 years. I have been told that trials will begin in the next 10-12 days," Dr. VK Paul, Member-Health, Niti Aayog said at a press conference today.
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.
The trial will be conducted on 525 healthy volunteers.
Covaxin, which has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used on adults in India's ongoing COVID-19 vaccination drive.