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.