News | May 13, 2021, 01:00 PM IST
The Drugs Controller General of India (DGCI) has approved Bharat Biotech's COVID-19 vaccine Covaxin for phase II/III clinical trial on those aged between two to 18 years. The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur. In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.
"The DCGI, after careful examination, has accepted the recommendation of Subject Expert Committee and accorded permission to conduct the Phase II/III clinical trial of Covaxin in the age group 2 to 18 years, to its manufacturer Bharat Biotech," the government said in a press note.