The National Regulator of the country, the Drugs Controller General of India (DCGI), has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID-19 vaccine) in the age group 2 to 18 years to its manufacturer Bharat Biotech Ltd. on May 12.
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A release issued by the Health Ministry on Thursday said that 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,” noted the release.
The Ministry added that 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/III clinical trial to certain conditions.