Bharat Biotech gets DCGI nod for Phase 2,3 Covaxin trials on 2 to 18 years
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New Delhi: The Drugs Controller General of India (DCGI) on Thursday approved Phase 2 and 3 clinical trial of Bharat Biotech's COVAXIN vaccine in the age group of 2 to 18 years, informed the Ministry of Health and Family Welfare.
"The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission 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, 2021," the ministry said.
Bharat Biotech will conduct trials in 525 healthy volunteers.
"In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28," it said.
As a rapid regulatory response, the proposal was deliberated in the Subject Expert Committee (SEC) (COVID-19) on May 11, 2021.
The Committee after detailed deliberation recommended for grant of permission to conduct the proposed Phase 2 and 3 clinical trials to certain conditions.
Covaxin is one of the two vaccines being manufactured in India at present and has been developed by Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology.
The firm on Tuesday informed that it has been supplying its COVID-19 vaccine directly to 18 states since May 1.
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