DCGI approves Bharat Biotech’s COVAXIN for Phase II/III clinical trial in 2-18 years


Delhi, May 13: The Drugs Controller General of India (DCGI) – the national regulator of the country, 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 Wednesday.

According to a Ministry of Health and Family Welfare statement, the 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, it said.

As rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) (COVID-19) on 11.05.2021. The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II/III clinical trial to certain conditions, it added.

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