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India approves Covaxin Phase 2, 3 clinical trials for children

Tests will be conducted on 525 healthy volunteers, says Health Ministry

Updated 5 years ago · Published on 13 May 2021 10:00PM

India approves Covaxin Phase 2, 3 clinical trials for children
Covaxin is India’s first Covid-19 vaccine, locally developed by Bharat Biotech in collaboration with the Indian Council of Medical Research. – EPA pic, May 13, 2021

NEW DELHI – India’s Drugs Controller General (DCGI) has approved Phase 2/3 clinical trials of the Covaxin vaccine against coronavirus for children aged 2-18.

The trials will be conducted on 525 healthy volunteers, the Health Ministry announced today.

“The DCGI, after careful examination, has accepted the recommendation of Subject Expert Committee and accorded permission to conduct the Phase 2/3 clinical trial of Covaxin (Covid vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd... The trial will be conducted in 525 healthy volunteers,” Sputnik news reported the ministry as saying in a statement.

The vaccine will be administered by intramuscular injections in two doses on Day 0 and Day 28, it added. – Bernama, May 13, 2021

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