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India approves phase II/III clinical trials of Covaxin for children aged 2-18

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

The trials will be conducted in 525 healthy volunteers, the ministry of health announced on Thursday.

“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 (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 quoting the ministry said in a press release.

The vaccine will be administered by intramuscular injections in two doses on day 0 and day 28, it added.-BERNAMA

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