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DCGI approves Covaxin’s phase II/III clinical trial on age group between 2-18

NEW DELHI: The National Regulator of the country, the Drugs Controller General of India (DCGI) has approved a Phase II/III clinical trial of Covaxin, a COVID-19vaccine developed by Hyderabad-based Bharat Biotech, in the children age group between 2 to 18.

The decision was taken after discussing the proposal in the Subject Expert Committee (SEC) (COVID-19) as fast regulatory response.

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The permission has been granted after extensive deliberation, under certain conditions.

“As a 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,” the health ministry said in a statement.

“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 12.05.2021,” the statement added.

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Bharat Biotech will perform the trial on 525 healthy volunteers, according to the ministry.

The vaccine will be given intramuscularly in two doses, one on day 0 and the other on day 28.

Bharat Biotech, which developed Covaxin in collaboration with the Indian Council of Medical Research, proposed conducting trials on children early this year.

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