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DCGI Approves Phase II, III Clinical Trial of Covaxin in 2-18 Years

DCGI Approves

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 and III clinical trial of Covaxin (COVID vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on 12 May 2021, the Union Ministry of Health and Family Welfare (MoHFW) said.

M/s Bharat Biotech International Ltd, Hyderabad had proposed to carry out a Phase-II and III clinical trials of Covaxin in the age group of 2 to 18 years. The trial will be conducted on 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) on 11 May 2021. The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II and III clinical trial to certain conditions, MoHFW added.

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