DCGI approves Phase 2/3 clinical trial of Covaxin in age group of 2-18

A medic administers the first dose of Covaxin vaccine, in New Delhi. File   | Photo Credit: PTI

The National Regulator of the country, the Drugs Controller General of India (DCGI), has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID-19 vaccine) in the age group 2 to 18 years to its manufacturer Bharat Biotech Ltd. on May 12.

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A release issued by the Health Ministry on Thursday said that 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,” noted the release.

The Ministry added that as rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) (COVID-19) on May 11. The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II/III clinical trial to certain conditions.

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Printable version | Jun 19, 2021 6:19:44 AM |

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