The Drugs Controller General of India (DCGI) has approved Phase II/III clinical trial of Covaxin, Hyderabad-based Bharat Biotech's COVID-19 vaccine, in the age group of 2 to 18 years.
"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 Ministry of Health and Family Welfare said in a statement.
The ministry on May 13 said Bharat Biotech will conduct the trial on 525 healthy volunteers. The vaccine will be administered by the intramuscular route, in two doses given at day 0 and day 28.
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"As 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 ministry said.
Covaxin, an inactivated vaccine against COVID-19, has been developed by Bharat Biotech in collaboration with the ICMR's National Institute of Virology (NIV).
Bharat Biotech had on April 24 said the Phase 3 study of Covaxin showed 78 percent overall efficacy against COVID-19 and 100 percent overall efficacy against severe disease and hospitalisation.
(This is a developing story. Please check back for updates.)
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