DCGI approves Phase 2/3 clinical trial of COVAXIN in age group of 2 to 18 years
The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, accepted the recommendation of the Subject Expert Committee (SEC) and accorded permission to conduct the Phase 2 and 3 clinical trials of Covaxin (COVID-19 vaccine) in the children of age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd.
Hyderabad-based Bharat Biotech International Ltd had proposed to carry out Phase 2 and 3 clinical trials of Covaxin in children of the age group of 2 to 18 years. According to the information, the trial will be conducted on 525 healthy volunteers.
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In the trial, the Bharat Biotech's COVID-19 vaccine Covaxin will be given by intramuscular route in two doses at day 0 and day 28.
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As per the rapid regulatory response, the proposal was deliberated in the Subject Expert Committee (SEC) (COVID-19) on May 11.
The Committee after detailed deliberation recommended for grant of permission to conduct the proposed Phase 2 and 3 clinical trials to certain conditions.
SEC recommended clinical trials of COVID-19 vaccine in the 2 to 18 years age group subject to the condition that the firm would submit the interim safety data of phase 2 clinical trial along to the CDSCO before proceeding to phase 3.
Covaxin is indigenously developed by Bharat Biotech in association with the Indian Council of Medical Research (ICMR).
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