Hyderabad-based Bharat Biotech had proposed to carry out Phase-2 and 3 clinical trials of Covaxin in the age group of 2 to 18 years. The trial will be conducted on 525 healthy volunteers

The national regulator Drugs Controller General of India (DCGI) has accepted the recommendation of the Subject Expert Committee and given approval to Bharat Biotech Ltd to conduct Phase 2/3 clinical trial of COVID-19 vaccine Covaxin in the age group 2 to 18 years.

In the trial, the vaccine will be given by intramuscular route in two doses on day 0 and day 28.

As a rapid regulatory response, the proposal was deliberated in the Subject Expert Committee  (COVID-19) on 11.05.2021. The Committee after detailed deliberation recommended for grant of permission to conduct the proposed Phase 2/3 clinical trial to certain conditions.

Earlier, on February 24, the proposal was deliberated in the Subject Expert Committee meeting and the firm was asked to submit a revised clinical trial protocol. Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults in India's ongoing COVID-19 vaccination drive.

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