Subject Expert Committee gives nod to Covaxin for Phase 2, 3 trials on children 2 to 18 years of age

The Subject Expert Committee (SEC) has given a nod to Bharat Biotech’s Covaxin for Phase 2 and 3 human clinical trials on children aged between two to eighteen years old.The Committee after the detailed deliberation, recommended conducting the phase 2 and 3 clinical trial of the whole virion inactivated Coronavirus vaccine in the age group of 2 to 18 years subject to the condition that the firm must submit the interim safety data of phase 2 clinical trial along with DSMB recommendations to the CDSCO ( Central Drug Standard Control Organization ) before proceeding to the phase 3 clinical trial.  Covaxin is one of the two vaccines being manufactured in India at present and has been developed by Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology.