DCGI Gives Green Signal For Covaxin Phase 2, 3 Clinical Trials For 2-18 Age Group
New-Delhi: The Drug Controller General of India (DGCI) on Thursday gave permission to Bharat Biotech to conduct clinical trials of its Covid-19 vaccines Covaxin on children belonging to the age group of 2 to 18 years.
Bharat Biotech will conduct the trials on 525 healthy volunteers, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur, the Hyderabad-based firm said.
After critical examination, DCGI has accepted the recommendation of the Subject Expert Commitee (SEC) on Covid-19 and accorded permission to conduct the phase 2-3 clinical trial of Covaxin on the age group 2-18 years.
Earlier the proposal was deliberated in the SEC meeting dated February 24 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.