Covaxin from Bharat Biotech Recommended by Expert Panel for Phase 2/3 Trials in Children 2-18 Years | India News
NEW DELHI: Bharat BiotechCovid-19 vaccine Covaxin It was recommended on Tuesday by an expert panel for a phase II / III clinical trial in people between the ages of two and 18, official sources said.
The trial will be conducted on 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
The Committee of Experts on the Subject (SECOND) in Covid-19 of Central Organization for Standard Control of Medicines (CDSCO) on Tuesday deliberated on Hyderabad-based Bharat Biotech’s request for permission to conduct phase II / III clinical trials to evaluate the safety, reactogenicity, and immunogenicity of Covaxin injections in children ages 2 to 18.
“After detailed deliberation, the committee recommended conducting the proposed phase II / III clinical trial of the whole virion inactivated coronavirus vaccine in the age group 2 to 18 years, subject to the condition that the company submits interim safety data from the phase II clinical trial along with DSMB’s recommendations to the CDSCO before moving on to phase III of the study, “said a source.
Previously, the proposal was deliberated at the SEC meeting dated February 24 and the company was asked to submit a revised clinical trial protocol.
Covaxin, developed indigenously by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR), is being used in adults in India’s ongoing Covid-19 vaccination campaign.