Covaxin Phases 2 & 3 Clinical Trials for Children: Official sources said that Covaxin, the COVID-19 vaccine developed by Bharat Biotech's in collaboration with the Indian Council of Medical Research (ICMR), was on Tuesday recommended by an expert panel for phase-2 and phase-3 clinical trials on those aged between 2 and 18 years.
Sources said that the trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Tuesday deliberated upon Hyderabad-based Bharat Biotech's application, seeking permission to conduct phase II/III clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years.
"After detailed deliberation, the committee recommended for conduct of proposed phase II/III clinical trial of whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study," the source added.
Earlier, the proposal was deliberated in the SEC meeting on February 24 and the firm was asked to submit a revised clinical trial protocol. Covaxin is being used in adults in India's ongoing COVID-19 vaccination drive.
Moreover, Bharat Biotech has been directly supplying Covaxin to 18 states since May 1, the company said on Tuesday. "Unflinching in our efforts, we will continue the steady supply of our vaccine," it said. The states are Andhra Pradesh, Assam, Bihar, Chhattisgarh, Delhi, Gujarat, Haryana, Jammu & Kashmir, Jharkhand, Karnataka, Madhya Pradesh, Maharashtra, Odisha, Tamil Nadu, Tripura, Telangana, Uttar Pradesh, and West Bengal.
The company had on April 24 announced pricing for Covaxin. It fixed the price of Covaxin at Rs.600 per dose for state governments.