The trial will happen in 525 topics at varied websites, together with AIIMS, Delhi, AIIMS Patna and Meditrina Institute of Medical Sciences, Nagpur.
Bharat Biotech’s COVID-19 vaccine Covaxin was on Tuesday really useful by an skilled panel for part II/III scientific trial on these aged between two to 18 years, official sources stated. The trial will happen in 525 topics at varied websites, together with 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 Organization (CDSCO) on Tuesday deliberated upon Hyderabad-based Bharat Biotech’s utility searching for permission to conduct part II/III scientific trials to judge the security, reactogenicity and immunogenicity of Covaxin jabs in kids 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 within the 2 to 18 years age group topic to the situation that the agency ought to submit the interim security information of part II scientific trial together with DSMB suggestions to the CDSCO earlier than continuing to part III a part of the examine,” a supply stated.
Earlier the proposal was deliberated within the SEC assembly dated February 24 and the agency was requested to submit a revised scientific trial protocol.
Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research ICMR), is being utilized in adults in India’s ongoing COVID-19 vaccination drive.