Bharat Biotech’s Covaxin advisable by professional panel for phase 2/3 trials on 2-18 year-olds
Bharat Biotech’s COVID-19 vaccine Covaxin was on Tuesday advisable by an professional panel for phase II/III scientific trial on these aged between two to 18 years, official sources mentioned. The trial will happen in 525 topics at numerous 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 in search of permission to conduct phase II/III scientific trials to judge the security, reactogenicity and immunogenicity of Covaxin jabs in youngsters 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,” a supply mentioned.
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.
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