An expert panel recommended the use of Bharat Biotech’s COVID-19 vaccine Covaxin for phase II/III clinical trials on those aged between two to 18 years on Tuesday.
The trials will be conducted on 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
“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,” PTI quoted a source as saying.
The vaccine has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). Currently, the vaccine is being used in adults in India’s ongoing COVID-19 vaccination drive.
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 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.
India recorded 3,48,421 new coronavirus cases in the last 24 hours taking the overall caseload to 2,33,40,938, according to data from the Union Health Ministry.
With 4205 deaths in the last 24 hours, the total death toll is 2,54,197.