Recently, Bharat Biotech’s vaccine Covaxin against COVID-19, has been advised by an expert panel for conducting phase 2/3 clinical trials on 2-18-year-olds. The trial will occur in 525 subjects at numerous sites, comprising AIIMS Delhi, AIIMS Patna and Meditrina Institute of Medical Sciences, Nagpur.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) dealing with COVID-19 on Tuesday is contemplating upon Hyderabad-based Bharat Biotech”s application seeking permission to conduct phase II/III clinical trials in children aged 2 to 18 years. After reports of mild symptoms being reported, many doctors raised concern over it’s safety in children. SME constrained the vaccine makers from proceeding to phase 3 unless phase 2 report is submitted.
In this regard, the consideration for third phase by the committee members is based on evaluation of the safety, reactogenicity and immunogenicity of Covaxin inoculations after assessing the phase 2 clinical trial interim report.
“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 source told the media portal.
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