The Subject Expert Committee (SEC) of the Central Drug Standards Control Organisation (CDSCO) is understood to have recommended Phase II and III clinical trials of Covaxin on children aged between 2 and 18 years.
Hyderabad-based maker of the vaccine, Bharat Biotech, had submitted a proposal in this regard and was asked to submit a revised clinical trial protocol.
clinical trials of Covaxin on children aged between 2 and 18 years
The company was also asked to submit the interim safety data of Phase II clinical trials along with the DSMB (Data and Safety Monitoring Board) recommendations to the CDSCO before proceeding to Phase III of the study, according to sources
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