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Large, simple vaccine safety trials needed for conclusive adverse event data -- FDA's Ellenberg.

Executive Summary

LARGE, SIMPLE VACCINE SAFETY TRIALS COULD ILLUMINATE WHETHER ADVERSE EVENTS are coincidental and not vaccine-induced, CBER Division of Biostatistics and Epidemiology Director Susan Ellenberg, PhD, told an Oct. 24 Drug Information Association meeting in Bethesda, Md. "This is my own proposal," Ellenberg emphasized. "It is not anything that FDA is about to go out and require you to do. But I think it is a useful thing to think about."



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