Vaccine Phase IV studies focused on VAERS reports under consideration at FDA.
Executive Summary
VACCINE PHASE IV ADVERSE EVENT-FOCUSED STUDIES UNDER FDA CONSIDERATION by Vaccine Adverse Event Reporting System administrators at the agency and at the Centers for Disease Control & Prevention. FDA Division of Biostatistics & Epidemiology Director Susan Ellenberg, PhD, listed the Phase IV studies based on VAERS data as one of several improvements of the system under consideration while speaking at the Vaccines & Related Biological Products Advisory Committee April 11.
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