Comprehensive Evaluation of Applicability, Reliability, Sensitivity and Specificity of Newly Developed Standardized Case Definitions for Adverse Events Following Immunization
Brief Project Description
Sponsor: CDC (through IPA); National Immunization Program
Epidemiologist/Co-investigator: Manya Magnus, PhD, MPH
This study is evaluating the applicability, reliability, sensitivity and specificity of newly developed standardized case definitions of Adverse Events Following Immuniztion (AEFI). The evaluation includes assessing whether modification of elements of these draft case definitions may improve their sensitivity or specificity. The outcome will include recommendations for improvements to the case definitions and to the Vaccine Adverse Event Reporting System (VAERS). VAERS, one of the world’s largest and most comprehensive passive surveillance systems for assessment of AEFI, is operated by the Centers for Disease Control and Prevention (CDC), in collaboration with the Food and Drug Administration (FDA). Reports of possible AEFI are submitted electronically, by phone, or by mail to VAERS by individuals, caregivers, providers, healthcare facilities, and vaccine manufacturers. Data are entered and maintained by the VAERS staff at CDC. These data are then used to generate hypotheses regarding AEFI, develop analytic studies to assess causality of vaccines in AEFI, and to signal detection.
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