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Findings from a Mini-Sentinel Assessment: Rotavirus Vaccines and Risk of Intussusception

    Event Information
    Event Type

    On July 23, the Engelberg Center for Health Care Reform at Brookings held a roundtable webinar, ā€œFindings from a Mini-Sentinel Assessment: Rotavirus Vaccines and Risk of Intussusceptionā€. This webinar highlighted a recent study which examined an association between rotavirus vaccinations and increased risk of intussusception in U.S. infants. Initiated by the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA), this study was conducted through the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program, a component of the Mini-Sentinel pilot for active medical product surveillance.

    Dr. Michael Nguyen, Deputy Director in the Division of Epidemiology at CBER, provided a brief description of the rationale for conducting this study and the FDA response to its findings. Dr. Katherine Yih, an epidemiologist and lecturer at Harvard Pilgrim Health Care Institute and Harvard Medical School, presented an overview of study methods, analysis, and results.


    Gregory W. Daniel PhD, MPH; Evidence Development & Innovation, Engelberg Center for Health Care Reform, Brooking Institution, Washington DC

    Medical Product
    rotavirus vaccine
    Health Outcome(s)
    Time Period
    2004 - 2011
    Population / Cohort
    All infants 5 to 36.9 weeks of age
    Data Source(s)
    Mini-Sentinel Distributed Database (MSDD)

    Michael Nguyen MD; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD

    Katherine Yih PhD, MPH; Department of Population Medicine, Harvard Pilgrim Healthcare Institute and Harvard Medical School, Boston, MA