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

Project Title Findings from a Mini-Sentinel Assessment: Rotavirus Vaccines and Risk of Intussusception
Date
Tuesday, July 23, 2013
Description

On July 23, the Engelberg Center for Health Care Reform at Brookings held a roundtable webinar, “Findings from a Mini-Sentinel Assessment: Rotavirus Vaccines and Risk of Intussusception”. 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.

Medical Product
RotaTeq
Rotarix
rotavirus vaccine
Health Outcome
intussusception
Population / Cohort
All infants 5 to 36.9 weeks of age
Time Period
2004 - 2011
Host

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

Data Sources
Mini-Sentinel Distributed Database (MSDD)
Location
Presenters

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

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