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Childhood vaccines and Kawasaki disease,Vaccine Safety Datalink, 1996-2006
Affiliation:1. Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta, GA, United States;2. Immunization Safety Office, Division of Healthcare Quality and Promotion, Centers for Disease Control and Prevention, Atlanta, GA, United States;3. Harvard Pilgrim Health Care Institute, Boston, MA, United States;4. Kaiser Permanente Vaccine Study Center, Oakland, CA, United States;5. Marshfield Clinic Research Foundation, Marshfield, WI, United States;6. Group Health Research Institute, Seattle, WA, United States;7. Kaiser Permanente Northwest, Portland, OR, United States;8. HealthPartners Research Foundation, Minneapolis, MN, United States;9. Kaiser Permanente Colorado, Denver, CO, United States;1. Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland;2. Department of Dermatology, Brown University, Providence, Rhode Island;1. Kaiser Permanente Center for Health Research, 3800 North Interstate Avenue, Portland, OR 97227, United States;2. Marshfield Clinic Research Institute, 1000 North Oak Avenue (ML2), Marshfield, WI 54449, United States;3. Kaiser Permanente of Colorado Institute for Health Research, 2550 South Parker Road, Suite 200, Aurora, CO 80014, United States;4. Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS V18-4, Atlanta, GA 30333, United States;5. Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle, WA 98101, United States;6. Department of Research and Evaluation, Kaiser Permanente Southern California, 100 South Los Robles Avenue, Pasadena, CA 91101, United States
Abstract:BackgroundKawasaki disease is a childhood vascular disorder of unknown etiology. Concerns have been raised about vaccinations being a potential risk factor for Kawasaki disease.MethodsData from the Vaccine Safety Datalink were collected on children aged 0–6 years at seven managed care organizations across the United States. Defining exposure as one of several time periods up to 42 days after vaccination, we conducted Poisson regressions controlling for age, sex, season, and managed care organization to determine if rates of physician-diagnosed and verified Kawasaki disease were elevated following vaccination compared to rates during all unexposed periods. We also performed case-crossover analyses to control for unmeasured confounding.ResultsA total of 1,721,186 children aged 0–6 years from seven managed care organizations were followed for a combined 4,417,766 person-years. The rate of verified Kawasaki disease was significantly lower during the 1–42 days after vaccination (rate ratio = 0.50, 95% CL = 0.27–0.92) and 8–42 days after vaccination (rate ratio = 0.45, 95% CL = 0.22–0.90) compared to rates during unexposed periods. Breaking down the analysis by vaccination category did not identify a subset of vaccines which was solely responsible for this association. The case-crossover analyses revealed that children with Kawasaki disease had lower rates of vaccination in the 42 days prior to symptom onset for both physician-diagnosed Kawasaki disease (rate ratio = 0.79, 95% CL = 0.64–0.97) and verified Kawasaki disease (rate ratio = 0.38, 95% CL = 0.20–0.75).ConclusionsChildhood vaccinations’ studied did not increase the risk of Kawasaki disease; conversely, vaccination was associated with a transient decrease in Kawasaki disease incidence. Verifying and understanding this potential protective effect could yield clues to the underlying etiology of Kawasaki disease.
Keywords:Kawasaki disease  Vaccine Safety Datalink  Adverse events  Vasculitis
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