American Journal of Epidemiology Vol. 154, No. 11 : 1006-1012
Copyright © 2001 by The Johns Hopkins University School of Hygiene and Public Health
ORIGINAL CONTRIBUTIONS |
Enhancing Vaccine Safety Surveillance: A Capture-Recapture Analysis of Intussusception after Rotavirus Vaccination
1 Epidemic Intelligence Service, Division of Applied Public Health Training, Epidemiology Program Office, Centers for Disease Control and Prevention, Atlanta, GA.
2 Vaccine Safety and Development Activity, Division of Epidemiology and Surveillance, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA.
3 Division of Data Management, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA.
4 Child Vaccine Preventable Disease Branch, Division of Epidemiology and Surveillance, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA.
5 Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD.
The Vaccine Adverse Event Reporting System (VAERS) is the passive reporting system for postmarketing surveillance of vaccine safety in the United States. The proportion of cases of an adverse event after vaccination that are reported to VAERS (i.e., VAERS reporting completeness) is mostly unknown. Therefore, the risk of such an event cannot be derived from VAERS only. To study whether its reporting sensitivity and risks could be estimated, VAERS was linked to data from a case-control and a retrospective cohort study in a capture-recapture analysis of intussusception after rotavirus vaccination (RV). Cases of intussusception after RV were selected from the common time frame (December 1998 through June 1999) and the common geographic area (19 states) of the three sources. Matching occurred on birth date, gender, state, date of vaccination, and date of diagnosis. Thirty-five matches were identified among a total of 84 cases. The estimated VAERS reporting completeness was 47%. The relative risks of intussusception in the periods 3–7 and 8–14 days after RV (relative risk = 22.7 and 4.4, respectively) were comparable with those reported in the two studies. Linkage of VAERS to complimentary data sources may permit more timely postmarketing assessment of vaccine safety.
intussusception, rotavirus; vaccines
Abbreviations: AIC, Akaike Information Criterion; CDC, Centers for Disease Control and Prevention; CI, confidence interval; MCO, managed care organization; RV, rotavirus vaccination; VAERS, Vaccine Adverse Event Reporting System
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