PubMed · 10169086
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Approaches to reducing medication errors.. https://pubmed.ncbi.nlm.nih.gov/10169086/
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The success of immunizations in nearly eliminating many vaccine-preventable diseases has resulted in an increase in the need to study risks from vaccines, combination or otherwise. The well-known limitations associated with prelicensure trials have led many to hope that postlicensure studies can address safety issues. This article reviews measures that have been or should be taken to meet this expectation: establishment of clinical immunization safety assessment centers, standardization of case definitions for vaccine adverse events, use of the Vaccine Identification Standards Initiative to improve the accuracy and efficiency with which vaccination records are transferred, integration of vaccine safety monitoring into immunization registries, establishment (and enlargement) of the Vaccine Safety Datalink project, use of innovative analytic tools for better signal detection, and implementation of various methods to overcome confounding by contraindication. Only by investing in vaccine safety infrastructure at a level commensurate with investments in vaccine development can we hope to retain the public's confidence in immunization.
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.
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