The Vaccine Safety Datalink: immunization research in health maintenance organizations in the USA

• Published in: Bulletin of the World Health Organization Vol. 78; no. 2; pp. 186 - 194
• Main Authors: Chen, R T, DeStefano, F, Davis, R L, Jackson, L A, Thompson, R S, Mullooly, J P, Black, S B, Shinefield, H R, Vadheim, C M, Ward, J I, Marcy, S M
• Format: Journal Article
• Language: English
• Published: Switzerland World Health Organization 01.01.2000; The World Health Organization
• Subjects: adverse drug reaction reporting systems; Biological products industry; Centers for Disease Control and Prevention (U.S.); Database Management Systems; Health Maintenance Organizations; Health Policy; Health Policy & Services; HMOs; Immunization; Immunization Programs; Quality management; United States; USA; Vaccines; Vaccines - adverse effects; Vaccines - standards; vaccines, combined, adverse effects; viral vaccines, adverse effects; United States; adverse drug reaction reporting systems; vaccines, combined, adverse effects; health maintenance organizations; viral vaccines, adverse effects; United States
• ISSN: 0042-9686; 1564-0604
• DOI: 10.1590/S0042-96862000000200006

The Vaccine Safety Datalink is a collaborative project involving the National Immunization Program of the Centers for Disease Control and Prevention and several large health maintenance organizations in the USA. The project began in 1990 with the primary purpose of rigorously evaluating concerns about the safety of vaccines. Computerized data on vaccination, medical outcome (e.g. outpatient visits, emergency room visits, hospitalizations, and deaths) and covariates (e.g. birth certificates, census data) are prospectively collected and linked under joint protocol at multiple health maintenance organizations for analysis. Approximately 6 million persons (2% of the population of the USA) are now members of health maintenance organizations participating in the Vaccine Safety Datalink, which has proved to be a valuable resource providing important information on a number of vaccine safety issues. The databases and infrastructure created for the Vaccine Safety Datalink have also provided opportunities to address vaccination coverage, cost-effectiveness and other matters connected with immunization as well as matters outside this field.