Vaccine Safety Datalink
The Vaccine Safety Datalink Project (VSD) was established in 1990 by the United States Centers for Disease Control and Prevention (CDC) to study the adverse effects of vaccines.
Four large health maintenance organizations, including Kaiser Permanente, were initially recruited to provide the CDC with medical data on vaccination histories, health outcomes, and subject characteristics. The VSD database contains data compiled from surveillance on more than seven million Americans, including about 500,000 children from birth through age six years (2% of the U.S. population in this age group).
The VSD data-sharing program is now being administered by the National Center for Health Statistics Research Data Center. The data sharing guidelines have been revised to include comments from interested groups as well as recommendations from the Institute of Medicine (IOM).
The Vaccine Adverse Event Reporting System (VAERS), the VSD, and the Clinical Immunization Safety Assessment (CISA) Network are tools by which the CDC and FDA measure vaccine safety to fulfill their duty as regulatory agencies charged with protecting the public. Data from the VSD Project have been utilized to address a number of vaccine safety concerns; examples include a study clarifying the risk of anaphylaxis after vaccine administration and several studies examining the rejected hypothesis of a link between thimerosal-containing vaccines and autism.
Participating healthcare organizations
The following organizations are members of the project:
- Group Health Cooperative of Puget Sound, Seattle, Washington
- Harvard Pilgrim Health Care, Boston, Massachusetts
- HealthPartners Research Foundation, Minneapolis, Minnesota
- Kaiser Permanente Northwest, Portland, Oregon
- Kaiser Permanente Medical Care Program of Northern California, Oakland, California
- Kaiser Permanente Colorado, Denver, Colorado
- Kaiser Permanente of Georgia, Atlanta, Georgia
- Marshfield Clinic Research Foundation, Marshfield, Wisconsin
- Southern California Kaiser Permanente Health Care Program, Los Angeles, California
- Chen RT; Glasser JW; Rhodes PH et al. (1997). "Vaccine Safety Datalink project: a new tool for improving vaccine safety monitoring in the United States. The Vaccine Safety Datalink Team". Pediatrics 99 (6): 765–73. doi:10.1542/peds.99.6.765. PMID 9164767.
- Centers for Disease Control and Prevention, Vaccine Safety Monitoring at CDC, retrieved 2015-03-11.
- Bohlke K, Davis RL, Marcy SM et al. (2003). "Risk of anaphylaxis after vaccination of children and adolescents". Pediatrics 112 (4): 815–20. doi:10.1542/peds.112.4.815. PMID 14523172.
- Geier DA, Geier MR (Spring 2006). "Early Downward Trends in Neurodevelopmental Disorders Following Removal of Thimerosal-Containing Vaccines" (PDF). Journal of American Physicians and Surgeons 11 (1).
- Verstraeten T, Davis RL, DeStefano F et al. (2003). "Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases". Pediatrics 112 (5): 1039–48. doi:10.1542/peds.112.2.e98. PMID 14595043.
- Thompson WW, Price C, Goodson B et al. (2007). "Early thimerosal exposure and neuropsychological outcomes at 7 to 10 years". N. Engl. J. Med. 357 (13): 1281–92. doi:10.1056/NEJMoa071434. PMID 17898097.
- NationalAcademies.org - 'Independent Oversight of Vaccine Safety Data Program Needed To Ensure Greater Transparency and Enhance Public Trust', National Academies (February 17, 2005)
- WHO.int (pdf) - 'The Vaccine Safety Datalink: immunization research in health maintenance organizations in the USA', R.T. Chen, F. DeStefano, R.L. Davis, L.A. Jackson, R.S. Thompson, J.P. Mullooly, S.B. Black, H.R. Shinefield, C.M. Vadheim, J.I. Ward, S.M. Marcy & the Vaccine Safety Datalink Team, World Health Organization