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 people in the United States, 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 used 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, Seattle, Washington
- Harvard Pilgrim Health Care, Boston, Massachusetts
- HealthPartners Institute, Minneapolis, Minnesota
- Kaiser Permanente Northwest, Portland, Oregon
- Kaiser Permanente Northern California, Oakland, California
- Kaiser Permanente Colorado, Denver, Colorado
- Kaiser Permanente Georgia, Atlanta, Georgia
- Marshfield Clinic Research Foundation, Marshfield, Wisconsin
- Kaiser Permanente Southern California, 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 March 11, 2015.
- 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.
- 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.
- "Vaccine Safety Datalink (VSD) – VSD – Monitoring – Ensuring Safety – Vaccine Safety – CDC". www.cdc.gov. January 10, 2019.
- 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