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).[1]
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[2] 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[3] and several studies examining the rejected hypothesis of a link between thimerosal-containing vaccines and autism.[4][5]
^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. PMID9164767.
^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. PMID14523172.
^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. PMID14595043.
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
