The Vaccine Safety Datalink project

Authors

  • Frank DeStefano MD, MPH

    Corresponding author
    1. National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA, USA
    • National Immunization Program (MS-F34), Centers for Disease Control and Prevention, Atlanta, GA 30341, USA.
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  • This article is a US government work and is in the public domain in the United States.

  • Other members of the Vaccine Safety Datalink team (by site): Robert T. Chen MD, MA; John Glasser PhD, MPH; Philip H. Rhodes PhD; Piotr Kramarz MD; Thomas Verstraeten MD; David Walker MPH; Catherine Okoro (National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Georgia); Robert S. Thompson MD; Lisa A. Jackson MD, MPH; Robert L. Davis MD, MPH; William E. Barlow PhD; Kari Bohlke ScD; Patti Benson MPH; Barbara Carste MPH; Jo Ann Habakangas BA; Christi Hanson BA; Minqi Jiang MS; Paula Lee Poy BA; Darren Malais BS; Viviana Rebolledo BS; Wendy Rogers BA; David Rubanowice BS; Dennis Sheeran MS; Onchee Yu MS; Ann Zavitkovsky MPH, MPA (Group Health Cooperative, Seattle, Washington); John P. Mullooly PhD; Julie E. Maher PhD, MS; Sheila Weinman PhD; Lois Drew BA; Jill Mesa; Kim Olson; Heather Houston RN; Colleen Chun MD; Steven Gancher MD; John A. Pearson MD; Jerry Slepak MD; Alan Bauck BS; Teresa Kimes MS; Joseph Murphy BA; Nadia Redmond MSPH; Karen Riedlinger MPH; Carol Sullivan; Gayle Thomas-Monk (Kaiser Permanente Northwest Region, Portland, Oregon); Steve B. Black MD; Henry R. Shinefield MD; Paula Ray MPH; Edwin Lewis MPH; Bruce H. Fireman MA; Joan Schwalbe; Ajit De Silva; Patti Hallam (Kaiser Permanente of Northern California, Oakland, California); Joel I. Ward MD; Connie M. Vadheim PhD; Hang Lee PhD; Ken Zangwill MD; Eileen Eriksen MPH; Tracy Zhang MS; Jennifer Lee MS; Jennie Jing MA; Nancy Goff; Jeffrey Perlman MD (Center for Vaccine Research Harbor-UCLA Medical Center, Torrance, California); S. Michael Marcy MD; Marlene Lugg DrPH (Southern California Kaiser Permanente, Los Angeles, CA); M. Miles Braun MD, MPH; Robert P. Wise MD, MPH, Robert Ball MD, MPH (Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD ); Vito Caserta MD, MPH; Geoffrey Evans MD (Division of Vaccine Injury Compensation, Health Resources and Services Administration, Rockville, MD).

Abstract

The Vaccine Safety Datalink (VSD) is a collaborative project between the National Immunization Program of the Centers for Disease Control and Prevention (CDC) and several large health maintenance organizations (HMOs) in the United States. 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. hospital discharge, outpatient visits, emergency room visits, and deaths), and covariate data (e.g. birth certificates and census) are prospectively collected at multiple HMOs (initially four) and linked under joint protocol for analyses. Approximately 6 million people (2% of the US population) are members of HMOs participating in the VSD. The VSD has proven to be a valuable resource that has provided important information on a number of vaccine safety issues. The databases and infrastructure created for the VSD have also provided opportunities to address other immunization questions including vaccination coverage and cost-effectiveness. In a recent investigation of intussusception following rotavirus vaccination, the VSD methodology was expanded to include 10 managed care organizations. A cohort study was conducted that allowed estimation of incidence rates of intussusception and attributable risks associated with rotavirus vaccine. Published in 2001 by John Wiley & Sons, Ltd.

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