26. Pharmacoepidemiologic Studies of Vaccine Safety

  1. Brian L. Strom MD, MPH4,5,6,7,
  2. Stephen E. Kimmel MD, MSCE6,7 and
  3. Sean Hennessy PHARMD, PHD6,7
  1. Robert T. Chen1,
  2. Jason M. Glanz2 and
  3. Claudia Vellozzi3

Published Online: 3 JAN 2012

DOI: 10.1002/9781119959946.ch26

Pharmacoepidemiology, Fifth Edition

Pharmacoepidemiology, Fifth Edition

How to Cite

Chen, R. T., Glanz, J. M. and Vellozzi, C. (2012) Pharmacoepidemiologic Studies of Vaccine Safety, in Pharmacoepidemiology, Fifth Edition (eds B. L. Strom, S. E. Kimmel and S. Hennessy), Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781119959946.ch26

Editor Information

  1. 4

    George S. Pepper Professor of Public Health and Preventive Medicine, Philadelphia, PA, USA

  2. 5

    Department of Biostatistics and Epidemiology, Philadelphia, PA, USA

  3. 6

    Center for Clinical Epidemiology and Biostatistics, Philadelphia, PA, USA

  4. 7

    Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

Author Information

  1. 1

    Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA

  2. 2

    Institute for Health Research, Kaiser Permanente Colorado, Department of Epidemiology Colorado, School of Public Health, Denver, CO, USA

  3. 3

    Division of Healthcare Quality and Promotion, National Center for Emerging and Zoonotic Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA

Publication History

  1. Published Online: 3 JAN 2012
  2. Published Print: 17 FEB 2012

ISBN Information

Print ISBN: 9780470654750

Online ISBN: 9781119959946



  • vaccine;
  • vaccination;
  • immunization;
  • vaccinovigilance;
  • adverse events following immunization (AEFI);
  • vaccine adverse event reporting system (VAERS);
  • vaccine-preventable diseases (VSD);
  • clinical immunization safety assessment (CISA)


Given that few vaccine-preventable diseases (VPD) are eradicable, continued immunization of new birth cohorts will be needed indefinitely. Whenever high immunization rates successfully reduce the incidence of their target VPDs, adverse events following immunizations, including those caused by and coincidental to immunization, become relatively more prominent. Such vaccine safety concerns—if not properly studied and managed—can destabilize immunization programs and result in resurgence of the VPD. Pharmacoepidemiologic principles can be applied to various aspects of the prelicensure and postlicensure processes for vaccines to enhance our scientific understanding of vaccine safety. This understanding can provide better quantification of the attributable risk of vaccines to guide risk–benefit decisions at the individual and societal levels and ideally, prevent such vaccine risks in the future.