33. Vaccine Safety

  1. W. John W. Morrow PhD, DSc, FRCPath4,
  2. Nadeem A. Sheikh PhD5,
  3. Clint S. Schmidt PhD6 and
  4. D. Huw Davies PhD7
  1. John Iskander MD, MPH1,
  2. Claudia Vellozzi MD, MPH2,
  3. Jane Gidudu MD, MPH2 and
  4. Robert T. Chen MD, MA3

Published Online: 20 JUN 2012

DOI: 10.1002/9781118345313.ch33

Vaccinology: Principles and Practice

Vaccinology: Principles and Practice

How to Cite

Iskander, J., Vellozzi, C., Gidudu, J. and Chen, R. T. (2012) Vaccine Safety, in Vaccinology: Principles and Practice (eds W. J. W. Morrow, N. A. Sheikh, C. S. Schmidt and D. H. Davies), Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781118345313.ch33

Editor Information

  1. 4

    Seattle, WA, USA

  2. 5

    Dendreon Corporation, Seattle, WA, USA

  3. 6

    NovaDigm Therapeutics, Inc., Grand Forks, ND, USA

  4. 7

    University of California at Irvine, Irvine, CA, USA

Author Information

  1. 1

    Office of the Associate Director for Science, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA

  2. 2

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

  3. 3

    Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA

Publication History

  1. Published Online: 20 JUN 2012
  2. Published Print: 3 AUG 2012

ISBN Information

Print ISBN: 9781405185745

Online ISBN: 9781118345313



  • vaccine safety;
  • vaccine adverse event;
  • immunization;
  • post-licensure surveillance


Pre-licensure vaccine testing is stringent. However, even the largest trials will not detect very rare adverse events and may exclude special populations. To protect the public health and improve the safety of vaccines, comprehensive post-licensure safety monitoring systems are needed. The primary objectives of post-marketing surveillance and research are to detect rare adverse events and assess their causal relationship to vaccination, monitor the safety of new vaccines, and ascertain risk factors for adverse reactions to vaccines. These goals are accomplished through passive surveillance using spontaneous reporting, active surveillance, and controlled epidemiologic studies, the latter two utilizing large linked databases. Passive reporting is primarily used to generate hypotheses about adverse events deserving of further study. Active surveillance and epidemiologic studies test hypotheses and yield information about whether or not studied events are causally related to vaccination. Recent advances in vaccine safety science include near real-time monitoring of new vaccines, clinical research on pathophysiologic factors underlying adverse events, and standardized adverse event case definitions.