Vaccine Safety Surveillance

Elizbeth Miller*, Julia Stowe

*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review

1 Citation (Scopus)

Abstract

Vaccines have successfully controlled many serious diseases. However, their very success has dimmed the public's memory of those diseases, and any risk from the vaccine tends to be perceived as being greater than the disease itself. In addition, indirect benefits to the unimmunized individual through herd immunity result in a complex benefit to harm balance, which may change through time as the incidence of the disease changes. Here we explain the pathogenesis of adverse reactions to vaccines, focusing on both direct and immune-mediated effects, and describe the methods used for the detection and investigation of safety concerns. The procedures used for establishing a causal relation between a vaccine and an adverse event are challenging, as they rely heavily on epidemiological studies of exposed populations, in which it may be difficult to identify comparable unexposed comparator groups. In the pre-licensing evaluation of vaccine safety, emphasis is on common adverse events-rare reactions are not seen, as the numbers of subjects in the trials are limited; furthermore, some reactions may occur only in a subgroup of the population who are not significantly represented. As rare adverse events following immunization (AEFIs) can only be identified in post-licensing studies, systems need to be in place both to identify a signal (hypothesis generation) and then to measure both the absolute and attributable risks (hypothesis testing). Sustaining public confidence and vaccine coverage by having robust methods of ascertainment and the ability to respond rapidly to safety scares remains a major public health challenge.

Original languageEnglish
Title of host publicationStephens' Detection and Evaluation of Adverse Drug Reactions
Subtitle of host publicationPrinciples and Practice, Sixth Edition
PublisherJohn Wiley and Sons
Pages603-624
Number of pages22
ISBN (Print)9780470986349
DOIs
Publication statusPublished - 30 Jan 2012

Keywords

  • Adverse events
  • Adverse reactions
  • Immunization
  • Safety
  • Vaccines

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