Preclinical Safety Assessment Considerations in Vaccine Development

  • Jeanine L. Bussiere
  • George C. McCormick
  • James D. Green
Part of the Pharmaceutical Biotechnology book series (PBIO, volume 6)

Abstract

No vaccine is totally safe and totally effective, and adverse reactions have been reported with all. However, adverse reactions to vaccines are generally mild, and severe events resulting in death or permanent damage are rare. Historically, for every approved vaccine, the benefits to the public of preventing the target disease far outweigh the risks and costs of vaccination (Duclos and Bentsi-Enchill, 1993). As the target disease disappears, however, rare adverse reactions to vaccines alter the risk: benefit ratio. Individuals become more concerned with the risk of adverse reactions to the vaccine than the risk of contracting the disease. Concern regarding adverse events from vaccination can have serious detrimental impact, as illustrated by events in the United Kingdom in the mid-1970s. Fear of the whole-cell pertussis vaccine was linked with vaccine complications ranging from fever to seizures, and the vaccine was even blamed for causing brain damage and death. This fear led to a 50% decline in immunizations. Several years later, pertussis cases began to increase significantly, which then led to a subsequent return to vaccination (Stuart-Harris, 1979). This event was, and still is, the subject of worldwide controversy.

Keywords

Toxicity Arthritis Interferon Meningitis Retrovir 

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Copyright information

© Springer Science+Business Media New York 1995

Authors and Affiliations

  • Jeanine L. Bussiere
    • 1
  • George C. McCormick
    • 1
  • James D. Green
    • 1
  1. 1.Department of Pathobiology and ToxicologyGenentech, Inc.South San FranciscoUSA

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