SPECIAL CONSIDERATIONS

As described in Chapter 3, the committee recognized that the risk of an adverse effect of a vaccine can be influenced by host factors, some known and others not yet understood. Where the committee thought the evidence—whether from epidemiologic analyses or from the clinical studies—regarding risks to subpopulations was informative, evidence-based, and biologically sound, it made separate conclusions. For example, the risk of invasive disease following varicella vaccine, a live virus vaccine, is likely much higher in immunocompromised persons than in persons who are immunocompetent. Other subpopulation analyses in the report include age and sex for some specific adverse events.

In their consideration of several adverse events, the committee concluded that the mechanism of injury was likely unrelated to the specific antigenic or other components of the vaccine. The committee concluded that the exposure of concern is not the injected vaccine, rather the injection of the vaccine. The adverse events include syncope, complex regional pain syndrome, and deltoid bursitis. These are covered in Chapter 12.

REFERENCES

Guyatt, G. H., A. D. Oxman, G. E. Vist, R. Kunz, Y. Falck-Ytter, P. Alonso-Coello, H. J. Schunemann, and G. W. Grp. 2008. GRADE: An emerging consensus on rating quality of evidence and strength of recommendations. British Medical Journal 336(7650):924-926.

Halsey, N. A. 2002. The science of evaluation of adverse events associated with vaccination. Seminars in Pediatric Infectious Diseases 13(3):205-214.

Hill, A. B. 1965. Environment and disease—association or causation? Proceedings of the Royal Society of Medicine-London 58(5):295-300.

IOM (Institute of Medicine). 1991. Adverse effects of pertussis and rubella vaccines: A report of the committee to review the adverse consequences of pertussis and rubella vaccines. Washington, DC: National Academy Press.

IOM. 1994. Adverse events associated with childhood vaccines: Evidence bearing on causality. Washington, DC: National Academy Press.

IOM. 2001a. Immunization safety review: Measles-mumps-rubella vaccine and autism. Washington, DC: National Academy Press.

IOM. 2001b. Immunization safety review: Thimerosal-containing vaccines and neuro-developmental disorders. Washington, DC: National Academy Press.

IOM. 2002a. Immunization safety review: Hepatitis B vaccine and demyelinating neurological disorders. Washington, DC: The National Academies Press.

IOM. 2002b. Immunization safety review: Multiple immunizations and immune dysfunction. Washington, DC: National Academy Press.

IOM. 2003a. Immunization safety review: SV40 contamination of polio vaccine and cancer. Washington, DC: The National Academies Press.

IOM. 2003b. Immunization safety review: Vaccinations and sudden unexpected death in infancy. Washington, DC: The National Academies Press.

IOM. 2004a. Immunization safety review: Influenza vaccines and neurological complications. Washington, DC: The National Academies Press.



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