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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality
English literature), analyzed information from U.S. Public Health Service-administered reporting systems for adverse reactions to vaccines, and considered material submitted by interested parties. The committee solicited input from scientists who were invited to participate in two open scientific meetings and from other interested parties at two open public meetings. Details regarding how the committee gathered information are given in Appendix B. All salient information from those reviews is contained in this report.
P.L. 99-660 stated that the review was to include those vaccines covered by the National Vaccine Injury Compensation Program. Haemophilus influenzae type b (Hib) and hepatitis B vaccines were added for consideration because of the increasing use of these vaccines and the supposition that in the near future they could be mandatory vaccines covered by the National Vaccine Injury Compensation Program. The list of adverse events investigated for this report derived primarily from negotiations with representatives of the U.S. Public Health Service. However, preliminary investigations into additional adverse events were prompted by queries from interested parties or committee members. After considering the information from these preliminary investigations, the committee added several vaccine-adverse event relations to the original list. Table B-1 in Appendix B contains a complete listing of the specific vaccine-adverse event relations under study.
The report begins with background information. Chapter 2 contains an in-depth discussion of the approach used by the committee to weight the evidence and assess causality. Information on the neurologic disorders and immunologic reactions discussed in much of the report is contained in Chapters 3 and 4. Chapters 5 through 9 include the vaccine-specific evidence and conclusions. All information (evidence, causality argument, and conclusions) regarding death as an adverse event associated with vaccination is contained in Chapter 10.
Adverse Effects of Pertussis and Rubella Vaccines (Institute of Medicine, 1991), the report of the predecessor IOM committee, provides an in-depth review of the literature concerning the adverse events associated with diphtheria and tetanus toxoids and pertussis vaccine (DPT), as well as pertussis vaccine, and should be referred to for conclusions regarding DPT. Appendix A contains the Executive Summary of that report. The charge to the Vaccine Safety Committee was to examine adverse events associated with tetanus toxoid as well as tetanus and diphtheria toxoid combination preparations. The committee reviewed data concerning DPT if the data also concerned diphtheria and tetanus toxoids for pediatric use (DT); however, it was beyond the committee's scope to make conclusions about pertussis vaccine or DPT.
The IOM Committee to Review the Adverse Consequences of Pertussis