The findings of the scientific and significance assessments provide the basis for the committee’s recommendations regarding the public health response on the issue. In particular, the committee addresses needs for immunization policy review, current and future research, and effective communication strategies. See Figure 1 for a schematic representation of the committee’s charge.

THE STUDY PROCESS

The committee held an initial organizational meeting in January 2001. CDC and NIH presented the committee’s charge at the meeting, and the committee conducted a general review of immunization safety concerns and determined its methodology for assessing causality. This approach would be used for the hypotheses to be considered at subsequent meetings. A website (www.iom.edu/imsafety) and a listserv were created to provide public access to information about the committee’s work and to facilitate communication with the committee. The conclusions and recommendations of the committee’s first three reports—Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism (IOM, 2001a), Immunization Safety Review: Thimerosal-Containing Vaccines and Neurodevelopmental Disorders (IOM, 2001b), and Immunization Safety Review: Multiple Immunizations and Immune Dysfunction (IOM, 2002)— are summarized in Appendix A.

For its evaluation of the hypothesis on hepatitis B vaccine and demyelinating neurological disorders, the committee first commissioned a background paper; its purposes were to review current understanding of the biological mechanisms thought to be involved in MS and other demyelinating disorders, and to analyze the relationship of those mechanisms to the putative role of hepatitis B vaccine in such disorders. The committee also held an open scientific meeting in March 2002 (see Appendix B) for presentations on issues germane to the topic. The commissioned paper and all information presented to the committee at the open meeting can be viewed on the project website (www.iom.edu/imsafety). In addition, the committee reviewed an extensive collection of material from the published, peer-reviewed, scientific and medical literature. A reference list of materials reviewed by the committee, even if not cited in this report, can be found on its website.



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