between the vaccine and the adverse event, and an examination of experimental evidence for any biological mechanism(s) relevant to the hypothesis.

  • The significance assessment addresses such considerations as the burden of the health risks associated with the vaccine-preventable disease and with the adverse event in question. Other considerations may include the perceived intensity of public or professional concern, or the feasibility of additional research to help resolve scientific uncertainty regarding causal associations.

The findings of the scientific and significance assessments provide the basis for the committee’s recommendations on public health response, which includes immunization policy review, current and future research, and effective communication strategies. There are limits to the committee’s charge, however. For example, recommending a change in the licensure, scheduling, or administration of a vaccine would exceed the committee’s authority. If it concluded that the scientific evidence or other important factors justified such action, it could recommend convening the appropriate advisory group(s) to examine the question. See Figure 1 for a schematic 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 facilitate communication with the committee and provide public access to information about its work. The committee’s conclusions and recommendations in the first two reports, Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism (IOM, 2001a) and Immunization Safety Review: Thimerosal-Containing Vaccines and Neurodevelopmental Disorders (IOM, 2001b), are summarized in Appendix B.

To evaluate the hypothesis on multiple immunizations and immune system dysfunction, the committee collected information from several sources. At an open scientific meeting in November 2001 (see Appendix C), academic researchers gave presentations on specific scientific issues germane to the topic. All information presented to the committee at that meeting can be viewed on the project Website (www.iom.edu/imsafety). In addition, an extensive review was performed of the published, peer-reviewed scientific and medical literature (see Appendix D). A reference list of material reviewed by the committee, even if not cited in this report, can be found on its website as well.



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OCR for page 25
Immunization Safety Review: Multiple Immunizations and Immune Dysfunction between the vaccine and the adverse event, and an examination of experimental evidence for any biological mechanism(s) relevant to the hypothesis. The significance assessment addresses such considerations as the burden of the health risks associated with the vaccine-preventable disease and with the adverse event in question. Other considerations may include the perceived intensity of public or professional concern, or the feasibility of additional research to help resolve scientific uncertainty regarding causal associations. The findings of the scientific and significance assessments provide the basis for the committee’s recommendations on public health response, which includes immunization policy review, current and future research, and effective communication strategies. There are limits to the committee’s charge, however. For example, recommending a change in the licensure, scheduling, or administration of a vaccine would exceed the committee’s authority. If it concluded that the scientific evidence or other important factors justified such action, it could recommend convening the appropriate advisory group(s) to examine the question. See Figure 1 for a schematic 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 facilitate communication with the committee and provide public access to information about its work. The committee’s conclusions and recommendations in the first two reports, Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism (IOM, 2001a) and Immunization Safety Review: Thimerosal-Containing Vaccines and Neurodevelopmental Disorders (IOM, 2001b), are summarized in Appendix B. To evaluate the hypothesis on multiple immunizations and immune system dysfunction, the committee collected information from several sources. At an open scientific meeting in November 2001 (see Appendix C), academic researchers gave presentations on specific scientific issues germane to the topic. All information presented to the committee at that meeting can be viewed on the project Website (www.iom.edu/imsafety). In addition, an extensive review was performed of the published, peer-reviewed scientific and medical literature (see Appendix D). A reference list of material reviewed by the committee, even if not cited in this report, can be found on its website as well.

OCR for page 25
Immunization Safety Review: Multiple Immunizations and Immune Dysfunction FIGURE 1 Committee Charge