reviewed written correspondence from the public throughout the duration of the study.

The committee held 5 deliberative meetings over 6 months between February and August 2012. To fully address its charge, the committee identified a consultant who prepared a commissioned paper on study designs that could be used to assess the safety of the immunization schedule (see Appendix D). The paper, written by Martin Kulldorff, was intended to provide methodological input to the committee, but the paper does not necessarily reflect the committee’s views or deliberations. To solicit stakeholders’ interest and feedback, a draft version of the commissioned paper was posted on the committee’s website on May 14, 2012, and comments on the paper were invited from the public. The comment period extended to May 31, 2012, and approximately 230 individuals provided written feedback. After a review of these comments and committee discussion, the committee requested revisions from the consultant. The commissioned paper was finalized on July 3, 2012, and again posted online for comment. The committee reviewed an additional 700 comments.

PREVIOUS IOM VACCINE STUDIES

Since the late 1970s, the IOM has conducted 60 studies on vaccination (see Appendix G). Each IOM study has relied on scientific evidence as the basis for its findings, conclusions, and recommendations. Committee members reviewed the summaries of 18 IOM studies that focused on vaccine safety. Reexaminations of safety are often prompted by new scientific findings and rising concerns usually in relationship to an individual vaccine and a possible adverse health outcome. However, the study of the present IOM committee is unique in that its focus is on the complete childhood immunization schedule.

This report follows a series of eight reports on vaccine safety that appeared between 2001 and 2004. The eighth report in this series examined the evidence about a possible link between autism and vaccines. That examination of the evidence found no association. A striking element described in each of these IOM reports is society’s sustained interest in vaccines (Fineberg, 2011).

The 2012 IOM committee report Adverse Effects of Vaccines: Evidence and Causality examined 158 pairs of vaccines and putative adverse effects and was the IOM’s most recent study of vaccine safety (IOM, 2012). No evidence to support a link between a vaccine and adverse events was found for the majority of adverse events, but this was often due to the rarity of the adverse event and the lack of evidence in general to support or reject a causal link. However, the committee concluded that very few health problems are caused by or are clearly associated with vaccines.



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