perspectives and reviewed the scientific literature on the safety of the recommended childhood immunization schedule. At the public forums, the committee heard presentations by pediatricians, representatives of federal and state agencies and public health agencies in other countries, vaccine safety researchers, advocacy groups, vaccine manufacturers, and methodological experts. The committee invited comments (both written and oral) from the general public and representatives from numerous organizations with an interest in vaccine safety.

The committee held five deliberative meetings over 6 months. To address its charge, the committee requested from consultant Martin Kulldorff a commissioned paper on study designs that could be used to assess the safety of the immunization schedule (see Appendix D). The paper was intended to provide methodological input to the committee but the paper does not necessarily reflect the committee’s views. To solicit stakeholders’ feedback, the commissioned paper was posted on the committee’s website.

STAKEHOLDER CONCERNS

A review of the scientific literature, as well as a detailed review of the oral and written public comments, revealed that among the various stakeholder groups,1 parents, health care providers, and public health officials share the sentiment that there is insufficient communication between providers and parents about the schedule’s safety. Even though the vast majority of parents adhere to the ACIP-recommended immunization schedule, some parents are concerned that the schedule may present unnecessary risks because of the timing and number of vaccinations.

Some parents request variations in the immunization schedule, such as a delay of one or more immunizations or the administration of fewer vaccinations at each visit. Some parents also refuse immunizations entirely on the basis of the premise that their children’s risks from vaccine-preventable diseases are less than the risks of adverse events associated with immunizations. Such decisions may reflect, in part, the significant and sustained decline in vaccine-preventable diseases that immunization policy has achieved in the past several decades and against which the risk of even extremely rare adverse events may be seen as not worth taking. Some parents are concerned about their child’s risk of complications after immunization on the basis of a family history or the child’s medical condition and thereby

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1Stakeholder groups include researchers; advocacy groups; federal agencies and advisory committees; the general public (including parents); the health care system and providers; international organizations; media; nongovernmental organizations; philanthropic organizations; state, local, and tribal government agencies; industries, such as travel and vaccine manufacturing industries; vaccine distributors; and investors in vaccine manufacturers.



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