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Summary
Pages 1-16

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From page 1...
... The childhood immunization schedule (defined in this report as the immunization schedule covering children from birth through age 6 years) immunizes children in a manner consistent with demonstrated efficacy, safety, and feasibility but also permits some degree of flexibility to accommodate individual preferences and logistics.
From page 2...
... issues guidance on the vaccines to be administered and immunization schedules for children, adolescents, and adults, based on recommendations from ACIP. To recommend new vaccines, ACIP uses a process in which it reviews a comprehensive set of data associated with the vaccine, including illnesses and deaths associated with the disease and specific high-risk groups; the results of clinical trials, including indicators of safety, efficacy, and effectiveness; cost-effectiveness; information on vaccine use provided by the manufacturer in the product's labeling or package insert; and the feasibility of incorporation of the vaccine into the existing immunization schedule.
From page 3...
... Before the first meeting and throughout the committee's deliberations, the committee gathered information on public BOX S-1 Statement of Task The Institute of Medicine will convene an expert committee to 1. Review scientific findings and stakeholder concerns related to the safety of the recommended childhood immunization schedule.
From page 4...
... 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.
From page 5...
... HEALTH OUTCOMES The committee searched for, assembled, and summarized evidence on the association between the immunization schedule and specific health conditions that was already published in the peer-reviewed literature. The health outcomes that the committee chose to review were selected on the basis of an examination of the peer-reviewed literature, previous IOM vaccine safety studies, and public presentations at open meetings of this committee.
From page 6...
... METHODOLOGICAL APPROACHES Moving from an analysis of stakeholder concerns and the limited scientific evidence about the association between the immunization schedule and adverse events to recommendation of specific research methods and study designs to address that association is an ambitious task in light of the complexity and changing nature of the recommended immunization schedule. Variables such as the number of doses, the age of administration, and the amount of time between doses permit the examination of a large number of potential research questions.
From page 7...
... Additionally, health care professionals serving participants placed in the group to receive fewer or no vaccines would have to go against professional medical guidelines that call on them to encourage patients to follow the recommended schedule. Even the use of a dispersed immunization schedule that is still within the accepted ACIP time frame for vaccinations as a trial arm would require an increased number of clinic visits, often in rapid succession over a period of a few weeks, which could prove difficult and costly for both the clinics and participating families and may be unacceptable to insurers if its improved effectiveness -- measured as a decreased rate of adverse outcomes -- was negligible.
From page 8...
... Although such studies would be the optimal design for evaluating long-term health outcomes associated with the childhood immunization schedule, they would require considerable time and funding, and the committee did not find adequate epidemiological evidence to recommend investment in this type of research at this time.
From page 9...
... Attempts to quantify the relative safety of contrasting immunization schedules need to take into account at least two separate health outcomes: adverse events after the administration of specific vaccines and the overall immunization schedule, and the respective impacts of alternative schedules on the circulation of vaccine-preventable diseases and the consequent adverse outcomes associated with infection. The intimate association between immunization and age-specific disease incidence needs to be addressed.
From page 10...
... However, an effective national vaccine program will require a more complete and systematic collection of information about stakeholder concerns about vaccine safety, the severity of vaccine-preventable diseases, individual- and population-level immunization rates, the efficacy of immunization, and the delivery and supply of vaccines recommended in the childhood immunization schedule. To more effectively implement immunization programs, a robust communication and engagement strategy that includes careful study of safety concerns is needed.
From page 11...
... Recommendation 5-1: To improve the utility of studies of the entire childhood immunization schedule, the committee recommends that the National Vaccine Program Office develop a framework that clarifies and standardizes definitions of • key elements of the schedule, • relevant health outcomes, and • populations that are potentially susceptible to adverse events.
From page 12...
... Before HHS agencies, such as CDC, FDA, the National Institutes of Health, and NVPO, initiate further research on the entire immunization schedule, a thorough review of the biological plausibility of the association of a particular outcome with an aspect of the immunization schedule should be conducted. Recommendation 6-1: The committee recommends that the Depart ment of Health and Human Services incorporate study of the safety of the overall childhood immunization schedule into its processes for setting priorities for research, recognizing stakeholder concerns, and establishing the priorities on the basis of epidemiological evidence, biological plausibility, and feasibility.  The decision to initiate further studies should depend on the evaluation of three considerations that the committee identified through its review of stakeholder concerns and scientific findings: 1.
From page 13...
... Because an RCT would increase the risk of preventable diseases in individuals and in the community and entail significant amounts of time, money, and other resources, the committee concludes that new RCTs of the childhood immunization schedule are not justified at this time. Recommendation 6-2: The Department of Health and Human Services should refrain from initiating randomized controlled trials of the child hood immunization schedule that compare safety outcomes in fully vaccinated children with those in unvaccinated children or those vac cinated by use of an alternative schedule.  The committee concludes that secondary analyses of existing data are more promising approaches to examination of the research questions identified by the committee in future studies of the childhood immunization schedule.
From page 14...
... CONCLUDING OBSERVATIONS The committee's efforts to identify priorities for recommended research studies did not reveal an evidence base suggesting that the childhood immunization schedule is linked to autoimmune diseases, asthma, hypersensitivity, seizures, child developmental disorders, learning disorders or developmental disorders, or attention deficit or disruptive behavior disorders. Although stakeholder concerns should be one of the elements used to drive searches for scientific evidence, these concerns alone, absent epidemiological or biological evidence, do not warrant the initiation of high-cost research studies.
From page 15...
... The childhood immunization schedule may become more complex over time as scientific advances are made and new vaccines are developed and incorporated into the schedule. Feasible research approaches to study potential adverse health outcomes will emerge only with sustained and substantial federal commitment to research on vaccine safety.


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