on costly clinical research, such as new randomized controlled trials or cohort studies.

The committee thus decided to make five general recommendations. Three recommendations focus on improvements to understanding stakeholder concerns, harmonizing research methods, and sequencing the process for selecting research questions. Two recommendations focus on research methods, including randomized controlled trials and data systems that would enable ongoing and improved observational studies.

Statement of Task (Part I): Review scientific findings and stakeholder concerns related to the safety of the recommended childhood immunization schedule.

Summary of Stakeholder Concerns

The committee’s findings and conclusions about stakeholder concerns are presented in Chapter 4. Although the committee identified the concerns of some parents about the number, frequency, and timing of immunizations in the overall immunization schedule, the committee did not find in its literature review that clinicians, public health personnel, or policy makers have similar safety concerns. Among the latter groups, the childhood immunization schedule is considered to be among the most effective and safe of the public interventions available to prevent serious disease and death. However, although health care professionals have much information about individual vaccines, they have much less information about the effects of administration of multiple vaccines at a single visit or the timing of the immunizations. Additionally, the cited concerns of health care professionals include efficacy of certain vaccines as well as appropriate delivery and communication regarding the recommended childhood immunization schedule.

Although the 2010 National Vaccine Plan addresses the need to provide health care providers with more timely, accurate, and transparent information about the benefits and risks of vaccines, the plan does not specifically address strategies to assist providers with questions about the safety of the immunization schedule (HHS, 2010). The committee concluded that parents and health care professionals would benefit from more comprehensive and detailed information with which to address parental concerns about the safety of the immunization schedule. Such information should clearly address vaccine-preventable diseases, the risks and benefits of immunizations, and the safety of the immunization schedule.

The committee’s literature review highlighted the lack of high-quality evidence supporting stakeholder concerns (the priority stakeholders are listed in Box 4-1) about the immunization schedule. In its role to ensure



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