consider expanding the collaboration with new health plan members and enhancing the data to improve its utility and generalizability.

CONCLUDING OBSERVATIONS

The committee’s efforts to identify priorities for recommended research studies did not reveal a base of evidence suggesting that the childhood immunization schedule is linked to autoimmune diseases, asthma, hypersensitivity, seizures or epilepsy, child developmental disorders, learning disorders or developmental disorders, or attention deficit or disruptive behavior disorders. While the committee found that there is no scientific evidence to justify the majority of safety concerns, perceptions dictate parental support and actions. Therefore further study of the full immunization schedule as well as further study to understand stakeholder perceptions and how they are formed may help improve awareness and education efforts. Stakeholder concerns should be one of the elements used to drive searches for scientific evidence, but these concerns alone, absent epidemiological or biological evidence, do not warrant the initiation of new high-cost randomized controlled trials. The committee concludes that data from existing data systems may be used to conduct observational studies and offer the best means for ongoing research efforts of the immunization schedule’s safety.

The committee found no significant evidence to imply that the recommended immunization schedule is not safe. Furthermore, existing surveillance and response systems have identified adverse events known to be associated with vaccination. The federal immunization research infrastructure is strong. A key component is the VSD project, which with ongoing support will be able to feasibly address the committee’s identified key research questions. Although the committee concludes that protection of children from vaccine-preventable diseases is of higher importance than testing of alternative immunization schedules without epidemiological or biological evidence indicating a safety problem, VSD should continue to examine the health outcomes of people who choose alternative schedules.

Looking to the future, the committee supports the work of the federal research infrastructure in ensuring that stakeholders are involved in all stages of development, implementation, evaluation, and dissemination of the immunization schedule. As electronic medical records become more commonly used, they may provide an opportunity to capture complete immunization data linked with hospital discharge records that will be useful to future studies. Further, the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program may have the capability to monitor rare adverse events potentially associated with the childhood immunization schedule. Initiatives such as the National Children’s Study also hold promise; it



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