utility will be expanded with the addition of more detailed demographic data and family medical histories.

Recommendation 6-3: The committee recommends that the Department of Health and Human Services (HHS) and its partners continue to fund and support the Vaccine Safety Datalink project to study the safety of the recommended immunization schedule. Furthermore, HHS should consider expanding the collaboration with new health plan members and enhancing the data to improve its utility and generalizability.


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. The committee concludes that the use of existing data from database systems to conduct observational studies offers the best means for ongoing research efforts about 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 known adverse events associated with vaccination. The federal research infrastructure is a strong system. A key component is the VSD project, which with ongoing support will be able to feasibly address the committee’s research questions identified in Box S-2. Although the committee concluded that protecting children from vaccine-preventable diseases is of higher importance than testing 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 to ensure that stakeholders are involved in all stages of the 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, which will be useful to future studies. Newer initiatives such as the National Children’s Study

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