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IOM Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule

At the request of the Department of Health & Human Services’ (HHS) National Vaccine Program Office (NVPO) and CDC, the Institute of Medicine (IOM) convened a Committee on Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule to conduct an independent evaluation of studying the safety of the childhood immunization schedule.  The task for this expert committee of the IOM was to:

  1. Review scientific findings and stakeholder concerns related to the safety of the recommended childhood immunization schedule
  2. Identify potential research approaches, methodologies, and study designs that could inform this question, including an assessment of the potential strengths and limitations of each approach, methodology and design, as well as the financial and ethical feasibility of doing them
  3. Issue a report summarizing their findings

The IOM process included reviewing available scientific findings in published and unpublished literature, then holding three public stakeholder meetings in 2012 (February, March and May) to listen to suggestions and concerns from a wide spectrum of individuals and organizations.  The Committee evaluated new data related to studying the safety of the recommended childhood immunization schedule as well, including commissioning a paper on potential study designs.

The IOM report, “The Childhood Immunization Schedule and Safety,”  was issued on January 16, 2013. In it, the Committee expressed support for the childhood immunization schedule as a tool to protect against vaccine preventable diseases.  The Committee recommended using existing healthcare records data to continue to study the safety of vaccines.  The Committee also reconfirmed a finding of the National Vaccine Advisory Committee (NVAC) that conducting a study [PDF - 631 KB] which required some children to receive fewer vaccines than the recommended schedule, as would be needed for a randomized controlled trial, would be unethical.

Additional information about the IOM assessment is available at http://www.iom.edu/Activities/PublicHealth/ChildhoodImmunization.aspx.

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