Immunization Safety Review

Type: Consensus Study
Topics: Children and Families, Public Health
Board: Board on Population Health and Public Health Practice

Activity Description

The Immunization Safety Review Committee (ISR) was a project within the Institute of Medicine that addressed current and emerging vaccine-safety concerns. The committee provided independent, non-biased advice to vaccine policy-makers, as well as practitioners and the public.

The committee met three times a year from 2001 - 2004. The topic of each meeting was a specific vaccine-safety question. For each vaccine-safety question, the committee read and discussed the relevant epidemiologic evidence for or against a causal relationship, as well as any case reports, and clinical evidence. The committee also heard presentations from the authors of key papers, as well as ongoing, unpublished research.

Committee reports, as well as their summaries and press releases, are available (scroll to bottom of the page) online in full-text format. Following each meeting, the committee wrote a report with three types of conclusions about:

  • the causal relationship between the vaccine and adverse effect,
  • the biologic mechanisms that could account for the adverse effect, and
  • the significance of the safety concern in the context of society at large (e.g., the seriousness, treatment, complications of the wild-type disease and hypothesized adverse effects of the vaccine).

Based on their conclusions, the committee made recommendations for future activities (i.e. surveillance, research, policy, communication) regarding the safety concern. The committee's reports are addressed to federal vaccine research policymakers, state and local vaccine program implementers, health care professionals, the public, and the media.  

The ISR committee was composed of 14 people with expertise in:

  • Medicine (pediatrics, nursing, infectious disease, internal medicine)
  • Public Health (epidemiology, biostatistics, health communication)
  • Medical and Scientific Research (immunology, genetics, neurology)
  • Risk Perception, Decision Analysis, Ethics


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