tion to consumers (CDC, 2010). Key provisions of the 1986 legislation include

  • The establishment of the National Vaccine Program Office, which coordinates immunization-related activities between all Department of Health and Human Services (HHS) agencies including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration, the National Institutes of Health, and the Health Resources and Services Administration (HRSA).
  • The requirement that all health care providers who administer vaccines provide a vaccine information statement (VIS) to the vaccine recipient, or his or her parent or legal guardian, prior to each dose. Each VIS contains a brief description of the disease as well as the risks and benefits of the vaccine. The CDC develops VISs and distributes them to state and local health departments as well as individual providers.
  • The requirement that health care providers must report certain and are encouraged to report other adverse events (health effects occurring after immunization that may or may not be related to the vaccine) following vaccination to the Vaccine Adverse Event Reporting System.
  • The creation of the National Vaccine Injury Compensation Program (VICP) to compensate those injured by vaccines on a no-fault basis. Importantly, this compensation system has two parts:
    • The Secretary of Health and Human Services has created a Vaccine Injury Table (Table) that “lists and explains injuries/conditions that are presumed to be caused by vaccines. It also lists time periods in which the first symptom of these injuries/ conditions must occur after receiving the vaccine. If the first symptom of these injuries/conditions occurs within the listed time periods, it is presumed that the vaccine was the cause of the injury or condition unless another cause is found” (http://www.hrsa.gov/vaccinecompensation/table.htm) and compensation is awarded.
    • Individuals who assert that they suffered an injury from a vaccine that is not on the Table (“off-Table” or “causation-in-fact”) must pursue their claim before Special Masters, who are appointed by the United States Court of Federal Claims, which hears any appeals. Claimants bear the burden of proving that the vaccine caused their injury, although the burden of proof is lower than that in the tort system.

A key component of the legislation, found in Sections 312 and 313, required the HHS secretary to consult with the Institute of Medicine (IOM)

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