National Childhood Vaccine Injury Act

During the mid-1970s, there was an increased focus on personal health and more people became concerned about vaccine safety. Several lawsuits were filed against vaccine manufacturers and healthcare providers by people who believed they had been injured by the diphtheria, pertussis, tetanus (DPT) vaccine. Damages were awarded despite the lack of scientific evidence to support vaccine injury claims. As a result of these decisions, liability and prices soared, and several vaccine manufacturers halted production. A vaccine shortage resulted and public health officials became concerned about the return of epidemic disease. To reduce liability and respond to public health concerns, Congress passed the National Childhood Vaccine Injury Act (NCVIA) in 1986. This act was influential in many ways.

The National Vaccine Program Office (NVPO) was established to coordinate immunization-related activities between all Department of Health and Human Services (DHHS) agencies including the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), National Institutes of Health (NIH), and the Health Resources and Services Administration (HRSA).

The NCVIA requires health care providers who administer vaccines to provide a vaccine information statement (VIS) to the person getting the vaccine or his or her guardian. A VIS must be given with every vaccination including each dose in a multi-dose series. Each VIS contains a brief description of the disease as well as the risks and benefits of the vaccine. CDC develops VISs and distributes them to state and local health departments as well as individual providers.

The NCVIA also requires health care providers to report certain 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 (VAERS).

Under the NCVIA, the National Vaccine Injury Compensation Program (NVICP) was created to compensate those injured by vaccines on a "no fault" basis.

The NCVIA established a committee from the Institute of Medicine (IOM) to review the literature on vaccine reactions. This group concluded that there are limitations in our knowledge of the risks associated with vaccines. The group looked at 76 health problems to see if they were caused by vaccines. Of those, 50 (66%) had no or inadequate research to form a conclusion. [1, 2] Specifically, the IOM identified the following problems:

  • Limited understanding of biological processes that underlie adverse events.
  • Incomplete and inconsistent information from individual reports.
  • Poorly constructed research studies (not enough people enrolled for the period of time).
  • Inadequate systems to track vaccine side effects.
  • Few experimental studies were published in the medical literature.
  • Significant progress has been made over the past few years to monitor side effects and conduct research relevant to vaccine safety.


1. Howson CP, Howe CJ, Finchere HV, eds. Institute of Medicine. Adverse effects of pertussis and rubella vaccines: A report of the Committee to Review the Adverse Consequences or Pertussis and Rubella Vaccines. Washington, DC: National Academy Press, 1991.

2. Stratton KR, Howe CJ, Johnsion RB, eds. Adverse events associated with childhood vaccines; Evidence bearing on causality. Washington, DC; National Academy Press, 1994.






Updated 12/14/17

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