Immunization History

Vaccines are one of the greatest success stories in public health. Through use of vaccines, we have eradicated smallpox and nearly eliminated wild polio virus. The number of people who experience the devastating effects of preventable infectious diseases like measles, diphtheria, and whooping cough is at an all-time low. To ensure the continued success of vaccines in the United States, it’s crucial to make sure that vaccines are safe.

Before vaccines are approved by the Food and Drug Administration (FDA), they are tested extensively by scientists to ensure they are effective and safe. Vaccines are the best defense we have against infectious diseases; however, no vaccine is actually 100% safe or effective for everyone because each person’s body reacts to vaccines differently. [1, 2, 3]

As infectious diseases become less common, we hear less about the serious consequences of preventable illnesses like diphtheria and tetanus and more about the risks associated with vaccines. It’s good to be informed about health choices, but the reality is that Americans have never been healthier than we are today and vaccines have never been safer than they are today. The benefits of vaccines far outweigh the risks. As science continues to advance, we strive to develop safer vaccines and improve delivery to protect ourselves against disease more effectively. This overview focuses on vaccine research, how vaccines are licensed, and how we make sure vaccines are safe. [1, 2, 3]

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. [4] Damages were awarded despite the lack of scientific evidence to support vaccine injury claims. [4] 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. [4, 5]

  • 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. [6, 7]

Specifically, the IOM identified the following problems:

    1. Limited understanding of biological processes that underlie adverse events.
    2. Incomplete and inconsistent information from individual reports.
    3. Poorly constructed research studies (not enough people enrolled for the period of time).
    4. Inadequate systems to track vaccine side effects.
    5. 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.

References

  1. Chen RT, Hibbs B. Vaccine safety: Current and future challenges. Pediatric Annals1998;27(7):445–455.
  2. Ellenberg SS, Chen RT. The complicated task of monitoring vaccine safety. Public Health Reports 1997;112(1):10–20.
  3. Centers for Disease Control and Prevention. (1997) "Epidemiology and prevention of vaccine-preventable diseases, vaccine safety" (chapter 15). Washington DC: Government Printing Office.
  4. Freed GL, Katz SL, Clark SJ. Safety of vaccinations: Miss America, the media, and public health.Journal of the American Medical Association 1996;276(23):1869–1872.
  5. Brink EW, Hinman AR. The vaccine injury compensation act: The new law and you.Contemporary Pediatrics 1989;6(3):28–32, 35–36, 39, 42.
  6. 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.
  7. Stratton KR, Howe CJ, Johnsion RB, eds. Adverse events associated with childhood vaccines; Evidence bearing on causality. Washington, DC; National Academy Press, 1994.

Source: http://www.cdc.gov/vaccinesafety/Vaccine_Monitoring/history.html

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