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BOX A11-1

Lessons Learned from the 1976 National Influenza Immunization Program (NIIP)

  1. Expect the unexpected: it will always happen. Some examples:

    • Children did not respond to the initial formulation of vaccine.

    • Liability for untoward events after immunization became a major issue.

    • Deaths occurred in Pittsburgh that were coincidental with but unrelated to the vaccines (Schmeck, 1976).

    • Cases of a new and unrelated disease, Legionnaires disease, appeared (Fraser et al., 1977).

    • “Excess” cases of Guillain-Barré syndrome appeared among recipients of vaccines (Schonberger et al., 1981).

    • Erroneous laboratory reports of viral isolates or serologic conversions occurred in Washington, DC, Boston, Virginia, and Taiwan.

    • The pandemic failed to appear.

  1. Surveillance for influenza disease worked well. This was plain, “old-fashioned” surveillance without computers. A new strain of influenza was identified within weeks of the first recognized outbreak of illness.

  2. Interagency cooperation works without formal agreements. The state health departments, military, National Institutes of Health, US Food and Drug Administration, and Center for Disease Control all worked together in a cooperative and mutually beneficial manner.

  3. Surveillance for untoward events demonstrated that only when large numbers of people are exposed to a vaccine or drug are adverse reactions identified (Guillain-Barré syndrome with influenza vaccines; paralysis with the Cutter poliovirus vaccine in 1955).

  4. Health legislation can and should be developed on the basis of the epidemiologic picture.

  5. Media and public awareness can be a major obstacle to implementing a large, innovative program responding to risks that are difficult, if not impossible, to quantitate.

    • Creating a program as a presidential initiative makes modifying or stopping the program more difficult.

    • Explanations should be communicated by those who can give authoritative scientific information.

    • Periodic press briefings work better than responding to press queries.

  1. The advisability of the decision to begin immunization on the strength of the Fort Dix episode is worthy of serious question and debate (see text).

  2. The risk of potentially unnecessary costs in a mass vaccination campaign is minimal. (The direct cost of the 1976 program was $137 million. In today's dollars, this is <$500 million.) The potential cost of a pandemic is inestimable but astronomical.

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