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- 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 (8).
- Cases of a new and unrelated disease, Legionnaires disease,
appeared (9).
- "Excess" cases of Guillain-Barré syndrome appeared
among recipients of vaccines (10).
- Erroneous laboratory reports of viral isolates or serologic
conversions occurred in Washington, DC, Boston, Virginia, and
Taiwan.
- The pandemic failed to appear.
- 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.
- 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.
- 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).
- Health legislation can and should be developed on the basis
of the epidemiologic picture.
- 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.
- 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).
- 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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