vaccine benefit was linked with the rationale for the vaccination program. On the basis of mass media coverage of program progress and a variety of additional sources, including presentations to the present Institute of Medicine (IOM) committee, it appears that despite the expressed sense of personal commitment (May et al., 2003) to protecting the public’s health, both individuals and institutions found the information available for decision-making inadequate in quantity and quality and ultimately not sufficiently conducive to an affirmative decision regarding vaccination.

Communication about the smallpox vaccination policy and the decisions that led to it was incomplete and vague, particularly information quantifying or explaining the available evidence about the threat of smallpox and information about the epidemiologic and public health reasoning regarding whom and when to vaccinate. Although sensitive, classified information may have been involved, it does not appear that the complete facts needed for decision-making and buy-in at the state and local levels were shared with constituencies, and failure to do that had a detrimental effect on the program’s progress and, more important, may have compromised the relationship of trust between CDC and the public health community.

The president’s announcement stated multiple times that the government had no information that a smallpox virus release was imminent (White House, 2002). Information provided by the Department of Health and Human Services (DHHS) and CDC largely reiterated the president’s statements and shed no additional light on the evidence that led to the decision to begin pre-event smallpox vaccination (U.S. Department of State, 2002). At least some of the information appeared to be many years old, dating back to the fall of the Soviet Union (Gellman, 2002), and it was never made clear to the public what accumulation of evidence made smallpox vaccination an urgent priority. The president’s announcement that the threat was not imminent, although not zero, restated what had been the case for at least a decade. Undoubtedly, the events of September and October 2001 were important in shaping how old information was being viewed (White House, 2002).

A complete risk-benefit analysis in the face of extreme ambiguity seemed impossible, and both institutional and personal decisions regarding vaccination were complicated by the lack of information. The factual information available to institutions and individuals considering participation in the voluntary vaccination program consisted primarily of the following:

  • The president’s statement about the threat assessment.

  • The statements of other federal officials (including the director of CDC) about the threat assessment.

  • The recent occurrence of domestic terrorism and bioterrorism.

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