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4 Lessons Learned from the Smallpox Vaccination Program
Pages 81-108

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From page 81...
... as public health agencies learn to work with national security and defense entities on matters of shared concern. The smallpox vaccination program is a case study in blending public health and national security interests to prepare for an event of low likelihood and high consequence -- bioterrorism in the form of a smallpox virus release.
From page 82...
... Although the committee recognizes that the terrorist attacks of 2001 were a dramatic and persuasive reminder of the importance of biopreparedness, it was never made clear to the public health and health care communities why smallpox was selected as a primary target for biopreparedness, how pre-event smallpox vaccination was identified as a core strategy, and why vaccination was urgent. Second, the scientific and public health rationale that led to the structure of the smallpox vaccination program (in its final form, characterized by the phases and numbers discussed elsewhere in this report)
From page 83...
... Among individual public health and health care workers, receiving what they perceived as insufficient information left them unable to accept smallpox vaccination. Lack of Scientific and Public Health Rationale for the Existence of the Vaccination Program In 2003, in Health Affairs, Kuhles and Ackman wrote: The key message we received from potential vaccinees was that civilians are unlikely to voluntarily assume personal risk without good reason.
From page 84...
... 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)
From page 85...
... . Finally, interviews conducted with health officials and other public health experts in the early months of the program's implementation indicated that some did not believe that a convincing case had been made to justify the pre-event vaccination program (Kuhles and Ackman, 2003; Markowitz and Rosner, 2004)
From page 86...
... . A recent CDC analysis of the swine influenza vaccination program of 1976 noted the importance of ensuring the credibility of decisions made by CDC (DHHS, 2004)
From page 87...
... Despite the bioterrorism grants that had been made available to states, state and local public health officials expressed frustration at the program's vast underestimation of its direct and opportunity costs and argued that the vaccination program necessitated a diversion from bioterrorism plans that they had already developed in anticipation of funding (ASTHO, 2003; Cook, 2003; GAO, 2003; Kuhles and Ackman, 2003; Markowitz and Rosner, 2004; NACCHO, 2003a, 2003b; Staiti et al., 2003; U.S. House of Representatives, 2004)
From page 88...
... . Planning for the smallpox vaccination program appears not to have included sufficient analysis of the potential effect of vaccination activities on the provision of essential public health services and on other preparedness efforts or analysis of the added costs of implementing such a large vaccination program (GAO, 2003; IOM, 2003b, 2003c)
From page 89...
... Confusing and Contradictory Information About the Policy and the Program The contradictory and confusing information provided during the implementation of the smallpox vaccination program may have constituted another barrier to implementation of the program and may have undermined CDC's credibility further. For example, the announcement of the policy and later explanations assured Americans that there was no imminent risk of smallpox virus release (U.S.
From page 90...
... . It is not clear whether CDC discussed the merits and costs of a pause in the vaccination program with its state and local counterparts.
From page 91...
... An attack on Iraq was argued on security, economic, foreign relations, military, and other grounds. Although the federal government did not explicitly link the war with Iraq and the vaccination program and at times even denied that the rationale for the program was related to the rationale for the war, several officials (DHHS Secretary Thompson, CDC Director Gerberding, and CDC National Immunization Program Director Walt Orenstein)
From page 92...
... The Senate and Central Intelligence Agency reports give rise to questions about why a sense of uncertainty about the probability of smallpox virus release was not more openly conveyed, with more information about the rationale for the policy, and why the threat assessment was not clarified, changed, or confirmed as the sense of urgency in the program diminished and the rate of vaccination dropped. Although DHHS and CDC officials expressed concern about the loss of momentum in the pre-event smallpox vaccination program and the apparent complacency among health care and public health workers, there was neither a formal reiteration of the threat assessment nor a formal reassessment of whether and how the program should continue (Fiorill, 2003; Meckler, 2003b)
From page 93...
... . Although CDC's rapid and appropriate response to the cardiac adverse events may provide partial evidence of the effectiveness of the adverse event active surveillance system and demonstrate the emphasis on safety, this IOM committee remained concerned that without a programmatic pause, states would have no opportunity to benefit from a national-level evaluation and perspective on the smallpox vaccination program.
From page 94...
... The smallpox vaccination program occurred in an environment of great uncertainty, so it required a clear explanation of its scientific and public health rationale and required every reasonable effort to ensure transparency and effective, regular communication among public health agencies at the federal, state, and local levels. The presentations of multiple public health and health care leaders at the committee's meetings, substantial coverage by the mass media, surveys and briefs from ASTHO and NACCHO, findings of the 2003 GAO report, a summary of interviews with public health workers (Markowitz and Rosner, 2004)
From page 95...
... The committee asserts that CDC's leadership role depends in part on the agency's ability to function as the definitive voice of science-based public health; its decisions and recommendations must always be seen as emerging logically from the best available scientific and public health reasoning. Many in the public health community did not perceive that to be the case during the smallpox vaccination program.
From page 96...
... Focus on Numbers Rather than Preparedness The initial distinction between pre-event vaccination plans and postevent plans may have caused some confusion because vaccination of response teams is an activity that could be simply included among smallpox post-event plans as the only type of vaccination activity that occurs in advance of a smallpox virus release. The CDC director's statement in November 2003 that the agency never had a vaccination program but had a preparedness program (a comment described by the mass media as a denial of the program's existence)
From page 97...
... . In a program already beset by ambiguity and unanswered questions, numbers seemed to constitute one concrete element, but the lack of an explanation of the scientific evidence and public health reasoning that went into shaping the smallpox vaccination program left the numbers-and the expectations of key actors, the mass media, and the public-ungrounded in factual information.
From page 98...
... The federal government's single-minded and intense focus on vaccination and vaccination targets also imposed great burdens on public health agencies that may have affected not just the routine work of the agencies (the Ten Essential Public Health Services) but their ability to develop comprehensive smallpox preparedness in the context of bioterrorism preparedness.
From page 99...
... and to advise CDC on their appropriateness and on ways to determine when an indicator had been met. The committee devoted its fifth report, included here as Appendix F, to a review of the indicators and included an assessment of relevant constituencies (state and local public health agencies, health care professionals, health care institutions, and first responders)
From page 100...
... . The committee recommends that, in collaboration with its state and local partners and in the context of broad bioterrorism preparedness, CDC define smallpox preparedness; set goals that reflect the best avail able scientific and public health reasoning; conduct regular, compre hensive assessments of preparedness at the national level and by state; and communicate to the public about the status of preparedness efforts.
From page 101...
... The public's confidence in the public health system's capacity to protect people in a bioterrorism event efficiently and effectively depends on evidence and reassurance that CDC and the nation's public health agencies are prepared. Although considerable resources and effort have been invested in the smallpox vaccination program, it remains unclear whether the nation is more prepared than it was before to respond to an attack with smallpox virus; preparedness has not been defined, clear goals have not been set, and there has been no comprehensive and systematic assessment of smallpox preparedness.
From page 102...
... 2003, February 8. Safety Concerns Hinder Participation in Smallpox Vaccination Program.
From page 103...
... 2002d. Supplemental Guidance for Planning and Implementing the National Smallpox Vaccination Program (NSVP)
From page 104...
... Presentation Before the IOM Com mittee on Smallpox Vaccination Program Implementation on December 19, 2002. Fauci AS.
From page 105...
... 2003. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation.
From page 106...
... 2003. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation.
From page 107...
... 2004. A Biodefense Failure: The Smallpox Vaccination Program One Year Later.


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