The Smallpox Vaccination Program Public Health in an Age of Terrorism (2005) / Chapter Skim
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3 The Implementation of the Smallpox Vaccination Program
3 The Implementation of the Smallpox Vaccination Program
Pages 39-80
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From page 39... ...
Major markers on the civilian smallpox vaccination program timeline include the following (see Figure 3-1 for a graph of weekly vaccination numbers in JanuarySeptember 2003, with several key events) : · December 13, 2002 -- National smallpox vaccination policy is announced.
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· May 2003 -- Department of Health and Human Services (DHHS) makes supplemental funding available for smallpox vaccination program.
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From page 41... ...
. To prepare the nation for the threat of smallpox, the military vaccination program would provide mandatory1 vaccination to selected members 1For designated military personnel without contraindications.
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From page 42... ...
. DHHS Secretary Tommy Thompson said that state pre-event vaccination plans designated a total of 439,584 people to be offered the vaccine.2 State plans included 1,100 public health smallpox response teams, adding up to 20,000 personnel that would be vaccinated, and 4,500 health care teams, adding up to 400,000 personnel that would be vaccinated; and DHHS officials also gave the figure of 10 million as a secondary target to include all health care workers and other first responders who would volunteer to be vaccinated (CDC, 2002d; Connolly and Milbank, 2002; McGlinchey, 2003a)
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From page 43... ...
. The secretary's declaration marked the true beginning of the smallpox vaccination program, in that states, territories, and municipalities chose to defer program implementation until the protec tions conferred by the Homeland Security Act went into effect (Kemper, 2003a)
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. This committee's first report recognized that the smallpox vaccination program was an atypical vaccination campaign that was neither a research study nor an ideal public health program, but a public health component of bioterrorism preparedness (IOM, 2003a)
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. Despite that, CDC continued to urge rapid implementation of the smallpox vaccination program without
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. Cardiac Adverse Events The myocardial infarction cases were only some of the cardiac adverse events associated with the civilian and military vaccination programs.
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From page 47... ...
and the ACIP Working Group on Smallpox Vaccination -- created in February 2003 to monitor vaccination program communication, surveillance, and research activities (ACIP, 2003a) -held an emergency meeting on March 28, 2003, to make recommendations to CDC about medical screening of potential vaccinees and follow-up of persons with cardiovascular risk factors after vaccination (CDC, 2003h)
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. Vaccination Program Safety Profile In the weeks surrounding the beginning of the program, health care and public health organizations described their unease regarding specific safety issues related to the vaccination program.
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From page 49... ...
for whom smallpox vaccine would hold a greater risk, and these conditions were included among the contraindications for smallpox vaccinations. Although there are many clinical data on reactions to smallpox vaccine, they predate contemporary immunosuppression.
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Both the events leading up to the war and the period after the declared end of major combat may have influenced public opinion and attitudes about and participation in the small pox vaccination program. President Bush declared an end to major hostilities in Iraq in April 2003 (although military action continued)
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. Multiple mass media reports indicate that some public health and health care workers believed that the vaccination program was linked with the war, and public opinion about the vaccination program was split, not unlike public opinion about the war (Russell, 2003)
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. The comprehensive compensation plan was proposed by DHHS in early March 2003, 6 weeks after the expected start of the vaccination program.
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released its evaluation of the progress of the smallpox vaccination program. GAO was asked to examine the implementation of the smallpox vaccination program and to describe program challenges.
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. As the smallpox vaccination program moved away from an emphasis on numbers to an emphasis on smallpox preparedness, public health agencies at the state and local levels reported that they lacked guidance about what preparedness meant and about how to assess whether they were prepared for a potential smallpox release (GAO, 2003; Selecky, 2003)
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From page 55... ...
and the National Governors Association (NGA) also expressed concern about the financial consequences of the smallpox vaccination program for the public health infrastructure and in the context of state and county budget deficits (NGA, 2003; Rosado, 2003)
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SARS placed enormous strains on many public health agencies in the United States. The emergence of SARS and later monkeypox during the course of the smallpox vaccination program was a reminder of the importance of public health preparedness for a wide array of potential problems (the "all-hazards" approach used by other agencies)
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From page 57... ...
. The smallpox vaccination program did not come to an official stop in response to the ACIP recommendation, but the pace of vaccination continued to decline.
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From page 58... ...
Some policy-makers contributed to the early discussion of policy options. In the weeks and months before the smallpox vaccination program was announced, Senators Bill Frist and Judd Gregg and others publicly urged the government to consider making smallpox vaccine available to all Americans to facilitate individual choice (Frist, 2002; Gregg, 2002; McKenna, 2003)
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From page 59... ...
. The smallpox vaccination program provided a unique opportunity for collaboration between CDC and DoD, and although the two programs involved very different circumstances and populations, there was much to be learned from both.
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. In the August 25, 2004, Smallpox Vaccination Program Safety Summary, DoD reported that over 631,000 personnel had been vaccinated and that most adverse events had occurred at a rate lower than historical rates (DoD, 2004c)
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From page 61... ...
The Informed Consent Process Like other aspects of smallpox vaccination program implementation, the informed consent process suffered from the program's rapid start and ambitious timeline. The early weeks of the program appeared to be caught up in a whirlwind of enormous effort on the part of CDC (GAO, 2003)
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From page 62... ...
was not operational until 3 weeks after the vaccination program began. The haste of implementation did not allow CDC to ensure that the system met the needs of state public health agencies, nor did it allow time for the creation of an active adverse event surveillance system.
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CDC provided training in smallpox vaccination and smallpox disease to public health and medical personnel, developed communication plans and tools, and regularly interacted with state and local public health agencies, answering questions related to implementation and providing technical assistance. Chapter 4 discusses two major lessons learned from the smallpox vaccination program, but the committee asserts that there are many lessons yet
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From page 64... ...
Important questions include these: · What was the general rate of work-limiting or recreation-limiting activities due to symptoms or illnesses in the first month after vaccination? · What are the current rates of serious adverse events related to smallpox vaccine in the civilian and military populations?
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From page 65... ...
. Evaluation and research activities could be undertaken in areas ranging from the administrative to the scientific, from determining the overall cost of the smallpox vaccination program and specific components to assessing the opportunity cost to public health agencies and identifying long-term effects of vaccine-related adverse events.
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TABLE 3-2 Smallpox Vaccination Program Timeline Events (policy, program, IOM Committee Date and other developments) Meeting or Report September 2000 DHHS contracts with OraVax (now a part of Acambis, Inc.)
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April 2002 NIAID study finds that Dryvax smallpox vaccine may be diluted to expand supply (Frey et al., 2002; NIH, 2002)
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. DHHS announces contracts to develop safer smallpox vaccines (DHHS, 2003b)
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From page 69... ...
CDC accepts ACIP's exclusion criteria and revises fact sheets, screening materials, and informed consent form. April 2003 More states suspend smallpox vaccination programs indefinitely, others for a limited length of time (Kemper, 2003c)
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. November 2003 Two independent panels examine four deaths Fourth meeting of potentially related to DoD's smallpox IOM committee vaccination program and found that one (April death of 22 year-old reservist)
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government contract to produce safer smallpox vaccine (DHHS, 2004)
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2002. Statement to the IOM's Committee on Smallpox Vaccination Program Implementation.
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2003h. Notice to readers: supplemental recommendations on adverse events following smallpox vaccine in the pre-event vaccination program: recommendations of the Advi sory Committee on Immunization Practices.
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2004b. Smallpox Vaccination Program Status by State, August 31, 2004.
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2003. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation.
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Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation on November 6, 2003. Hirshon J
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2002. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation.
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2003a. Advisory Committee on Immunization Practices Smallpox Vaccine Safety Working Group: Summary of Vaccination Program Safety Monitoring, April 2003.
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2002. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation.
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From page 80... ...
2003. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation.
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