3
The Implementation of the Smallpox Vaccination Program

As described in Chapter 2, a long chain of events and policy decisions led to the revival of civilian smallpox vaccination in the United States. Plans to implement pre-event vaccination of a limited number of health care and public health personnel began to take shape in late 2002.

A detailed timeline of the vaccination program is provided at the end of this chapter (Table 3-2). The chapter does not address every event in the timeline, but in the first section highlights a short list of relevant events and program milestones. Each subsection begins with a description of an event and then moves on to a broader discussion of its significance. For example, the monkeypox outbreak that occurred several months into the implementation of the program is summarized, and then there is a discussion of the outbreak as a proxy event that tested public health preparedness in general and smallpox preparedness specifically.

Major markers on the civilian smallpox vaccination program timeline include the following (see Figure 3-1 for a graph of weekly vaccination numbers in January–September 2003, with several key events):

  • December 13, 2002—National smallpox vaccination policy is announced.

  • January 24, 2003—Civilian pre-event smallpox vaccination begins.

  • March 19, 2003—War with Iraq begins. Both the buildup to the war and the declared end of major combat appeared to have an effect on the smallpox vaccination program.



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The Smallpox Vaccination Program: Public Health in an Age of Terrorism 3 The Implementation of the Smallpox Vaccination Program As described in Chapter 2, a long chain of events and policy decisions led to the revival of civilian smallpox vaccination in the United States. Plans to implement pre-event vaccination of a limited number of health care and public health personnel began to take shape in late 2002. A detailed timeline of the vaccination program is provided at the end of this chapter (Table 3-2). The chapter does not address every event in the timeline, but in the first section highlights a short list of relevant events and program milestones. Each subsection begins with a description of an event and then moves on to a broader discussion of its significance. For example, the monkeypox outbreak that occurred several months into the implementation of the program is summarized, and then there is a discussion of the outbreak as a proxy event that tested public health preparedness in general and smallpox preparedness specifically. Major markers on the civilian smallpox vaccination program timeline include the following (see Figure 3-1 for a graph of weekly vaccination numbers in January–September 2003, with several key events): December 13, 2002—National smallpox vaccination policy is announced. January 24, 2003—Civilian pre-event smallpox vaccination begins. March 19, 2003—War with Iraq begins. Both the buildup to the war and the declared end of major combat appeared to have an effect on the smallpox vaccination program.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism FIGURE 3-1 Timeline of smallpox vaccination program with number of weekly vaccinations and key events. SOURCE: Henderson (2003b). *MMWR = Morbidity and Mortality Weekly Report. **ACIP = Advisory Committee on Immunization Practices. Late March and early April 2003—Concerns about vaccine and program safety reach high point in response to reported fatal cardiac adverse events and cases of heart inflammation, known as myo/pericarditis. April 2003—Smallpox vaccination compensation plan is enacted in response to widespread concern about vaccine-related injuries. April 2003—General Accounting Office (GAO, now Government Accountability Office) report provides first systematic assessment of vaccination program progress and highlights challenges. May 2003—Department of Health and Human Services (DHHS) makes supplemental funding available for smallpox vaccination program. May and June 2003—Monkeypox outbreak tests public health (and smallpox) preparedness. June 2003—Advisory Committee on Immunization Practices (ACIP) recommends ending smallpox vaccination after completing vaccination of response teams; vaccination continues, very slowly approaching 40,000 vaccinees. The section on program milestones is followed by a discussion of two noteworthy features of the program (congressional interest and involvement, and the significance of the parallel military smallpox vaccination program). The chapter’s third section focuses on the committee’s findings

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism about challenges that arose in the course of the vaccination program and about which the committee has written in previous reports, included here as Appendixes B-G. The fourth and final section highlights some of the favorable outcomes of the smallpox vaccination program. In this chapter and elsewhere in this report, the committee has cited multiple articles from the mass media on the smallpox vaccination policy and on the program implementation. Using news media references was necessary because of the limited scientific peer-reviewed and other formal literature available on the newly initiated and continuing program. Although newspaper articles may capture events in a manner that is incompletely documented, subjective, and even out of context, the committee found that some themes emerged consistently from diverse media sources and provided useful information about how the program was perceived in the public health and health care communities. More important, mass media coverage of the program was concordant with the information presented at committee meetings by state and local public health officials and health care administrators, with the congressional testimony of public health leaders, and with findings from qualitative surveys that became available later in the course of the program. Mass media reports reflected the perceptions of key constituencies and the public; their perceptions of CDC, the program, and the federal government’s role may provide insight into the lessons to be learned from this program. MAJOR MILESTONES AND RELEVANT EVENTS The Policy Is Announced On December 13, 2002, President George W. Bush announced that smallpox vaccine would be administered to selected civilians and members of the military. The announcement was the culmination of planning and decision-making that spanned the latter half of 2002. The president explained that “government has no information that a smallpox release is imminent. Yet it is prudent to prepare for the possibility that terrorists would kill indiscriminately” with biologic weapons (White House, 2002b). To prepare the nation for the threat of smallpox, the military vaccination program would provide mandatory1 vaccination to selected members 1   For designated military personnel without contraindications.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism of the military and offer vaccination to others who “serve America in high-risk parts of the world,” and a civilian smallpox vaccination program would make the vaccine “available on a voluntary basis to medical professionals and emergency personnel and response teams that would be the first on the scene in a smallpox emergency” (White House, 2002b). Although the president’s announcement acknowledged and reiterated that there was no imminent danger and that pre-event vaccination would therefore be limited to specified groups, he stated that vaccination would be offered to members of the general public “who insist on being vaccinated” (White House, 2002b). The program’s general structure and timeline were only sparsely outlined in the president’s announcement and the White House news release. Additional details were conveyed in later telebriefings, program guidance, and other communications from the secretary of Health and Human Services and from Centers for Disease Control and Prevention (CDC) officials (CDC, 2002a, 2002b, 2002d; Connolly and Milbank, 2002; McGlinchey, 2003a). In the joint CDC–DHHS telebriefing on December 14, 2002, the number of prospective vaccinees was discussed in some detail (CDC, 2002d). 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). The public health and health care communities came to understand that the program would progress in three stages or phases: Phase I would involve the vaccination of designated members of health care and public health smallpox response teams with a goal of about 500,000 and a timeline of 30 days. Phase II would involve the expansion of vaccination to up to 10 million health care personnel and other first responders, such as firefighters and police. In Phase III, intended to begin in 2004, vaccination with a new, not yet approved, vaccine would be offered to members of the public who in the absence of a smallpox release insisted on being vaccinated. 2   Recipients of CDC funding for bioterrorism preparedness who developed smallpox plans include not only states, but also the U.S. territories, the District of Columbia, and three metropolitan jurisdictions. State is used here to include all those entities.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism The Program Begins The program did not begin immediately after the president’s announcement, because government coverage of liability (of vaccine manufacturers, hospitals, and health departments that would operate vaccination clinics) in the provision of bioterrorism countermeasures (vaccine) would not go into effect until weeks later. On January 22, 2003, CDC began shipping smallpox vaccine from its vaccine stockpiles to the 11 states that had requested it. On January 24, 2003, the secretary of Health and Human Services declared that the smallpox vaccination program could begin under the authority of an amendment to the Public Health Service Act by Section 304 of the Homeland Security Act3 (DHHS, 2003a). 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 protections conferred by the Homeland Security Act went into effect (Kemper, 2003a). 3   The Homeland Security Act was signed by the president on November 25, 2002. Vaccination programs in the 62 states, territories, and municipalities began gradually. Some jurisdictions ordered vaccine stocks as soon as CDC made them available and began vaccinating immediately after the program was authorized. Other jurisdictions delayed ordering vaccine and initiating vaccination in order to finalize their plans, or in expectation of CDC’s completion of program components (such as the safety system and informational materials), or to await the settlement of the unresolved vaccine injury compensation issue for people injured by the vaccine or the accidental, inadvertent transmission of vaccinia from a vaccination site. The vaccination program was generally supported by the public health and health care communities in recognition of the need for biopreparedness (ANA, 2002; Hardy, 2002; Libbey 2003). A survey of state health officials in June 2002 found that a majority (77 percent of 44 respondents) favored smallpox vaccination of designated response teams (Banks and Hannan, 2002). Two surveys of physicians, nurses, and other health care personnel largely working in emergency departments, conducted in late 2002, found that that a majority of respondents (61 percent of 1,165 respondents in one survey, 73 percent of 1,701 respondents in the other) expressed a willingness to receive smallpox vaccination as part of a pre-event program (Everett et al., 2002; Yih et al., 2003). However, support of the program by the public health and health care communities was qualified because of questions and concerns about several aspects of the program; these contributed

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism to implementation delays and to other challenges. Subjects of concern ranged from the scientific—such as the reliability of historical measures for estimating transmission rates, and the relevance and accuracy of historical adverse events data—to the procedural and administrative, including the structure of the vaccination program and its effect on overall bioterrorism preparedness, the actual and opportunity costs of the program, the adequacy of measures to address compensation and liability, and the safety of the vaccine. Questions and concerns were communicated in open letters to DHHS and to the White House, in press releases and policy statements, at congressional hearings, and at meetings of the present committee (ANA, 2002; Baker, 2003; Libbey, 2003; NGA, 2003; Rosado, 2003). 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). The committee also emphasized the program’s voluntary nature and the need for a focus on safety, requiring active monitoring of side effects related to vaccination. Unlike the views and input of national organizations, which were made public through press releases and other formal communications, the perspectives of individual hospitals and those of health care and public health workers were captured largely in mass media reports. In late January and early February 2003, people involved in the program were interviewed or cited in newspaper articles and news broadcasts; their comments reflected a wide array of feelings and opinions. They included commitment to doing what was needed to protect the public’s health, confusion and suspicion about the rationale for the program, confidence in the usefulness of vaccination, concern about the vaccine’s safety and about potential loss of wages because of non-life-threatening but important postvaccination symptoms, and criticism of or worry about the reluctance of many public health and health care workers to be vaccinated (Bavley and Dvorak, 2003; Kemper, 2003a; Marchione, 2003; McKenna, 2003; Meckler, 2003a). The net results of individual and institutional concerns were hesitation and low participation among public health and health care workers and great variability in hospital participation. Hospitals differed greatly in their anticipated degree of participation in the smallpox vaccination program. Some hospitals planned to participate, at least by having a small number of staff members vaccinated to serve later as vaccinators, but others (DHHS Secretary Thompson estimated about one-third of hospitals) planned to opt out (Bavley and Dvorak, 2003; Ornstein and Richardson, 2003). Some of the hospitals that did not plan to participate in vaccination chose to hold training sessions and to educate their staff on smallpox disease and smallpox vaccination (Judson, 2003; Toomey, 2003). Hospitals that chose not to participate in pre-event vacci-

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism nation cited various reasons: the desire to avoid infecting immunosuppressed patients, concerns about strain on their workforce (due to sick time necessary because of complications or to prevent patient exposure), and questions about liability if nonstaff (families and patients) were inadvertently infected with the vaccinia virus (Associated Press, 2003; McCullough, 2003; McNeil, 2003; Ornstein and Bonilla, 2003; Pasternack, 2003). Some newspaper editorials described hospital decisions against implementing vaccination as “deplorable” and characterized workers who opted out as “refuseniks” and “vaccine-dodgers” (New York Times, 2002; Washington Post, 2002; Boston Herald, 2003; Washington Times, 2003). Physicians spoke of being criticized as “unpatriotic” for not being willing to receive the vaccine (Connolly, 2003a). Despite such tensions, CDC guidelines and the efforts of public health agencies sought to ensure that the voluntary nature of the program was preserved while the implementation of the biopreparedness policy continued. Confusion About the Program Goals and Timeline The program goals and timetable were not communicated clearly, and that created confusion and challenges throughout the implementation of the program (ACIP, 2002; Connolly and Milbank, 2002; Meckler, 2002). Later communications appeared to augment the confusion and created the perception (also discussed in Chapter 4) that the program was characterized by frequently shifting goals rather than by a clear purpose and effective implementation. As the program progressed more slowly than expected, it became evident that the original goals and timeline would not be met. However, the 500,000 and 30-day figures had become de facto program goals, as the mass media seized on numerical figures as indicators of program progress both locally and nationally. In February 2003, many CDC officials cautioned the public and those involved in the program against focusing on numbers and acknowledged that CDC was moving away from the initial 30-day timeline, arguing that the variation in public health system structures across the country and in local needs and characteristics made it impossible and undesirable to require specific numbers and set a strict deadline (CDC, 2003d). In communication with members of the mass media in February 2003, DHHS and CDC personnel de-emphasized the focus on numbers of vaccinees and began to emphasize the importance of preparedness. One CDC spokesperson stated: “We’re trying to do a better job of clarifying what the purpose of this program is, and the purpose of this program is to better prepare our country to respond to a bioterrorism event involving smallpox” (McGlinchey, 2003a). Despite that, CDC continued to urge rapid implementation of the smallpox vaccination program without

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism guidance on how states could determine the pace and scope of their vaccination efforts (GAO, 2003). Cardiac Adverse Events and Other Safety Concerns In late March 2003, three vaccinees—two civilian women and one man in the military program—died from myocardial infarction (heart attack) within 5, 6, and 22 days of smallpox vaccination, respectively. All three had a history of heart disease or risk factors, including smoking and hypertension, so it was not immediately clear whether their deaths were related to vaccination. Later study showed that the deaths were consistent with what would have been expected in the population, and there was no evidence that smallpox vaccination created a higher-than-expected risk of heart attacks. But their deaths, combined with concern about a newly identified cardiac adverse event, had a substantial chilling effect on the willingness of volunteers to receive the vaccine. A total of 1,000 people were vaccinated in the first 2 weeks of the program (different jurisdictions began at different times). After that, the number of vaccinees grew at a relatively steady rate of roughly 3,000–5,000 every week. That changed with the appearance of cardiac adverse events at the end of March 2003, when the program slowed down to fewer than 1,500 per week. By the end of April 2003, only a few hundred volunteers were being vaccinated every week (Henderson, 2003b). The number of weekly vaccinations continued to decline and never recovered, reaching a handful of vaccinees weekly, then monthly. Between April 30, 2004, and July 31, 2004, 25 people received smallpox vaccination, and during August 2004, 5 people were vaccinated (CDC, 2004a, 2004b, 2004c). Cardiac Adverse Events The myocardial infarction cases were only some of the cardiac adverse events associated with the civilian and military vaccination programs. Several cases of myocarditis and pericarditis (types of heart inflammation collectively labeled myo/pericarditis) were identified in the civilian program after smallpox vaccination, beginning in February 2003. Although they made a more subtle impression than fatal heart attacks, their association with vaccination was more worrisome. A report in the March 28, 2003, issue of Morbidity and Mortality Weekly Report listed seven cardiac adverse events in the civilian program: three myocardial infarctions, including the two fatal civilian cases noted above; two cases of angina; and two cases

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism of myo/pericarditis (CDC, 2003f). By March 21, 2003, the military program had documented 10 cases of myo/pericarditis in addition to the heart attack noted above (CDC, 2003f; Connolly, 2003c). Recent and historical evidence supported an association between myo/pericarditis and smallpox vaccination (CDC, 2003k). The Department of Defense (DoD) identified a likely causal association between smallpox vaccination and myo/pericarditis (Halsell et al., 2003); the evidence of a causal association in the civilian population remained unclear (ACIP, 2003b). Concern about cardiac complications associated with smallpox vaccine caused apprehension in people planning to be vaccinated and led many states to temporarily suspend vaccination and wait for CDC guidance (Connolly, 2003c; Kuhles and Ackman, 2003). The Advisory Committee on Immunization Practices (ACIP) 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). The working group recommended the deferral of volunteers who had known cardiac disease, those who had three or more risk factors (for example, smoking, high blood pressure, and high blood cholesterol concentrations) for heart disease, and those over 50 years old (Neff, 2003a). ACIP accepted the first two recommendations but not the last, because of concerns that it would exclude a substantial proportion of potential civilian vaccinees likely to be older and previously vaccinated (and therefore considered less vulnerable to vaccine complications) (Neff, 2003b). ACIP also looked at historical evidence about myo/pericarditis, found largely in the context of military vaccination among young Finnish men (Helle et al., 1978; Kanjalainen et al., 1983). U.S. data from the 1960s were limited to pediatric vaccination, in which myo/pericarditis could have been missed (CDC, 2003h). Finally, ACIP recommended to CDC the following exclusion criteria: known underlying heart disease with or without symptoms and the presence of three or more of the known major cardiac risk factors (CDC, 2003a, 2003h). CDC accepted ACIP’s recommendations and moved rapidly to revise the vaccination information package, screening materials, and informed consent form. Myo/pericarditis, the cardiac complication not previously recognized among expected adverse events of smallpox vaccination, constituted a major safety finding and was later identified in the context of clinical trials of a second-generation smallpox vaccine. The pharmaceutical company Acambis in April 2004 temporarily suspended volunteer recruitment for the ACAM2000 clinical trials of cell-culture smallpox vaccine because of the occurrence of at least three cases of myo/pericarditis (Roos, 2004a). In

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism September 2004, the Food and Drug Administration lifted the clinical hold on enrollment in the ACAM2000 trials and concurred with Acambis that enrollment could be closed and analysis of the data could begin. Acambis undertook 12-month followup of affected study subjects. Both DoD and CDC conducted followup of vaccinees with myo/pericarditis (Mootrey, 2003). Research on myo/pericarditis is needed, and efforts are already in progress. In July 2004, the National Institutes of Health provided funding for research on the effect of smallpox vaccine on cardiac cells in mice (Roos, 2004b). 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. Although the program was voluntary, the potential of inadvertent transmission of vaccinia virus meant that adults and children who had neither consented to vaccination nor been screened for contraindications could become infected and face the risk of severe adverse events or even death (AAP, 2003). Some organizations also feared that the pace of the vaccination program could make it difficult to arrange staff schedules to provide time for leave or furlough in order to ensure patient safety (Burstein, 2002; Peterson, 2002; Schulman, 2002; Baker, 2003). Reintroducing the smallpox vaccine in the absence of the disease required special attention to safety, including screening for contraindications and preventing the inadvertent transmission of vaccinia virus to contacts because the risk-benefit ratio was less clear in the absence of naturally occurring smallpox. CDC and its state and local counterparts worked to ensure safety at every step before, during, and after vaccination. CDC made every effort to develop effective and efficient screening methods and guidelines for pre-event smallpox vaccination clinics. In response to the present committee’s recommendations, CDC developed an information sheet for contacts of vaccinees and modified the Pre-Event Vaccination System to document active surveillance of vaccine-related adverse events that required hospitalization or outpatient care, contraindications to vaccination among volunteers or their household contacts not identified before vaccination, and vaccinia-virus transmission to contacts (CDC, 2003e; IOM, 2003a). Volunteers were given multiple opportunities to learn about the vaccine and vaccination and to opt out if they determined that they were unable or unwilling to be vaccinated, and a thorough informed consent process was put into place.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism The ACIP identified several contraindications to smallpox vaccination, and CDC included them in the screening process and in training and education materials. Prospective vaccinees would be excluded from vaccination for the following reasons: age (no one under 18 years old would be vaccinated in nonemergency situations), history of allergic reaction to vaccine or its components, breastfeeding, and moderate or acute illness. Prospective vaccinees would also be excluded if they or immediate household contacts had any of the following contraindications: pregnancy; disease, conditions, or treatments that cause immunosuppression or immune deficiency; and any acute, chronic, or exfoliative skin conditions, such as eczema and atopic dermatitis (CDC, 2003b). Furthermore, there are many people with compromised immune systems (because of HIV infection, immunosuppression for organ transplantation, or cancer therapy) 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. And very little information about fetal vaccinia and adverse events in inadvertently vaccinated pregnant women is available. After the vaccination of six civilians who later discovered that they were pregnant, ACIP established a pregnancy registry that would conduct follow-up of civilian and DoD pregnant women who were vaccinated (CDC, 2003g). Concerns about program safety persisted. The present committee and the Association of State and Territorial Health Officials (ASTHO) recommended a pause between phases I and II to evaluate safety and ensure an adequate level of planning for expanded vaccination to a new population that required extensive communication and education for safety (for example, prevaccination screening and postvaccination site care). Phase III, intended to make the vaccine available to insistent members of the public, seemed even more problematic, in that it would pose public health threats, vast logistic challenges, and special and intensive communication requirements. Also, the final phase of the program would offer a potentially harmful vaccine in the context of an unknown risk, creating a philosophic conflict with health care and public health workers’ injunction to “do no harm” (AAP, 2003; Libbey, 2002). In February 2004, the program’s safety profile reflected a small number of cases of inadvertent inoculation, indicating that vaccinees were probably effectively educated to prevent transmission. That and the fact that three of the four historically noted serious adverse events did not occur at all are also likely indicators of effective training and screening (see Table 3-1).

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Date Events (policy, program, and other developments) IOM Committee Meeting or Report August 2003 Oregon Health Sciences University researchers find that smallpox immunity may persist for decades, but there is disagreement about the meaning of the findings (Roos, 2003b). Fourth report of IOM committee October 2003 Ohio decides against offering smallpox vaccination to first responders (Shockman, 2003). MMWR reports that a review of death records shows that 1947 NYC smallpox vaccination campaign did not lead to increase in cardiac deaths (CDC, 2003o).   November 2003 Two independent panels examine four deaths potentially related to DoD’s smallpox vaccination program and found that one (April death of 22 year-old reservist) may have been triggered by vaccinations including vaccinia (DoD, 2003). Fourth meeting of IOM committee December 2003 Federal government issues interim final rule for Smallpox Emergency Personnel Protection Act of 2003 (SEPPA), plan for smallpox vaccine injury compensation. CDC updates smallpox case definitions. Fifth report of the IOM committee January 2004 HHS secretary’s declaration regarding administration of smallpox countermeasures extended until and including January 23, 2005 (keeping SEPPA in place).   February 2004 Military infant contracts vaccinia from breastfeeding (CIDRAP, 2004). DoD reports that 581,183 service members received smallpox shots from December 13, 2002, to February 11, 2004. Seventy-two vaccinees, or about 1 in 8,072, suffered myopericarditis, and there were 30 cases of vaccinia infection in contacts of vaccinees. Other complications included 36 cases of generalized vaccinia, most of which required only outpatient treatment, and one case of encephalitis (DoD, 2004d). March 2004   Fifth meeting of the IOM committee

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Date Events (policy, program, and other developments) IOM Committee Meeting or Report April 2004 Acambis temporarily suspends volunteer recruitment for its clinical trials of cell-culture smallpox vaccine because of occurrence of at least three cases of myo/pericarditis in one trial (Roos, 2004a). DoD reports that 10 HIV-positive members of military who received smallpox vaccination did not experience adverse events (Tasker et al., 2004).   May 2004 A review of New York City death certificates from 1946, 1947, and 1948 shows that the 1947 mass smallpox vaccination campaign in New York did not show an increase in cardiac deaths postvaccination (Thorpe et al., 2004). June 2004 DoD announces anthrax and smallpox vaccinations for all personnel deployed by Central Command and, for first time, select units in Pacific Command. Since December 2002, 625,000 troops have been vaccinated against smallpox (Malenic, 2004). July 2004 The Senate Select Committee on Intelligence issues report on US intelligence community’s prewar intelligence assessments on Iraq; among other findings, report describes evidence on Iraq’s possession of smallpox as weak (U.S. Senate Select Committee on Intelligence, 2004). Sixth report of the IOM committee Sixth meeting of the IOM committee September 2004 Aventis Pasteur vaccine produced in the 1950s shown to be effective, even in dilutions of 1:5 and 1:10 (Talbot et al., 2004).   October 2004 Acambis and Bavarian Nordic A/S win $177 million U.S. government contract to produce safer smallpox vaccine (DHHS, 2004). CIA issues Comprehensive Report of the Special Advisor to the Director of Central Intelligence on Iraq’s WMD. Report concludes that, although Iraq had capability to work with smallpox virus, there is “no direct evidence that Iraq either retained or acquired smallpox virus isolates or proceeded with any follow up smallpox related research” (CIA, 2004).

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism REFERENCES AAP (American Academy of Pediatrics). 2003. Testimony of Jon Abramson, Chair, Committee on Infectious Diseases of the American Academy of Pediatrics. Senate Health, Education, Labor, and Pensions Committee. Heading on the Smallpox Vaccination Plan: Challenges and Next Steps. ABC 13 News. 2003. Virginia’s First Responders Get Smallpox Vaccinations. WSET/ABC 13 News. ACIP (Advisory Committee on Immunization Practices). 2002. Record of the Meeting of the Advisory Committee on Immunization Practices (Centers for Disease Control and Prevention, National Immunization Program). Atlanta, GA. ACIP. 2003a. Record of the meeting of the Advisory Committee on Immunization Practices, February 26-27, 2003. ACIP. 2003b. Record of the meeting of the Advisory Committee on Immunization Practices, June 18-19, 2003. ACIP. 2003c. Advisory Committee on Immunization Practices (ACIP) Statement on Smallpox Preparedness and Vaccination. [Online] Available at http://www.bt.cdc.gov/agent/smallpox/vaccination/pdf/acipjun2003.pdf. Accessed July 17, 2003. ANA (American Nurses Association). 2002. Statement to the IOM’s Committee on Smallpox Vaccination Program Implementation. Anderson R. 2003. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation. Transcript of Meeting Three on May 1, 2003, Washington, DC. ANSER Institute for Homeland Security. 2003. Dark Winter. [Online] Available at http://www.homelandsecurity.org/darkwinter/index.cfm. Accessed September 14, 2004. APHA (American Public Health Association). 2002. APHA Policy Statement on Smallpox Vaccination. [Online] Available at http://www.apha.org/legislative/policy/smallpox.pdf. Accessed June 17, 2003. Associated Press. 2001, November 5. CDC Workers Get Smallpox Vaccination. Associated Press. 2003, February 3. St. Vincent Won’t Give Smallpox Vaccinations. KARK.Com. ASTHO (Association of State and Territorial Health Officials). 2001. Testimony Before the Senate Committee on Appropriations, Subcommittee on Labor, Health and Human Services, and Education Appropriations, October 3, 2001. Bioterrorism Preparedness. [Online] Available at http://www.astho.org/templates/display_pub.php?u=JnB1Yl9pZD0zMTQ=. Accessed December 12, 2004. ASTHO. 2003. ASTHO Smallpox Preparedness Survey Results. [Online] Available at http://www.astho.org/pubs/spxsummaryb2.pdf. Accessed May 21, 2003. August J (Assistant Director for Health and Safety, Department of Research and Collective Bargaining Services). 2003. Testimony for the American Federation of State, County and Municipal Employees (AFSCME). Senate Appropriations Committee: Labor, Health and Human Services and Education Subcommittee , January 29, 2003. Baker M. 2003. Testimony on Behalf of the Service Employees International Union, AFL-CIO Before the U.S. Senate Committee on Health, Education, Labor, and Pensions on the Administration’s Smallpox Vaccination Plan: Challenges and Next Steps. January 30, 2003. [Online] Available at www.SEIU.org. Banks S, Hannan C. 2002. ASTHO Ensures State Health Officials Are Heard in Smallpox Debate. [Online] Available at http://astho.org/templates/displau_pub.php?pub_id=336. Accessed September 15, 2004. Bavley A, Dvorak J. 2003, February 8. Safety Concerns Hinder Participation in Smallpox Vaccination Program. Kansas City Star. Boston Herald. 2003, January 23. Editorial: Vaccine Dodgers Grow.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Bresnitz E. 2003. Presentation. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Two on February 13, 2003, Washington, DC: 62-85. Burstein J. 2002. Statement of the American College of Emergency Physicians. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting One on December 19, 2002, Washington, DC:267-271. Calabresi M, August M. 2004, July 26. Was Smallpox Overhyped? (The Smallpox Scare: Was the Germ-Warfare Risk Overblown?). TIME 16. CDC (Centers for Disease Control and Prevention). 2001. Vaccinia (smallpox) vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2001. Morbidity and Mortality Weekly Report 50(RR-10):1-25. CDC. 2002a. CDC Telebriefing Transcript: ACIP Smallpox Vaccine Meeting Briefing, October 17, 2002. [Online] Available at http://www.cdc.gov/od/oc/media/transcripts/t021017.htm. Accessed August 1, 2004. CDC. 2002b. Supplemental Guidance for Planning and Implementing the National Smallpox Vaccination Program (NSVP). CDC. 2002c. Press Release, December 12, 2002. CDC Initial Review of State Smallpox Vaccination Plans Complete. [Online] Available at http://www.cdc.gov/od/oc/media/pressrel/r021212.htm. Accessed August 1, 2004. CDC. 2002d. CDC Telebriefing Transcript: HHS Teleconference on Smallpox Policy. [Online] Available at http://www.cdc.gov/od/oc/media/transcripts/t021214.htm. Accessed January 10, 2003. CDC. 2003a. Interim Smallpox Fact Sheet: Smallpox Vaccine and Heart Problems. [Online] Available at http://www.bt.cdc.gov/agent/smallpox/vaccination/heartproblems.asp. Accessed January 15, 2001. CDC. 2003b. Smallpox Fact Sheet—Information for Clinicians: Smallpox (Vaccinia) Vaccine Contraindications. CDC. 2003c. Smallpox Vaccination Program Status by State, July 25, 2003. CDC. 2003d. CDC Telebriefing Transcript: Smallpox Vaccine Adverse Events Monitoring and Response System. [Online] Available at http://www.cdc.gov/od/oc/media/transcripts/t030206.htm. Accessed March 11, 2003. CDC. 2003e. Notice to readers: smallpox vaccine adverse events monitoring and response system for the first stage of the smallpox vaccination program. Morbidity and Mortality Weekly Report 52(05):88-89, 99. CDC. 2003f. Cardiac adverse events following smallpox vaccination—United States, 2003. Mortality and Morbidity Weekly Report 52(12):248-250. CDC. 2003g. Notice to readers: national smallpox vaccine in pregnancy registry. Mortality and Morbidity Weekly Report 52(12):256. CDC. 2003h. Notice to readers: supplemental recommendations on adverse events following smallpox vaccine in the pre-event vaccination program: recommendations of the Advisory Committee on Immunization Practices. Mortality and Morbidity Weekly Report 52(13):282-284. CDC. 2003i. CDC Telebriefing Transcript: Update: Monkeypox Investigation in the U.S. CDC. 2003j. Updated Interim CDC Guidance for Use of Smallpox Vaccine, Cidofovir, and Vaccinia Immune Globulin (VIG) for Prevention and Treatment in the Setting of an Outbreak of Monkeypox Infections. CDC Guidelines and Resources. [Online] Available at http://www.cdc.gov/ncidod/monkeypox/treatmentguidelines.htm. Accessed December 15, 2004. CDC. 2003k. Update: cardiac and other adverse events following civilian smallpox vaccination—United States, 2003. Mortality and Morbidity Weekly Report 52(27):639-642.

OCR for page 39
The Smallpox Vaccination Program: Public Health in an Age of Terrorism CDC. 2003l. Update: multistate outbreak of monkeypox—Illinois, Indiana, Kansas, Missouri, Ohio, and Wisconsin, 2003. Mortality and Morbidity Weekly Report 52(27):642-646. CDC. 2003m. Update: adverse events following smallpox vaccination—United States, 2003. Mortality and Morbidity Weekly Report 52(13):278-282. CDC. 2003n. Advisory Committee on Immunization Practices (ACIP) Statement on Smallpox Preparedness and Vaccination. [Online] Available at http://www.bt.cdc.gov/agent/smallpox/vaccination/pdf/acipjun2003.pdf. Accessed July 17, 2003. CDC. 2003o. Cardiac deaths after a mass smallpox vaccination campaign—New York City, 1947. Morbidity and Mortality Weekly Report 25(39):933-936. CDC. 2003p. Smallpox Vaccination Report Status and Adverse Events. [Online] Available at http://www.cdc.gov/od/oc/media/smpxrpt.htm. Accessed March 7, 2003. CDC. 2003q. CDC Health Advisory (via Health Alert Network): Smallpox: People with Known Cardiac Disease Should Not Be Vaccinated. [Online] Available at http://www.phppo.cdc.gov/han/Documents/AlertDocs/OldAlerts/129.asp. Accessed January 26, 2005. CDC. 2003r. Smallpox Emergency Personnel Protection Act of 2003: Benefits and Compensation for Smallpox Vaccine Injuries. [Online] Available at http://www.bt.cdc.gov/agent/smallpox/vaccination/bene-comp.asp. Accessed June 16, 2003. CDC. 2003s. Smallpox vaccine adverse events among civilians—United States, March 4-10, 2003. Mortality and Morbidity Weekly Report 52(10):201-203. CDC. 2004a. Smallpox Vaccination Program Status by State, April 30, 2004. CDC. 2004b. Smallpox Vaccination Program Status by State, August 31, 2004. CDC. 2004c. Smallpox Vaccination Program Status by State, July 31, 2004. CDC. 2004d. Update: adverse events following civilian smallpox vaccination—United States, 2003. Mortality and Morbidity Weekly Report 53(05):106-107. CDC. 2004e. Secondary and tertiary transfer of vaccinia virus among U.S. military personnel—United States and worldwide, 2002-2004. Morbidity and Mortality Weekly Report 53(05):103-105. CIA (Central Intelligence Agency). 2004. Comprehensive Report of the Special Advisor to the Director of Central Intelligence on Iraq’s WMD. [Online] Available at http://www.cia.gov/cia/reports/iraq_wmd_2004/. Accessed January 26, 2005. CIDRAP (Center for Infectious Disease Research and Policy). 2004, February 12. Contact Vaccinia in Soldier’s Baby Linked to Breast-feeding. CIDRAP News. CIDRAP and IDSA (Infectious Diseases Society of America). 2004. Smallpox: Current, Comprehensive Information on Pathogenesis, Microbiology, Epidemiology, Diagnosis, Treatment, and Prophylaxis. [Online] Available at http://www.cidrap.umn.edu/cidrap/content/bt/smallpox/biofacts/smllpx-summary.html. Accessed August 23, 2004. Colacecchi J, Jones M. 2003. Testimony Before the Senate Appropriations Committee: Senate Labor, Health and Human Services and Education Appropriations Subcommittee, January 29, 2003. State Smallpox Pre-event Phase 1 Vaccination Program Estimated Costs. [Online] Available at http://appropriations.senate.gov/releases/record.cfm?id=190233. Accessed January 21, 2005. Connolly C. 2003a, February 24. Bush Smallpox Inoculation Plan Near Standstill; Medical Professionals Cite Possible Side Effects, Uncertainty of Threat. Washington Post, A6. Connolly C. 2003b, July 17. Focus on Smallpox Threat Revived. Washington Post, A3. Connolly C. 2003c, March 29. 2 States Halt Smallpox Shots: Pentagon Reports First Post-Inoculation Fatal Heart Attack. Washington Post. Connolly C, Milbank D. 2002, December 14. U.S. Revives Smallpox Shot. Bush Says He Will Receive Vaccine with Military, Emergency Workers. Washington Post, A1.

OCR for page 39
The Smallpox Vaccination Program: Public Health in an Age of Terrorism Daschle T, and 21 members of Senate (Democrat). 2003, January 22. Letter to President George W. Bush. DHHS (Department of Health and Human Services). 2001, November 28. News Release: HHS Awards $428 Million Contract to Produce Smallpox Vaccine. Acambis/Baxter Will Produce 155 Million Doses by End of 2002. DHHS. 2003a, January 24. News Release: HHS Secretary Authorizes Smallpox Vaccination Program. [Online] Available at www.hhs.gov/news/press/2003pres/20030124e.html. Accessed January 25, 2003. DHHS. 2003b, February 25. News Release: HHS Announces Contracts to Develop Safer Smallpox Vaccines. DHHS. 2003c, May 5. News Release: Secretary Thompson to Release $100 Million to Assist States with Smallpox Vaccination Programs. DHHS. 2003d, March 5. News Release: HHS Proposes Smallpox Vaccination Compensation Plan. [Online] Available at http://www.hhs.gov/news/press/2003pres/20030305.html. Accessed March 7, 2003. DHHS. 2004, October 7. News Release: HHS Awards $232 Million in Biodefense Contracts for Vaccine Development. DoD (Department of Defense). 2003. Panels Issue Reports on Vaccine Adverse Event Cases: Vaccination Possibly Related to Soldier’s Illness and Death. Press release, November 19, 2003. DoD. 2004a. Vaccination Possible Cause of Soldier’s Illness and Death. [Online] Available at http://www.vaccines.mil/documents/337safetypanelQA.pdf. DoD. 2004b, June 30. News Release: Anthrax, Smallpox Protection Policies Updated. News Release No. 624-04. [Online] Available at http://www.defenselink.mil/releases/2004/nr20040630-0955.html. Accessed January 30, 2005. DoD. 2004c. DoD Smallpox Vaccination Program Safety Summary. [Online] Available at http://www.smallpox.army.mil/event/SPSafetySum.asp. DoD. 2004d. Smallpox Vaccination Program Summary: DoD Smallpox Vaccination Program as of February 11, 2004. Everett W, Coffin S, Zaoutis T, Halpern S, Kim J, Strom B. 2002. Smallpox Willingness: A National Study of Emergency Department Personnel. Presented to the IOM Committee on Smallpox Vaccination Program Implementation on December 19, 2002 . FDA (Food and Drug Administration). 2002. The Bioterrorism Act of 2002. [Online] Available at http://www.fda.gov/oc/bioterrorism/bioact.html. Accessed January 26, 2005. Federal Register. 2003a. Smallpox Vaccine Injury Compensation Program: Administrative Implementation. August 27, 2003, Washington, DC, 51492-51499. [Online] Available at http://www.gpoaccess.gov/fr/index.html. Federal Register. 2003b. Smallpox Vaccine Injury Compensation Program: Administrative Implementation. December 16, 2003, Washington, DC, 70080-70106. [Online] Available at http://www.gpoaccess.gov/fr/index.html. Fiorill J. 2003, October 24. U.S. Smallpox Official Acknowledges Vaccination “Targets Were Not Achieved”. Global Security Newswire. Fischler D. 2003. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation. Transcript of Meeting Four on November 6, 2003, Washington, DC. Frey SE, Newman F, Cruz J, Shelton WB, Tennant JM, Polach T, Rothman AL, Kennedy JS, Wolff M, Belshe RB, Ennis FA. 2002. Dose-related effects of smallpox vaccine. New England Journal of Medicine 346(17):1275-1280. Frist B. 2002, August 9. Op-Ed: Deciding Who Is Protected Against Smallpox. New York Times. GAO (General Accounting Office). 2003. Smallpox Vaccination: Implementation of National Program Faces Challenges. Washington, DC: General Accounting Office, GAO-03-578.

OCR for page 39
The Smallpox Vaccination Program: Public Health in an Age of Terrorism Gellman B. 2002, November 5. Findings Spur New Smallpox Concerns. Albany (NY) Times Union. Grady D, Altman L. 2003, March 25. Experts See Gains and Gaps in Planning for Terror Attack. New York Times. Gregg J. 2002, October 6. Commentary: Let the Public Choose on Smallpox Vaccine. Washington Post. Gursky E. 2003. Progress and Peril: Bioterrorism Preparedness Dollars and Public Health. Century Foundation. [Online] Available at http://www.tcf.org/Publications/HomelandSecurity/Gursky_Progress_Peril.pdf. Accessed January 30, 2005. Hallow R. 2002, November 24. Governors Seek Access to Smallpox Vaccine. Washington Times, A4. Halsell JS, Riddle JR, Atwood JE, Gardner P, Shope R, Poland GA, Gray GC, Ostroff S, Eckart RE, Hospenthal DR, Gibson RL, Grabenstein JD, Arness MK, Tornberg DN. 2003. Myopericarditis following smallpox vaccination among vaccinia-naive U.S. military personnel. Journal of the American Medical Association 289(24):3283-3289. Hardy G. 2002. Statement of the Association of State and Territorial Health Officials. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation. Transcript of Meeting One on December 19, 2002, Washington, DC. HealthLeaders. 2003. Smallpox Scare: Hospitals May Incur Costs, Downtime from Vaccinations. Green Sheet, February 2003. [Online] Available at http://www.healthleaders.com/magazine/2003/feb/greensheet.php. Accessed July 7, 2004. Heil E. 2003, July 24. Panel Questions HHS on Low Smallpox Vaccinations. GovExec.com. [Online] Available at http://www.govexec.com/dailyfed/0703/072409cd2.htm. Accessed September 29, 2003. Helle EP, Koskenvuo K, Heikkila J, Pikkarainen J, Weckstrom P. 1978. Myocardial complications of immunisations. Annals of Clinical Research 10(5):280-287. Henderson J. 2003a. National Smallpox Vaccination Program Update. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation on May 1, 2003. Henderson J. 2003b. Update on National Smallpox Preparedness: Smallpox Preparedness Indicators. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation on November 6, 2003. Hirshon J. 2003. Presentation to the IOM Committee on Smallpox Vaccination Program Implementation. Transcript of Meeting Four on November 6, 2003, Washington, DC. IOM (Institute of Medicine). 2002a. The Future of the Public’s Health in the 21st Century. Washington, DC: The National Academies Press. IOM. 2002b. Scientific and Policy Considerations in Developing Smallpox Vaccination Options: A Workshop Report. Washington, DC: The National Academies Press. IOM. 2003a. Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation: Letter Report #1. Washington, DC: The National Academies Press. IOM. 2003b. Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation: Letter Report #2. Washington, DC: The National Academies Press. IOM. 2003c. Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation: Letter Report #3. Washington, DC: The National Academies Press. IOM. 2003d. Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation: Letter Report #4. Washington, DC: The National Academies Press.

OCR for page 39
The Smallpox Vaccination Program: Public Health in an Age of Terrorism IOM. 2004. Learning from SARS: Preparing for the Next Disease Outbreak. Washington, DC: The National Academies Press. Judson F. 2003. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation. Transcript of Meeting Three on May 1, 2003, Washington, DC. Karjalainen J, Heikkila J, Nieminen MS, Jalanko H, Kleemola M, Lapinleimu K, Sahi T. 1983. Etiology of mild acute infectious myocarditis. Relation to clinical features. Acta Medica Scandinavica 213:65-73. Kemper V. 2003a, January 17. States Lag at Start of Smallpox Program. Los Angeles Times. Kemper V. 2003b, March 14. Few Volunteer for Smallpox Vaccination. Los Angeles Times. Kemper V. 2003c, March 29. Guardsman Dies After Receiving Smallpox Vaccine; California Suspends All Inoculations and Wants New Federal Guidelines for Adverse Reactions. Los Angeles Times. Kuhles D, Ackman D. 2003. The federal smallpox vaccination program: where do we go from here? Health Affairs (Web Exclusive) W3:503-510. Libbey P. 2002. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation. Transcript of Meeting One on December 19, 2002, Washington, DC. Libbey P. 2003. Testimony on Behalf of NACCHO (National Association of County and City Health Officials) Before the Subcommittee on Labor, Health, and Human Services, Education and Related Agencies, Committee on Appropriations, U.S. Senate. Hearing on Smallpox Vaccination, January 29, 2003. MacLeod M. 2003, February 2. State Puts Smallpox Program on Hold Until Feds Resolve Liability Issue. Macomb Daily [Michigan]. Malenic M. 2004. U.S. to Expand Military Vaccinations. Global Security Newswire. Manning A. 2003, April 22. Second Round of Smallpox Vaccinations Begins. USA Today. Manning A, Sternberg S. 2002, October 7. Officials Ponder Timing, Sequence of Immunizations. USA Today. Marchione M. 2003, February 7. Health Workers Enlist in Smallpox Fight; State Giving Hospitals Time to Educate Workers About Risk of Shot. Milwaukee Journal Sentinel, 15A. McCullough M. 2003, February 7. Americans Aren’t Rolling Up Their Sleeves for Smallpox Inoculation. The Salt Lake Tribune. McGlinchey D. 2003a, February 26. CDC Says It Never Aimed for 500,000 Smallpox Vaccinations. Global Security Newswire. McGlinchey D. 2003b, June 12. Monkeypox Outbreak Tests Bioterrorism Response System. Global Security Newswire. McKenna M. 2003, February 15. No Vaccination for Nation’s Fear; Unease Hinders Smallpox Program. Atlanta Journal-Constitution. McNeil D. 2003, February 7. Many Balking at Vaccination for Smallpox. New York Times. Mendieta A. 2003. A Young Soldier from the South Suburbs Died of a Mysterious Illness Before She Could Fulfill Her Dream of Serving Her Country on the Front Lines. Chicago Sun-Times, 6. Meckler L. 2002, October 5. US Divided on Smallpox Policy. Associated Press. Meckler L. 2003a, February 22. Smallpox Vaccinations Off to Slow Start. Associated Press. Meckler L. 2003b, April 2. Lawmakers Split on Smallpox Compensation. Associated Press. Meckler L. 2003c, February 5. Concerns About Compensation for People Injured by the Smallpox Vaccine Are Hampering Inoculation Program . Associated Press. Mitchell S. 2003, June 12. Monkeypox Shows Gap in Bioterror Readiness. United Press International. Mootrey G. 2003. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation. Transcript of Meeting Three on May 1, 2003, Washington, DC. Murphy W. 2003, April 14. FDNY Sets Terms for Smallpox Vaccinees. Newsday.

OCR for page 39
The Smallpox Vaccination Program: Public Health in an Age of Terrorism NACCHO (National Association of County and City Health Officials). 2003a. Impact of Smallpox Vaccination Program on Local Public Health Services. Research Brief No. 9. NACCHO. 2003b. Costs of Smallpox Vaccination Program: Summary of Preliminary Data. Research Brief No. 10. Neff J. 2003a. Advisory Committee on Immunization Practices Smallpox Vaccine Safety Working Group: Summary of Vaccination Program Safety Monitoring, April 2003. Neff J. 2003b. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation. Transcript of Meeting Three on May 1, 2003, Washington, DC. New York Times. 2002, December 22. Editorial: Ducking Smallpox Vaccinations. NGA (National Governors Association). 2003. Statement of the National Governors Association for the Senate Labor, Health and Human Services and Education Appropriations Subcommittee on Smallpox Vaccination Funding. Senate Appropriations Commitee: Senate Labor, Health and Human Services and Education Appropriations Subcommittee. NIH (National Institutes of Health). 2001. Fact Sheet: Study Seeks to Determine Effectiveness of Diluted Smallpox Vaccine. [Online] Available at http://www.vrc.nih.gov/factsheets/btsmallpox.htm. Accessed January 26, 2005. NIH. 2002. Press Release: NIAID Study Results Support Diluting Smallpox Vaccine Stockpile to Stretch Supply. [Online] Available at http://www.nih.gov/news/pr/mar2002/hhs-28.htm. Accessed January 26, 2005. Nikolai K. 2003. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation. Transcript of Meeting Three on May 1, 2003, Washington, DC. Ornstein C, Bonilla D. 2003, February 6. Smallpox Plan Divides Hospitals: Fifteen in the County Refuse Vaccinations for Employees. Nine Accept; Most Are Undecided. Los Angeles Times. Ornstein C, Richardson L. 2003, February 8. U.S. Far Behind Schedule for Smallpox Vaccinations. Los Angeles Times. Pasternack N. 2003, February 5. State to Give Vaccine: First Shots Will Be for Health Workers. Olympia (WA) Olympian. Peterson C. 2002. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation. Transcript of Meeting One on December 18, 2002, Washington, DC. Pezzino G. 2003. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation. Transcript of Meeting Three on May 1, 2003, Washington, DC. Rath E, Turcotte J. 2003, March 6. Press Release: Senator Gregg to Move Smallpox Compensation Legislation Through Senate. Office of Judd Gregg, U.S. Senator for New Hampshire. Reuters. 2003, March 27. Experts Urge Caution in US Smallpox Plan. Roos R. 2003a, February 5. Many Doses of Smallpox Vaccine Shipped, But Few Shots Given so Far. CIDRAP News. Roos R. 2003b, August 21. D.A. Henderson Critiques Report on Duration of Smallpox Immunity. CIDRAP News. Roos R. 2003c, November 19. Vaccines Might Have Contributed to Death of Army Reservist. CIDRAP News. Roos R. 2004a, April 13. Myopericarditis Cases Complicate Acambis Smallpox Vaccine Trials. CIDRAP News. Roos R. 2004b, June 16. Pilot Study to Probe Cardiac Effects of Smallpox Vaccine. CIDRAP News. Rosado E. 2003. Fact Sheet: Smallpox. National Association of Counties. Russell S. 2003, January 18. Smallpox Vaccine Plan Starts Tuesday, Despite Concerns; Some Health Workers May Opt Out Over Risks, Compensation Issues. San Francisco Chronicle.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Schulman R. 2002. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation. Transcript of Meeting One on December 18, 2002, Washington, DC. SEIU (Service Employees International Union). 2002. As Bush Plan for Mass Smallpox Stirs Controversy, Nation’s Largest Health Care Organization Says Hospital Workers, Patients Will Face Unnecessary Risk. [Online] Available at http://www.seiu.org/media/press_releases/press.cfm?ID=1096. Accessed January 8, 2003. Selecky M. 2003. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation. Transcript of Meeting Three on May 1, 2003, Washington, DC. Shockman L. 2003, March 28. Nationwide Smallpox Protection Program for Health Workers Is Shy of Goal. Toledo [Ohio] Blade. Skivington S. 2003. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation. Transcript of Meeting Three on May 1, 2003, Washington, DC. Staiti A, Katz A, Hoadley J. 2003. Has Bioterrorism Preparedness Improved Public Health? Center for Studying Health System Change Issue Brief No. 65. Talbot T, Stapleton J, Bready R, Winokur P, Bernstein D, Germanson T, Yoder S, Rock M, Crowe J, Edwards K. 2004. Vaccination success rate and reaction profile with diluted and undiluted smallpox vaccine: a randomized controlled trial. Journal of the American Medical Association 292(10):1205-1212. Tasker S, Schnepf G, Lim M, Caraviello H, Armstrong A, Bavaro M, Agan B, Delmar J, Aronson N, Wallace M, Grabenstein J. 2004. Unintended smallpox vaccination of HIV-1 infected. Clinical Infectious Diseases 38(9):1320-1322. Temte J. 2003. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation. Transcript of Meeting Four on November 6, 2003, Washington, DC. Thorpe L, Schwartz S, Manning S, Marx M, Frieden T. Mass smallpox vaccination and cardiac deaths, New York City, 1947. Emerging Infectious Diseases 10(5):917-920. Toomey K. 2003. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation. Transcript of Meeting Two on February 13, 2003, Washington, DC. U.S. House of Representatives. 2004. U.S. Representative Thomas M. Davis (R-VA) Holds Hearing on Health System Preparedness. House Government Reform Committee. U.S. House of Representatives Select Committee on Homeland Security (Democratic Members). 2004. A Biodefense Failure: the Smallpox Vaccination Program One Year Later. U.S. Senate Select Committee on Intelligence. 2004. Report on the U.S. Intelligence Community’s Prewar Intelligence Assessments on Iraq. [Online] Available at http://intelligence.senate.gov/iraqreport2.pdf. Accessed July 8, 2004. Washington Times. 2003, January 23. Editorial: Smallpox refuseniks. Washington Post. 2002, December 19. Editorial: Doctors’ Orders. White House. 2002a. President Bush Signs Homeland Security Act. Remarks by the President at the Signing of H.R. 5005 the Homeland Security Act of 2002. [Online] Available at http://www.whitehouse.gov/news/releases/2002/11/20021125-6.html. Accessed January 26, 2005. White House. 2002b. President Delivers Remarks on Smallpox. [Online] Available at http://www.whitehouse.gov/news/releases/2002/12/20021213-7.html. Accessed January 8, 2003. White House. 2003a. National Threat Level Raised. Statement by Homeland Security Secretary Tom Ridge. [Online] Available at http://www.whitehouse.gov/news/releases/2003/03/20030317-8.html. Accessed January 26, 2005. White House. 2003b. President Bush Addresses the Nation. [Online] Available at http://www.whitehouse.gov/news/releases/2003/03/20030319-17.html. Accessed January 26, 2005.

OCR for page 39
The Smallpox Vaccination Program: Public Health in an Age of Terrorism White House. 2003c. President Bush Announces Major Combat Operations in Iraq Have Ended. Remarks by the President from the USS Abraham Lincoln at Sea off the Coast of San Diego, California. [Online] Available at http://www.whitehouse.gov/news/releases/2003/05/iraq/20030501-15.html. Accessed January 26, 2005. Witt D. 2003. Presentation Before the IOM Committee on Smallpox Vaccination Program Implementation. Transcript of Meeting Three on May 1, 2003, Washington, DC. Yee D. 2003, June 19. CDC: Not Enough Health Workers Have Smallpox Shots. Associated Press. Yih W, Lieu T, Rego V, O’Brien M, Shay D, Yokoe D, Platt R. 2003. Attitudes of healthcare workers in U.S. hospitals regarding smallpox vaccination. BMC Public Health 3:20.