2
Policy Context of Smallpox Preparedness

In 1980, the World Health Organization (WHO) declared smallpox eradicated, three years after the last endemic case of smallpox and after two years of effective surveillance that enabled the certification of a final few nations as smallpox-free. With eradication came a series of policy changes that brought to an end general vaccination against smallpox and the production of smallpox vaccine in the United States. In 1980, the Advisory Committee on Immunization Practices (ACIP),1 the federal advisory body that develops guidance and recommendations for national immunization policy, recommended smallpox vaccination only for particular groups of laboratory workers (CDC, 2001). In 1982, Wyeth ceased production of smallpox vaccine for general use, and a Centers for Disease Control and Prevention (CDC) notice in Morbidity and Mortality Weekly Report informed readers that smallpox vaccine would no longer be available to civilians (CDC, 1983). Military smallpox vaccination from 1984 was limited to recruits entering basic training, and it was finally discontinued in 1990 (DOD, 2002).

1  

ACIP is a federal advisory body consisting of 15 experts in fields associated with immunization. ACIP members are selected by the Secretary of Health and Human Services to provide advice and guidance to the secretary, the assistant secretary for health, and the Centers for Disease Control and Prevention on the most effective means to prevent vaccine-preventable diseases. ACIP develops written recommendations for the routine administration of vaccines to the pediatric and adult populations and schedules regarding the appropriate periodicity, dosage, and contraindications applicable to the vaccines (CDC, 2004a).



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The Smallpox Vaccination Program: Public Health in an Age of Terrorism 2 Policy Context of Smallpox Preparedness In 1980, the World Health Organization (WHO) declared smallpox eradicated, three years after the last endemic case of smallpox and after two years of effective surveillance that enabled the certification of a final few nations as smallpox-free. With eradication came a series of policy changes that brought to an end general vaccination against smallpox and the production of smallpox vaccine in the United States. In 1980, the Advisory Committee on Immunization Practices (ACIP),1 the federal advisory body that develops guidance and recommendations for national immunization policy, recommended smallpox vaccination only for particular groups of laboratory workers (CDC, 2001). In 1982, Wyeth ceased production of smallpox vaccine for general use, and a Centers for Disease Control and Prevention (CDC) notice in Morbidity and Mortality Weekly Report informed readers that smallpox vaccine would no longer be available to civilians (CDC, 1983). Military smallpox vaccination from 1984 was limited to recruits entering basic training, and it was finally discontinued in 1990 (DOD, 2002). 1   ACIP is a federal advisory body consisting of 15 experts in fields associated with immunization. ACIP members are selected by the Secretary of Health and Human Services to provide advice and guidance to the secretary, the assistant secretary for health, and the Centers for Disease Control and Prevention on the most effective means to prevent vaccine-preventable diseases. ACIP develops written recommendations for the routine administration of vaccines to the pediatric and adult populations and schedules regarding the appropriate periodicity, dosage, and contraindications applicable to the vaccines (CDC, 2004a).

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism In 1991, ACIP updated its recommendations regarding the use of smallpox vaccine for occupational exposures to include “health-care workers involved in clinical trials using recombinant vaccinia virus vaccines” and lengthened to 10 years the recommendation for revaccination of relevant groups of laboratory workers (CDC, 2001). A series of domestic and international terrorist attacks occurred over the decade that followed, ranging from sarin gas attacks on the Tokyo subway to anthrax attacks by mail in the United States. Those developments stimulated robust discussion of the need for new public health policy and legislation to confront the possibility of bioterrorist attack. When the 1991 ACIP recommendations were updated in June 2001, they included “recommendations for the use of vaccinia vaccine if smallpox (variola) virus were used as an agent of biological terrorism or if a smallpox outbreak were to occur for another unforeseen reason” (CDC, 2001). ACIP concluded that recommendations regarding pre-exposure vaccination should be on the basis of a calculable risk assessment that considers the risk for disease and the benefits and risks regarding vaccination. Because the current risk for exposure is considered low, benefits of vaccination do not outweigh the risk regarding vaccine complications. If the potential for an intentional release of smallpox virus increases later, pre-exposure vaccination might become indicated for selected groups (e.g., medical and public health personnel or laboratory workers) who would have an identified higher risk for exposure because of work-related contact with smallpox patients or infectious materials. After the events of 2001, the possibility of future bioterrorism and the specter of deliberate exposure to the smallpox virus, a dangerous category A pathogen,2 caused CDC to reconsider smallpox vaccination as a tool for preparedness. CDC requested that ACIP provide an update of recommendations for the use of smallpox vaccine. The Department of Health and Human Services (DHHS) began to assess the status of smallpox vaccine stocks and initiated planning and activities for increasing the vaccine stocks, and CDC, the National Institutes of Health, and the Department of Defense intensified their work in the development of new vaccines (such as safer or less reactogenic smallpox vaccines) to prepare effectively for a potential smallpox virus release (Cohen and Marshall, 2001). The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, signed into law on June 12, 2002, included provisions for supporting smallpox vaccine development. 2   This CDC classification denotes biologic agents that: are easy to disseminate or transmit person-to-person; cause high mortality; might cause public panic and social disruption; and require special action for public health preparedness (CDC, 2000, 2002a).

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism STEPS TOWARD READINESS FOR A SMALLPOX VIRUS RELEASE Role of Public Health Organizations Over the 15 months between September 11, 2001, and the announcement of the smallpox vaccination policy on December 13, 2002, CDC, other government agencies, public health organizations, and other interested professional groups had extensive and productive interactions that led to the development of smallpox response plans and the discussion of strategies to prepare for a potential smallpox threat (Alliance for Health Reform, 2002; ASTHO, 2001; McIlroy, 2002). For example, the Association of State and Territorial Health Officials (ASTHO), the National Association of County and City Health Officials, the American Public Health Association, the Association of Public Health Laboratories, and the Council of State and Territorial Epidemiologists (CSTE) interacted regularly to discuss needs and strategies for bioterrorism (including smallpox) preparedness and urged the federal government to focus on increasing bioterrorism preparedness and to improve public health infrastructure funding (ASTHO, 2002). ASTHO also testified about public health preparedness on October 3, 2001, before the Senate Subcommittee on Labor, Health and Human Services, and Education Appropriations (ASTHO, 2001). At that hearing, ASTHO recommended that a national plan be developed for responding to a smallpox virus release, including vaccine delivery and administration. CDC’s Smallpox Vaccination and Preparedness Activities Shortly after the 2001 attacks, CDC took steps to strengthen its internal smallpox response capacity by forming 20 multidisciplinary smallpox response teams of 10 persons each and vaccinating them (ACIP, 2002; Altman, 2002a). CDC also adopted a two-pronged approach to strengthening the ability of the nation’s state and local public health agencies to respond effectively to a smallpox virus release: pre-event planning and activities (largely involving the advance vaccination of specific types of personnel who would respond to an attack) and post-event planning and activities, pertaining to the personnel, resources, facilities, and capabilities necessary for effective response. The present Institute of Medicine (IOM) committee was charged with providing guidance to CDC on subjects related to the pre-event smallpox vaccination program, and this task has been the committee’s main focus. Therefore, the present report briefly mentions post-event planning only as part of the setting for the smallpox vaccination program and smallpox preparedness in general. On November 21, 2001, CDC published the federal Post-Event Smallpox Response Plan and Guidelines and forwarded it to state and local

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism public health agencies. In the October 2002 version3 of the Post-Event Response Plan and Guidelines, CDC asked states and the District of Columbia, the territories, and the nation’s three largest municipalities (all CDC grantees under the Cooperative Agreement on Public Health Preparedness and Response for Bioterrorism) to develop their own post-event plans and to submit them to CDC by December 12, 2002 (CDC, 2002f). The Post-Event Response Plan and Guidelines included a description of a model smallpox vaccination clinic and provided instruction on all aspects of planning, setting up, and operating voluntary vaccination clinics on a large scale. On November 22, 2002, CDC issued Supplemental Guidance for Planning and Implementing the National Smallpox Vaccination Program; this guidance added specific smallpox vaccination and planning requirements to the Cooperative Agreement on Public Health Preparedness and Response for Bioterrorism. States, territories, three municipalities and the District of Columbia were asked to submit their pre-event vaccination plans by December 9, 2002 (CDC, 2002e). In addition to the pre-event and post-event programmatic guidance, CDC provided a series of smallpox-related training opportunities to help to develop the knowledge and skills of public health workers and clinicians, including video training, webcasts, slide sets, and other training materials on topics from vaccine administration to the clinical diagnosis of smallpox (CDC, 2004b). It is important to note that training and education activities occurred in an unusual context, in preparation for responding to a disease unfamiliar to most health care providers and public health workers, and a disease for which the evidence base is decades old. Evolution of the Smallpox Vaccination Policy The policy for pre-event smallpox vaccination was developed while discussion was occurring and guidance was being issued at several different levels: CDC gave ACIP several options and questions to consider and asked it to make recommendations about smallpox vaccination; federal officials considered the various strategies for pre-event vaccination; the White House was debating vaccination approaches; IOM was asked by CDC to hold a forum for discussing vaccination options; and an array of public health partners and others contributed recommendations and advice. The minutes and recommendations of ACIP, the variety of public opinion on the matter, and the perspectives of public health organizations are documented in this and subsequent chapters. There is little information, however, about the 3   The Post-Event Smallpox Response Plan and Guidelines also underwent several updates from December 2003 to June 2004.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism decision-making process at the highest levels of government. A lack of information about the development of health policy does not always provoke concern. However, the nature of the decisions about the smallpox vaccination program use of a vaccine with known potential complications to protect against an eradicated disease has brought into question the evidence, data, and reasoning that contributed to the fashioning of the final policy. Rationale for the Policy The smallpox vaccination policy announced in December 2002 was unusual in bringing together a national security program with a public health strategy. The president stated on December 13, 2002, that “we believe that regimes hostile to the United States may possess this dangerous virus” (White House, 2002). The initial policy announcement and later clarifications by DHHS provided little information about the threat assessment other than reassuring the public that there was no information to suggest that a smallpox virus release was imminent. The combination of known vaccine-related problems and unmeasurable disease threat was deeply problematic, and was reminiscent of the challenges faced by decision makers who planned the swine influenza campaign of 1976 discussed in Chapter 4. The intelligence considered in the development of the policy was not shared with the public or with those who would be called upon to respond to a smallpox event. However, coverage in the print and broadcast media provided fragments of information about intelligence and speculation about the suspected location of smallpox virus around the world. In 2002, the mass media reported that two unnamed U.S. government officials who had received classified briefings revealed that the federal government had information about Iraq’s possession of smallpox virus. Other news reports suggested that North Korea, Iraq, Russia, and France might possess stocks of smallpox, and reported on the smallpox vaccination status of Iraqi prisoners of war, and reported on other possible indications that the Iraqi bioweapons program included smallpox (Boyle, 2002; Gellman, 2002). In fall 2002, the possibility of war with Iraq loomed, owing in part to fears that Iraq possessed weapons of mass destruction. At the same time, the federal government named Iraq as one of the nations suspected of possessing smallpox stocks that could be used in a bioterrorist attack (Manning and Sternberg, 2002; Meckler, 2002b; National Journal Group, 2002). This may help to explain the perception of many in the public health and health care communities that the government’s decisions about the Iraq war and some of the considerations leading to the smallpox vaccination policy were associated in some way, and this perception later influ-

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism enced the course of the vaccination program (Krupnick, 2003; Kuhles and Ackman, 2003; Manning, 2003; McNeil, 2003). The comments of legislators and other officials that may have contributed to this perception are discussed in Chapter 4. June 2002 ACIP Meeting In 2001, CDC asked ACIP to review the recommendations for smallpox vaccination in light of the recent anthrax attacks. ACIP met in June 2002 to review and discuss vaccination needs for smallpox readiness. At the time of the meeting, the vaccination policy options being considered (see Box 2-1) revolved around two key issues: in the pre-event scenario, identifying who, if anyone, should be vaccinated before a smallpox virus release (issue is addressed by questions 1 and 2), and in the post-event scenario, identifying what vaccination strategy should be used (that is, ring vs. mass vaccination, addressed by a third question not included in Box 2-1). The second issue, in the post-event scenario, is outside this IOM committee’s charge and will not be discussed here. ACIP achieved consensus on Option 1 for Question 1 (against recommending vaccination of the general public in the absence of a confirmed smallpox case or attack) and on Option 2 for Question 2 (for restricting pre-event vaccination of designated persons who would have direct contact with or be called upon to investigate initial cases of smallpox) (ACIP, 2003). The groups targeted for such limited vaccination were later defined in greater detail as smallpox public health response teams and smallpox health care teams, or people who would conduct public health investigation and implement other public health activities and those who would provide medical care to people infected with smallpox virus (CDC, 2002c). Although ACIP did not provide a target number of vaccinees at its meeting, ACIP Chairperson John Modlin suggested in a CDC telebriefing that up to 20,0004 designated smallpox response team members with specific functional roles (health care and public health response) would be an appropriate target for pre-event vaccination (Brown, 2002b; CDC, 2002b; Roos, 2002; Maguire, 2003). That recommendation reflected the most limited of the pre-event vaccination options that ACIP considered. ACIP members explained that risks related to the vaccine and what was known about the risk of attack were factors used in making the recommendation (Brown, 2002a). 4   The ACIP chairperson provided an estimate of 10,000-20,000. Media reports have cited the figure as either 20,000 or 15,000, the midpoint of the range. To avoid confusing the reader, “up to 20,000” will be used in this report in referring to ACIP’s initial target number for pre-event smallpox vaccination.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism BOX 2-1 CDC’s Draft Policy Options CDC asked ACIP to consider three questions and develop options under each. The results of its deliberations, presented as options, follow each question. The following two questions refer to pre-event vaccination. A third question about postevent vaccination options is not provided below. Question 1: With no known cases of smallpox worldwide, should there be any change in the current recommendation for not vaccinating members of the general public? Option 1: In the absence of a confirmed smallpox case or a confirmed smallpox bioterrorism attack, ACIP does not recommend vaccination of members of the general public (i.e., no change from the current recommendation). Option 2: In the absence of a confirmed smallpox case or a confirmed smallpox bioterrorism attack, ACIP does not recommend that members of the general public be vaccinated; however, members of the general public may choose to be vaccinated. (This is a negative recommendation by ACIP, but there is choice by members of the public.) Option 3: In the absence of a confirmed smallpox case or a confirmed smallpox bioterrorism attack, ACIP recommendations for smallpox vaccine do not now include members of the general public; however, members of the general public may choose to be vaccinated. (ACIP is neutral, and there is choice by the public.) Option 4: In the absence of a confirmed smallpox case or a confirmed smallpox bioterrorism attack, ACIP recommends vaccination for those members of the general public who decide to receive the vaccination. Question 2: In addition to laboratory workers who work with viruses related to smallpox, are there other individuals in specific occupational groups who should be vaccinated to enhance smallpox preparedness? If so, what guidelines should be used to determine which individuals should be vaccinated? Option 1: In the absence of a confirmed smallpox case or a confirmed smallpox bioterrorism attack, ACIP does not recommend pre-exposure vaccination for any individuals other than laboratory or medical personnel who work with non-highly attenuated orthopox viruses. Option 2: In the absence of a confirmed smallpox case or a confirmed smallpox bioterrorism attack, ACIP recommends smallpox vaccination of persons predesignated by the appropriate bioterrorism and public health authorities who have responsibility for direct contact or investigation of the initial cases of smallpox. Option 3: In the absence of a confirmed smallpox case or a confirmed smallpox bioterrorism attack, ACIP recommends extending Option 2 above to include smallpox vaccination of “essential” medical and non-medical service personnel predesignated by the appropriate bioterrorism and public health authorities. SOURCES: ACIP (2002); IOM (2002b).

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism ACIP further developed the primary strategy for controlling and containing a smallpox outbreak. Its recommendations, developed in consultation with the DHHS National Vaccine Advisory Committee and CDC’s Hospital Infection Control Practices Advisory Committee, were forwarded to the acting CDC director and to the Secretary of HHS for review and consideration. Reported Viewpoints of Top Officials As ACIP deliberated and DHHS and CDC discussed pre-event vaccination options and their ramifications, information about the discussion and debate occurring within the administration was also relayed in the mass media. President Bush expressed concern about immunizing the general public before a smallpox virus release (pre-event) and risking fatal complications, and he stated he would consider all available options before making a decision (Altman, 2002a; Federal Document Clearing House, 2002). Perhaps in part because of the advice of D. A. Henderson, who was opposed to widespread smallpox vaccination on safety grounds (U.S. Senate, 2001), the president reportedly planned to wait to see the results of the first phases of vaccinations before deciding how to proceed with a wider offering of the vaccine (National Journal Group, 2002). Vice President Dick Cheney reportedly preferred widespread vaccination before a smallpox virus release, due to concerns about the ability of DHHS to stop an outbreak with efficient mass vaccination (Cohen and Enserink, 2002; McKenna, 2003). DHHS Secretary Tommy Thompson reportedly supported a delayed voluntary program with an improved, safer vaccine (Altman, 2002a; CDC, 1983; CDC, 2001, 2002c; Gellman, 2002; IOM, 2002a; Meckler, 2002b; National Journal Group, 2002). CDC Director Julie Gerberding stated that the agency favored waiting until a new vaccine was licensed before offering it to the public (Meckler, 2002b) but recognized that individual citizens may, after evaluating the risks and benefits of the vaccine for themselves, choose to receive the existing vaccine and should have the opportunity to make such a choice (Meckler, 2002a). Others, including some governors and legislators, favored making the vaccine available to the public (Frist, 2002; Gregg, 2002; Hallow, 2002). The reported arguments for offering the vaccine to the public included these: people need to have options and the ability to decide whether they want to choose vaccination for themselves and their families rather than having the decision made for them, and people should not have to depend on the government to deliver the vaccine in a crisis (Bicknell, 2002; Frist, 2002; Gregg, 2002; Hallow, 2002; Kemper, 2002).

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism CDC’s Efforts to Inform Government Policy Elsewhere in this report, the committee discusses its concerns about CDC’s independence to speak authoritatively about the scientific and public health rationale for the smallpox vaccination program. However, it must be noted that CDC made substantial efforts to involve its public health partners and the general public in a national discussion about the risk of smallpox, the smallpox vaccine, and vaccination options. In May 2002, CSTE presented its recommendations on smallpox vaccination to an ACIP working group (Pezzino, 2003). The organization opposed large-scale immunization of all first responders and advocated limiting vaccination to personnel who would be likely to come into contact with an index case of smallpox. In June 2002, CDC held a series of public forums in New York, San Francisco, St. Louis, and San Antonio, to inform health professionals and the general public about smallpox and smallpox vaccine, to discuss the risks and benefits of reviving smallpox vaccination, and to solicit opinions on the use of smallpox vaccine before and after a potential smallpox virus release (Serafini, 2002). A total of five hundred people participated; many spoke on the CDC-developed options the ACIP would consider in its meeting later that month (see Box 2-1). The informal consensus favored Option 1 for Question 1: no vaccination of members of the general public in the absence of a confirmed smallpox case or a confirmed smallpox bioterrorism attack. Forum attendees were divided with regard to Question 2. Both Option 2 (vaccinate members of designated state smallpox response teams) and Option 3 (vaccinate, in addition, essential medical and non-medical personnel designated by authorities) seemed acceptable to various constituencies. CDC also asked IOM to hold a workshop to consider the scientific, clinical, administrative, and procedural aspects of various smallpox immunization options (IOM, 2002a). The June 15, 2002, IOM workshop provided a forum for discussion of the array of options being considered by ACIP were discussed and debated. A workshop summary, titled Scientific and Policy Considerations in Developing Smallpox Vaccination Options, was later published. Early News of the DHHS Plan On July 7 and 8, 2002, the New York Times reported for the first time on the federal government’s plans to vaccinate a half-million health care and emergency workers against smallpox, a much higher number than the maximum of 20,000 recommended by ACIP in June (Broad, 2002; Connoly, 2002). Government officials emphasized that the secretary of DHHS had

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism not yet approved a plan to be forwarded to the White House, but details about the probable outline of the plan continued to circulate (Connolly, 2002). According to the New York Times, D.A. Henderson, then principal science adviser to the DHHS secretary for public health preparedness, explained the federal government’s tentative new plan for a larger number of vaccinees (Broad, 2002): “We could easily be at a half-million without too much difficulty…. Wide peacetime vaccinations,” he said, “would help educate not only the nation’s medical community on the practical aspects of smallpox immunization but also the public.” The pre-event smallpox vaccination plan, believed to reflect to some extent ACIP’s June 2002 recommendations, was sent by DHHS to the White House in August 2002 (Moscoso, 2002). By fall 2002, the administration was beginning to build a case for war against Iraq and, as discussed later in this report, that fact may have provided some of the context within which decisions regarding smallpox vaccination were made. At an October 4, 2002, news conference,5 DHHS officials reportedly outlined the program’s three-part structure, beginning with vaccination of up to 500,000 designated personnel, continuing with the vaccination of other health care workers and first responders, and finally, offering vaccination to the public using a new vaccine yet to be developed (Altman and Stolberg, 2002; Meckler, 2002a; Meckler, 2002b). The Associated Press, the New York Times and the Washington Post reported on October 5 and 6, 2002, that the federal government’s smallpox vaccination plans were near completion and appeared to call for vaccinating millions of health care workers (Manning and Sternberg, 2002; McGlinchey, 2003; Meckler, 2002b). On October 7, 2002, an article in USA Today quoted CDC Director Gerberding’s explanation of why the federal government was planning to vaccinate a number much greater than that recommended by ACIP in June. She reportedly stated: “We were in an environment where we were confident the threat was low. Where we are right now is still an environment where we have no imminent threat … but we recognize that we are in the process of considering war on our enemies. The context has changed a bit” (Manning and Sternberg, 2002). The New York Times also reported that at the October 4, 2002, news conference at DHHS, members of the press learned that the federal government was planning to make the smallpox vaccine available eventually to all Americans who wanted it (Altman, 2002b) as part of a program that would provide “ongoing and ever-expanding access to immunization” (Meckler, 2002a). 5   A transcript was unavailable.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism October 2002 ACIP Meeting In September 2002, CDC asked ACIP to provide additional guidance on eight smallpox vaccination implementation issues: types of health care workers to be included in smallpox health care response teams, vaccination site care, need for administrative leave, screening for atopic dermatitis, screening for HIV, screening for pregnancy, simultaneous administration of smallpox vaccine and other vaccines, and the vaccination of smallpox vaccinators (CDC, 2002d). ACIP responded to CDC’s request at its October 17, 2002, meeting. It recommended the vaccination of smallpox vaccinators (who would then vaccinate the public health and health care response teams) to reduce the possibility of inadvertent inoculation (and to contribute to the development of a cadre of experienced vaccinators who could be deployed immediately in the event of a smallpox virus release), provided guidance on vaccination site care, confirmed that smallpox vaccination could be administered together with other immunizations except chickenpox and concluded that administrative leave would not be required for vaccinated health care workers but recommended phasing in vaccination in participating hospitals, beginning with a small number of hospitals and staggering vaccination to minimize the impact on workforce. ACIP developed contraindications screening guidelines for the conditions identified by CDC and recommended that previously vaccinated people be preferentially targeted for vaccination, given the decreased incidence of adverse events in revaccinees (CDC, 2002d). ACIP also provided specific guidance to CDC on the type of health care staff and support personnel to be included in the composition of smallpox health care teams, and the potential number of vaccinees was noted later on October 17, 2002, during a CDC press telebriefing. The ACIP chairperson estimated that if each of about 5,100 acute-care hospitals in the United States participated in the program of precautionary, pre-event smallpox vaccination, and each hospital had a team of approximately 100, that would add up to about 500,000 health care workers (CDC, 2002c). However, both the ACIP chairperson and CDC officials participating in the call emphasized the importance of the composition of response teams and the adequacy of coverage within a given hospital rather than the number of vaccinees. In the same telebriefing, the timeframe of 30 days was given as a rough goal for the first phase of vaccination. One member of ACIP, Paul Offit, dissented from ACIP’s endorsement of the new, larger number of vaccinees (500,000) and observed that “the sense was that the course was already set and we wouldn’t make any difference” (ACIP, 2002; Manning, 2002; McCullough, 2003). The timing of ACIP’s revision of its recommendation, after news of the federal

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism government’s intention to vaccinate 500,000, seemed oddly coincidental to observers concerned about undue pressure on the federal advisory panel (Cohen and Enserink, 2002). However, ACIP Chairperson John Modlin and members of ACIP explained that the first, smaller number was based on the assumption that only staff at designated “smallpox hospitals” would be vaccinated (in addition to public health response teams). Later discussion with various stakeholders indicated that hospitals would resist a “smallpox” designation, and at a more practical level, smallpox victims would be more likely to go to the nearest emergency department rather than to a specific hospital (Brown, 2002b; Cohen and Enserink, 2002; Kemper, 2002; Maguire, 2003; Manning and Sternberg, 2002). ACIP had therefore changed its basic assumptions and expanded the number of prospective vaccinees to account for the participation of more hospitals. However, ACIP did not endorse any vaccination beyond the 500,000 response team members and was explicit in its opposition to offering vaccine to the general public, given the vaccine-related risks and the smallpox threat assessment at that time (Brown, 2002b, 2002c; Maguire, 2003). The Policy With the exception of phase I (vaccination of 500,000 volunteers), the federal government’s final policy decision was an unprecedented departure from the ACIP recommendations (Altman, 2002a). As announced by the president on December 13, 2002, and further elaborated in DHHS and CDC communications and telebriefings, the policy called for resuming military vaccinations and in the civilian sector first vaccinating smallpox response team members (a target of about 500,000 was provided by DHHS officials after the president’s announcement). This would be followed by an even larger number of health care and emergency personnel (up to 10 million), and finally, members of the general public who insisted on receiving the vaccine would be vaccinated (although with the caution that the government does not recommend smallpox vaccination for the general public, and with the caveat that the public would be given a new smallpox vaccine not yet developed at the time) (CDC, 2002g; White House, 2002). Funding for Bioterrorism and Smallpox In 1999, DHHS launched a bioterrorism initiative that had six goals: preventing bioterorrism, strengthening infectious disease surveillance, enhancing medical and public health readiness for mass casualty events, the National Pharmaceutical Stockpile (renamed the Strategic National Stockpile on March 1, 2003), conducting research on and development of new drugs and vaccines, and strengthening the information technology infra-

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism structure (Redhead et al., 2002). In the wake of the terror attacks of 2001, the DHHS budget for bioterrorism preparedness increased from $305 million for FY 2001 to $2.98 billion for FY 2002 (DHHS, 2002b). In 2002, Congress appropriated $940 million to CDC, which made $918 million available to 62 state, territorial, and local public health agencies as part of its Cooperative Agreement on Public Health Preparedness and Response (DHHS, 2002a). Twenty percent of the award was available for immediate use, and 80 percent was contingent on approval of plans submitted to CDC. In FY 2003, funding for CDC’s cooperative agreement was $870 million; in FY 2004, funding had decreased to $849 million (DHHS, 2003a, 2003b). Proposed funding for FY 2005 is $829 million (ASTHO, 2004). The smallpox vaccination program began as an agent-specific effort somewhat linked with other bioterrorism preparedness activities. When the smallpox vaccination program was announced, there was no specific funding linked with it; the November 2002 planning guidelines provided by CDC stated that the vaccination program would be funded by the already disbursed bioterrorism funds provided to grantees under the CDC cooperative agreement. After state and local public health agencies began to express concerns about the costs of the smallpox vaccination program and about their having to absorb a substantial proportion of funding earmarked for more general bioterrorism preparedness, in addition to other resources, the federal government provided $100 million in one-time supplemental funding for smallpox-related activities (DHHS, 2003b). CONCLUDING OBSERVATIONS The federal government’s decision to reintroduce smallpox vaccination was unprecedented and emerged at the challenging intersection of public health with national security considerations related to potential terrorism. A public health immunization program against a nonexistent disease was an unusual step initiated in the context of concern about the possible existence and whereabouts of illegal smallpox virus stocks and the recent bioterrorist attacks on U.S. soil. The smallpox vaccination policy emerged at the intersection of public health with national security considerations related to potential terrorism. ACIP has long served as a key advisory body to the federal government in all vaccination policy, and ACIP filled this role as it provided recommendations regarding specific aspects of the smallpox vaccination program. Little information has been made public about the other advisory groups and individuals most intimately involved in fashioning the actual policy. However, information available in the news media and in government communications shows that multiple opinions were considered at various

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism levels and that the formulation of the policy captivated public and mass media interest for some time. Greatly increased federal funding was made available to help states with bioterrorism preparedness, and additional funding was allocated for smallpox vaccination and related activities several months after the vaccination program began. REFERENCES ACIP (Advisory Committee on Immunization Practices). 2002. Record of the Meeting of the Advisory Committee on Immunization Practices, June 19-20, 2002. Centers for Disease Control and Prevention, National Immunization Program, Atlanta, GA. ACIP. 2003. 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. Alliance for Health Reform. 2002. Preparing for Smallpox: Who to Vaccinate? How Soon? Washington, DC. Altman L. 2002a, August 25. Health Workers Await Official Smallpox Policy. New York Times. Altman L. 2002b, October 8. The Doctor’s World: At the Health Department, the Messengers Still Stumble. New York Times. Altman LK, Stolberg SG. 2002, October 5. Smallpox Vaccine Backed for Public. New York Times, A1. ASTHO (Association of State and Territorial Health Officials). 2001. Bioterrorism Preparedness. Testimony Before the Senate Committee on Appropriations: Subcommittee on Labor, Health and Human Services, and Education Appropriations, October 3, 2001. [Online] Available at http://www.astho.org/templates/display_pub.php?u=JnB1Yl9pZD0zMTQ=. Accessed August 1, 2004. ASTHO. 2002. 2002 Government Relations Committee Annual Report—September. [Online] Available at http://www.astho.org/?template=government_relations_committee.html. Accessed January 30, 2005. ASTHO. 2004. Preparedness Policy Fact Sheet: Public Health Preparedness FY 2005 Appropriations. [Online] Available at http://www.astho.org/pubs/FactSheetBioTAppropriations.pdf. Accessed January 30, 2005. Bicknell WJ. 2002. The Case for voluntary smallpox vaccination. New England Journal of Medicine 346(17):1323-1325. Boyle A. 2002, December 13. The How and Why of Smallpox Shots. Bioterror News. [Online] Available at http://msnbc.msn.com/id/3076449. Accessed February 6, 2003. Broad W. 2002, July 7. US to Vaccinate 500,000 Workers Against Smallpox. New York Times. Brown D. 2002a, June 21. Limited Smallpox Vaccine Use Eyed; Expert Panel Rejects Mass Inoculations. Washington Post. Brown D. 2002b, October 17. Panel Alters Advice on Smallpox Shots: Wider Use for Health Workers Backed. Washington Post, A3. Brown D. 2002c, October 17. Panel Leery of Mass Smallpox Doses; Major Risks Outweigh Benefits of Immunizing the General Public, Experts Say. Washington Post. CDC (Centers for Disease Control and Prevention). 1983. Notice to readers smallpox vaccine no longer available for civilians—United States. Morbidity and Mortality Weekly Report 32(29):387.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism CDC. 2000. Biological and chemical terrorism: strategic plan for preparedness and response. Morbidity and Mortality Weekly Report 49(RR04):1-14. CDC. 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. Frequently Asked Questions About Smallpox. [Online] Available at http://www.bt.cdc.gov/agent/smallpox/disease/faq.asp. Accessed January 30, 2005. CDC. 2002b. CDC Telebriefing Transcript Smallpox Vaccine, June 20, 2002. [Online] Available at http://www.cdc.gov/od/oc/media/transcripts/t020620.htm. Accessed August 9, 2004. CDC. 2002c. 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 July 31, 2003. CDC. 2002d. Summary of October 2002 ACIP Smallpox Vaccination Recommendations. [Online] Available at http://www.bt.cdc.gov/agent/smallpox/vaccination/acip-recs-oct2002.asp. Accessed January 9, 2003. CDC. 2002e. Supplemental Guidance for Planning and Implementing the National Smallpox Vaccination Program (NSVP). [Online] Available at http://www.bt.cdc.gov/agent/smallpox/vaccination/pdf/supplemental-guidance-nsvp.pdf. Accessed December 15, 2002. CDC. 2002f, December 12. Press Release: CDC Initial Review of State Smallpox Vaccination Plans Complete. [Online] Available at http://www.cdc.gov/od/oc/media/pressrel/r021212.htm. Accessed July 7, 2004. CDC. 2002g. 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. 2004a. Advisory Committee on Immunization Practices (ACIP) Website. [Online] Available at http://www.cdc.gov/nip/ACIP/default.htm. Accessed January 30, 2005. CDC. 2004b. Smallpox: Training. [Online] Available at http://www.bt.cdc.gov/agent/smallpox/training/index.asp. Accessed January 30, 2005. Cohen J, Enserink M. 2002. Rough-and-tumble behind Bush’s smallpox policy. Science 298:2312-2316. Cohen J, Marshall E. 2001. Vaccines for biodefense: a system in distress. Science 294: 498-501. Connolly C. 2002, July 8. Smallpox Vaccine Program Readied: Inoculations May Surpass 500,000 Under US Plan. Washington Post. DOD (Department of Defense). 2002, December 13. News Release: DOD Details Military Smallpox Vaccination Program . [Online] Available at http://www.dod.gov/releases/2002/b12132002_bt634-02.html. Accessed January 30, 2005. DHHS (Department of Health and Human Services). 2002a, June 6. News Release: HHS Approves State Bioterrorism Plans so Building Can Begin. States, Cities to Receive Additional Funds for Strengthening Public Health Systems. [Online] Available at http://www.hhs.gov/news/press/2002pres/20020606c.html. Accessed January 30, 2005. DHHS. 2002b. News Release: Highlights of 2002. [Online] Available at http://www.hhs.gov/news/press/2002pres/20021227.html. Accessed January 30, 2005. DHHS. 2003a, March 20. News Release: HHS Announces Bioterrorism Aid for States, Including Special Opportunity for Advance Funding. [Online] Available at http://www.os.dhhs.gov/news/press/2003pres/20030320.html. Accessed January 30, 2005. DHHS. 2003b, May 9. News Release: Guidelines for Bioterrorism Funding Announced. [Online] Available at http://www.hhs.gov/news/press/2003pres/20030509.html. Accessed January 30, 2005.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Federal Document Clearing House. 2002. Transcript: George W. Bush Holds News Conference. Frist B. 2002, August 9. Deciding Who Is Protected Against Smallpox. New York Times. Gellman B. 2002, November 5. Findings Spur New Smallpox Concerns. Albany (NY) Times Union. Gregg J. 2002, October 6. Let the Public Choose on Smallpox Vaccine. Washington Post. Hallow R. 2002, November 24. Governors Seek Access to Smallpox Vaccine. The Washington Times, A4. IOM (Institute of Medicine). 2002a. Biological Threats and Terrorism: Assessing the Science and Response Capabilities. Washington, DC: National Academy Press. IOM. 2002b. Scientific and Policy Considerations in Developing Smallpox Vaccination Options: A Workshop Report. Washington, DC: The National Academies Press. Kemper V. 2002, October 5. Public Access to Smallpox Vaccine Is Urged; People Should Be Allowed to Opt in After Emergency Workers Are Inoculated, Officials Say. The White House Is Undecided. Los Angeles Times. Krupnick M. 2003, January 24. CNA Calls Smallpox Program “Political”; Nursing Union Offical Says Bush’s Plan Carries More Risks Than Benefits. Contra Costa Times, A1. Kuhles D, Ackman D. 2003. The federal smallpox vaccination program. Where do we go from here? Health Affairs (Web Exclusive) W3:503-510. Maguire P. 2003, January. As the Country Gears Up for Smallpox Vaccinations, Physicians Find Themselves on the Front Lines. ACP-ASIM Observer, American College of Physicians-American Society of Internal Medicine. [Online] Available at http://www.acponline.org/journals/news/jan03/smallpox.htm. Accessed January 30, 2005. Manning A. 2002, October 17. Advisory Panel Expands Smallpox Vaccine Plan. USA Today. 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. McCullough M. 2003, February 7. Americans Aren’t Rolling Up Their Sleeves for Smallpox Inoculation. The Salt Lake Tribune. McGlinchey D. 2003, February 26. CDC Says It Never Aimed for 500,000 Smallpox Vaccinations. Global Security Newswire. McIlroy C. 2002. HHS to Formulate Smallpox Vaccination Strategy. Front & Center, Newsletter of the National Governors’ Association Center for Best Practices. 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. Meckler L. 2002a, October 4. US Health Officials Say Smallpox Vaccine Should Be Rolled Out Slowly. Associated Press. Meckler L. 2002b, October 5. US Divided on Smallpox Policy. Associated Press. Moscoso E. 2002, August 28. Smallpox Plan in White House Hands. Atlanta Journal-Constitution, 9A. National Journal Group. 2002, November 25. Smallpox: Bush Favors Extensive Immunization. Global Security Newswire. Pezzino G. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Three on May 1, 2003, Washington, DC:106-122. Redhead C, Vogt D, Tiemann M. 2002. Bioterrorism: Legislation to Improve Public Health Preparedness and Response Capacity. Report for Congress. Congressional Research Service, Library of Congress. Roos R. 2002, June 21. ACIP Urges Smallpox Shots Only for Response Teams, Some Hospital Workers. CIDRAP News.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Serafini MW. 2002. Smallpox vaccinations: who should decide? National Journal 34(24):1800. U.S. Senate. 2001. U.S. Senator Edward Kennedy (D-MA) Holds Hearing on Bioterrorism. Senate Health, Education, Labor and Pensions Committee: Health Subcommittee. White House. 2002. President Delivers Remarks on Smallpox. [Online] Available at http://www.whitehouse.gov/news/releases/2002/12/20021213-7.html. Accessed January 8, 2003.