E
Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation, Letter Report #4

August 12, 2003

Dr. Julie Gerberding

Director

Centers for Disease Control and Prevention

1600 Clifton Road, NE Atlanta, GA 30333

Dear Dr. Gerberding:

The Committee on Smallpox Vaccination Program Implementation is pleased to offer you the fourth in a series of brief reports providing timely advice to assist Centers for Disease Control and Prevention (CDC) and its partners in their implementation of the vaccination program.1 This report responds to issues raised by CDC at the committee’s May 1, 2003, meeting. In particular, the report includes: (1) a discussion of smallpox preparedness and its integration into overall public health preparedness; (2) the committee’s advice regarding offering vaccination to members of the general public who insist on receiving it; and (3) an examination of selected aspects of smallpox vaccination program implementation.

In a previous report (IOM, 2003c), the committee remarked on the

1  

As of July 25, 2003, 38,004 civilian volunteers have been vaccinated against smallpox (CDC, 2003l), and as of June 13, 2003, 2,125 hospitals have participated in the smallpox vaccination program (Strikas, 2003).



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The Smallpox Vaccination Program: Public Health in an Age of Terrorism E Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation, Letter Report #4 August 12, 2003 Dr. Julie Gerberding Director Centers for Disease Control and Prevention 1600 Clifton Road, NE Atlanta, GA 30333 Dear Dr. Gerberding: The Committee on Smallpox Vaccination Program Implementation is pleased to offer you the fourth in a series of brief reports providing timely advice to assist Centers for Disease Control and Prevention (CDC) and its partners in their implementation of the vaccination program.1 This report responds to issues raised by CDC at the committee’s May 1, 2003, meeting. In particular, the report includes: (1) a discussion of smallpox preparedness and its integration into overall public health preparedness; (2) the committee’s advice regarding offering vaccination to members of the general public who insist on receiving it; and (3) an examination of selected aspects of smallpox vaccination program implementation. In a previous report (IOM, 2003c), the committee remarked on the 1   As of July 25, 2003, 38,004 civilian volunteers have been vaccinated against smallpox (CDC, 2003l), and as of June 13, 2003, 2,125 hospitals have participated in the smallpox vaccination program (Strikas, 2003).

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism importance of working to attain a level of smallpox preparedness and not simply focusing on numbers of vaccinated individuals. Since then, CDC officials have remarked that the smallpox program is “not about a number, it is not about should we have 40,000 people or 400,000 or 4 million people…. It’s about how do we get prepared” (CDC, 2003i). Furthermore, CDC plans to conduct an assessment of its smallpox preparedness efforts and recommend program adjustments to emphasize education and training and ways to facilitate reporting and test readiness (Connolly, 2003b). The report is organized into three main sections: (1) Integrating Smallpox Preparedness into Overall Public Health Preparedness; (2) Vaccination of Members of the General Public Who Insist on Receiving Smallpox Vaccine; and (3) Selected Aspects of Smallpox Vaccination Program Implementation. INTEGRATING SMALLPOX PREPAREDNESS INTO OVERALL PUBLIC HEALTH PREPAREDNESS State health departments have been actively involved in planning and preparing for the possibility of a bioterrorist event. We are now seeing that this level of preparation can also assist in unexpected natural outbreaks. Tommy Thompson, Secretary of the Department of Health and Human Services, in reference to the monkeypox outbreak (CDC, 2003a) The discussion of integration of smallpox preparedness into overall public health preparedness is organized around four main topics: (1) Challenges in Defining and Assessing Public Health Preparedness; (2) Elements of Preparedness; (3) Testing Preparedness; and (4) Sustaining Smallpox and Overall Public Health Preparedness. Challenges in Defining and Assessing Public Health Preparedness There is significant agreement about the difficulties and flaws that characterize the public health infrastructure, and in the last 2 years there has been considerable discussion about the need for public health preparedness. Public health system leaders know the system is not sufficiently prepared based on the way it has responded to a number of threats and crises in recent years. However, the public health system is still in the early stages of developing consensus on defining preparedness and identifying evidence-based standards for planning for and evaluating preparedness. At a minimum, public health preparedness requires adequate and sustained funding based on priorities supported by evidence and a strong public health infra-

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism structure, including surveillance, workforce, and communication (IOM, 2002). Assessments of the public health infrastructure’s capacity to respond to bioterrorism conducted after the events of September and October 2001 found a severe lack of financial resources and a great deal of fragmentation within the public health system, from surveillance systems (which were multiple, overlapping and duplicative, and incompatible in various ways) to communication (which was limited, reliant on obsolete, inefficient channels, etc.) both internal and with other sectors (IOM and NRC, 1999; Heinrich, 2001; Peters et al., 2001; IOM, 2002; Salinsky, 2002). It is unclear at this time whether the recent influx of funding aimed at strengthening the public health infrastructure is being used to reinforce public health capacity in an integrated way, responsive to local needs and epidemiologic evidence, or to simply create new funding and program categories, adding to existing fragmentation. The IOM Committee on Emerging Microbial Threats to Health in the 21st Century has described recent funding increases as opportunities for the nation to prepare to “protect against acts of bioterrorism and improve the U.S. public health response to all microbial threats” but expressed alarm that “some of these funds have been diverted from multipurpose infrastructure building to single-agent preparedness” (IOM, 2003a). In fact, smallpox may have “received the lion’s share of attention and … drawn attention away from the wide range of other agents that could be used” in a bioterror attack (Powers and Ban, 2002). Vaccination: Only One Component of Smallpox Preparedness In the early months of the smallpox preparedness program, preparations to respond to a potential smallpox attack have consisted largely of vaccination-related activities. These have been resource-intensive, giving rise to concerns about the opportunity costs (i.e., to essential public health services) of the smallpox vaccination program and about the optimal balance of investment of public health funds (e.g., are smallpox-related activities funded at the expense of a more wide-ranging kind of preparedness?) (APHA, 2002; Libbey, 2003; Madlock, 2003; NACCHO, 2003b; Nikolai, 2003). Surely, being prepared for a potential attack requires much more than just vaccination. It includes planning for a range of possible scenarios, including contingencies for crowd control, quarantine, and isolation; training, retraining, and management of response teams; education and training of health care providers, emergency responders, and many others to facilitate rapid surveillance, reporting, and notification; planning and coordination with many partners, including some at the state and federal level; and testing and continuous improvement of plans.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism The smallpox vaccination program and associated activities implemented by CDC and its state and local partners have provided information and training about smallpox disease and vaccine to public health and health care workers, have probably improved clinician knowledge and rash illness diagnostic skills, and have led to vastly improved communication and collaboration among public health agencies, between the public health and clinician communities, and among public health, law enforcement, and emergency response agencies (Committee on Smallpox Vaccination Program Implementation Study Staff, 2003; Elliott, 2003; NACCHO, 2003b). However, much more is necessary to strengthen and test smallpox preparedness and to ensure that smallpox-related efforts are part of overall public health preparedness activities. The committee hopes that this report will provide some useful direction toward that end. Smallpox Preparedness: Only One Component of Overall Public Health Preparedness The national smallpox vaccination program may well be the first disease-specific test of implementing public health preparedness in a systematic and comprehensive manner and with some public visibility. The smallpox vaccination program has taken the notion of preparedness beyond the realm of public health professionals and academics and has brought it to the attention of a broader audience of health care workers, emergency responders, and even the general public. Implementing the smallpox vaccination program, however, has also highlighted the need to integrate smallpox preparedness into readiness to respond to a vast range of public health challenges, including bioterror agents and other weapons of mass destruction, emerging or reemerging infectious diseases, natural disasters, and the insidious and growing threat of chronic diseases and their predisposing conditions (e.g., obesity). Smallpox is just one of a multitude of actual and potential threats to the public’s health. The Continuation Guidance for Cooperative Agreement on Public Health Preparedness and Response for Bioterrorism (CDC, 2003b), describes the capacities needed for smallpox response in the context of all other bioterrorism threats, even calling for coordination with the National Public Health Performance Standards, which guide public health activities in general. In practice, such integration has been lacking and has been difficult to accomplish, in part due to the intense emphasis on smallpox vaccination, which has been advanced perhaps at the expense of other aspects of smallpox preparedness, as well as overall public health preparedness to respond to any threat.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism A Standard for Smallpox Preparedness The federal government should consider playing a more concerted role in providing resources and instituting unified standards for the common defense against the microbial threat, while giving state and local authorities the flexibility to implement programs in a manner that will best meet local needs. (Brower and Chalk, 2003) The question of what exactly is involved in preparedness to respond to a smallpox attack has been a recurrent theme at committee meetings and in presentations to the committee. Many of the requirements for smallpox preparedness apply to preparedness in general; there are necessary components of the public health infrastructure including workforce, surveillance and laboratory capacity, information technology, legal authority, and communication networks. What remains to be clarified at the state level, with the guidance of CDC, are the specifics (e.g., vaccination sites; numbers of responders, vaccinated or not; strategies for training, communicating with, and mobilizing responders, etc.) needed to act effectively in each state and jurisdiction. Before the occurrence of a public health emergency, such as a smallpox release, planning, coordination, and communication among local, state, and federal public health agencies must take place in order to establish leadership and responsibility (ASTHO, 2002; Salinsky, 2002). In the event of a bioterror attack, final authority in the matter must reside somewhere. Similarly, leadership is required to establish a minimum standard against which preparedness may be tested. Having 50 or more different standards for preparedness seems inconsistent with a coordinated, effective response; for example, one state might prepare enough to mass vaccinate all residents in 10 days, while a neighboring state could be prepared to accomplish this in 2 days. Such variation may cause confusion and weaken confidence in the public health system’s handling of a crisis. In the pre-event setting, CDC has been flexible in its guidelines to states and has advised states to define preparedness needs locally, in recognition of the fact that bioterrorism occurs at the local level. However, due to the infectiousness of certain agents, such as smallpox, the local quickly becomes national, and jurisdictional boundaries become less relevant. The regional planning required to prepare for a response to major fires is analogous to the preparedness planning required across jurisdictional boundaries for a response to a smallpox attack. Such circumstances would require stronger national (i.e., CDC) leadership to set some standards for preparedness while collaborating with state public health agencies in acknowledgement of the great variety in circumstances and resources across states and localities (ASTHO,

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism 2002; Brower and Chalk, 2003; IOM, 2003c). The committee recommends that CDC provide guidance to assist state public health agencies (and their partners,2 as appropriate) in establishing a baseline level or a minimum standard of preparedness for a smallpox attack, after which, each state could individually assess its priorities and further expand its preparedness against smallpox and other threats to the public’s health as needed. The committee has been informed that CDC is developing metrics/indicators of preparedness to guide all state partners in implementing their cooperative agreements with CDC. The smallpox preparedness metrics/indicators will be the subject of the committee’s meeting on September 4, 2003, and the committee hopes this effort will help to establish a minimum standard of smallpox preparedness. Smallpox preparedness activities conducted in the first months of 2003 have enhanced the readiness of state and local public health agencies to respond to a potential smallpox attack (Committee on Smallpox Vaccination Program Implementation Study Staff, 2003; NACCHO, 2003a), but as noted above, vaccination alone—the focus of most of these activities—is not sufficient for preparedness. In fact, many states are pausing in their smallpox vaccination activities before proceeding to a broader group of potential vaccinees to evaluate their progress and ensure safety, to address changing circumstances by updating forms, materials, and processes, and finally, to consider what level of vaccination is needed for preparedness (ASTHO, 2003; IOM, 2003c). The deliberate and cautious implementation of the vaccination program to date testifies to the influence of lessons learned from the Swine Flu vaccination program of 1976 (Hardy, 2002; Strikas, 2002). Attaining a high level of preparedness may well be possible without vaccinating any personnel pre-event. For example, Virginia Commonwealth University Health System, which presented its hospital preparedness plans to the committee at the May 1, 2003, meeting, has chosen not to have health care workers vaccinated pre-event (Edmond, 2003).3 The health system’s decision was based on considerations of hospital patient safety. Although no vaccinated teams of responders were formed, a policy on smallpox vaccination was developed, with plans to revisit the policy as needed. Furthermore, a working group on smallpox preparedness was established, facilities were modified in accordance with requirements for treat- 2   State partners may include, but not be limited to, emergency management agencies, law enforcement, fire and emergency medical services, hospital and other health care associations. 3   The ACIP estimated approximately 5,100 acute care hospitals would be eligible to participate in the smallpox vaccination program (ACIP, 2002). As of June 13, 2003, 2,125 hospitals have participated, with whole or partial teams of vaccinated response personnel (Strikas, 2003).

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism ing smallpox victims, training on smallpox diagnosis, treatment, and infection control measures was conducted, and plans were put in place to rapidly vaccinate hospital staff in a post-event scenario. The committee believes that Virginia Commonwealth University Health System’s smallpox preparedness activities provide a good example of how an organization or jurisdiction can be well prepared to respond to a smallpox attack without necessarily having workers vaccinated pre-event. CDC’s initial attention to the numerical targets so well publicized in the media may have contributed to confusion and concern about goals and outcomes among the public health and health care communities, as well as in the general public (ASTHO, 2003; Connolly, 2003a; ENA, 2003; GAO, 2003; Russell, 2003; Solet, 2003). It has not been made completely clear to most audiences how national estimates of numbers of vaccinees were derived and how they relate to the publicly available threat assessment and to smallpox preparedness. Although the committee recognizes that the CDC has publicly acknowledged that preparedness is not about numbers (see page 1), it is clear that there is lingering confusion about the vaccination program’s aims. This confusion is reflected in recent media reports that characterize the program as having fallen short of its goals (Connolly, 2003a; Snowbeck, 2003)—when comparing the fewer than 40,000 vaccinees in early July 2003 (CDC, 2003l) to the initially publicized target of vaccinating approximately 500,000 and 10 million individuals, in the first and in the second rounds of vaccination, respectively. There also is lingering confusion about how the 500,000 estimate described by CDC related to the 15,000 estimate cited by the ACIP in June 2002 (AAFP, 2002; CIDRAP News, 2002; Manning, 2002). Public confidence and clarity about preparedness efforts would likely be enhanced if the CDC explained how and why it came to view its earlier benchmarks as less than helpful (e.g., were early estimates of vaccinee numbers the upper bounds of what was needed for an effective response to a smallpox attack?). Given that CDC supports ongoing smallpox immunization (CDC, 2003m), there should be clarification about the goals and objectives being pursued (IOM, 2003c) to help reconcile the apparent incongruity between the claim that preparedness is “not about a number” and the stated intent to move forward with vaccination to ensure there are “enough people … immunized” (CDC, 2003i). What number of vaccinees is needed for preparedness? Vaccinating many more than the number needed may waste precious resources that could be utilized to prepare against other threats to the public’s health. Vaccinating fewer than what is needed to respond effectively and rapidly may leave the public vulnerable and unprotected. The recent severe acute respiratory syndrome (SARS) and monkeypox episodes have provided CDC the opportunity to once again demonstrate its authoritative voice and competence as the nation’s public health leader.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism However, these serious infectious disease threats posed relatively straightforward public health challenges, without the national security issues that complicate the smallpox vaccination program. To maintain its credibility, CDC should demonstrate a sustained commitment to clarity and openness about its smallpox preparedness goals by working toward a concrete description of what preparedness entails (despite the complexities and unknowns involved), communicating regularly with the public, and discussing any specific numbers of vaccinees only within this broader context. Elements of Smallpox Preparedness At the committee’s May 2003 meeting, one presenter described the essentials for improving smallpox preparedness as planning, training to the plan, exercising to the plan, and revising the plan (Selecky, 2003). In presentations and conversations with several state and local health departments, the committee heard similar comments about what program administrators believe are the “ingredients” of smallpox preparedness (Committee on Smallpox Vaccination Program Implementation Study Staff, 2003). Most programs remarked on the importance of: developing relationships with all relevant partners (might help enhance surveillance and reporting, as well as planning and implementation of smallpox response); engaging in regular communication with other local and state public health agencies; communicating openly, regularly, and consistently with the media and the public to create a foundation of optimal communication before a potential smallpox event; having a core of set of workers to provide initial response and vaccinate others; having concrete plans, including job descriptions and locations; and educating and training all participants before an event. These themes are consistent with the three elements of smallpox preparedness identified in Annex A of the DHHS/CDC Continuation Guidance for Cooperative Agreement on Public Health Preparedness and Response for Bioterrorism (CDC, 2003b) and discussed in greater detail below: Preparing key responders—with a section devoted to health care responders and preparedness in the health care sector (includes the relationship-building, training, and planning described above); Rapid public health response—rapid detection, identification, in-

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism vestigation, and response to suspected or confirmed cases of smallpox (also includes the training, communication and relationships noted above, in addition to infrastructure capacity for surveillance, prompt reporting by providers, etc.); and Protecting the public (e.g., through mass vaccination)—all ingredients described above contribute to the ability of jurisdictions to operate orderly, efficient mass vaccination clinics. Two additional elements are discussed briefly below to address areas not directly covered by the three elements of preparedness listed above. These include the important role of the health care community in overall public health preparedness and the role of public and media communication. Preparing Key Responders The first element of smallpox preparedness described in the CDC/Department of Health and Human Services (DHHS) guidance involves preparing key responders. As the committee noted before, this does not necessarily involve vaccinating workers, but it would ideally include training and education of key responders, and even prescreening for vaccination in the event of a smallpox attack. It is unclear what level of pre-event smallpox vaccination is needed and how numbers of vaccinated personnel relate to the ability to respond effectively to a smallpox attack. This is a decision that must be made in the face of great uncertainty by each jurisdiction before deciding whether to vaccinate additional volunteers and, if so, the number and type of personnel to vaccinate. CDC and its partners have worked to strike a balance between vaccine risk and the benefit of having vaccinated health care and public health personnel pre-event, but it is difficult to determine when the line has been crossed between having insufficient people vaccinated to mount an effective and rapid response and exposing more people than absolutely necessary to a vaccine that is not free of risk, in the absence of imminent threat of disease. It appears that most jurisdictions have chosen to address this dilemma by cautiously vaccinating at least a small number of volunteers, having apparently concluded that smallpox preparedness is served by having a cadre of vaccinated individuals, typically organized into health care and public health response teams (based either institutionally or regionally), in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations regarding the organization of smallpox response efforts (CDC, 2002d). However, having a number of personnel immune to smallpox and ready to vaccinate, conduct public health investigations, and treat victims is not the sum of preparedness, especially if responders are scattered

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism across the jurisdiction in multiple facilities. Whether vaccinated before an event or not, effective mobilization of key responders requires prior preparation to ensure, at a minimum: adequate size and composition of health care and public health response teams; regularly tested and updated plans known to all participants and relevant agencies; initial and periodic training, including training about response plan(s) (as well as training of vaccinators, case investigators, etc.); job assignments and descriptions for all responders (e.g., vaccinators, public health investigators, crowd control, and security), and consideration of relevant licensure or practice privileges should teams need to cross jurisdictional, state, or even national borders; and reliable and efficient channels of communication among all relevant parties, including methods for contacting team members (e.g., pagers), and for the movement of information between health care organizations and public health agencies and between the health sector and traditional first responder agencies such as law enforcement and emergency management (English et al., 1999). Furthermore, having adequate workforce to respond to a smallpox (or other) event requires managing staff turnover (workers who leave or retire), and the ability to mobilize as many vaccinated personnel as possible. One recipient activity described in Annex A of the DHHS/CDC guidance is the development and maintenance by states and territories of a registry of all public health, health care, security, and other personnel who may be occupationally at risk and should receive vaccination immediately in the event of a smallpox release. In addition to having identified such priority occupational groups to be vaccinated post-event, programs should take necessary steps to maximize the use of any available vaccinated personnel. For example, the Department of Defense (DoD) has vaccinated over 400,000 military personnel, some of whom are reservists, and others who will complete military service. The committee hopes that CDC and DoD could collaborate to maintain contact with vaccinees, particularly those who enter civilian life, and to link them to any mechanism developed to include as many as possible in planning for preparedness. Contact also should be maintained with health care or public health workers who received a smallpox vaccine because of exposure to a case of monkeypox, so they could be utilized for response to a smallpox event. The committee recommends that CDC support the establishment of state and/or local and, if appropriate, national

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism voluntary registries of individuals who have undergone vaccination to be mobilized, trained, and assigned as needed in the event of a smallpox attack. Such registries would include all willing vaccinated personnel not associated with a response team ranging from retired or relocated health care or public health workers to military reservists and former military personnel. Such registries might help supplement and enhance the personnel available to respond to public health crises (e.g., participating in the mass distribution of vaccines or other pharmaceuticals, caring for casualties, providing security, managing crowds). Establishing such registries will require consideration of issues related to confidentiality and privacy, among others. Ongoing efforts to organize volunteer personnel to help in emergencies (e.g., the USA Freedom Corps and the Public Health Service reserve corps) may serve as resources (Thompson, 2003). Decisions also should be made about the vaccination activities needed to maintain a cadre of key responders immune to smallpox virus in the long term, but the evidence on the level of long-term immunity proffered by smallpox vaccination is mixed. Older data suggested that smallpox immunity lasts 3 to 5 years after vaccination (CDC, 2002a), while more recent research suggests possibly longer duration of immunity (Frelinger and Garba, 2002; Slifka, 2003). More conclusive research would undoubtedly assist in future policy decision-making regarding smallpox preparedness. Given the 454,856 personnel vaccinated through the DoD smallpox vaccination program (Grabenstein, 2003), many of whom have had and will have a series of serum specimens included in the Department of Defense Serum Repository, CDC should work with DoD to explore how the DoD Serum Repository can support research on smallpox antibody levels at different periods of time post-vaccination. Whether a jurisdiction vaccinates traditional emergency responders, from law enforcement to firefighters, these parties should be considered partners in overall public health preparedness. Previously, emergency management officials, police, and fire departments had not considered public health agencies to be emergency responders, and health departments typically have not counted emergency and fire personnel among the ranks of public health responders. The committee has heard at every meeting about the importance of building relationships with a wide range of partners in the community; a common outcome of the smallpox vaccination program has been the forging of linkages between the public health and health care communities, and between public health and traditional emergency response agencies. Communication between all relevant partners is essential, including mechanisms for notification and information sharing.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism consider whether such information also should be sent to everyone who has already been vaccinated. As of June 20, 2003, 17 suspected cases of myo/pericarditis and 4 probable cases of myo/pericarditis following smallpox vaccination were reported in the civilian population (CDC, 2003n). Because of the probable association of smallpox vaccination with increased incidence of myo/pericarditis, CDC is now including myo/pericarditis in the tables of “selected adverse events associated with smallpox vaccination among civilians” appearing weekly in the Morbidity and Mortality Weekly Report. The ACIP Smallpox Vaccine Safety Working Group has concluded that “Smallpox vaccination increases risk of myo-pericarditis” (Neff, 2003). The DoD has stated, “the observed rate of myopericarditis among primary vaccinees is 3.6-fold higher than the expected rate among personnel on active duty who were not vaccinated” (Halsell et al., 2003). Research in non–smallpox vaccine settings suggests that some people who experience myocarditis may develop long-term sequelae such as left ventricular dysfunction (Hiroe et al, 1985) and cardiomyopathy (Hayakawa et al., 1984; Das et al., 1985; Drucker and Newburger, 1997). As of June 20, 2003, two cases of dilated cardiomyopathy were diagnosed in civilian smallpox vaccinees 3 months after vaccination (CDC, 2003n). CDC is now advising, “Because smallpox vaccination appears to be associated causally with myocarditis, which can cause [dilated cardiomyopathy], further evaluation is warranted” (CDC, 2003n). In one study, one-fourth of patients reporting to a major medical center with symptomatic dilated cardiomyopathy died within a year, and half died within 5 years (Dec and Fuster, 1994). The possibility of long-term sequelae from the smallpox vaccine must be acknowledged. Whereas the acute smallpox vaccine injuries are relatively well understood, less is known about smallpox vaccine injuries that occur on a longer-term basis. SEPPA specifies that an individual who was administered the vaccine who is requesting a benefit under the law must file an initial request for benefits or compensation “not later than one year after the date of administration of the vaccine” (U.S. Congress, 2003). (Individuals who experienced accidental vaccinia inoculation, however, have up to “two years after the date of the first symptom or manifestation of onset of the adverse effect” [U.S. Congress, 2003] to file an initial request.) For individuals who received the smallpox vaccine, it currently is unclear to the committee how, if at all, any injuries that manifest themselves more than 1 year after vaccination will be addressed. It also is unclear how longer-term sequelae that result from an acute smallpox vaccine injury (e.g., cardiomyopathy that results from a “silent” case of myocarditis, with no initial request for benefits filed in the year after vaccination) will be handled. Also, in SEPPA, a “covered injury” is covered if it is “determined … to have been

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism sustained by an individual the direct result of administration to the individual of a covered countermeasure during the effective period of the Declaration” (U.S. Congress, 2003). (The term ‘Declaration’ refers to the Declaration Regarding Administration of Smallpox Countermeasures issued by the Secretary on January 24, 2003, and published in the Federal Register on January 28, 2003.) The committee believes that it will be important to clarify and explain in the interim final rule the interpretation of “a direct result of … a covered countermeasure” (i.e., smallpox vaccine), since this will affect the level of evidence required for an injury to be covered. The committee encourages CDC to work with those who are developing the interim final rule for the smallpox vaccine injury table to clarify the conditions under which longer-term sequelae from the smallpox vaccine will be considered to be a direct result of smallpox vaccination. The last two key messages of the report are: The safety system appears to be working well to date, but CDC and its partners should remain vigilant to ensure the continuing safe implementation of the program. The development of a research agenda for the smallpox vaccination program is important to ensuring the long-term success of smallpox preparedness efforts, as well as providing useful information for overall public health preparedness. CONCLUDING REMARKS The committee offers its assistance in the future in any areas that would prove useful to CDC. Two possible areas include developing a research agenda to support and evaluate the implementation of the smallpox preparedness program and exploring how to better integrate smallpox preparedness into overall public health preparedness. In closing, the committee summarizes several of the key messages set forth in this report: First, smallpox is not the only threat to the public’s health, and vaccination is not the only tool for smallpox preparedness. Second, to improve smallpox preparedness, it is essential to “plan, train to the plan, exercise to the plan, and revise the plan” (Selecky, 2003). Third, vaccinating members of the general public beyond the key personnel states deem necessary for preparedness should proceed only un-

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism der the aegis of smallpox vaccine clinical research trials or other well-structured clinical arrangements that meet the basic requirements of medical and public health ethics. Fourth, the safety system appears to be working well to date, but CDC and its partners should remain vigilant to ensure the continuing safe implementation of the program. Fifth, the development of a research agenda for the smallpox vaccination program is important to ensuring the long-term success of smallpox preparedness efforts, as well as providing useful information for overall public health preparedness. The committee wishes to thank you for the continuing opportunity to be of assistance to the Centers for Disease Control and Prevention and its partners as they work to protect the nation’s health. Brian L. Strom, Committee Chair Kristine M. Gebbie, Committee Vice Chair Robert B. Wallace, Committee Vice Chair Committee on Smallpox Vaccination Program Implementation REFERENCES AAFP (American Academy of Family Physicians). 2002. Panel calls for limited smallpox vaccination. FP Report 8(8). ACIP (Advisory Committee to Immunization Practices). 2002. Record of the Meeting of the Advisory Committee on Immunization Practices—June 19-20, 2002. [Online] Available at http://www.cdc.gov/nip/acip/minutes/acip-min-jun02.rtf. Accessed July 30, 2003. 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. ACIP SVS WG (Advisory Committee on Immunization Practices Smallpox Vaccine Safety Working Group). 2003a. March 20-21, 2003, Meeting of the Advisory Committee on Immunization Practices (ACIP) Smallpox Vaccine Safety Working Group, Chicago, IL: Summary of the Chairs. ACIP SVS WG. 2003b. Operating Procedures of the ACIP Smallpox Vaccine Safety Working Group (ACIP SVS WG). 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. AP (Associated Press). 2003a, May 13. SARS Battle Strains U.S. Health System. FOX News Channel. AP. 2003b, June 16. AMA Seeks to Standardize Training for Bioterrorism. The Wall Street Journal. ASTHO (Association of State and Territorial Health Officials). 2002. Nature’s Terrorist Attack: Pandemic Influenza. [Online] Available at http://www.astho.org/pubs/Pandemic%20Influenza.pdf. Accessed July 15, 2003.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism CDC. 2003k. Women with smallpox vaccine exposure during pregnancy reported to the national smallpox vaccine in pregnancy registry—United States, 2003. Morbidity and Mortality Weekly Report 52(17):386-388. CDC. 2003l. Smallpox Vaccination Program Status by State, July 25, 2003. [Online] Available at http://www.cdc.gov/od/oc/media/spvaccin.htm. Accessed July 31, 2003. CDC. 2003m. CDC Telebriefing Transcript: Safer, Healthier Summer. [Online] Available at http://www.cdc.gov/od/oc/media/transcripts/t030626.htm. Accessed July 6, 2003. CDC. 2003n. Update: cardiac and other adverse events following civilian smallpox vaccination—United States, 2003. Morbidity and Mortality Weekly Report 52(27):639-642. CDC. 2003o. Smallpox Vaccination Information for Women Who Are Pregnant or Breastfeeding. [Online] Available at http://www.bt.cdc.gov/agent/smallpox/vaccination/pdf/preg-factsheet.pdf. Accessed July 17, 2003. CIDRAP (Center for Infectious Disease Research and Policy) News. 2002. Scope of Smallpox Vaccination Program Not Yet Decided, HHS Official Say. [Online] Available at http://www.cidrap.umn.edu/cidrap/content/bt/smallpox/news/pox2shots.html. Accessed August 1, 2003. Columbia University School of Nursing. 2003. Project Public Health Ready. [Online] Available at http://www.nursing.hs.columbia.edu/institute-centers/chphsr/phready.html. Accessed July 1, 2003. Committee on Smallpox Vaccination Program Implementation Study Staff. 2003. Unpublished. Conversations with Public Health Agencies About the Smallpox Vaccination Program and Smallpox Preparedness: Synthesis and Detailed Notes. Connolly C. 2003a, April 15. Smallpox Vaccine on Verge of Spoiling. Washington Post. Connolly C. 2003b, June 20. Panel Urges Caution on Smallpox Inoculation. Washington Post, A9. Cook R. 2003, April 5. Smallpox Planning Detracts from Core Public Health, Officials Say. Associated Press. Covert MH. 2001. Public Health System’s Capacity to Respond to Bioterrorism. Testimony on Behalf of AHA (American Hospital Association) Before the Subcommittee on Technology and Procurement Policy, Committee on Government Reform, U.S. House of Representatives on December 14, 2001. Das SK, Colfer HT, Pitt B. 1985. Long-term follow-up of patients with previous myocarditis using radionuclide ventriculography. Heart Vessels 1(Suppl.):195-198. Dec GW, Fuster V. 1994. Idiopathic dilated cardiomyopathy. New England Journal of Medicine 331(23):1564-1575. DiGiovanni C Jr., Reynolds B, Harwell R, Stonecipher EB, Burkle Jr. F. 2003. Community reaction to bioterrorism: prospective study of stimulated outbreak. Emerging Infectious Diseases 9(6):708-712. DoD (Department of Defense). 2003. Smallpox Information. [Online] Available at http://www.smallpox.army.mil/media/pdf/Smallpoxinfo.pdf. Accessed June 17, 2003. Drucker NA, Newburger JW. 1997. Viral myocarditis: diagnosis and management. Advances in Pediatrics 44:141-171. Edmond M. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Three on May 1, 2003 , Washington, DC:231-251. Elliott VS. 2002, April 22/29. Public Health Reporting Flaws Spell Trouble: Doctors Complain About Requirements That Appear to Lack Follow-Through. American Medical News. Elliott VS. 2003, February 24. Public Health’s Main Fear Over Bioterrorism: Surge Capacity. American Medical News. ENA (Emergency Nurses Association). 2003. Status: U.S. Smallpox Vaccination Program. ENA Washington Update. May 2003.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism English JF, Cundiff MY, Malone JD, Pfeiffer JA, Bell M, Steele L, Miller JM. 1999. Bioterrorism Readiness Plan: A Template for Healthcare Facilities. [Online] Available at http://www.ntis.gov/search/product.asp?ABBR=PB2002108954. Accessed July 7, 2003. Fock R, Bergmann H, Bussmann H, Fell G, Finke EJ, Koch U, Niedrig M, Peters M, Riedmann K, Scholz D, Wirtz A. 2002. Influenza pandemic: preparedness planning in Germany. Euro Surveillance 7(1):1-5. Fraser MR, Fisher VS. 2001. Elements of Effective Bioterrorism Preparedness: A Planning Primer for Local Public Health Agencies. Washington, DC: NACCHO. Frelinger JA, Garba ML. 2002. Responses to smallpox vaccine. New England Journal of Medicine 347(9):689-690. GAO (U.S. General Accounting Office). 2000. West Nile Virus Outbreak: Lessons for Public Health Preparedness. GAO/HEHS-00-180. Washington, DC: Health, Education, and Human Services Division. GAO. 2003. Bioterrorism: Preparedness Varied Across State and Local Jurisdiction. GAO-03-373. Washington, DC: Health, Education, and Human Services Division. Grabenstein JD. 2003. U.S. Military Smallpox Vaccination Program. Presented to the CDC Advisory Committee on Immunization Practices Meeting on June 18, 2003. 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. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting One on December 19, 2002, Washington, DC:284-291. Hayakawa M, Inoh T, Yokota Y, Kawanishi H, Kumaki T, Takarada A, Seo T, Fukuzaki H. 1984. A long-term follow-up study of acute myocarditis: an electrocardiographic and echocardiographic study. Japanese Circulation Journal 48(12):1362-1367. Heinrich J. 2001. Bioterrorism: Public Health and Medical Preparedness. Testimony on Behalf of GAO (United States General Accounting Office) Before the Subcommittee on Public Health, Committee on Health, Education, Labor, and Pensions, U.S. Senate on October 9, 2001. Henderson J. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Three on May 1, 2003, Washington, DC:54-82. Hiroe M, Sekiguchi M, Take M, Kusakabe K, Shigeta A, Hirosawa K. 1985. Long follow-up study in patients with prior myocarditis by radionuclide methods. Heart Vessels 1(Suppl.):199-203. Hupert N, Cuomo J, Callahan MA, Mushlin AL. 2003. Modeling Efficient Mass Vaccination Campaigns. Paper Presented June 26, 2003 at AcademyHealth’s Public Health Systems Research Meeting in Nashville, TN. IOM (Institute of Medicine). 2000. Ending Neglect: The Elimination of Tuberculosis in the United States. Washington, DC: National Academy Press. IOM. 2002. The Future of the Public’s Health in the 21st Century. Washington, DC: The National Academies Press. IOM. 2003a. Microbial Threats to Health: Emergence, Detection, and Response. Washington, DC: The National Academies Press. IOM. 2003b. Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation: Letter Report #1. Washington, DC: The National Academies Press. IOM. 2003c. Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation: Letter Report #2. Washington, DC: The National Academies Press.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism IOM. 2003d. Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation: Letter Report #3. Washington, DC: The National Academies Press. IOM and NRC (National Research Council). 1999. Chemical and Biological Terrorism: Research and Development to Improve Civilian Medical Response. Washington, DC: National Academy Press. Libbey PM. 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 on January 29, 2003. Madlock Y. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Three on May 1, 2003, Washington, DC:152-173. Manning A. 2002, October 16. Advisory Panel Expands Smallpox Vaccine Plan. USA Today. McNeil DG Jr. 2003, June 18. After the War: Biological Defenses; 2 Programs to Vaccinate for Smallpox Come to a Halt. New York Times, A13. Mitchell S. 2003, June 12. Monkeypox Shows Gap in Bioterror Readiness. United Press International. Mootrey G. 2003a. Adverse Events Following Smallpox Vaccination in Civilians. Presented to the IOM’s Committee on Smallpox Vaccination Program Implementation on May 1, 2003. Mootrey G. 2003b. Adverse Events (non-cardiac) Following Smallpox Vaccination in Civilians. Presented to the CDC Advisory Committee on Immunization Practices Meeting on June 18, 2003. Mootrey G. 2003c. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Three on May 1, 2003, Washington, DC:72-73. Mulinare J, Broder K, Cano M, Seward J. 2003. Preventing Inadvertent Exposure of Pregnant Women to Smallpox Vaccine. Presented to the CDC Advisory Committee on Immunization Practices Meeting on June 18, 2003. NACCHO (National Association of County and City Health Officials). 2001. West Nile Virus: Lessons Learned for State and Local Planning. [Online] Available at http://archive.naccho.org/documents/WestNileVirus.pdf. Accessed June 17, 2003. NACCHO. 2003a. Bt CREATE: A Customizable Bioterrorism Tabletop Exercise Builder. [Online] Available at http://www.naccho.org. NACCHO. 2003b. Impact of Smallpox Vaccination Program on Local Public Health Services. NACCHO Research Brief No. 9. Neergaard L. 2003, May 12. SARS Battle Strains U.S. Health System. The Kansas City Star. Neff J. 2003. Report for the Work Group on Smallpox Vaccine Safety. Presented to the CDC Advisory Committee on Immunization Practices Meeting on June 18, 2003. Nikolai K. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Three on May 1, 2003, Washington, DC:173-189. NVAC (National Vaccine Advisory Committee). 2003. Letter from NVAC Chairman to Acting Assistant Secretary for Health and Director, National Vaccine Program. [Online] Available at http://www.cdc.gov/od/nvpo/meetings/jun2003/letter.pdf. Accessed July 30, 2003. Peters KE, Drabant E, Elster AB, Tierney M, Hatcher B. 2001. Cooperative Actions for Health Program: Lessons Learned in Medicine and Public Health Collaboration. Chicago, IL: American Medical Association; and Washington, DC: American Public Health Association. Powers MJ, Ban J. 2002. Bioterrorism: threat and preparedness. The Bridge 32(1):29-33.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism 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. Salinsky E. 2002. Will the Nation Be Ready for the Next Bioterrorism Attack? Mending Gaps in the Public Health Infrastructure. NHPF Issue Brief No. 776. Selecky MC. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Three on May 1, 2003, Washington, DC:82-106. Slifka, M. 2003. Is There Still Immunity to Smallpox? [Online] Available at http://www.asm.org/Media/index.asp?bid=17304. Accessed June 26, 2003. Snowbeck C. 2003, July 4. Thousands of Smallpox Shots Unused. Pittsburgh Post-Gazette. Solet D. 2003, February 19. Smallpox Pre-vaccinations Misdirect Resources. Seattle Post-Intelligencer. Strikas R. 2002. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting One on December 19, 2002, Washington, DC:65-67. Strikas R. 2003. National Smallpox Vaccination Program Update. Presented to the CDC Advisory Committee on Immunization Practices Meeting on June 18, 2003. Teutsch SM, Churchill RE, eds. 1994. Principles and Practices of Public Health Surveillance. New York: Oxford University Press. Thacker SB, Stroup DF. 1994. Future directions for comprehensive public health surveillance and health information systems in the United States. American Journal of Epidemiology 140(5):383-397. Thompson T. 2003. Medical Reserve Corps (MRC): A Message from HHS Secretary Tommy G. Thompson. [Online] Available at http://www.medicalreservecorps.gov/. Accessed August 6, 2003. Turning Point Public Health Statute Modernizing Collaborative. 2003. The Turning Point National Excellence Collaboratives—Draft Document . [Online] Available at http://www.turningpointprogram.org/Pages/MSPHA013103.pdf. Accessed June 17, 2003. U.S. Congress. 2003. Smallpox Emergency Personnel Protection Act of 2003 (Public Law 108-20). [Online] Available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=108_cong_public_laws&docid=f:publ020.108.pdf. Accessed July 11, 2003. 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. LETTER REPORT #4, APPENDIX SUMMARY OF RECOMMENDATIONS: INTEGRATING SMALLPOX PREPAREDNESS INTO OVERALL PUBLIC HEALTH PREPAREDNESS A Standard for Smallpox Preparedness The committee recommends that CDC provide guidance to assist state public health agencies (and their partners,6 as appropriate) in establishing a baseline level or a minimum standard of preparedness for a smallpox at- 6   State partners may include, but not be limited to, emergency management agencies, law enforcement, fire and emergency medical services, hospital and other health care associations.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism tack, after which, each state could individually assess its priorities and further expand its preparedness against smallpox and other threats to the public’s health as needed. Preparing Key Responders The committee recommends that CDC support the establishment of state and/or local, and if appropriate, national, voluntary registries of individuals who have undergone vaccination to be mobilized, trained, and assigned as needed in the event of a smallpox attack. Such registries would include all willing vaccinated personnel not associated with a response team ranging from retired or relocated health care or public health workers to military reservists and former military personnel. Using Scenarios to Test Preparedness The committee recommends that CDC facilitate the development of a range of scenarios for potential smallpox attack(s), including one or more multithreat scenarios, and urge states to use these to expand and continuously improve their plans to respond to a wide range of possibilities. VACCINATION OF MEMBERS OF THE GENERAL PUBLIC WHO INSIST ON RECEIVING SMALLPOX VACCINE The committee recommends that CDC proceed with a deliberate and stepwise approach toward meeting the president’s policy of offering vaccine to members of the general public who insist on receiving it by: Conducting brief quantitative surveys to determine public interest and desire for smallpox vaccine. These surveys should include public and private health agencies as well as the general public, in order to understand the potential scope of public interest. Determining the budgetary and other requirements that would meet the demand noted. Identifying, monitoring, and referring people to existing or planned smallpox vaccine clinical research trials or other well-structured clinical arrangements that meet the basic requirements of medical and public health ethics, including assurances for safety of vaccinees and their contacts, acceptable balance between risk and benefit, and acceptable distribution of scarce public health resources to meet all preparedness as well as other public health goals. The committee encourages CDC to consider utilizing a pilot program or some other means of evaluating the initial experiences with this effort.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism SELECTED ASPECTS OF SMALLPOX VACCINATION PROGRAM IMPLEMENTATION Communicating About and Coordinating the Response to Adverse Events To help ensure that the adverse event reporting and follow-up procedures work as seamlessly as possible, the committee recommends that CDC coordinate better with their state partners and provide feedback to local partners who reported the adverse event. Streamlining Data Collection The committee recommends that CDC pursue ways to streamline the data systems that are used in the smallpox vaccination program, improving user-friendliness and integrating the multiple systems to avoid duplicate data entry, especially considering that any future expansion of the vaccination program would require a larger number and greater diversity of data system users, some of whom may be using these systems for the first time. Utility of the Active Surveillance System Because the civilian smallpox vaccination program is a true partnership between CDC, states, and local jurisdictions, the committee recommends that CDC continue and expand their communication with states and local jurisdictions about the imperativeness of their participation in the Active Surveillance System, stressing that the safety of the vaccination program cannot be guaranteed without their full participation and cooperation. Pregnancy Screening Considering that the rate of inadvertent exposure to smallpox vaccine during pregnancy is lower than expected and it is impossible to detect all pregnancies at the time of vaccination, the committee does not recommend extra pregnancy screening efforts at this time. Evaluation and Safety Studies The committee recommends that CDC begin developing a structured, prioritized research agenda that can aid decision-making as the smallpox preparedness program moves forward. The committee recommends that in the short term, studies of the serious adverse events should receive the highest priority. For safety-related

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism questions, in the longer term, studies examining long-term outcomes for those who experienced both serious and mild adverse events and studies of how mild adverse events contributed to lost work or social function should be a high priority. For system-related questions, in the longer term, studies of cost and opportunity costs should be a high priority.