Both the institute of medicine (IOM) and the Advisory Committee

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1 Smallpox Program The Federal Smallpox Vaccination Program: Where Do We Go From Here? The United States should take advantage of a pause in the program to assess its performance and prospects. by Daniel J. Kuhles and David M. Ackman ABSTRACT: Despite the underwhelming response to the federal government s initiative to inoculate health care workers against smallpox, the Bush administration has indicated that the program will continue and that it could be expanded to include other health care providers, emergency service workers, and others deemed essential for continuity of government. We discuss the reasons for the program s failure to date, outline recent advisories questioning the extent of the vaccination effort, and suggest suspension of further vaccination efforts until certain questions and issues are resolved. Both the institute of medicine (IOM) and the Advisory Committee on Immunization Practices (ACIP) recently issued recommendations for a pause in the federal government s smallpox vaccination program. 1 The government planned to initially vaccinate approximately 500,000 hospital and public health employees (phase I), who would serve on response teams capable of treating and investigating known or suspected cases of smallpox without risk of infecting themselves. After this initial effort, an additional ten million first responders (fire, police, emergency medical technicians) and health care workers would be vaccinated over a one-year period (phase II). In spite of efforts from the highest levels of government and public health leadership, only 38,000 health care and public health workers have agreed to be vaccinated to date. Nevertheless, the Centers for Disease Control and Prevention (CDC) has not retreated from its initial goals and will soon be releasing a strategy to reaffirm the importance of the smallpox program. 2 In response to the IOM recommendations, Jerome Hauer, head of public health preparedness at the U.S. Department of Health and Human Services (HHS), stated, We are not pausing the program. The IOM has its opinions. We certainly understand that. It doesn t mean that we follow them. 3 Other administration officials and advisers have also called for renewed efforts to reach the goal of vaccinating ten million people. 4 Given the debate over future smallpox vaccina- Daniel Kuhles (dkuhles@health.co.nassau.ny.us) is assistant director, Division of Disease Control, Nassau County Department of Health, in Mineola, New York. David Ackman is the county health commissioner. HEALTH AFFAIRS ~ Web Exclusive W3-503 DOI /hlthaff.W Project HOPE The People-to-People Health Foundation, Inc.

2 Public Health tions, it is important to review the recent experience, understand the reasons why the initial effort failed, and consider the wisdom of renewing efforts to revive phase I or to proceed with a wider vaccination strategy. Background On Vaccination Strategies The federal government has been concerned about U.S. vulnerability to bioterrorism since at least the early 1990s. 5 Immediately following the 11 September 2001 attacks and the subsequent dispersal of anthrax through the U.S. mail, the urgency of preparing for a bioterrorist attack (especially one employing smallpox) grew. To allow for an unimpeded response to such an attack, experts at the CDC and the ACIP initially proposed vaccinating 15,000 people. While presumably having the same intelligence assessments, many of our allies in the war on terrorism decided against vaccination entirely or chose to vaccinate only several hundred health care and public health workers. 6 Eventually the administration decided to attempt to vaccinate 500,000 people, which would provide for approximately 100 vaccinated health care workers at each of the nation s 5,000 hospitals. The rationale behind the plan to vaccinate another ten million people is less clear. Authorities might have been persuaded by mathematical models predicting that an attack using aerosolized agent would overwhelm containment efforts using ring vaccination strategies and result in thousands of deaths. Furthermore, under such a scenario, having a well-vaccinated police and emergency services force might combat the chaos or hysteria that would result from even a limited smallpox outbreak. Polls taken just prior to President George W. Bush s announcement showed that two-thirds of Americans were ready to be vaccinated. 7 Fire chiefs asked to be included in the decision-making process to vaccinate first responders. 8 Nevertheless, in contrast to the decision to vaccinate health care workers, the jump to ten million people was never explained in detail. The federal vaccination effort, led by the CDC, began in January 2003 with training of state and local health authorities. Because of the limited vaccine stock and concerns over liability, the CDC directed that vaccinations be given solely under the direction of public health departments. State departments of health were responsible for identifying the types of personnel eligible for vaccination and for oversight of the vaccine, while local health departments were responsible for educating and vaccinating hospital workers and their own staffs and for drawing up plans for mass vaccination of the entire population should smallpox reappear. Public health agencies generally accepted phase I, in that it would allow state and local governments to respond rapidly and effectively to the first cases, although several hospitals and prominent physicians questioned the plan. 9 Experience In Nassau County In Nassau County, New York, a large suburban community of 1.3 million people with thirteen hospitals, only forty-five people have been vaccinated. Our experi- W October 2003

3 Smallpox Program ence as a local health department suggests a number of reasons why health care and public health workers have declined to be vaccinated. The CDC s fear of adverse events, especially progressive vaccinia, eczema vaccinatum, and postvaccinial encephalitis, led to the development of an elaborate process of screening and informed consent. This entailed two separate screenings for contraindications, viewing a video explaining possible adverse effects, and signing an informed-consent form. The prevalence of contraindications, especially any history of skin conditions in the vaccinee or household members, immediately disqualified percent of health workers. 10 The ostensible purpose for this procedure was to exclude people at greatest risk of adverse reactions, but it also dissuaded a large number of people without contraindications who had initially expressed interest in being vaccinated. In the Nassau County Department of Health, of the ninety-five people asked to consider vaccination, forty-seven initially expressed interest, but only eleven were actually vaccinated. Although these numbers provide Nassau County with its own public health response team, it seems likely that the lengthy exposure to discussions and illustrations of severe vaccine reactions, and the possibility of infecting family members, simply dissuaded many workers. Experience Around The Country Adverse reactions. Many public health officials had expected more volunteers after the first group had been successfully vaccinated. However, just the opposite has occurred, and by the end of July 2003 the program was at a virtual standstill. In the U.S. military program, which has vaccinated more than 450,000 healthy people, the overall rate of adverse reactions is estimated at 32.0 per 100,000 doses. 11 Although lower than expected, this adverse reaction rate is higher than those of routine immunizations such as influenza (3.1 per 100,000) and measles, mumps, and rubella (MMR, 16.3 per 100,000). 12 Screening for contraindications has been effective in preventing cases of eczema vaccinatum and progressive vaccinia. Even so, workers clearly remain concerned about the risks of the vaccine. Fears may have been fed by weekly reports on the number of adverse reactions (as opposed to rates). 13 The CDC has catalogued more than 700 people adversely affected by the civilian program, including one case of postvaccinial encephalitis, three cases of generalized vaccinia, twenty-one cases of inadvertent autoinoculation, and twenty-two cases of myopericarditis. 14 The unexpected cases of postvaccination myopericarditis, angina, and myocardial infarctions led to the addition of certain cardiac risk factors to the list of contraindications and also could have diminished confidence in the CDC s ability to limit risk for vaccinees. 15 Inadequate compensation. Others might have refused to volunteer because of a perceived inadequacy of compensation coverage. Under the Homeland Security Act, people must demonstrate negligence in order to successfully recover compensation through the Federal Tort Claims Act. Injuries to vaccinees that result from the HEALTH AFFAIRS ~ Web Exclusive W3-505

4 Public Health The communicability and pathogenesis of smallpox give health officials a reasonable window to effectively prevent disease spread. vaccine itself are channeled through state workers compensation programs, whose coverage and adequacy vary widely. 16 In New York State the early confusion over compensation, and whether it would extend to family members, might have created the impression that the government wanted individuals to foot the bill for national bioterrorism preparedness. The federal government has attempted to address these concerns by strengthening coverage through a no-fault compensation fund. It remains to be seen whether this will address the concerns of potential vaccinees. Overblown risk of attack. Skepticism over the true risk of an attack might have biased others against vaccination. Smallpox is classified by the CDC as a category A bioterrorism agent. Such agents are easily disseminated or transmitted person to person, result in high mortality rates, may cause panic and public disruption, or require special actions for preparedness. 17 Despite the classification, the probability of a smallpox attack remains unknown. The administration s attempts to provide a balanced assessment of the risk and probability of biological terrorism have been problematic; this underscores the difficulty of risk communication for low-probability/high-impact health threats. 18 Statements were made to convey a sense of the catastrophic consequences of a release and presumably to provide a rationale for vaccination and accepting a small personal risk. 19 Yet at the same time, the federal government was offering messages of reassurance to the public. President Bush, in his December 2002 announcement, stated that there is no evidence that smallpox immediately threatens [the United States]. 20 Furthermore, the claims about the immediacy of the smallpox threat were made as the United States was making a case for war against Iraq. As of September 2003 none of the suspected biological or chemical weapons has been found, and the reliability of prewar intelligence reports has been questioned. 21 Post-exposure protection. It is also possible that potential vaccinees believed that opportunities for post-exposure vaccination provided sufficient protection to make vaccination unnecessary before an actual smallpox event occurs. Smallpox control plans rely heavily on the efficacy of post-exposure vaccination, and this information was available to hospital workers at the time they were considering vaccination. The result was that health care workers were either left confused and skeptical, or were reassured and declined vaccination. Emphasis On Preparedness The failure of phase I of the government s smallpox vaccination program makes the IOM s March 2003 report on the program even more important. Rather than specifying the number of vaccinees required locally or nationally, the report em- W October 2003

5 Smallpox Program phasizes the importance of preparedness as the overall goal. The IOM s analysis is summarized as follows: CDC s goals for the entire program (i.e. preparedness/capacity to respond, protection of those who will investigate and treat suspected cases, and gaining experience with vaccination) suggest that states may determine that once each local jurisdiction: (1) has ready access to both a public health and health care response team; (2) is capable of investigating an outbreak and caring for cases; and (3) is ready to rapidly and safely vaccinate anyone else necessary from additional health care workers to the general public it can conclude that it has completed precautionary smallpox vaccination of critical personnel, thus accomplishing one component of overall preparedness. 22 In its June 2003 statement, the ACIP also noted the need to view vaccination as just one part of overall bioterrorism preparedness and emphasized the need for additional training of both smallpox response teams and mass vaccination clinic staff, the development of laboratory capacity, and the need to conduct drills and exercises to test plans that have been developed. 23 The ACIP statement did not specify a target number of vaccinees for response teams, and the group never endorsed the ten-million-person target for first responders. Bill Foege, former director of the CDC, wrote that clinical suspicion leading to early identification of cases, followed by ring vaccination and eventually mass vaccination or prophylaxis (with a safer vaccine, it is hoped), were the essential safeguards against an attack using smallpox or any other viral or bacterial agent. 24 Early CDC guidance on bioterrorism preparedness highlighted the importance of surveillance, investigation, ring vaccination, and communication; this was also reflected in the grant deliverables given to health departments for bioterrorism preparedness. 25 Vaccinating another ten million people would not greatly reduce the work of local health departments in the event of mass vaccinations, nor would it necessarily increase the capabilities for local response. Protecting public-safety workers during the early phases of response would be possible by quickly vaccinating exposed workers, then those who might become exposed, and by providing personal protective equipment. Although it is prudent to plan and prepare for the worst case, the communicability and pathogenesis of smallpox give health officials a reasonable window to effectively prevent disease spread. 26 Consequences For Local Health Departments The plan s consequences for local health departments in both financial impact and public health preparedness have been largely absent from the national debate. Cost. The cost of phase II has been estimated at between $600 million and $1 billion. 27 If phase II goes forward, Nassau County will be expected to vaccinate approximately 45,000 people (0.46 percent of ten million first responders nationwide). We estimate that the personnel costs to perform these vaccinations will approach $460,000 for our county staff alone. Phase I was supported in part by the $1.08 billion allotted to states for general bioterrorism preparedness and public health infrastructure, but this grant, made before the announcement of the smallpox program, was intended to improve local infrastructure. Diverting funds to vaccination de- HEALTH AFFAIRS ~ Web Exclusive W3-507

6 Public Health The key message from potential vaccinees was that civilians are unlikely to voluntarily assume personal risk without good reason. feated this purpose in part. If the government expands its vaccination efforts, the $100 million dispensed for smallpox activities in fiscal year will be insufficient to cover local costs. Because many state and local governments face large budget deficits, proceeding to phase II would further redirect bioterrorism funding away from critical preparedness activities such as developing quarantine and isolation protocols, integrating surveillance and communication systems, logistical preparation for the Strategic National Stockpile, and recruiting and training volunteers for mass prophylaxis clinics. Dilution of other public health activities. Supporters of the government s bioterrorism plans have argued that the federal funding is dual use in nature and will strengthen the public health infrastructure. The activities undertaken and equipment purchased with bioterrorism funds will certainly allow for local health departments to better respond to emergencies. Yet the most severe problems in public health relate not to emergencies but to altering behavior with adverse health outcomes, such as smoking, risky sexual practices, physical inactivity, and poor diet. Like others in public health, we are concerned that the high levels of bioterrorism funding will siphon federal support from programs in these areas. 28 Lessons From The Vaccination Effort The current pause in the vaccination program provides the government with valuable time to learn from the experience of phase I. From a policy perspective, many of these lessons have been articulated by the IOM s fourth report on the vaccination program. 29 Two of these lessons deserve special emphasis. Key lessons. First, a defined minimum standard of preparedness is needed against which states and localities can measure themselves. Every jurisdiction does not require the same level of preparedness. The resources needed for a response to an attack in the metropolitan New York region are different from those needed in a rural area. Second, once the demand for vaccination is assessed, adequate fiscal and human resources should be provided. The economic situation in hospitals is akin to that in the public health sector. Institutions cannot afford to divert limited staff from revenue-generating activities without compensation. Our experience implementing the plan on a local level is also illustrative. The key message we received from potential vaccinees was that civilians are unlikely to voluntarily assume personal risk without good reason. Before performing an invasive procedure, physicians are required to undertake an informed-consent process with the patient, which spells out the indications, alternatives, and risks. The government owes its health care, public health, and first-responder communities the same consideration, particularly as it relates to the indications for vaccination, which thus far has been lacking. W October 2003

7 Smallpox Program Reasons the program should be suspended. Recent guidance from the CDC suggests that phase II will be left to the discretion of state and local authorities. 30 Unfortunately, allowing local discretion only increases the uncertainty over the need and role of pre-event vaccinations. Instead, the CDC should suspend phase II of the smallpox vaccination program for several reasons. First, it is unlikely that the next ten million people will be more willing to accept the vaccine than hospital and public health workers were. At least until we better understand the reasons for health workers reluctance and take action to address these concerns, delay is the only way to avert a second failed effort. Second, the federal government needs to better explain the risk posed by smallpox and reconcile the difference in approach between itself and other potential terrorist targets, such as Great Britain. Extensive pre-event vaccination might make sense if we face the type of attack played out in Dark Winter. 31 Third, much of the initial debate over the program was shaped by the concern that Iraq was developing weapons of mass destruction. While there is no way to know if the absence of any such weapons is indicative of a lower risk for the United States, the government should reexamine its initial analysis of the need for phase II. Fourth, labor-intensive vaccination efforts will divert resources from carrying out recommendations made by the IOM regarding other preparedness activities and improving the public health infrastructure. Fifth, given the media attention paid to controversies such as an association between MMR (a wellestablished vaccine) and autism, the public could attribute the risks associated with the current vaccine to a new, safer vaccine. Our experience, similar to that of thousands of communities across the nation, suggests that expansion of the smallpox vaccination program is likely to fail, even while the need for it is under substantial question. NOTES 1. Institute of Medicine, Review of the Centers for Disease Control and Prevention s Smallpox Vaccination Program Implementation, Letter Report no. 3 (Washington: National Academies Press, 2003). 2. C. Connolly, Focus on Smallpox Threat Revived; Experts Say Immunization Program Is Crucial to Homeland Security, Washington Post, 17 July M. Weinstock, Medical Experts Renew Call to Freeze Smallpox Vaccinations, GovExec.com, 27 May 2003, (28 May 2003). 4. Connolly, Focus on Smallpox Threat Revived. 5. J. Miller et al., Germs: Biological Weapons and America s Secret War (New York: Simon and Schuster, 2001), S. Ford, NHS Staff to Get Smallpox Vaccine, HealthyPages, 2 December 2002, news.asp?newsid=2455 (15 April 2003). 7. D. McNeil, Mixed Reactions to Inoculations but Doubts Raised, New York Times, 15 December International Association of Fire Chiefs, Fire Chiefs Guide to Smallpox Vaccination, 28 January 2003, org/downloads/smallpoxguide2003.pdf (19 September 2003). 9. J. Gettleman, Two Hospitals Refuse to Join Bush s Plan for Smallpox, New York Times, 19 December J. Bartlett et al, Smallpox Vaccination in 2003: Key Information for Clinicians, Clinical Infectious Diseases 36, no. 7 (2003): J.D. Grabenstein and W. Winkenwerder, U.S. Military Smallpox Vaccination Program Experience, Jour- HEALTH AFFAIRS ~ Web Exclusive W3-509

8 Public Health nal of the American Medical Association 289, no. 24 (2003): W. Zhou et al, Surveillance for Safety after Immunization: Vaccine Adverse Event Reporting System United States, , Morbidity and Mortality Weekly Report 52, no. SS-1 (2003): A rate is a measure of some event, disease, or condition in relation to a unit of population, along with some specification of time. 14. Centers for Disease Control and Prevention, Update: Adverse Events following Civilian Smallpox Vaccination United States, 2003, Morbidity and Mortality Weekly Report 52, no. 34 (2003): CDC, Supplemental Recommendations on Adverse Events following Smallpox Vaccine in the Pre-Event Vaccination Program: Recommendations of the Advisory Committee on Immunization Practices, Morbidity and Mortality Weekly Report 52, no. 13 (2003): National Association of City and County Health Officials, National Public Health Associations Urge Legislative Action to Protect Smallpox Vaccine Volunteers, Press Release, 7 March 2003, press66.cfm (15 May 2003). 17. CDC, Biological and Chemical Terrorism: Strategic Plan for Preparedness and Response: Recommendations of the CDC Strategic Planning Workgroup, Morbidity and Mortality Weekly Report 49, no. RR-4 (2000): M.G. Morgan, Risk Analysis and Management, Scientific American 269, no. 1 (1993): 32 35, D.A. Henderson, CDC Telebriefing Transcript: HHS Teleconference on Smallpox Policy, 14 December 2002, (16 May 2003). 20. G.W. Bush, President Delivers Remarks on Smallpox, Press Release/Transcript, 13 December 2002, (10 April 2003). 21. D. Jehl and J. Miller, The Struggle for Iraq: The Weapons; Draft Report Said to Cite No Success in Iraq Arms Hunt, New York Times, 24 September IOM, Review of the Centers for Disease Control and Prevention s Smallpox Vaccination Program Implementation. 23. Advisory Committee on Immunization Practices, Statement on Smallpox Preparedness and Vaccination, 18 June 2003, (1 August 2003). 24. W. Foege, Can Smallpox Be as Simple as 1 2 3? Washington Post, 29 December CDC, Continuation Guidance for Cooperative Agreement on Public Health Preparedness and Response for Bioterrorism Budget Year Four, 2 May 2003, index.asp (19 May 2003). 26. K.A. Sepkowitz, How Contagious Is Vaccinia? New England Journal of Medicine 348, no. 5 (2003): R. Pilch, Smallpox: Threat, Vaccine, and U.S. Policy, 10 March 2003, cns.miis.edu/pubs/week/pdf/ smallpox.pdf (10 April 2003). 28. L.K. Altman and A. O Connor, Health Officials Fear Local Impact of Smallpox Plan, New York Times, 5 January IOM, Review of the Centers for Disease Control and Prevention s Smallpox Vaccination Program Implementation, Letter Report no. 4 (Washington: National Academies Press, 2003). 30. Weinstock, Medical Experts Renew Call. 31. Dark Winter was a fictional exercise conducted in June 2001 by the Johns Hopkins Center for Civilian Biodefense Strategies, which portrayed a smallpox attack on the United States. Lessons from the exercise included the following: (1) Leaders are unfamiliar with the potential consequences of an attack; (2) policy decisions would be dependent upon the knowledge of public health leaders; and (3) the lack of vaccine limited response options. W October 2003