Smallpox Vaccination: Implementation of National Program Faces Challenges
Released: 2003-04-30T00:00:00

Letter

Background

Since the terrorist attacks of September 11, 2001, and the subsequent anthrax cases, there has been heightened public awareness and fear of potential bioterrorist attacks, including an attack involving smallpox. Smallpox is a contagious disease whose symptoms include fever and a distinctive progressive skin rash. It is fatal in about 30 percent of cases and is considered by CDC to be one of the six biological agents that pose the greatest potential threat for adverse public health impact and have a moderate to high potential for large-scale dissemination. There is no specific treatment for smallpox, but according to CDC it can be prevented or its course can be significantly modified in most people through vaccination within 3 days of exposure, and vaccination 4 to 7 days after exposure will probably offer some protection or may lessen the severity of the symptoms.

Role of Vaccination in Public Health

The successful use of mass vaccinations to control deadly and debilitating diseases worldwide is one of the great public health achievements of the past century. Routine immunization programs have been built around safe and effective vaccines targeted at smallpox, poliomyelitis, measles, rubella, tetanus, diphtheria, influenza, and other infectious diseases. Although vaccination programs have provided great benefits, they also carry some risk. Most vaccines, like most medications, have a very small rate of severe adverse reactions.

Smallpox Vaccination

Public vaccination for smallpox began in the United States in the early 1800s, when Massachusetts began to require smallpox vaccinations for its residents. By the late 1800s, smallpox was coming under control in the United States as the practice of vaccination became more routine. By the 1960s, experience had shown that for every 1 million people vaccinated for the first time, between 14 and 52 could experience serious and potentially life-threatening adverse events and 1 to 2 could die. But these risks were deemed acceptable to control this contagious and often fatal disease. By 1972 the risk of smallpox in the United States was sufficiently remote that routine vaccinations were discontinued, 8 years before WHO’s announcement that the disease had been eradicated worldwide.

Immunity to the virus that causes smallpox—the variola virus—is conferred through inoculation with a vaccine made from the closely related vaccinia virus. The smallpox vaccine does not contain the variola virus and cannot cause smallpox. The smallpox vaccine is a “live virus” vaccine; that is, the vaccinia virus it contains is living and may produce mild reactions, including rash, fever, and head and body aches. In certain groups of people, including those with compromised immune systems and certain skin conditions such as eczema, adverse events associated with the vaccine can be severe. Because the virus is live, it can be transmitted to other parts of the body or to other people, who could also face potentially serious complications, and so care has to be taken to minimize the risk of spreading the vaccinia virus from the vaccination site. Previous experience with the vaccine has shown that it spreads to other parts of the vaccinee’s body at a rate of 25 to 532 per million individuals vaccinated and spreads from the vaccinee to others at a rate of 20 to 60 per million.

The National Smallpox Vaccination Program

The National Smallpox Vaccination Program is unique in the history of civilian immunization programs in that it is not a public health program in the traditional sense but rather a program of bioterrorism preparedness. The population to be vaccinated in the first and second stages of the civilian part of the program is not the general public as in traditional programs, but key public health, health care, and emergency response workers. Smallpox Response Teams vaccinated in the first stage would receive vaccine not solely to protect their own health but primarily to increase the nation’s capacity to respond to a smallpox attack by investigating an outbreak, caring for patients, and vaccinating members of the public who may have been exposed. Because vaccination soon after exposure can prevent or reduce the severity of the disease, planners project that there will be sufficient time for these key workers to vaccinate members of the public as needed to contain a smallpox outbreak after it has been recognized.

CDC’s guidance allows the 62 jurisdictions some flexibility in forming their Smallpox Response Teams. For example, it provides recommendations for the types of workers to be included in the two types of Smallpox Response Teams—the Public Health Smallpox Response Teams and the Healthcare Smallpox Response Teams—but leaves the numbers of workers and exact composition of teams to the jurisdictions to decide on the basis of their particular needs. For the public health teams, which are based at state and local public health agencies, the guidance states that each team should have a medical expert as team leader and should include public health advisors, medical epidemiologists, disease investigators, laboratory workers, nurses, and vaccinators. For the health care teams, which are based at hospitals, the criteria for choosing which health care workers to include are to be developed locally. Each jurisdiction was to have formed at least one public health team and as many other public health and health care teams as it deemed necessary by 30 days from the announced start date of vaccination. The jurisdictions’ plans vary widely in terms of the time line for the first stage of vaccination and their targets for the numbers of teams and workers to be vaccinated (see table 1). The jurisdictions with CDC-approved plans proposed to vaccinate 1,101 public health teams and 4,532 health care teams, for a total of 415,691 vaccinated volunteers nationwide. Although CDC had called for the first stage of vaccinations to be completed in 30 days, many jurisdictions expected vaccinations to take longer than that to complete.

CDC has said that safety is the top priority in implementing this program. To enable jurisdictions to implement this program in the safest manner possible, the agency has provided guidance and materials for critical elements of the program, including education and training of health workers who will be administering the education and screening of volunteers to rule out those who may be at greater risk for severe reactions; care of the site of vaccination on the vaccinee’s body to prevent secondary infection or transmission to others; monitoring of adverse events; distribution of the two investigational drugs used in treating certain adverse reactions caused by the vaccine, vaccinia immune globulin (VIG) and cidofovir; and systems for ongoing collection, management, and analysis of program data—including adverse events, transmissions of the vaccinia virus to individuals the vaccinee was in contact with following the vaccination (or “secondary transmission”), requests for VIG or cidofovir, needlestick injuries to vaccinators, and vaccine wastage—to evaluate the program and make adjustments as necessary.

In addition, CDC is sponsoring an advisory group, the IOM Committee on Smallpox Vaccination Program Implementation, to provide advice to program officials at CDC on selected aspects of program implementation, including guidelines and instruments for screening; measures to ensure the early recognition, evaluation, and appropriate treatment of adverse events; plans for collecting and analyzing data; and the achievement of overall goals of the smallpox vaccination program. This committee has issued two of a planned series of reports.

Originally, the program had no provisions to compensate anyone for lost time from work, health care costs, disability, or death due to adverse events. Instead, it was expected that workers would be covered by existing mechanisms such as workers’ compensation and insurance.

Initial Federal Funding for the Smallpox Vaccination Program

The initial federal funding for the smallpox vaccination program came from CDC’s bioterrorism preparedness funding. Since fiscal year 1999, HHS has distributed funding for bioterrorism preparedness to state and local health departments in the 62 jurisdictions primarily through CDC’s Bioterrorism Preparedness and Response Program. In January 2002, HHS announced the availability of supplemental funding through the CDC program and a Health Resources and Services Administration (HRSA) program. Under the CDC program, $918 million in supplemental funding was made available to jurisdictions for general bioterrorism preparedness. HHS required jurisdictions to submit their applications for these funds by April 15, 2002. Each jurisdiction was to develop a plan during 2002 to improve general bioterrorism preparedness within six categories: preparedness planning and readiness assessment, surveillance and epidemiology capacity, laboratory capacity for biological agents, communications and information technology, risk communication and health information dissemination, and education and training. At the same time, under the Bioterrorism Hospital Preparedness Program, HRSA made $125 million available through cooperative agreements to the jurisdictions to enhance the capacity of hospitals and associated health care entities to respond to bioterrorist attacks, as well as other public health emergencies.

In March 2002, CDC announced the extension of its Bioterrorism Preparedness and Response Program through August 2005, without indicating whether additional funds would be available. On November 22, 2002, CDC notified the jurisdictions that they were to plan and implement the National Smallpox Vaccination Program by utilizing and redirecting the monies previously disbursed under the Bioterrorism Preparedness and Response Program. These plans for the first stage of smallpox vaccination were due to CDC on December 9, 2002.

Implementation Is Slower Than CDC Planned

Implementation of the smallpox vaccination program has proceeded more slowly than CDC planned. Because of the slow pace, not enough data have been generated to determine whether implementation is proceeding as safely as possible according to the program’s goal.

Specifically, vaccination of health workers in the first stage has proceeded slowly. CDC’s initial target date for completion of the first stage has passed. As of the start date for vaccination, January 24, 2003, most of the jurisdictions were not ready to begin vaccinating: More than half of the jurisdictions had not yet requested vaccine from CDC, and most of the remaining jurisdictions had requested that their vaccine not be shipped until after the start date. (See table 2.) On the first day, four health care workers in one jurisdiction—Connecticut—were vaccinated. As many jurisdictions had projected in their individual plans, the vaccination of health workers in the first stage of the program is taking longer than the 30 days set by CDC as an initial target. By the end of the tenth week, April 4, 2003, 7 jurisdictions had yet to request vaccine, but the rest had requested and received their shipments. Although CDC reported that a total of 31,297 health workers (about 6 percent of the initial target) had been vaccinated in 54 of the 62 jurisdictions by week 10, about half of those vaccinated were distributed across eight states: Florida, Minnesota, Missouri, Nebraska, North Carolina, Ohio, Tennessee, and Texas. Sixty-two percent of those vaccinated were Healthcare Smallpox Response Team members, and 33 percent were Public Health Smallpox Response Team members; the remaining 4 percent were “other,” which includes public officials who are not part of a Smallpox Response Team. As of late April, CDC did not have information about the number of complete response teams formed. As of week 10, CDC reported that roughly one-third of an estimated 5,000 acute care hospitals in the jurisdictions began vaccinations. Almost half of these hospitals are in seven jurisdictions: Florida, Louisiana, Missouri, Nebraska, Ohio, Tennessee, and Texas.

Because progress has been slow, to date there are not enough data to precisely gauge indicators of the safety of implementation. For example, too few health care workers have been vaccinated and too little time has passed since their vaccination to precisely estimate rates of adverse events. Therefore it cannot yet be determined whether the rates are the same as would have been anticipated on the basis of historical data or different enough to trigger reconsideration of how the program should proceed. As of April 4, 2003, CDC had received reports of 68 moderate to severe adverse events and 250 less severe adverse events, such as fever and rash, potentially related to smallpox vaccination. In addition, CDC had received reports that two volunteers who had been vaccinated died of heart attack, but CDC has not yet determined whether the deaths were related to the smallpox vaccine. CDC officials maintain that the low number of severe adverse events associated historically with smallpox vaccination strongly suggests that screening efforts and measures to prevent transmission of vaccinia virus to contacts have been effective. However, the experience of more vaccinees would have to be examined in order to derive precise rates of how often the rare but most severe adverse events occur. Further, because more than half of the individuals were vaccinated during weeks 6 through 10, some of the adverse events that can occur weeks after vaccination would not yet have been detected. Moreover, not all planned vaccination monitoring systems were in place until more than 3 weeks after vaccination began, and some jurisdictions report ongoing difficulties in using the systems required by CDC. Therefore some of the experience to date may not have been captured by these systems.

The data obtained as of week 10 are also insufficient to answer other important safety questions. For example, although CDC had reported no needlestick injuries as of late April, too few vaccinations have been given to precisely estimate the rate of such injuries. Similarly, there are not enough data to evaluate the effectiveness of the screening process, the effectiveness of measures to prevent the spread of vaccinia virus, the safety and effectiveness of VIG and cidofovir, and the effectiveness of CDC’s distribution system for these investigational drugs.

Major Challenges Are Program Schedule and Hesitancy on Part of the Two Main Groups Involved in Program

Implementation of the smallpox vaccination program is facing two major challenges. One is the program schedule, and the other is hesitancy on the part of the two main groups involved in the program—those needed to implement it and those needed to volunteer to be vaccinated. Although these two groups have generally expressed support for the goals of the program, they have concerns regarding the availability of resources to implement the program, liability protection, safety, and workers’ compensation.

Program Schedule Has Challenged CDC and the Jurisdictions

The program schedule is challenging and has placed heavy demands on CDC and the jurisdictions (see table 3). CDC has developed a wide range of implementation materials, which it has distributed through multiple channels. These materials include guidance documents and educational and training programs. The effort to produce materials quickly has led to difficulties. Some of the materials that were distributed needed to be revised, and some were inconsistent or untested. Some key materials were not available until after the start of vaccination. For example, the package of materials to be used to obtain informed consent for vaccination from volunteers was first made available 8 days before the start of vaccination, and the revised version was issued the day before vaccination was to start. The delayed availability of these materials created difficulties for those trying to implement the program. In addition, CDC has provided conflicting information about the precise method for administering the vaccine. Further, the materials used to educate and screen volunteers were not tested for comprehensibility to ensure that the screening process would function as intended. Moreover, while CDC provided preliminary guidance for adverse event monitoring in November, it hosted training on this issue 2 days before the program began and did not issue detailed guidance about the adverse event monitoring system until 2 weeks after vaccination had begun.

The program schedule has pressured the advisory process that CDC has set up through IOM to help ensure that the program achieves its goals safely, and the advisory committee has been concerned that the schedule might not allow for a thorough evaluation of the program. Little time was available for IOM’s Committee on Smallpox Vaccination Program Implementation to undertake its first review and for CDC to respond to the committee’s first report, which was issued 8 days before the start of the vaccination effort. Consequently, many of the IOM recommendations that relate to ensuring the safety of the program and facilitating implementation had not been addressed at the start of vaccination. For example, the IOM committee recommended that the materials to be used to screen volunteers be pretested for comprehensibility before vaccination started, but CDC responded that the schedule of the program precluded such testing and initiated vaccination with the untested screening materials. To ensure that the program proceeds safely, IOM also called for a thorough evaluation by IOM and others following the first stage, prior to beginning the second stage, as one of its key recommendations. CDC has said that because of the need to implement the program rapidly there is no distinction between the first and second stages and it does not expect to identify a formal end to the first stage. Instead, CDC expects that evaluation will be ongoing. In its second report, IOM reiterated its concern that a too rapid expansion of the program could preclude the opportunity to learn from the first stage before proceeding, and it again urged CDC to comprehensively evaluate the smallpox vaccination program and its outcomes in order to improve its implementation and to protect the vaccinees and the public.

The program schedule has also placed heavy demands on the jurisdictions. CDC required the jurisdictions to develop plans and targets for the first stage of vaccination in less than 3 weeks. It provided some guidance on the types of workers to be vaccinated on each type of team, but no guidance for estimating the number of workers on teams or the number and distribution of teams within a jurisdiction needed to provide sufficient smallpox response capacity. CDC expected the jurisdictions to be ready to begin vaccinating less than 2 months after it approved their plans. The jurisdictions are dependent on the guidance, educational and training programs, and other materials produced by CDC, but these materials have been changing since the program started. In accord with IOM’s recommendation, some jurisdictions have also indicated that they would benefit from an evaluation of the first stage of the program before proceeding to the second. CDC has indicated that the jurisdictions are to proceed to the second stage as they determine they are ready to do so. However, CDC has not provided guidance to help them plan and implement the second stage of the program.

Implementers and Organizations That Represent Them Are Hesitating to Participate Because of Concerns about Adequacy of Resources and Liability Protection

The smallpox vaccination program is to be implemented in the jurisdictions by state and local public health authorities and individual hospitals. But these implementers are hesitating to participate in the program because of concerns about adequacy of resources and liability protection.

State and local health officials have stated that they are committed to the safe and timely implementation of the smallpox vaccination program; however, some have expressed concerns about the availability of resources to implement this program. CDC initially provided no cost estimates, but in testimony given in late January the Director estimated the basic cost of administering the vaccine at $13 per vaccinee. State and local health officials assert that CDC has underestimated the cost of planning and implementing the program. According to recent ASTHO and NACCHO surveys, estimates of the cost of the whole first-stage vaccination process—from planning through follow-up—range from $79 to $1,784 per vaccinee. ASTHO and NACCHO estimate that the average cost per vaccinee is $265 and $204, respectively. CDC expects jurisdictions to redirect funds made available through bioterrorism cooperative agreements to pay for the smallpox vaccination program. However, state and local health officials report that as of March 2003 most of these funds were already committed to other bioterrorism activities; on average only 7 percent of these funds remain available. Thus in order to meet the demands of the smallpox vaccination program, they would need to divert funds supporting other bioterrorism preparedness efforts and other public health services. According to a recent NACCHO survey, about 79 percent of local public health agency respondents reported that smallpox work is adversely affecting their other bioterrorism preparedness efforts. About 53 percent reported that resources for other public health services such as childhood immunization have been diverted to smallpox and other bioterrorism efforts. ASTHO and some of the jurisdictions have told us that although they are working to manage the first stage of smallpox vaccination by diverting resources from other efforts, they anticipate that it will be difficult if not impossible to find resources to implement the second stage.

Organizations representing hospitals have indicated that hospitals are generally committed to participating in the program, but many have concerns about inadequate resources and about the balance between the risks and benefits of vaccination. Hospitals are concerned that they may have to assume the costs of implementing the program and note that they lack adequate resources to do so. Hospitals include in their cost calculations staff time to receive, administer, and follow up on vaccinations; materials (e.g., forms) and supplies (e.g., bandages); treatment for adverse events; and sick leave. Hospitals contend that the $125 million previously provided by HRSA to states for use on the creation of regional hospital response plans has proved insufficient for that purpose and cannot cover the additional costs of the smallpox vaccination program. However, resources are not the primary concern for all hospitals. Hundreds of hospitals have opted not to participate in the smallpox vaccination program at this time, contending that the risks outweigh the benefits. Because the administration has characterized the threat of a smallpox attack as being low, some hospitals estimate that the countervailing risks to their patients of vaccinating hospital staff are too great. These hospitals have indicated that they would reconsider their decisions regarding participation should the risk of an attack increase or cases of smallpox appear.

State and local health officials and hospital representatives are also concerned about the scope of liability protection provided by the Homeland Security Act of 2002 and have requested clarification. These officials are requesting amendments to the act that would provide explicit liability protection to vaccination program participants not specifically protected by the act, such as public health departments and public health workers. In addition, since the act provides no apparent protection for entities that do not participate in the smallpox vaccination program, hospital representatives are concerned that a nonparticipating hospital, for example, may not be protected if one of its health care workers who was vaccinated elsewhere transmits vaccinia virus to one of its patients.

Volunteers and Organizations That Represent Them Are Primarily Concerned about Safety and Compensation for Injury

Many of the organizations that represent the public health and health care workers who are needed to volunteer to be vaccinated have expressed their willingness to participate in the smallpox vaccination program. However, they have concerns about the possibility of experiencing adverse reactions to the vaccine, ranging from fatigue to death, and the possibility of transmitting the vaccinia virus to coworkers, family members, or patients who could also face mild to severe complications. They also have concerns about compensation for such injuries.

Volunteers are concerned about the adequacy of CDC’s screening process for ruling out volunteers with conditions that may put them at greater risk for severe reactions. For example, CDC recommends screening volunteers for pregnancy or HIV, either of which can put a volunteer at greater risk. However, volunteers do not believe they should have to undertake the effort and expense to independently be tested for these conditions. The provision of free testing for these risk factors as part of the screening process is left to the discretion of the individual participating jurisdictions and institutions. Volunteers are concerned that the lack of free, routine testing could hinder identification of potential vaccinees who may not be aware that they are pregnant or have HIV.

Volunteers who work in hospitals are concerned about the possibility of transmission of vaccinia virus to their patients. CDC asserts that following optimal infection control practices, such as using special bandages and checking them daily, wearing clothing that covers the vaccination site, and hand washing, should essentially eliminate the risk of vaccinated health care workers transmitting vaccinia virus to patients. Therefore, CDC guidance does not require that vaccinated workers be kept separate from patients until they can no longer transmit vaccinia virus. Volunteers are uncertain whether the practices that CDC recommends will be sufficient. Moreover, it is left to the individual participating jurisdictions and hospitals to determine whether any leave taken to avoid contact with patients will be paid for by the institution or the health care worker. Thus, workers are concerned that they may lose income if they choose or are required to be kept separate from patients.

Nursing associations and unions representing health care workers are concerned about the two-pronged needle that CDC provides for use with the smallpox vaccine, noting that it lacks safety features such as a protective sheath available with other needles. Health care workers assert that the needles being used in the program may increase the risk of needlesticks and exposure to the blood of vaccinees, both for those administering the vaccine and for those along the path of needle disposal. They have recommended that an alternative needle with safety features be used instead. CDC has stated that it does not provide these alternative needles because it has determined that no commercially available safety- engineered two-pronged needle is an appropriate replacement for the one included in the prepackaged kit it is distributing for the smallpox vaccination program.

Many of the organizations representing health care workers have expressed support for the goal of the program. However, in the literature some individual physicians have questioned the program and raised concerns that the risks of smallpox vaccination to workers, their families, and patients may outweigh the benefits to society of preparedness for a smallpox attack. Like some hospital administrators, these physicians are recommending against vaccination at this time because program officials have characterized the risk of an attack with smallpox as very low and because there is a window in which vaccination is effective even after exposure. They too have indicated that they would reconsider their decision should the risk of smallpox increase.

The decision that health care workers face about whether to be vaccinated is further complicated by potentially confusing educational and screening materials for volunteers. For example, some CDC materials specifically mention that certain asthma patients who are taking immune-suppressing drugs should be excluded. Other CDC materials screen out asthma patients for different reasons, and still others do not mention asthma patients at all. The differences in these materials may create confusion for individuals with asthma who are trying to determine if they should be excluded from vaccination. Also, because each jurisdiction can tailor some of the guidance and materials provided by CDC according to its own judgment, health care workers who live and work in separate jurisdictions could receive inconsistent materials. For example, CDC does not recommend against vaccinating individuals with an infant at home, but some jurisdictions have decided to exclude such volunteers from vaccination because of the seriousness of vaccinia virus in infants.

Organizations representing health workers are further concerned about whether the costs to volunteers and their families would be covered should they experience an adverse event and require time off from work, need medical treatment, become disabled, or die. HHS officials have stated that they expect costs due to adverse events to be covered by sick leave, workers’ compensation, or individual, institutional, or jurisdictional insurance policies. However, sick leave benefits vary from institution to institution, and thus some workers may lose income. Health care coverage also varies by institution and by policy, and thus not all volunteers are guaranteed to have coverage for the costs of treating their adverse reactions. For example, sick volunteers may have to pay co-payments for medical care. In addition, ASTHO has surveyed states and found wide variation in workers’ compensation programs. Some states anticipate that vaccinated volunteers will be covered under their workers’ compensation programs. However, given that workers’ compensation eligibility is determined on a case-by-case basis, many states refrain from generalizing about such coverage. Even when applicable, workers’ compensation may provide only a percentage of salary and may not provide coverage for individuals who received vaccinia virus from a vaccinated volunteer.

Major Challenges Have Not Been Overcome and Continue to Affect Implementation

CDC and HHS have been working to address the major challenges of program schedule and hesitancy of participants, but to date they have not been able to overcome them. With regard to the challenging program schedule, CDC has reconsidered whether the initial targets for time for completion and the total number of vaccinated health care workers are required to achieve the goal of preparedness. Although CDC has said that it expected the first stage to take more than 30 days, it has not set a new target for completion of the first stage. The Director of CDC has stated, however, that it may not be necessary to vaccinate 500,000 health care workers to achieve the goal of preparedness. She has indicated that as few as 50,000 would suffice but has not explained how CDC arrived at that number. CDC has not said how these workers should be organized and distributed within the Smallpox Response Teams and across the nation. As of late April, CDC had yet to set new targets for the first stage or to request that the jurisdictions reconsider their plans to meet new targets. Most of the jurisdictions have initiated the first stage of vaccination as they had originally planned, although many have started later and have vaccinated fewer workers than they anticipated. Some jurisdictions have indicated that they are attempting to follow their original plans while awaiting resolution of the liability and compensation issues, and others have said that they have begun to revise their targets downward for the first stage without waiting for a request from CDC.

CDC has not said what the implications of this potential change in targets for the first stage would be for the second stage. In addition, although CDC announced that it would provide guidance for and request plans from the jurisdictions for the second stage, it has not done so. Thus the jurisdictions cannot determine how the workers to be vaccinated in the second stage will be used to expand response capacity. Specifically, they do not have guidance for how they should estimate their targets for the types, number, and distribution of the additional workers to be vaccinated.

CDC and HHS have made some progress in addressing the two major concerns regarding resources and liability that are contributing to the hesitancy of the implementers to participate in the program. CDC has indicated that it is developing cost estimates and working to identify additional resources to support implementation. In late March, HHS announced that jurisdictions would be allowed to obtain up to 20 percent of their 2003 federal bioterrorism preparedness funding immediately upon approval of their application by CDC. One of the activities that this funding may be requested for is smallpox vaccination. As of late April, the application procedure for obtaining these funds had not been specified. With regard to the liability concerns, CDC officials reported that they have worked with HHS to clarify the scope of the protection provided by the Homeland Security Act of 2002. HHS issued a letter and a declaration from the Secretary, and CDC published guidance and question-and-answer documents. Nonetheless, implementers continue to have questions and say they would prefer changes in the act itself to be assured of liability protection.

In addition, Congress has taken steps to address implementers’ concerns about resources. On April 16, 2003, legislation was enacted appropriating $100 million to the Public Health and Social Services Emergency Fund intended to support implementation of the smallpox vaccination program. However, because CDC still has not estimated costs, it is unclear whether these funds will be sufficient to address the resource concerns of the implementers. Furthermore, details on how funds will be made available to jurisdictions have yet to be outlined.

Although CDC is working to address the volunteers’ safety concerns that are leading to their hesitancy to participate, some concerns have not been resolved to the volunteers’ satisfaction. CDC has decided not to change its guidance on several safety issues important to volunteers but has agreed to study some of these issues further. For example, it has not changed its recommendation that health care workers do not need to be routinely separated from patients while they are capable of transmitting vaccinia virus because it maintains that if the recommended safety measures, such as special bandaging, are followed they will provide sufficient protection. Further, CDC said that in making its decision about whether to change the needles provided with the vaccine kits, it reviewed an HHS evaluation of the alternative needle and concluded it was not safer. It does not intend to change the needles at this time, but it does intend to study the issue further and in the meantime to monitor unintentional needlesticks. Finally, CDC has not changed its recommendations regarding the provision of testing for pregnancy and HIV as part of the screening process. Thus, it is still at the discretion of jurisdictions to provide such testing routinely and free of charge. CDC plans to maintain a registry of pregnant women who may have been exposed to smallpox vaccine. Volunteers are, however, still concerned about these safety issues.

Congress has taken steps to address volunteers’ compensation concerns. On April 24, 2003, it presented legislation to the President for his signature to create a smallpox vaccination compensation program. This program would provide benefits to public health and health care response team members participating in a smallpox emergency response plan and public safety personnel who are injured as a result of receiving the smallpox vaccine. Organizations representing public health and health care workers have reacted positively to the new legislation. Other legislation that addresses challenges facing the smallpox vaccination program in addition to compensation, such as the safety concerns raised by volunteers, has been introduced in the House of Representatives.

Conclusions

We recognize that CDC and the jurisdictions have been trying to mount a large effort in a short time. The National Smallpox Vaccination Program is unprecedented and complex. Our public health system has not had experience with either smallpox or smallpox vaccination in over 30 years. Further, the context for the program is one of great uncertainty about both the risk of a smallpox attack and the individual health risks involved in vaccination.

As might be expected with such a complex program, challenges have been encountered. Implementers and volunteers have indicated that they are unlikely to participate in the smallpox vaccination program in the numbers needed to achieve the initial targets unless their major concerns have been addressed. Because many concerns remain unresolved, it may be difficult to achieve the initial targets for the first stage. It is also too soon to evaluate the impact on participation in the program of steps that have been taken to provide additional resources and compensation for injuries.

However, CDC and some of the jurisdictions have indicated that as the program unfolds and they learn more, they are less concerned about achieving their initial targets and are considering revising them. However, if the estimates are reduced for the numbers and types of vaccinated health workers in Smallpox Response Teams, CDC would need to provide guidance to ensure that smaller or fewer teams are organized and distributed in a manner that will provide adequate response capacity—that is, the capacity to effectively investigate an outbreak, care for patients, and vaccinate members of the public. Setting revised targets for the total number of vaccinations necessary would also provide a basis for more accurately estimating what is needed to address the major concerns of implementers and volunteers regarding resources, liability, and compensation for adverse events.

A change in targets for the first stage would likely have implications for the second stage. CDC has not provided guidance for determining how the workers to be vaccinated in the second stage will be used to expand response capacity. Thus it may be difficult for the jurisdictions to estimate targets and plan implementation of the second stage.

With regard to the top priority for implementation—safety—the important questions cannot yet be answered. To answer these questions and ensure that program implementation proceeds through the first stage as safely as possible, CDC and the jurisdictions need to collect and analyze data on an ongoing basis. To date, not enough data have been collected to provide the needed information. Answers to these questions are also important for ensuring safe expansion to as many as 10 million additional volunteers in the second stage of the program.

Recommendations

To ensure that the National Smallpox Vaccination Program successfully develops adequate response capacity for a potential terrorist attack involving smallpox, we recommend that the Director of CDC provide guidance and specific parameters to the jurisdictions for estimating response capacity needs and work with the jurisdictions to revise local and national targets for the first stage and provide guidance to the jurisdictions for implementing the second stage of the program.

Agency Comments

In its comments on a draft of this report, CDC concurred with our recommendations, and indicated that it will issue guidance to assist jurisdictions in their efforts to identify, train, and vaccinate appropriate responders (see appendix I). CDC also provided technical comments, which we incorporated as appropriate.

We are sending copies of this report to the Director of CDC and other interested officials. We will also provide copies to others upon request. In addition, the report will be available at no charge on GAO’s Web site at http://www.gao.gov. If you or your staff have any questions about this report, please call me at (202) 512-7119. Another contact and key contributors are listed in appendix II.

Appendix I: Comments from the Centers for Disease Control and Prevention

Appendix II: GAO Contact and Staff Acknowledgments

GAO Contact

Acknowledgments

Other key contributors to this report are George Bogart, Barbara Chapman, Angela Choy, Chad Davenport, Nkeruka Okonmah, and Roseanne Price.

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Bioterrorism: Federal Research and Preparedness Activities. GAO-01- 915. Washington, D.C.: September 28, 2001.

Chemical and Biological Defense: Improved Risk Assessment and Inventory Management Are Needed. GAO-01-667. Washington, D.C.: September 28, 2001.

Occupational Safety: Selected Cost and Benefit Implications of Needlestick Prevention Devices for Hospitals. GAO-01-60R. Washington, D.C.: November 17, 2000.

Food Safety: Agencies Should Further Test Plans for Responding to Deliberate Contamination. GAO/RCED-00-3. Washington D.C.: October 27, 1999.

Combating Terrorism: Need for Comprehensive Threat and Risk Assessments of Chemical and Biological Attacks. GAO/NSIAD-99-163. Washington, D.C.: September 14, 1999.

Chemical and Biological Defense: Program Planning and Evaluation Should Follow Results Act Framework. GAO/NSIAD-99-159. Washington, D.C.: August 16, 1999.

Combating Terrorism: Observations on Biological Terrorism and Public Health Initiatives. GAO/T-NSIAD-99-112. Washington, D.C.: March 16, 1999.