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

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Amid growing concerns about a potential smallpox attack, the Centers for Disease Control and Prevention (CDC) is working with 62 state, local, and territorial jurisdictions to implement the civilian part of the National Smallpox Vaccination Program. The goal is to increase the nation's response capacity by vaccinating health workers for Smallpox Response Teams as quickly as is safely possible. A civilian program using vaccination to bolster bioterrorism preparedness is unprecedented, the health risks are uncertain, and the public health system has had little recent experience with smallpox. Safe implementation of such a program will be complex. GAO was asked to examine implementation and its challenges. GAO reviewed program materials and data and interviewed CDC officials and representatives of organizations involved.
section_title: What GAO Found
paragraphs: Implementation of the smallpox vaccination program has proceeded more slowly than CDC planned. Vaccinations are to be given to volunteers in two stages. CDC's nationwide target for the first stage was an estimated 500,000 health workers in 30 days. The number of health workers was based on the jurisdictions' combined targets for their Smallpox Response Teams. In the second stage, CDC plans to expand the program to as many as 10 million additional health workers and other emergency response personnel. On the official start date of vaccination, January 24, 2003, only one state began vaccinating. CDC reports that by week 10 (April 4, 2003) about 6 percent of the number of volunteers targeted for the first stage had been vaccinated. Eight states accounted for about half of the vaccinees. Because of the slow pace, not enough data were generated by week 10 to evaluate whether the program is proceeding as safely as possible. Implementation of the program is facing two major challenges. The first is the program schedule, which placed heavy demands on CDC and the jurisdictions. The second is hesitation on the part of the two main groups needed to participate in the program--the state and local public health authorities and hospitals needed to implement it, and the health workers needed to volunteer to be vaccinated. Many implementers are concerned about insufficient resources to support the program and about liability protection. Many potential volunteers are concerned about health risks to themselves and their co-workers, families, and patients and about compensation for adverse events and lost income. Program officials and Congress have been working to address some of the major challenges but it is too soon to evaluate the impact of these efforts on participation in the program. Unless these efforts succeed in overcoming the hesitancy of the participants, it may be difficult to achieve the initial targets for the first stage. CDC has reconsidered the initial targets and said that as few as 50,000 vaccinated health workers nationwide would provide sufficient response capacity. But as of late April, CDC had not set a new nationwide target or requested that the 62 jurisdictions adjust their targets for numbers and types of vaccinated health workers and distribution of response teams. CDC also 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 yet done so.

section_title: Letter
paragraphs: On January 24, 2003, four physicians in Connecticut became the first  civilians in this country to receive the smallpox vaccine—which has not  been routinely administered in over 30 years—as part of the  administration’s National Smallpox Vaccination Program. The program,  which was announced by the President in December 2002, was developed  in response to growing concern that a terrorist or hostile regime might  have access to the smallpox virus and attempt to use it as an agent of  bioterrorism against the American people. In 1980, after a successful  eradication program, the World Health Organization (WHO) declared the  world free of naturally occurring smallpox. However, concern remains  that stockpiles of the virus may exist in laboratories other than the two  repositories designated by WHO following eradication. Although the  administration indicated that a terrorist attack involving smallpox is not  imminent, it determined that the program should proceed as quickly as is  safely possible.
The Centers for Disease Control and Prevention (CDC) is charged by the  Department of Health and Human Services (HHS) with implementing the  civilian part of the smallpox vaccination program. The goal of the  program is to increase the nation’s smallpox preparedness capacity by  offering vaccinations safely to volunteer health workers to increase their  readiness to respond to a smallpox attack. CDC planned for the  vaccinations to be carried out in two stages. The first stage began on  January 24, 2003, the date on which protection against liability for injury  or death arising from smallpox vaccine administration became effective  under the Homeland Security Act of 2002 for entities or individuals  involved in implementing the program. CDC planned that during the first  stage the vaccine would be offered on a voluntary basis to an estimated  500,000 public health and health care workers, who would be formed into  Smallpox Response Teams. These teams would be responsible for  investigating an outbreak following a bioterrorist attack, caring for  patients, and vaccinating members of the public who may have been  exposed to the virus. CDC planned to complete the first stage in 30 days.  During the second stage, the program would be expanded to as many as 10  million other health care workers, police officers, firefighters, and  emergency medical technicians, again on a voluntary basis.
CDC is implementing the smallpox vaccination program in collaboration  with 62 state, local, and territorial governments. Thus the plan for the  program is embodied in multiple federal guidance documents and  recommendations, the individual CDC-approved plans of the 62  jurisdictions, and the plans of thousands of individual hospitals involved.  Each of the jurisdictions and hospitals has tailored its first-stage planning  and targets for numbers and distribution of teams and numbers and types  of health workers on the teams to its own particular circumstances. CDC  has defined the program’s targets for national preparedness as the sum of  the targets set by the jurisdictions in their plans.
A large-scale public vaccination program against a disease that no longer  exists as a natural threat is unprecedented and presents many challenges.  The relatively small and known risks of adverse events associated with  vaccines in past vaccination programs have been justified on the basis of  the need to reduce a known incidence of disease in the population. For  smallpox, such justification no longer exists. Both the nature and rates of  adverse events to be expected in today’s population and the risk of a  bioterrorist attack are uncertain, making the development and safe  implementation of a program of smallpox vaccination especially  challenging.
In recognition of the potential difficulties in implementation of the  smallpox vaccination program, you requested that we determine (1) how  implementation of the civilian part of the program is proceeding, (2) what  challenges have been encountered, and (3) whether these challenges have  been addressed.
In carrying out our work, we conducted a literature review and examined  program-related materials and data and interviewed officials and  representatives involved in the program. Specifically, we obtained  program-related materials and data on plans, numbers of health workers  vaccinated, shipments of vaccine, adverse events reported, and other  relevant information from CDC through the first 10 weeks of vaccination.  We obtained data about the jurisdictions from the Association of State and  Territorial Health Officials (ASTHO) and the National Association of  County and City Health Officials (NACCHO). We reviewed relevant  materials from the Department of Defense (DOD), the Institute of  Medicine (IOM), WHO, the 62 jurisdictions, and 25 organizations  representing state and local health authorities, hospitals, physicians,  nurses, and other health workers. In addition, we interviewed  representatives from some of those organizations, including the American  College of Emergency Physicians, the American Hospital Association, the  American Nurses Association, ASTHO, NACCHO, and the Service  Employees International Union, as well as CDC and IOM and selected  jurisdictional public health officials. We did not systematically review the  jurisdictional plans nor survey the jurisdictions, and thus we provide  information about jurisdictions only to illustrate the range of policies and  activities they encompass. We did not independently verify data provided  to us by CDC and organizations involved in the program; however, we  tested the data and determined that they were adequate for our purposes.  We conducted our work from January 2003 through April 2003 in  accordance with generally accepted government auditing standards.
subsections: section_title: Background
paragraphs: 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.
subsections: section_title: Role of Vaccination in Public Health
paragraphs: 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.
section_title: Smallpox Vaccination
paragraphs: 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.
section_title: The National Smallpox Vaccination Program
paragraphs: 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.
section_title: Initial Federal Funding for the Smallpox Vaccination Program
paragraphs: 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.
section_title: Implementation Is Slower Than CDC Planned
paragraphs: 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.
section_title: Major Challenges Are Program Schedule and Hesitancy on Part of the Two Main Groups Involved in Program
paragraphs: 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.
subsections: section_title: Program Schedule Has Challenged CDC and the Jurisdictions
paragraphs: 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.
section_title: Implementers and Organizations That Represent Them Are Hesitating to Participate Because of Concerns about Adequacy of Resources and Liability Protection
paragraphs: 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.
section_title: Volunteers and Organizations That Represent Them Are Primarily Concerned about Safety and Compensation for Injury
paragraphs: 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.
section_title: Major Challenges Have Not Been Overcome and Continue to Affect Implementation
paragraphs: 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.
section_title: Conclusions
paragraphs: 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.
section_title: Recommendations
paragraphs: 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.
section_title: Agency Comments
paragraphs: 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.
section_title: Appendix I: Comments from the Centers for Disease Control and Prevention
section_title: Appendix II: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Acknowledgments
paragraphs: Other key contributors to this report are George Bogart, Barbara  Chapman, Angela Choy, Chad Davenport, Nkeruka Okonmah, and  Roseanne Price.
section_title: Related GAO Products
paragraphs: Bioterrorism: Preparedness Varied across State and Local Jurisdictions.  GAO-03-373. Washington, D.C.: April 7, 2003.
Homeland Security: Voluntary Initiatives Are Under Way at Chemical  Facilities, but the Extent of Security Preparedness Is Unknown. GAO-03- 439. Washington, D.C.: March 14, 2003.
Weapons of Mass Destruction: Observations on U.S. Threat Reduction  and Nonproliferation Programs in Russia. GAO-03-526T. Washington,  D.C.: March 5, 2003.
Food-Processing Security: Voluntary Efforts Are Under Way, but Federal  Agencies Cannot Fully Assess Their Implementation. GAO-03-342.  Washington, D.C.: February 14, 2003.
Chemical and Biological Defense: Observations on DOD’s Risk  Assessment of Defense Capabilities. GAO-03-137T. Washington, D.C.:  October 1, 2002.
Anthrax Vaccine: GAO’s Survey of Guard and Reserve Pilots and  Aircrew. GAO-02-445. Washington, D.C.: September 20, 2002.
Bioterrorism: The Centers for Disease Control and Prevention’s Role in  Public Health Protection. GAO-02-235T. Washington, D.C.: November 15,  2001.
Bioterrorism: Review of Public Health Preparedness Programs. GAO-02- 149T. Washington, D.C.: October 10, 2001.
Bioterrorism: Public Health and Medical Preparedness. GAO-02-141T.  Washington, D.C.: October 9, 2001.
Bioterrorism: Coordination and Preparedness. GAO-02-129T.  Washington, D.C.: October 5, 2001.
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.