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. 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. 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. 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. As of late April, CDC did not  have information about the number of complete response teams formed. 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. The program schedule has also placed heavy demands on the jurisdictions. 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. They also have concerns about compensation for such injuries. Volunteers are  uncertain whether the practices that CDC recommends will be sufficient. 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. 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 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. The National Smallpox Vaccination Program is  unprecedented and complex. Because many concerns remain unresolved, it may be difficult  to achieve the initial targets for the first stage. 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. Bioterrorism: The Centers for Disease Control and Prevention’s Role in  Public Health Protection.
Why GAO Did This Study

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.

What GAO Found

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.