Smallpox Vaccination:

Implementation of National Program Faces Challenges

GAO-03-578: Published: Apr 30, 2003. Publicly Released: Apr 30, 2003.

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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.

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.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    Recommendation: To ensure that the National Smallpox Vaccination Program successfully develops adequate response capacity for a potential terrorist attack involving smallpox, the Director of the Centers for Disease Control and Prevention should 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention

    Status: Closed - Not Implemented

    Comments: The smallpox program is no longer in existence.

    Recommendation: To ensure that the National Smallpox Vaccination Program successfully develops adequate response capacity for a potential terrorist attack involving smallpox, the Director of the Centers for Disease Control and Prevention should provide guidance to the jurisdictions for implementing the second stage of the program.

    Agency Affected: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention

    Status: Closed - Not Implemented

    Comments: The smallpox program is no longer in existence.

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