GAO: CDC should clarify next steps in smallpox program

May 1, 2003 (CIDRAP News) – The Centers for Disease Control and Prevention (CDC) should help states adjust their smallpox vaccination plans and goals to reflect the reality that relatively few health workers have volunteered for the shots so far, the General Accounting Office (GAO) of Congress says in a report released yesterday.

The GAO describes the vaccination program as rushed, underfunded, and hindered by the use of confusing educational materials, among other problems. The report says these problems have contributed to the reluctance of health departments, hospitals, and health workers to participate. The study was requested by Sen. Susan M. Collins, R-Maine, chair of the Senate Governmental Affairs Committee.

The goal of the first stage of the program was to quickly vaccinate up to 500,000 public health and healthcare workers, as the report notes, but fewer than 35,000 have been vaccinated since the program was launched last Jan 24. Since then the CDC has said that as few as 50,000 vaccinated health workers might be enough to respond to a smallpox outbreak, but it has not set a new goal or asked states to adjust their plans, the report says. In addition, the agency has not said how a lower goal would affect the second stage of the vaccination program, which envisions vaccinations for up to 10 million health and emergency response workers.

Accordingly, the GAO recommends that the CDC director provide guidance to the states, cities, and territories for "estimating response capacity needs and revising targets" for the first stage of the program and for implementing the second stage.

The CDC says it agrees with the recommendations and is already planning to address them. In a letter included in the GAO report, CDC Director Julie Gerberding said the agency will issue a guide, called the "FY 2003 Continuation Guidance for the Bioterrorism Cooperative Agreement," that will help state and local health agencies complete their vaccination programs. She didn't say when the document would be issued.

The GAO report says Gerberding has indicated that as few as 50,000 vaccinated health workers may be sufficient but "has not explained how CDC arrived at that number." The report continues, "CDC has not said how these workers should be organized and distributed within the Smallpox Response Teams and across the nation." Meanwhile, most states are trying to follow their original vaccination plans, but some have begun to revise their goals downward, according to the report.

If the vaccination goals are in fact lowered, the GAO says, the CDC will 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."

CDC has not spelled out how scaling back the first round of vaccinations will affect the second round or provided any guidance on how to manage the second round, the report says. As a result, health departments "cannot determine how the workers to be vaccinated in the second stage will be used to expand response capacity."

The GAO says that the vaccination program schedule "is challenging and has placed heavy demands on CDC" and on state and local health departments. The hurried scheduled forced the CDC to develop training and educational materials very quickly and also put pressure on the Institute of Medicine advisory committee that was set up to help ensure safety, the report says. State and local health departments also felt the pressure, as CDC gave them only 3 weeks to develop plans and goals for the first stage of the program, with no guidance on how many response teams would be needed.

The report attributes the slow progress of the vaccination campaign to two factors: (1) reluctance on the part of hospitals and public health agencies to vaccinate, mainly because of worries about costs and liability; and (2) reluctance of health workers to be vaccinated, largely because of concerns about safety and compensation for adverse events and lost income. Some steps have been taken to overcome these challenges, but more needs to be done, according to the report.

In January, Gerberding estimated the cost of administering the vaccine at $13 per vaccinee, according to the report. But the Association of State and Territorial Health Officials and the Council of State and Territorial Epidemiologists have estimated the cost at $265 and $204, respectively. Health departments were expected to fund their programs from general bioterrorism preparedness grants, but most of those funds were already committed to other activities by March 2003, the report says.

In late March, the Department of Health and Human Services (HHS) said it would quickly provide states with up to 20% of their 2003 bioterrorism funding, but by late April HHS had not told states how to apply for the money, the report says. Also, on Apr 16 Congress appropriated $100 million in emergency funds for the smallpox vaccination program. But because the CDC has not estimated program costs, it is not clear if this will be enough to meet the need, the GAO concludes.

The report notes that Congress recently passed legislation to compensate health workers harmed by the vaccine, but says it is too early to assess the effect of that measure on participation in the program.

The report also says the rapid launching of the program caused the CDC to produce educational and screening materials that were inconsistent or untested. For example, some CDC materials say that asthma patients who are taking immunosuppressive drugs should not be vaccinated, while other materials exclude asthma patients for different reasons or don't mention them at all.

In other observations, the GAO says that as of Apr 4—10 weeks into the program—eight states accounted for about half of all vaccinees: Florida, Minnesota, Missouri, Nebraska, North Carolina, Ohio, Tennessee, and Texas.

See also:

GAO report "Smallpox Vaccination: Implementation of National Program Faces Challenges"
http://www.gao.gov/new.items/d03578.pdf

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