States take a stand on smallpox: Do no harm, go slow, stay small

Organizations of state and local governments have told federal officials that they fully support President Bush’s smallpox vaccination plan but have several key issues that must be resolved, not the least of which is how to pay for all they are being asked to do.

In testimony on Dec. 19 to the Institute of Medicine (IOM) Committee on Smallpox Vaccination Program Implementation, National Association of County and City Health Officials executive director Patrick Libbey said that, especially as the vaccination program moves into its second phase in which up to 10 million first responders will be vaccinated, "this program has serious and far-reaching implications for local public health practice. Our message, based on the classic admonition, First, do no harm,’ is straightforward. It is, Slow down and stay small.’"

While respecting the sense of urgency conveyed by the president, Mr. Libbey said, "We also believe that in light of the president’s statement, there is no imminent risk of a smallpox outbreak; we owe it to our communities to proceed carefully and take the time to evaluate our vaccination activities as we go. We must also understand and document clearly the consequences of the necessary diversion of resources from other critical public health work to smallpox vaccination."

Mr. Libbey told the IOM that as local public health agencies proceeded with planning for the initial program phase of vaccinating 500,000 volunteer medical and public health response team members, they encountered questions about the presence or absence of liability protection for entities engaged in vaccination and availability of compensation for vaccinated people who lose work time or incur medical care costs as a consequence of their vaccination.

"Local health agencies also need consistent guidance in several areas," he said. "They need accurate, uniform guidelines for clinical practice. They need guidance for communicating with potential vaccinees. They need guidance for communicating with their communities, particularly in explaining the program as the president has established it and in explaining the particular course of action that their state has adopted. It is appropriate and expected that state plans for initial vaccinations will vary, but it is essential that local public health officials be able to explain why the types and numbers of people who will be asked to volunteer for vaccination vary markedly among the states."

Mr. Libbey called on federal officials to take the time necessary to evaluate the initial round of vaccinations before proceeding to vaccinate larger numbers of additional people. That evaluation, he said, should include monitoring side effects, identifying unexpected logistical barriers to vaccination, consulting more thoroughly with the next larger group of people to be vaccinated, and putting quality assurance measures in place.

He pointed out that while the logistics for vaccinating the first 500,000 people nationwide (those on volunteer smallpox response teams) can be mastered by state and local governments, those same plans and logistics will not work when the objective expands by a factor of 20 to cover up to 10 million first responders. "The broader program cannot be successful unless we take the time not only to apply the lessons learned in the first phase of the program, but also to tackle significantly greater logistical problems. We have only begun to identify the potential issues. These include: Who will provide vaccinations and how will they be indemnified? How do we get vaccine to a larger group of vaccinators and assure its proper storage, handling, and administration? How do we train vaccinators? How do we ensure that emergency and routine first responders can be vaccinated without disrupting essential community services?"

Mr. Libbey said it also is essential to look at the costs of the program since states and localities already have diverted significant resources to smallpox vaccination and there is no endpoint in sight. "We are greatly concerned about two effects of such diversion," he testified. "First, staff hired through the state and local grants for bioterrorism preparedness cannot also pursue the other important preparedness activities that are now under way. We already see these activities slowing or halting in many locations. A disproportionate amount of resources may be spent on smallpox vaccination for an indefinite time, at the expense of other bioterrorism and emergency preparedness programs. Second, the magnitude of a program to vaccinate 10 million [people], and possibly also other members of the general public, will drain general public health resources at an alarming rate for an unknown period of time."

American Public Health Association executive director Georges Benjamin, who had been Mary-land’s health secretary and also once led the Association of State and Territorial Health Officials, tells State Health Watch that while all states had submitted their initial plans by early December as required by the federal government, work remained to be done on how to handle the Phase 2 vaccination of 10 million first responders.

"Liability is one of the issues that needs to be more clearly defined," Mr. Benjamin says "We need to look at workers’ compensation because it’s going to be hard to get people to participate if workers’ compensation won’t cover them if they have problems. Congress is going to have to look at federal liability coverage. Some states are self-funded for workers’ compensation. If a problem develops and a lot of people get sick, it could be costly to those states. The relative risk is small initially. It will be more of a problem as we move to larger groups to vaccinate."

Mr. Benjamin also points to access to care as an issue needing to be addressed. "As we expand the number of people to be vaccinated," he says, "we can’t forget the citizens who are the most vulnerable such as the poor, the homeless, mentally ill, shut-ins, and those who are institutionalized. We have to think very carefully about how to obtain informed consent from such individuals and be sure they are adequately informed. We haven’t yet seen educational materials, but they need to be in multiple languages and at an appropriate reading level. Health educators need to be well informed so they can share the message. States have had lots of experience with wide-scale campaigns, but we need to remember that this type of vaccination is different."

Because there are many health care workers who don’t have health insurance coverage or are underinsured, Mr. Benjamin tells State Health Watch, an issue might develop over how to deal with the uninsured in any wide-ranging vaccination effort. "States need to work with insurers and managed care organizations about coverage for people who have an adverse reaction to the vaccination."

Mr. Benjamin reiterates Mr. Libbey’s recommendation that things move slowly enough to allow evaluation and learning from the early steps. "We should pause and understand what happens when the first 500,000 people are vaccinated," he says, "and then reassess going forward, including an assessment of whether the general public really is at risk. We shouldn’t vaccinate the mass population unless there is a credible risk."

States likely are to vary in how they will handle their responsibilities, according to Mr. Benjamin, with some contracting out the work or adding to existing contracts.

George Hardy, Association of State and Territorial Health Officials executive director, said at the IOM’s Dec. 19 hearing that there were a number of issues the agency should consider within its charge:

Timing and reassessment. While most people agree with plans to vaccinate members of smallpox response teams, many question the need to move to additional phases of mass vaccination unless there is a criminal release of the smallpox virus, and certainly will see a need for evaluation before moving quickly ahead. "If there is one thing we learned from the swine flu experience in the 1970s, it is the critical need for built-in reassessment points throughout this process," he said. "Moving rapidly from Phase 1 to Phase 2 without appropriate analysis has the very real potential to cause more harm than good and violate our responsibility to do no harm."

Liability and compensation. Mr. Hardy cautioned that protections under the Homeland Security legislation accrue to the vaccinator and the manufacturer, but offer essentially no protection for the people who are vaccinated or any secondary contacts of those who are vaccinated.

On-demand vaccination. While endorsing the administration’s strong recommendation that there is no need at this time for routine vaccination of the general public, he said there are concerns about the announced policy of making the vaccine available to members of the general public who insist upon getting it. "We urge a slow, measured approach to vaccination of the general public that is based on evaluation of the first phase of the vaccination plan."

Communication. "It’s critical that the public, physicians who advise the public, and other health care providers fully understand the nature, extent, and rationale for this vaccination program and the benefits and risks of vaccination," he said.

Resources. Mr. Hardy told the IOM that bioterrorism money given to states earlier this year was intended to strengthen the public health infrastructure so that it would be prepared to anticipate and respond to multiple possible threats and was not intended to be used for smallpox vaccinations. "We cannot afford to be unprepared for other possible agents because we have focused solely on smallpox. If we move to Phase 2, extensive funding will be needed for implementation at the state and local levels. At a time when 46 states are experiencing budget deficits, this cost would need to be borne by the federal government. It’s important to prepare for smallpox, but not at the expense of preparedness for other health threats. We must remember there is more to public health than our preparedness responsibilities. Prevention and health promotion efforts cannot be lost in the process."

Work force. He said that state governments have both short- and long-term work force development needs. "Public health can divert staff for a while as was done during the anthrax crisis, but such diversion is not without cost. The long-term consequences of diversion include a less healthy public and a less prepared work force."

While many concerns were raised, the officials stressed support for what the administration wants to accomplish. Mr. Hardy summed it up: "No program of this magnitude and controversy could expect to be easy, seamless, or without differences of opinion. I want to close by reiterating our deep conviction that the Centers for Disease Control and Prevention is doing everything possible to seek input and respond to the ideas and concerns of its state and local government partners."

[Contact Mr. Libbey at (202) 783-5550; Mr. Benjamin at (202) 777-2430; and Mr. Hardy at (202) 371-9090.] 

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