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Hospitals, schools could become clinics for administering vaccine
Thinking the unthinkable down to chilling detail (e.g., stock Post-it notes and a flashlight), the Centers for Disease Control and Prevention (CDC) has issued hands-on, how-to plans for setting up emergency smallpox vaccination clinics in the event of a bioterrorism attack.
"It takes into consideration a lot of the logistics associated with doing this," says Joseph Henderson, MPA, associate director for terrorism preparedness and response at the CDC. "We are issuing guidance to state and local health agencies to help them understand what they need as far as tools to develop their strategies to respond to smallpox, should an event happen tomorrow."
And what event would activate the plan? One case of smallpox. The variola virus has been eradicated in the wild, but is held in stocks by the United States and Russia and could be in the hands of terrorists or rogue states. "Basically, given that smallpox has been eradicated from the world, a single case of smallpox, assuming that the evidence is that it’s intentionally caused, would constitute an attack," says David Fleming, MD, deputy director for science and public health at the CDC. "In the event where we have a highly suspected case or a confirmed case, we would act, at that point, as if the nation were under attack and would immediately implement this response plan."
The Smallpox Vaccination Clinic Guide comes as a revision and update of the CDC’s overall Smallpox Response Plan, which first was released in November 2001 and updated last January. The plan, which will continue to be updated and revised, is designed for implementation following a smallpox attack. Thus, it is not to be confused with the still unresolved, as of this writing, strategy of identifying how many health care workers, first responders, and others will be immunized against smallpox "pre-attack." While federal bioterrorism officials are making that decision, there is no doubt that health care workers would be offered vaccine if there was a smallpox attack, Henderson says. "There is no question that we will look to immunize our immunizers and first responders," he says. "This becomes a universal infection control issue. If people start showing up at hospitals, you want to protect the frontline work force."
The new CDC guidance is essentially a clinic blueprint, including consent forms, supply checklists and a "model clinic" schematic. (See consent form.) "States will be using this information to develop plans that will enable them to deliver these services as absolutely quickly as they possibly can," Fleming says. "The time frame [for clinic setup] we’ve given in the guidelines is 10 days. That can be scaled up or down, depending on the specifics of the circumstances that an individual state is presented with."
While actual implementation of the plan is left to state and local health departments, the thinking is that vaccination clinics could be set up in schools, hospitals, and recreational facilities in the event of terrorist attack involving smallpox, Henderson says.
"Knowing the number of people that you are going to attract to the clinics, you want to use a facility that can accommodate people and get them out of the weather," he tells Bioterrorism Watch. "You want to run them through with some degree of privacy where you are immunizing them and talking to them personally so that they can clearly weigh the risk and benefits of receiving the vaccine. Then [have an area] to monitor them post-vaccination for a short period of time to make sure they don’t suffer any serious adverse events."
Regarding the informed consent process, Henderson says it will be left to the individual patient’s assessment of his or her own health — rather than trying to test for HIV or other contraindicated conditions. "If there is some suspicion — based on us going through the pre-screening material with them — that maybe they need further work up, then we would refer them to their primary care provider before we would vaccinate them," he says. "That’s where they could receive lab tests, etc."
In issuing the guidance, CDC officials say they are not abandoning the controversial "ring vaccination" strategy of immunizing around first cases and contacts. Rather mass vaccination could be used as a complementary strategy to the ring outbreak containment approach.
"The decision to do mass vaccination will be dependent upon an assessment of the magnitude of the attack, the potential duration of the attack, and the mode of the attack," explains Walter Orenstein, MD, director of the CDC’s national immunization program. "We would do some form of contact tracing or ring vaccination and vaccination of contacts regardless."
The plan calls for voluntary vaccination — given the potential serious side effects — but bioterrorism experts have little doubt people would cue up by the thousands if smallpox were let loose upon the land. It is well remembered as a disfiguring disease with a mortality rate of roughly one-third of those infected. "The estimates of deaths [from vaccination] come from 1960s data, and at that point, it was roughly one death per million vaccinations," Orenstein says.
"I would think in [the current] population where we have more people with immune problems and more people with certain skin rashes that put them at greater risk of some of the severe complications, it would probably be a little bit higher than that. This is in marked contrast to smallpox itself, which in the past has been associated with a 300,000 per million death rate. So we think in the setting of a smallpox outbreak, the vast majority of people would react quite favorably to getting this vaccine," he says.
While a new vaccine is under development, the CDC currently has enough of the old vaccine to immunize about 155 million people, Henderson says. Ongoing dilution studies indicate that the available vaccine could be expanded and still be effective if necessary. "That would expand [the supply] by the end of this year to cover the entire population," he says.
At least part of the cost of establishing the clinics would come from federally allocated bioterrorism preparedness funds. The cost of running a smallpox vaccination clinic would be in the neighborhood of $5 to $10 a patient, but costs will not be a driving factor in the event of an attack, Fleming says. "We’re talking about a decision that for the most part is one that we want to make based on how many lives we can save."
(Editor’s note: To see the complete CDC smallpox clinic document, go to www.bt.cdc.gov/agent/smallpox/response-plan/index.asp.)