Wise or ill-advised? Smallpox vaccine program hits hiatus
Can system be prepared but unvaccinated?
While experts argue whether it is a prudent pause or a dangerous delay, one thing is clear: National smallpox immunization efforts have ground to a virtual stop with some 38,000 health care workers immunized.
Yet the current, cautious pace of the program is in line with what is being recommended by a smallpox panel at the Washington, DC-based Institute of Medicine (IOM), which has been advising the Centers for Disease Control and Prevention (CDC) on the controversial program.
"I think it has largely halted, or at least paused," says Brian L. Strom, MD, MPH, chairman of the IOM panel and director of the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania School of Medicine in Philadelphia.
"And that is exactly what we called for. The focus has been on numbers, and it makes no sense to focus on numbers. I think [the CDC] needs to focus on planning what is needed for preparedness, and then any additional vaccinations should be triggered by what those preparedness plans dictate," he says.
In that regard, the committee recently recommended that the CDC provide guidance to assist state public health agencies and their partners in establishing a baseline level or "a minimum standard of preparedness for a smallpox attack."1
Vaccination is not preparedness’
After that is done, each state could individually assess its priorities and further expand its preparedness against smallpox, the IOM recommends. The committee emphasized that vaccination is not the only tool for smallpox preparedness.
"Vaccination is not preparedness," Strom says. "That’s our central theme over and over again. Vaccination may contribute to preparedness, but we think it is a major problem that the focus has been on vaccination."
According to the IOM report, other aspects of smallpox preparedness beyond vaccination include developing relationships with all relevant partners; communicating openly and regularly with each other, the media, and the public; having a core group of workers to provide initial response and vaccinate others; having concrete plans, including job descriptions and locations; and educating and training all participants before an event.
From scorn to praise
For example, the IOM panel is impressed with hospitals such as the Medical College of Virginia in Richmond, which has diligently prepared for a smallpox contingency but declined the initial round of vaccinations. Although no vaccinated teams of responders were formed, a policy on smallpox vaccination was developed.
Furthermore, a working group on smallpox preparedness was established and education was done on infection control measures and how to recognize and treat smallpox victims. A plan was drawn up to rapidly vaccinate hospital staff in a post-event scenario.
"We thought they were extraordinarily well prepared, and they have not vaccinated a single person," Strom says.
"I’m not saying that people shouldn’t be vaccinated. The focus should be preparedness and using vaccine as needed to achieve preparedness. If there were an attack tomorrow they would know what to do. That’s what preparedness is about. You can vaccinate all the people you want, but if don’t know what you are going to do with them in response to an attack, then there is no purpose to it," he points out.
Indeed, the medical college is prepared to work with local health officials and vaccinate thousands people at the first word of smallpox anywhere in the world, says Richard Wenzel, MD, professor and chairman of the department of internal medicine at the facility.
"We are prepared to immunize 6,000 employees within 24 hours if the need arises — if there were a single case of smallpox anywhere in the world," he says.
"We also have plans to isolate first cases in negative-pressure rooms. If there were a case of smallpox, say in Florida or Europe, you probably would have a couple of days of a grace period in which to deliver immunization and protect employees and family. If smallpox actually arrived in Richmond, we would vaccinate a number of us immediately, and then we would immediately begin vaccinating other people."
Wenzel recalls that the hospital drew scorn when officials cited patient and employee safety in rejecting the national immunization plan.
"We were the first institution to become visible as opposing the vaccine program for smallpox," he says. "At that time, both the New York Times and the Washington Post editorialists described our decision as deplorable.’ Of course they are not going to retract that now."
The medical college has followed through with contingency plans just as officials had announced at the time, he emphasized.
"We did what we said we would," Wenzel says. "Our internal people are ready to go, and we would probably partner with our health department. And not only is there no smallpox to be found in Iraq, there are some reports coming out that there never was any. Given that, we take some comfort in our policy to be prepared without injuring our employees."
Others say nation not ready
Indeed, with no weapons of mass destruction yet found in Iraq, the national smallpox plan is regrettably running out of steam, says William Bicknell, MD, PhD, professor of international health at Boston University.
Instead of being well on the way to protecting the nation’s civilian population by vaccinating up to 10 million health, emergency, and public safety workers, the country is "stalled" at 37,971 vaccinated civilians while 450,000 military, he notes.
Yet Iraq was only one of a number of nations suspected of possessing smallpox. Though there is continuing debate about persistent immunity in those immunized as children, the country remains vulnerable to an attack because millions and millions of people have never been immunized.
The notion that you can be prepared for a disease like smallpox without being vaccinated is particularly irksome to Bicknell, a veteran public health scholar who has been vaccinated twice against the disease.
"I find that unfathomable, impenetrable, and absurd," he says, noting that the IOM report even concedes it may be necessary to ration vaccine in certain post-attack scenarios. "That’s called non-preparation. That [IOM] report is a public health embarrassment. They should know better."
One problem is that both medicine and public health are very risk-averse professions operating within a risk-averse culture, he argues in a recently published analysis of the situation.1
We have not yet realized the complexity and difficulty of vaccinating millions of Americans rapidly after an attack, he says.
Another factor is that the original CDC recommendation to immunize some 15,000 people in response teams nationwide was overridden and expanded at higher levels of government. Though some argue that it was just a "working" projection, suddenly the debate included as many as 500,000 immunized health care workers.
"The initial vaccination plan proposed by CDC in late 2001 and early 2002 was viewed by the administration as inadequate," Bicknell wrote.
"Responsibility for development of what became the president’s plan was removed from Advisory Committee on Immunization Practices [ACIP] and the CDC by [the Department of] Health and Human Services [HHS] and the White House. Now the same organization and many of the same people whose advice was rejected have been asked to implement a plan they did not develop. That unusual history may help to explain some of the delay and hesitation shown by CDC," he stated.
Strom and the IOM see it differently, particularly since the nation now has far exceeded the original 15,000 immunized health care workers called for by ACIP.
"It’s not that they needed [500,000 immunized] that was a planning number," he says. "The goal needs to be preparedness. It’s concerning because the focus on vaccination has sucked resources and attention away from preparedness in general and away from other public health measures."
However, when asked if that means 38,000 immunized health workers represents sufficient preparedness, Strom says.
"There is no way to know, which is part of the problem. But the focus shouldn’t be numbers. Undoubtedly, our expectation is that once there is a clear focus on preparedness, then there are some places that are going to have plenty of people vaccinated and won’t need more and other places that might not need more," he continues.
"That depends on the plan. The Medical College of Virginia didn’t need any. Other places, if they use a plan that relies on people being vaccinated, then they need to be sure that they have enough [immunized]."
Undermining the program
Regardless, the overall effort already has been somewhat undermined because discussions have centered heavily around risks of the vaccine, even though historical mortality figures were skewed by deaths in children — a group that is not currently targeted for vaccination, Bicknell emphasizes.
"The bad information about how dangerous it is really scared people," Bicknell says.
"CDC and HHS knew full well that liability was going to be an issue, but they waited to get legislation until everybody was up a tree [in fear]. They missed the opportunity to say if this goes according to what is likely with healthy adults, nobody is going to get hurt. And the Bush administration once they made the announcement, stopped backing it," he says.
"Then they were hoisted by their own petard — smallpox wasn’t in Iraq, and there are no weapons of mass destruction," Bicknell asserts.
With the process well short of the originally discussed goals, the government seems to be falling back to a position of "declaratory achievement" by deciding we’re prepared or more prepared then we were, he says.
Bicknell argues that the minimum level needed to prepare for a smallpox terrorist attack is to complete phase one and vaccinate as many as 2 million people. But with a presidential election looming, he predicts the smallpox initiative will remain in limbo.
"If nothing happens before the election, we are blessed," he points out. "If something happens before the election, we are going to have one big mess."
References
1. Committee on Smallpox Vaccination Program Implementation. Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation. Letter Report #4: Integrating Smallpox Preparedness into Overall Public Health Preparedness. Washington, DC: Institute of Medicine; Aug 12, 2003.
2. Bicknell WJ, Bloem KD. Smallpox and Bioterrorism Why the Plan to Protect the Nation Is Stalled and What to Do. Paper No. 85. Washington, DC: Cato Institute; Sept. 5, 2003.
While experts argue whether it is a prudent pause or a dangerous delay, one thing is clear: National smallpox immunization efforts have ground to a virtual stop with some 38,000 health care workers immunized.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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