Will dropout fever’ spread? Hospitals opting out of smallpox offer draw fire

We come down on the side of above all, do no harm’

Deciding that the risk of smallpox vaccine outweighs the current benefit of immunization, an increasing number of hospitals are refusing the government’s offer to vaccinate key health care workers. Though public health authorities still are expecting widespread compliance, the move has raised concerns that the nonparticipants will undermine bioterrorism preparedness.

The declinations were branded as "deplorable" in an editorial in The New York Times that warned that "the refusal to participate raises needless suspicions about the nation’s smallpox preparations and could, if dropout fever spreads too widely, undermine efforts to prepare for bioterrorism."1

Richard Wenzel, MD, professor and chairman of the department of internal medicine at the Medical College of Virginia in Richmond, defends the hospital’s decision to opt out of the voluntary program. "It’s not an issue of patriotism," he says. "This issue is purely one of medical risk and benefit. As we looked at the risk and benefit of vaccination and potential transfer [of vaccinia] to vulnerable populations, we thought there was substantial risk."

The institutional decision was welcomed by Randy Smith, RN, MS, CIC, an infection control professional at the Virginia hospital.

"I’m in agreement with the policy," he tells Hospital Infection Control. "I am not going to go out on my own and get immunized. I have a 2-year-old. Unless it is mandatory, I wouldn’t do it. I am not going to subject him to possibly being exposed to the virus in the vaccine."

It is concern for others, particularly, immune-compromised patients, that has some hospitals balking at the bioterrorism response plan recommended by the Centers for Disease Control and Prevention (CDC). After the Bush administration gave the green light to CDC’s recommendation to immunize 500,000 hospital workers nationwide, hospital clinicians and administrators began weighing the pros and cons. Issuing one of the first declinations was the Grady Health System in Atlanta. The hospital said it will not immunize workers at this time, but would act quickly if a case appears or there is clear imminent danger. Grady issued a statement citing concern for the "safety and health of our patients and our health care workers." The hospital added — somewhat oddly, given that this is a national effort — that there was no evidence of the "capacity of any enemy to launch an attack on Georgia with smallpox."

Patients take precedence

Factored into such decisions is the low but potentially serious risk to the person vaccinated, and beyond that, to any immunocompromised (e.g., HIV) or otherwise contraindicated (e.g., atopic dermatitis) potential contacts of vaccinees.

"We are a center hospital for HIV and have many transplant patients, both solid organ and bone marrow," Wenzel explains. "We have a number of people who are on steroids or immune suppressors."

Paul Offit, MD, infectious disease chief at the Children’s Hospital of Philadelphia, cites similar reasons for declining, saying any rush to immunize workers runs counter to the old admonition, "don’t test the water with both feet." Offit is a member of the CDC’s Advisory Committee on Immunization Practices (ACIP), which approved the hospital vaccination plan last year. However, he cast the lone vote against the recommendation. Now his hospital has followed suit and declined the vaccine offer. Will such defections undermine the ACIP effort?

"I don’t think ACIP would see it that way," he says. "Individual hospitals have to make a decision for what they think is right for their hospital. It’s a voluntary program. This is not mandatory. We all believe that in case of an event, there will be time to respond. We’re not prepared to recommend the vaccine for our frontline health care workers at this time."

Despite the defections, Julie Gerberding, MD, MPH, CDC director, says the agency expects about 3,600 of the nation’s estimated 5,000 hospitals to participate. "This is a voluntary program, and we know from our long experience in working with the public health system that implementation varies from jurisdiction to jurisdiction," she says. "So, it’s really not surprising that some hospitals would have chosen not to vaccinate.

"We know that we’re going to be far more prepared with the response teams that are stepping up to the plate," she adds.

Once the first group of hospitals demonstrates that the vaccine can be administered safely, other facilities will likely follow, adds William Bicknell, MD, PhD, professor of international health at Boston University. "If the double semipermeable membrane dressing, which the CDC recommends for hospitals workers is used [to cover the vaccine site], and if people are rotated off burn units and transplant units, I think there really isn’t any significant danger," he says. "Some hospitals will opt out, but many will opt in. I think we will see that if it is done carefully, the risks are going to minimal and very acceptable. I think that the hospitals that [vaccinate] are being responsible to patients, the general public, and their staff. The hospitals that don’t are understandably cautious, but I would say overly cautious."

Though liability issues have not been given for the declinations, that is clearly an issue that is making some hospitals reticent, he adds. The American Hospital Association (AHA) in Chicago has raised liability concerns on its web site, but nonetheless, says it is encouraging hospitals to participate.

A question of risk

"This is a voluntary effort, and we have supported it all along the way," says Rick Wade, AHA spokesman. "We urge our members to cooperate if they possibly can. We are still trying to solve the liability issue. We have not urged anyone to drop out for that reason. We hope to get that cleared up so that will not be a barrier to anyone’s participation. Hospitals are on the front lines as first responders. We have to prepare ourselves. This is not going to be something that it is going to be easy for any hospitals to opt out of."

Still, another factor that has dogged the situation from the onset is that — despite months of theoretical discussions — the actual threat of a smallpox attack remains largely undefined, or possibly more to the point, undisclosed.

As a result, like the proverbial elephant to the blind men, the risk appears differently to different observers. Many were waiting for some kind of definitive statement when the Bush administration approved the plan. Instead, to some the offer of vaccine with little emphasis on the threat of smallpox appeared counterintuitive.

"President Bush said on Dec. 13 that we had no imminent threat of smallpox bioterror," Wenzel says. "If there is a credible risk, you wouldn’t immunize a small portion of the health profession [anyway]; you would do widespread immunization. I think there is a lack of logic with the current policy." Indeed, with the last known cases occurring decades ago, should smallpox appear anywhere in the world the likely national response would be large-scale immunizations — not hospital teams, he notes.

"We’re very flexible," Wenzel says. "We would change our mind under any one of several scenarios, one of which is a single case of smallpox anywhere in the world." In addition, the hospital would quickly begin immunizing if a vial of smallpox was reported in a country outside the two known repositories in Russia and the United States.

"If the intelligence community said that this was truly a high-risk situation and had credible information, that would completely change [our decision]," he says. "But for the time being, as we look at the risk and benefit medically, we come down on the side of above all, do no harm."

Another critical factor is that stocks of smallpox vaccine have been steadily increased. With vaccine readily available, protection against smallpox infection still would be possible several days after an exposure to an incoming patient, Wenzel argues. "Even if I had direct contact today, I have four days to get vaccinated and be protected," he says. "I think the government has done a good job of increasing the supply [of vaccine]. To me, that is the most important thing."

Thus, Wenzel concludes that a small-scale attack (e.g., infected terrorists trying to expose others) could be contained without pre-event immunizations. On the other hand, having small groups of health care workers immunized will be of little import in a worst-case scenario of a massive attack. "If somebody drops an aerosol over the city of Atlanta, certainly a handful of immunized physicians will have no impact," he says.

"We would be no different if we immunized a small fraction of our health care workers than where we are now. It’s a drop in the bucket. The only thing that protects you from that kind of exposure is widespread, pre-event vaccination," Wenzel says.


1. Ducking Smallpox Vaccinations. Editorial. The New York Times, Dec. 22, 2002; 4:10.