Risks must be balanced with public health concerns
At the University of Connecticut Health Center in Farmington, infectious diseases physician John D. Shanley, MD, faced a difficult decision last month. Would he be one of his hospital’s smallpox response team volunteers and receive the vaccine?
As a child, Shanley received the inoculation and experienced no ill effects. He has studied vaccinia, the virus used in smallpox vaccine, and observed cases of vaccine complications. These place him among those favored by public health officials to be on the front lines of preparations to respond to a bioterrorist attack.
But a member of his household has eczema, and Shanley routinely treats AIDS patients in a hospital clinic. These people would be placed at risk for transmission of the vaccinia virus and at high risk of experiencing potentially fatal complications if he chooses to participate.
"I am in kind of a funny spot. If you read the CDC [Centers for Disease Control and Prevention] guidelines, I shouldn’t get it, unless I move out of my house [for about two weeks, during which the virus is contagious], which is probably what I am going to do," he tells Medical Ethics Advisor. "I also work with vaccinia in research and have elected not to take the vaccine. Using proper laboratory technique, I have a very small chance of getting it [vaccinia]. If I take the vaccine, I have a 100% chance of getting it. But as long as this whole thing is going on right now, I have another reason to do it, so I’ll probably go ahead and get it."
Hospitals and health care workers across the country face similar dilemmas as they consider the federal government’s proposal for protecting the public from an attack with weaponized smallpox virus.
According to the plan, announced Dec. 13, an estimated 450,000 public health personnel, police officers, firefighters, and emergency health care workers will receive pre-event vaccination. These vaccinations, unlike those mandated for members of the military, will be voluntary. The civilian volunteers would be protected from the virus and able to care for victims of a smallpox outbreak — if one should occur — while the rest of the population receives the vaccine.
Following the announcement, state health departments began contacting hospitals and asking them to form response teams at each facility. Shanley’s facility is slated to be the first in Connecticut to form a team. After the volunteers are vaccinated, they will fan out to hospitals across the state to educate their health care workers and administer the vaccine.
"The plan is that we will identify critical people who will volunteer for this and who would be essential for the hospital to run in the event there was an index case," he explains. "That is the basic plan and it would include emergency room physicians, nurses, infectious disease doctors, radiologists, respiratory therapists, and people who take care of the physical plant, etc."
Not just a personal decision’
Recruiting volunteers won’t be the hard part, Shanley speculates. But hospitals are already struggling to ensure they will be able to maintain adequate staffing, ensure that no patients or other health care workers are jeopardized, and that the volunteer vaccines have adequate protections.
"With this vaccine, it is not just a question of personal choice — of a person being informed of the risks and benefits and making a decision," explains Gregory J. Moran, MD, associate professor of medicine in the department of emergency medicine and division of infectious diseases at Olive View-UCLA Medical Center in Sylmar, CA. "The person getting the vaccine is potentially putting other people at risk as well. It is a live vaccine, and it is possible to spread the virus to other contacts. It is not just a personal decision or personal liberty issue."
Vaccine has high adverse-event rate
The smallpox vaccine is a live-virus vaccine, which contains the vaccinia virus. People inoculated with vaccinia develop immunity to infection with variola, the virus that causes smallpox.
However, vaccinated people can experience complications. Some people develop a condition known as progressive vaccinia, in which the virus spreads from the inoculation site and causes a serious infection. A small number of people can develop encephalitis and die from receiving the vaccine.
And vaccinated people can transmit vaccinia from their inoculation site to other people until the site has been covered by a scab, which occurs approximately two weeks after administration.
People with compromised immune systems, or who have certain skin conditions are at high risk for contracting vaccinia and experiencing severe complications.
According to the Centers for Disease Control and Prevention (CDC), for every 1 million vaccinations, there will be one to two deaths; 14-15 life-threat-ening reactions (which may include gangrene, encephalitis, and severe skin infection), and 50-900 other minor side effects, such as rashes, fevers, and viral eruptions from the inoculation site.
"The vaccine is not really an acceptable vaccine by 21st century standards, except in the event that there really is an exposure," Shanley says. "Whenever you talk about vaccines, it is a balance between perceived and actual risk of the disease vs. the adverse effects of the vaccine. And with the adverse effects of this vaccine, there better be pretty good reason to give it."
Some hospitals opt out
After studying the federal plan, a few hospitals decided that the risk of potential harm to healthy health care workers and the potential for transmission of vaccinia to vulnerable patients was too great balanced with the uncertainty of a smallpox attack.
Grady Memorial Hospital in Atlanta and Virginia Commonwealth University in Richmond will not participate in the federal program and ask their health care workers to be vaccinated.
"Grady has balanced the known dangers of the smallpox vaccine, which can, in some instances, cause serious side effects, against the unlikely risk of exposure to the smallpox virus," says Curtis Lewis, MD, the Grady Health System’s chief of staff and senior vice president. "As a result, Grady will not vaccinate its health care workers for smallpox at this time, but would move rapidly to vaccinate health care workers if a case of smallpox is reported or a clearly imminent danger of smallpox transmission is shown to exist."
In coming to the decision, Lewis says hospital officials relied on opinions from its infectious diseases experts and other authorities, including a former member of the CDC’s smallpox eradication program.
In addition, the state health department indicated that it had no solid information that Georgia was at risk for a smallpox attack, he adds. Based on the available information, they determined that not participating was their best option, he says.
The hospitals’ position is an understandable one, notes Shanley. Given that the actual risk of a smallpox attack seems very remote and the risks of complications from the vaccine are significant, some hospitals may feel that they have a higher obligation to protect the patients already there.
Health care workers at his medical center have also expressed concern about the risk of transmitting vaccinia to vulnerable contacts, he says.
"Even though the ACIP [Advisory Committee on Immunization Practices] guidelines say that you don’t have to furlough workers as long as they keep the site covered and clean, there is still a risk of transmission," he notes. "The risk is small, but it is not zero."
His hospital will probably reassign vaccinated volunteers to low-risk work and he will probably stop seeing AIDS patients in the clinic until his inoculation site is healed, Shanley says. "Ethically, I just cannot take the chance of acting as a vector for them."
Ensuring voluntary participation
If hospitals decide to participate in the federal program, some protections for the volunteer health care workers need to be in place first, adds Moran.
"The CDC has made it pretty clear that this is going to be voluntary, so I don’t think that anyone is going to be forced into it," he notes. "But I think there probably are some implementation issues that the hospitals need to address. They need to do their implementation in such a way that people don’t feel coerced into doing it."
At Olive View-UCLA, the facility will determine categories of health care workers and others who should be vaccinated, he explains.
"We will select a certain number of people needed from emergency medicine, from infection control and infectious disease, also ward nurses and others that might have to take care of that first group of people on the ward," he says. "We will come up with just some general allocations of numbers and then leave it up to individual departments and groups to decide within themselves who is interested in and volunteers to be vaccinated."
It is unlikely that there will be too few volunteers to step forward, he says.
"Based on just a kind of informal polling locally, I think the majority of people are willing to take it, and there are a sizeable minority of people who aren’t," he says. "I think we can work around it."
Liability protections for vaccinated workers
Another big area of concern is whether vaccinated health care workers can be held legally liable for inadvertently transmitting vaccinia to patients, says Moran.
Section 304 of the Homeland Security Act specifically covers the vaccine manufacturers and personnel who administer the vaccine — stipulating that the federal government will be the sole entity offering compensation for adverse events. But it is not clear that this section will cover the vaccinated health care workers.
"For example, say I am an emergency physician and am vaccinated and, while I have this lesion on my arm, even though I have it properly covered and keep it clean, a patient with HIV comes in and somehow is infected and has a complication," Moran says. "They may potentially sue me because I should have known better than to take care of an immunocompromised patient if I had the smallpox vaccine — even though ACIP does not recommend any restrictions on patient care, there is always the potential for that to happen."
It isn’t fair to ask the health care workers themselves to bear the burden of liability, he says. "Since we are asking health care workers to get vaccinated, not so much for the benefit of them as for the benefit of society, I think it is fair that we ask society to bear the burden of liability."
In addition, the issue of workers’ compensation for complications suffered by vaccinated health care workers has not been addressed and should be, before inoculations begin, Moran says.
Dealing with those not chosen’
In addition to ensuring protections for the volunteers, hospitals also should have a plan for addressing the concerns of the health care workers who are not selected to serve on the designated response teams.
It its proposed implementation plan, the CDC has indicated that state and local health departments would administer the vaccine to the initial health care volunteers at special clinics set up for the purpose. Only specific volunteers designated by the hospital will get the vaccine.
Health care workers or other personnel in departments not included as part of the emergency team categories may feel that they are being denied the protection the vaccine offers, Moran says.
"We are just going to have to recognize that there are a limited number of doses available in the first round, and it is likely that there will be more vaccine offered at a later stage to those who want to be vaccinated," he says. "People will just have to understand that the experts designated in their facility are just going to have to make some decisions about what the priorities are."
Hospitals also should consider that many of the drugs related to smallpox preparation and treatment are investigational new drugs (INDs) and are yet to be approved by the Food and Drug Administration (FDA), says Shanley.
The existing smallpox vaccine supply consists of the Dryvax vaccine, which is FDA-approved, he explains. That vaccine is grown from calf lymph. However, the newer versions of smallpox vaccine will be grown using new tissue-culturing technology.
Vaccine manufactured in this manner has yet to be approved. And the vaccinia immunoglobulin product — the medication given if a person experiences a severe reaction to the vaccine — also is not yet FDA-approved.
"That changes how you do your vaccines," Shanley warns. "This might fall under the human use committee at our university. If it is a voluntary program and a pre-event situation, then we must give the participant informed consent, do all the paperwork, and the tracking is completely different."
The question for most institutions, he asks, is: Which institutional review board would have jurisdiction?
"That pretty much hit us out of the clear blue and we don’t have an answer yet," he says. "But before we do anything that has to be clearly defined — who will review this and is this considered under the purview of the IRB?"
Right now, most facilities are asking the same questions and trying to have answers in place by the time the government begins releasing the vaccine to health departments, he adds. "We are all still scurrying around trying to figure out how to do this."
- Gregory J. Moran, Department of Emergency Medicine and Division of Infectious Diseases, Olive View-UCLA Medical Center, 14445 Olive View Drive, Sylmar, CA 91342.
- John D. Shanley, MD, Director, Division of Infectious Diseases, University of Connecticut Health Center, 263 Farmington Ave., Farmington, CT 06030-3212.