Have you been vaccinated?

By Dorothy Pennachio and Ken Terry
Senior Editors

The scourge of smallpox is again a threat, but the vaccination program planned to thwart it is controversial. What will you tell patients? What will you do yourself?

Experts agree that a single confirmed case of smallpox would signal a bioterrorism attack and would have to be treated as an international health emergency. But what steps should be taken to cope with such an occurrence remains a subject of controversy. The government favors a mass vaccination program now. The opposition from health professionals is based on fears that the vaccine itself could endanger them and their patients.

To review what has happened so far: Earlier this year, the CDC and federal health officials recommended a three-phase, voluntary vaccination plan for the US civilian population. In the first phase, a select group of doctors, nurses, and other caregivers at hospitals and public health agencies—up to 450,000 people—were offered the vaccine. (At press time, only a small percentage of these health workers had accepted the offer.) Those individuals who'd been vaccinated would be ready to respond if a case of smallpox were suspected or identified.

The second phase encompasses all remaining health care workers, including office-based physicians, and other first responders such as EMTs and law enforcement officers. That would involve another 10 million people. The general public would be eligible to receive smallpox vaccinations in the third phase.

Vaccinations would not be administered to pregnant women, the immunocompromised, those with a history of eczema or certain other skin conditions, or to household members of people in those categories. In March the CDC added persons diagnosed with heart disease to that list, due to reports of heart problems in seven vaccinated health care workers.

You and the rest of the nation's physicians are already facing the decision of whether to be vaccinated. Should you?

The answer depends upon your perception of the threat, says William Schaffner, chairman of the preventive medicine department at Vanderbilt University School of Medicine in Nashville and a member of the CDC committee that proposed the vaccination program. "If you believe the possible risk of smallpox introduction is high, the equation solves in favor of vaccination," he says. "If you think it's low, the equation solves as 'be prepared.' "

The case for being immunized

The American College of Physicians supports vaccinating only those people who serve on designated smallpox public health response and health care teams. Any decision to move the program beyond this first group should be made only after review of updated clinical data and a reassessment of the threat. Internist John Mitas, the society's deputy executive vice president, thinks the CDC was right to propose that emergency response teams be vaccinated at hospitals all over the country.

"Rather than wait for an event to occur, it's better to do these vaccinations under controlled circumstances," Mitas says. "This way you can select the appropriate people without being under the pressures of a panic."

Internist Richard Garibaldi also thinks the CDC's immunization plan is appropriate. "It's important to have health care workers who are protected, so that if the need arises, a core group can do a more massive vaccination campaign," he says. He and three other doctors at the University of Connecticut Health Center were among the first to be vaccinated in January. Their "Genesis" team is vaccinating other health care providers. They will also vaccinate members of the public if that becomes necessary.

Garibaldi, chairman of the department of medicine at U Conn, points out that few controversies surrounded the vaccination program of the 1950s, when infants were routinely vaccinated. "And kids like to scratch what itches," he says. "Precautions are in effect now that people back in the '50s and '60s weren't even aware of," he says.

"This vaccination plan is a landmark event," adds Garibaldi, "but it's not like vaccinations haven't been going on throughout recent decades. Individuals received smallpox shots if they were involved in certain research projects or were in the military."

Why should our focus be on smallpox when there are several other weaponizable candidates for conducting germ warfare? "Smallpox is a disease that is highly contagious and one for which we have preventive action," says Garibaldi. "We don't have effective and readily available vaccines for the other diseases."

James Garb was vaccinated as a child and has been again, in accordance with the CDC plan. Garb, the director of employee health services at Baystate Medical Center in Springfield, MA, believes the CDC's warning that there's a risk of smallpox release.

"The risk may be small, but it exists," he says, "and we can't wait for an outbreak. There'd be too much confusion."

Did he ever consider not volunteering for the immunization? "No," he says. "If there's an attack, the benefit will be monumental."

"Until we finish Phase II of the president's plan, our nation won't be protected," says William J. Bicknell, professor of international health at Boston University School of Public Health. "Let's vaccinate people in each state and get data on side effects and complications as we go." He believes vaccination of healthy adults is safe, as long as precautions are followed. "Careful screening before vaccination and the use of semipermeable dressings can prevent the vast majority of the vaccine's serious side effects," he says.

Bicknell does have a quibble with the CDC's handling of the program, though. "Although we have all the material necessary to control an outbreak, administratively we're far from ready," he says. "The CDC's Web site is chaotic." He faults the organization for not having clear, concise directions for health care workers and for not making it clear that the vaccine is safe in healthy adults.

"With the millions of vaccinations of healthy adults from 1963 to the present US military experience, there's not been a single vaccine-related death," says Bicknell.

Why some physicians and facilities are balking

Many hospitals and physicians around the country, however, are saying No to the voluntary vaccination program, either because they're concerned that their patients and families may contract vaccinia, or because they're not convinced that the smallpox threat is real. At press time, hundreds of hospitals had declined to participate in the program, and many more hadn't decided. In addition, a report by an expert committee of the Institute of Medicine raised questions about the program's potential effects on patient safety.

The AAFP says the three-phase program must be closely monitored, and it doesn't support immunization of the general public. The American Nurses Association and the Service Employees International Union have asked that the campaign be delayed until key concerns are addressed, including potential transmission of vaccinia virus, the right to coverage of medical costs associated with receiving the vaccine, compensation for lost time at work due to adverse effects, and protection from job discrimination or retaliation for refusing to be vaccinated.

At press time, several states had temporarily suspended their vaccination programs.

Julie Gerberding, the CDC's director, has expressed concern about the opposition. She's "optimistic that we will be able to close these gaps. . . . We recognize that concerns about compensation are resulting in people being slow to accept the vaccination program. . . . Right now, primarily what's going on is that we are vaccinating vaccinators, and we have to get the people who are going to be handling the vaccine protected so that they can safely administer the program."

Even in medical centers that support the campaign, the number of physicians, nurses, and other health care workers who've volunteered so far for vaccination is far lower than expected. At Garibaldi's University of Connecticut Health Center, for example, 25 physicians and staffers have been vaccinated, about half of the number eventually anticipated for the institution. The situation is similar in many other health care systems.

William Schaffner's Vanderbilt University Medical Center declined to participate in the program entirely. The chiefs of services made the decision and the medical staff supported it. "We would accept the risk of vaccination to us personally," says Corey Slovis, chairman of the department of emergency medicine, "but we're afraid to hurt patients, especially the immunocompromised, elderly, or very young. We worried the dressings might not completely prevent leaks of vaccinia, contaminating others."

What clinched the chiefs' decision, says Slovis, was the notion that "we could get hundreds of us immunized within hours of the first confirmed smallpox case." The view is that the hospital could summon physicians and nurses to get shots by using its beeper and phone callout system.

The medical staff of Cooley Dickinson Hospital in Northampton, MA, also recommended that its hospital not participate in the program. Again, protection of patients was the paramount concern, says Ira Helfand, chairman of the emergency department and president of the medical staff. He points out that in the '50s and '60s there were far fewer immunocompromised patients than now—few people on chemotherapy or high-dose steroids, no HIV patients.

"Also, there isn't any credible threat of the imminent use of smallpox as a bioweapon," he says.

Another reason for the staff's decision: "The vaccine is highly protective even if you receive it up to four days after you've been exposed," says Helfand.

Schaffner agrees. "This was the strategy that was used in the global campaign to eradicate smallpox: find the cases, vaccinate everyone directly exposed, then vaccinate more generously around the cases in the community," says Schaffner.

William Bicknell disagrees. "Vaccine administered right after exposure doesn't prevent disease, it just makes it less severe and decreases the risk of death," he says. Vaccination during the first four days of contact may actually make a person more dangerous to others because the patient's less visibly sick and more mobile, he adds.

"From a personal point of view, if you've contracted smallpox, you want the vaccine," he says, "but as a public health strategy, inoculation after the fact is worthless, even counterproductive."

What about medical coverage and liability protection?

The CDC, citing past experience, admits that one or two people out of every 1 million vaccinated may die as a result of life-threatening reactions to the vaccine. About 30 percent of those who have smallpox shots will experience side effects severe enough to be out of work for a while, the agency adds. At press time, several cases of heart inflammation, angina, and MI—including three that resulted in death—had been reported in vaccine recipients.

Few hospitals have chosen to furlough vaccinated staff, but Johns Hopkins Medicine in Baltimore has taken a middle path to deal with that issue. Under its "low risk, go slow" approach, Hopkins is vaccinating only five or six people a week and reassigning them temporarily to duties that don't involve patient care. That way, the health care system can gradually build an immunized emergency team without the risk of endangering patients or putting too much strain on its daily operations.

Part of Hopkins' concern is its liability exposure, since the federal government isn't insuring hospitals against suits from vaccinated volunteers who become ill or from patients who contract vaccinia. Workers' compensation is also an issue for employees who might stay home sick with side effects.

Some health care workers are also worried about insurance coverage. "Who'll pay the bill in the event of severe complications or consequences?" asks Jon Temte, clinic director and associate professor in the family medicine department at the University of Wisconsin Medical School in Madison. "Some public health departments have heard from insurers that complications of the vaccine would not be covered, and that's not uncommon across the country. The risk is low, but if there are complications, costs could be high."

Currently, under the provisions of the Homeland Security Act, state and local health departments and medical facilities that administer the vaccine and vaccine manufacturers are protected from liability. Individuals harmed by the vaccine may have to sue the federal government and prove negligence to receive compensation. The Service Employees International Union has met with the Bush administration to say it's wrong to ask 750,000 health care workers to volunteer without addressing the compensation issue. As we go to press, the Bush Administration proposed a plan for compensating health care workers and other critical personnel injured by the vaccine. The proposed package, which provides money for medical expenses not covered by insurance and to workers who die or who are permanently disabled due to adverse events related to the vaccine, was defeated in the House of Representatives.

Transmission fears may be overblown

What's the risk that vaccinated doctors will infect patients or their own family members with vaccinia? That remains unclear. But to prevent dissemination of the virus, the CDC recommends covering the vaccination site with sterile gauze loosely secured by first aid adhesive tape and topping that with a semipermeable dressing. Caregivers should wear clothing to cover the vaccination site and wash their hands frequently. Changing the dressing every three or four days reduces viral shedding 95 to 99 percent, says Bicknell.

Richard Garibaldi wore a gauze dressing covered with a Tegaderm patch, in turn covered by clothing. "The site was itchy," he says, "but fine otherwise—nothing I'd miss work over." He says none of those vaccinated at his facility missed work, and they all saw patients during the time the site was potentially contagious.

William Schaffner says transmission fears have been overblown. "If you bandage the site, keep an eye on it, wash your hands appropriately, the risk of nosocomial transmission can be close to zero," he says. Mitas, similarly, notes that when he was in the military, he just put a Band-Aid on the site and had no problem treating patients.

"If you keep your shirt on, cover the area with a Band-Aid, and remember not to scratch it, you shouldn't be posing a big risk to anyone," he says.

 

Ken Terry, Dorothy Pennachio. Have you been vaccinated?. Medical Economics Apr. 25, 2003;80:57.