Smallpox slowdown: Some call for halt before phase 2

Some states already vaccinate first responders

First responders and law enforcement officers began receiving smallpox vaccines in some states, even while cardiac events associated with the vaccine continued to draw scrutiny.

Myopericarditis — inflammation of the heart or the membrane covering the heart — has officially been added as a vaccine-related adverse event. In all, 21 health care workers developed the condition after smallpox vaccination, according to the Centers for Disease Control and Prevention (CDC).1 That includes seven vaccinees who developed dysrhythmias, which is part of the case definition of myopericarditis. Six vaccinees suffered a heart attack — including two who died — and three had angina, but the CDC has not yet determined if those incidents were related to the vaccine. If the current cardiac-risk screening tools had been in place, only three of the nine would have received the vaccine.

Only about 36,000 health care workers have received the smallpox vaccine, far fewer than the 500,000 once envisioned by the CDC. The response varied greatly around the country. For example, about 3,600 health care workers were vaccinated in Florida, but as of May 19, only 10 public health workers had received the vaccine in Nevada.

About half of those vaccinated were concentrated in eight states: Florida, Minnesota, Missouri, Nebraska, North Carolina, Ohio, Tennessee, and Texas.

"Right now, we’re considering whether or not vaccination should be expanded [to other groups]," Lisa Rotz, MD, of the CDC’s Bioterrorism Preparedness Response Program said at the American Occupational Health Conference in Atlanta in May. The conference is sponsored by the American Association of Occupational Health Nurses and the American College of Occupational and Environmental Medicine. "Some states have moved forward, and that’s OK. We just haven’t done it on a national, across-the-board basis."

An Institute of Medicine panel had urged the CDC to evaluate the vaccination program before going ahead. A General Accounting Office (GAO) report said that not enough information was available on the program’s safety.2 "Although the CDC announced that it would provide guidance for and request plans from the jurisdictions for the second stage, it has not done so," the GAO said.

The report noted that "too few health care workers have been vaccinated and too little time has passed since their vaccination to precisely estimate rates of adverse events. Therefore, it cannot yet be determined whether the rates are the same as would have been anticipated on the basis of historical data or different enough to trigger reconsideration of how the program should proceed."

Advocates for health care workers also urged caution, particularly while the CDC investigates whether serious cardiac events are related to the vaccine. "There needs to be a distinct period where evaluation is done and modification is done to make sure we’re moving appropriately into this next round of vaccinations," says Cheryl Peterson, RN, senior policy fellow with the American Nurses Association in Washington, DC. "I don’t see that happening, and I think that’s unfortunate."

The CDC has promoted smallpox vaccination as a critical part of bioterrorism preparedness and had advocated a smooth transition from stage one to stage two. Some states have taken that message to heart.

"This is not about a vaccination program. This is about a preparedness program — [for] health and emergency response teams to be ready in the event of a smallpox attack," says David Miller, coordinator of Operation Vaccinate Florida. He predicted phase two would take six to nine months as the state offered the vaccine to emergency medical workers, fire and rescue workers, and law enforcement officers in May. He didn’t have an estimate of how many might eventually receive the vaccine.

In Tennessee, public health authorities began planning for phase two but put off implementation until fall. "We would like to evaluate the experience with phase one and also hope that the CDC will come forth with more about the adverse events," says Allen Craig, MD, state epidemiologist with the Tennessee Department of Health.

The response to phase two may be less than enthusiastic. At University Hospital in Newark, NJ, first responders were offered the vaccine as part of phase one. The hospital-affiliated emergency medical service (EMS) provides medical response for the city of Newark and the Newark International Airport. Only three EMS workers were vaccinated.

"There will not be a big outcry for the vaccine," predicted Lawrence Budnick, MD, MPH, director of the occupational medicine service at the University of Medicine & Dentistry of New Jersey, also in Newark. A new federal compensation program may address some concerns about compensation for adverse events. But conversely, the end of the war in Iraq may have dampened the sense of urgency and threat, he noted.

Meanwhile, some employee health professionals began wondering about the long-term maintenance of their preparedness teams — how to cope with staff turnover and the potential need for boosters. Immunity diminishes after about five years, Rotz said. "The initial goal is to get some teams vaccinated. We’ve got some time to work out those other issues."

(Editor’s note: For a copy of the GAO report on the smallpox vaccination program, go to: www.gao.gov/new.items/d03578.pdf.)

References

1. Centers for Disease Control and Prevention. Update: Cardiac-related events during the civilian smallpox vaccination — United States, 2003. MMWR 2003; 52:492-496.

2. U.S. General Accounting Office. Smallpox vaccination: Implementation of National Program Faces Challenges. Washington, DC; April 2003.