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CDC: Few hospitals have complete team of smallpox responders
Focus now on regional or post-event response
Fewer than half of the nation’s acute care hospitals have vaccinated even a single employee against smallpox, and only 235 have vaccinated a response team of at least 25 employees, the Centers for Disease Control and Prevention has reported. That means hospitals will need to consider other mechanisms to ensure bioterrorism preparedness, CDC experts said.
"Regional hospital teams may have to be formed to ensure that there are enough vaccinated persons to manage an outbreak," Raymond Strikas, MD, director of Smallpox Preparedness and Response Activity for CDC’s National Immunization Program, told a federal advisory panel in June.
When CDC launched the smallpox vaccination program, federal officials hoped to vaccinate as many as 500,000 health care workers. Only about 24,000 hospital workers have received the vaccine. Another 11,700 public health workers have been vaccinated. Vaccinations are concentrated in a handful of states, including Florida, Texas, Tennessee, Ohio, California, Nebraska, and Minnesota.
By June, the program had virtually halted, with about 100 vaccinations taking place per week around the nation, Strikas said.
Hospitals should evaluate their preparedness and look at other options, says Walter Orenstein, MD, director of the National Immunization Program. "If you could increase the number of people on response teams, that would be ideal," he says.
If hospitals don’t have a vaccinated response team, they should work with local health departments to ensure vaccine would be readily available if a smallpox outbreak occurs, he says. They also should determine how they would transport a smallpox patient to a hospital that has a response team, he says.
"Each hospital needs to be prepared to deal with [a potential outbreak]," Orenstein says. "The goal was to have a staff that could provide care 24/7 to cases that came in."
Lacking that capacity, "we’ll work with what we have," he says. "This has always been a voluntary program. We have never mandated it. People have to weigh the risks and benefits for themselves."
Meanwhile, the future of the smallpox vaccination program is unclear. CDC asked states to submit a plan for vaccinating first responders, such as law enforcement officers, by July 1. The agency will review the plans and respond by Aug. 1. The state of Florida already has begun vaccinating first responders. (See HEH, July 2003, p. 89.)
In June, the Advisory Committee on Immunization Practices (ACIP) recommended keeping the target group limited to hospital and public health workers, without expansion. An Institute of Medicine panel also called for a pause in vaccinations to allow for evaluation.
"The official CDC guidance is that if states want to, they can go forward," says Orenstein.
In a press briefing, CDC director Julie L. Gerberding, MD, said ACIP recommendations have "a very strong persuasive impact on decisions that we make." But she added that bioterrorism preparedness has national security as well as public health implications, and that smallpox vaccinations would continue.
"This is a situation [where] we are balancing the public health issues and the safety and indications for vaccination with a homeland security issue and our need to make sure that we truly can prepare our nation in the event of a smallpox attack," she said. "It’s very tempting to conclude that somehow the smallpox risk has miraculously evaporated, and that’s just simply not true."
The small vaccination response has made it more difficult for CDC to analyze the risk of adverse events among civilian vaccinees. For example, the CDC had planned to survey 10,000 health care workers at 10 and 21 days after vaccination. Instead, just 735 workers were surveyed.
DoD screens for contraindications
Better information on vaccine-related events has been collected by the Department of Defense, which vaccinated about 455,000 military and health care personnel. Those vaccinees typically were younger than the health care worker population and more likely to be primary vaccinees.
One conclusion: Screening for contraindications appears to have been a success. Several of the serious adverse events previously associated with the vaccine, such as eczema vaccinatum, were not reported in any vaccinee.
The most common serious adverse event was actually one not expected at the start of the vaccination program. There were 22 civilian and 46 military cases of reported myo/pericarditis. All have recovered.
The cardiac screening that began in March would only have prevented a portion of those cases. Among the civilian vaccinees that developed myo/pericarditis, 41% had no cardiac risk factors, and none had three or more risk factors, the CDC reported. The current screening rules out individuals with a diagnosed heart condition or three or more cardiac risk factors.
Yet the smallpox vaccine appears not to be the culprit in ischemic cardiac events that followed vaccination. Two civilian health care workers died of heart attacks within days after vaccination, and three other vaccinees suffered heart attacks. Those rates are within the range of expected events, according to Juliette Morgan, MD, of the CDC’s Smallpox Vaccination Adverse Events Monitoring Activity.
One military vaccinee who died of a heart attack was a 55-year-old smoker with a pre-existing heart condition and no myocarditis. "At this stage, we attribute zero deaths to the smallpox vaccine," says John Grabenstein, RPh, PhD, deputy director of clinical operations for the Military Vaccine Agency in Falls Church, VA.
A review of the vaccination program also found that:
• Twenty-six health care worker vaccinees and 28 contacts of vaccinees had contraindications that were identified after vaccination. No breakdown was available on those cases, but at least eight involved women who did not know they were pregnant when they were vaccinated or who became pregnant within a month of vaccination. In the military program, 125 were pregnant before or within a month after vaccination, and 10 HIV-infected people were vaccinated. They had a normal vaccine reaction with no adverse events. There have been no cases of fetal vaccinia.
• There were no needlesticks associated with the bifurcated needle used to administer the vaccine. However, CDC officials said they are investigating the use of a safety-engineered device.
• No cases of transmission occurred between vaccinated health care workers and patients. Based on the military experience, "the greatest risk [of contact transmission] is to people you share your bed with," Grabenstein says.