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http://www.mindfully.org/Health/2003/Smallpox-Vaccination-Death28mar03.htm

Second Death Follows Smallpox Vaccination

DENISE GRADY / NY Times 28mar03

A second health care worker has died of a heart attack after receiving a smallpox vaccination, the Centers for Disease Control and Prevention reported yesterday.

The woman, 57, had a heart attack on March 16, 18 days after being vaccinated, and died on Wednesday.

She was among seven health workers to suffer heart problems 4 to 18 days after receiving the vaccine voluntarily, as part of the United States' effort to prepare medical teams to cope with bioterror attacks. Three volunteers had heart attacks, including another woman who died; two had chest pain; and two had heart inflammation.

In addition, 10 military recruits had heart inflammation after being vaccinated for the first time; all recovered, said Col. John D. Grabenstein, the Army's deputy director for vaccines. He added that the problem appeared extremely rare, since only 10 cases were known in more than 350,000 recruits who were given the vaccine. So far, Colonel Grabenstein said, there is no feature to link the cases or help doctors predict who might be vulnerable to the condition.

Although it is not known whether any of the problems in the civilians or the military were from the vaccine or were merely a coincidence the disease centers on Tuesday ordered a temporary suspension of smallpox vaccinations for anyone with heart disease, while researchers try to determine whether there really is a link. Several health workers had heart disease or risk factors for it, including the ones who died, the centers said, but the military recruits, all healthy young men, did not.

At a news briefing, Dr. Walter Orenstein, director of the centers' national immunization program, said: "In terms of what this will do to the program, we are working to try to maintain the program. The vast majority of people would not be included in the risk factors. We need to continue our efforts to improve preparedness."

Heart inflammation after a smallpox vaccination has been reported occasionally in the past, but not chest pains or heart attacks, officials of the centers said. But earlier vaccination campaigns in the United States centered on children and young people, while in the current program, two-thirds of the volunteers are over 45, and so they are more likely to have underlying heart problems making them prone to heart attacks or chest pain from blocked arteries.

Cardiologists said a connection between the vaccine and the different types of heart problems was biologically plausible. The reason is that a smallpox vaccination causes a low-grade infection with the vaccine virus, vaccinia, a relative of smallpox. The infection can cause widespread inflammation, which in rare cases can involve the heart, even in healthy people. In someone who already has heart disease and blocked arteries, inflammation may increase the tendency to form blood clots, which can lead to a heart attack.

The American Heart Association issued a statement yesterday that it supported the temporary suspension of vaccinations for people with heart disease, until more information about the risks becomes available.

In a separate report yesterday, the Institute of Medicine, an arm of the National Academy of Sciences, said the government should re-evaluate the costs, risks and goals of the vaccination program and determine whether some states had already inoculated enough health workers to cope with a bioterror attack.

The program has vaccinated 25,645 workers, far fewer than expected. In December, President Bush authorized a voluntary program to inoculate as many as 439,000 doctors, nurses and emergency workers who would act as first responders if a smallpox attack occurred. At that time, federal officials predicted that the program might be finished as early as March.

The Institute of Medicine report, by an independent panel of experts, mostly professors at medical schools, said that instead of focusing on mere numbers of workers vaccinated, state and federal officials should gauge preparedness by determining whether their teams were able to collaborate and communicate.

"Numbers alone don't constitute preparedness," Dr. Brian Strom, chairman of the panel, said.

The report also noted that many health workers were refusing to volunteer for the vaccine because the government has no program to compensate them if they are harmed or lose time at work because of side effects. Congress is considering legislation to cover them, but nothing has been passed yet.

The report also noted that some states were claiming that the vaccination program was draining resources from other badly needed public health programs.

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