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Second Heart Death Tied to Smallpox Vaccine

CDC also reports 10 cases of heart inflammation in military

THURSDAY, March 27, 2003 (HealthDayNews) -- Two women have now died apparently as a result of heart attacks suffered in the wake of receiving vaccinations against the smallpox virus.

Five other individuals have developed heart-related conditions, including one additional heart attack, two cases of angina (chest pain), and two cases of myopericarditis, or inflammation of the heart muscle or sac surrounding the heart.

In addition, 10 military personnel are known to have developed myopericarditis after being vaccinated.

It is not yet clear which, if any, of these cases are a direct result of the vaccinations.

"While the evidence is somewhat suggestive that the vaccine is playing a role in the myopericarditis, particularly based on the military data, the data from the civilian side from the heart attacks and from the cases of angina are within what we might have expected from chance alone," Dr. Walt Orenstein, director of the U.S. Centers for Disease Control and Prevention's (CDC) National Immunization Program, said at a news briefing on Thursday.

One of the civilian women was 50 years old and had a history of hypertension and smoking. She was vaccinated on March 18, developed chest tightness, dizziness, nausea and vomiting on March 22, and died 24 hours later. A preliminary autopsy indicated a heart attack.

The second woman, identified by the St. Petersburg Times as Virginia Jorgensen, a nurse's aide in St. Petersburg, Fla., was 57 and also had a history of hypertension and smoking. She first went to an emergency room on March 4, six days after her vaccination, and was diagnosed with an exacerbation of chronic obstructive pulmonary disease and dehydration. She was hospitalized again on March 16 after a sudden cardiopulmonary arrest at her home, and died on Wednesday. Jorgensen had had a previous cardiac catheterization during which she had suffered a transient ischemic attack, or "mini-stroke."

At least in the civilian population, the heart conditions may be consistent with what would occur naturally in the population, health officials say.

The military cases appear more suspicious. All of the cases of myopericarditis occurred among individuals who had never before been vaccinated against smallpox, indicating that they were born after 1972, when smallpox vaccinations for the general population were halted. There have been no reports of adverse events among military personnel who were previously vaccinated. "It's only in the first vaccination group that this is occurring," Orenstein said. From a biological perspective, experts might expect to see some kind of increased inflammation, he added.

Roughly two-thirds of the civilians vaccinated are over the age of 45, Orenstein said.

Orenstein indicated that all of the military personnel have recovered and are back at their regular duties, but this could not be confirmed.

Even though the exact relationship between the heart ailments and the vaccine is unclear, health officials are recommending that people with cardiac disease be excluded from the program. The CDC also advises anyone who develops shortness of breath or other symptoms of cardiac disease after the smallpox vaccination seek medical attention.

There have been reports of myopericarditis following smallpox vaccination in the past, but the majority of the reports came from Australia and Europe, where a different strain of the vaccine was used. "Heart problems were not scientifically accepted adverse events of the smallpox vaccine," Orenstein said. "Certainly there may be occasional reports of this but not enough to support a role for the vaccine."

Meanwhile, the CDC appears to be proceeding with the second phase of the smallpox vaccination program, which calls for voluntary vaccination of all health-care and public safety workers such as firefighters and police nationwide. Although official guidelines will not be released to states until mid-April, according to Orenstein, indications are that some jurisdictions may already be proceeding.

However, the Institute of Medicine (IOM) is urging the CDC to take a more careful look before continuing. The institute's Smallpox Vaccination Program Committee, in a report released to the CDC on Thursday, recommends the CDC "comprehensively evaluate the program and its outcomes in order to improve its implementation and to protect the vaccinees and the public." The committee's first report recommended a pause between the first and second phases.

"Efforts from here on in should be focused on what is needed for preparedness," said Dr. Brian Strom, chairman of the IOM committee. "This is an opportunity to recalibrate and redirect the program to make sure the focus is on what is really needed in the future."

More information

Read the committee's letter at the Institute of Medicine. For more on smallpox, visit the U.S. Centers for Disease Control and Prevention or the U.S. Department of Health and Human Services.

SOURCES: March 27, 2003, news briefing with Walt Orenstein, M.D., director, National Immunization Program, U.S. Centers for Disease Control and Prevention, Atlanta; March 27, 2003, news briefing with Brian Strom, M.D., chairman, Institute of Medicine Committee on Smallpox Vaccination Program Implementation, and professor, biostatistics and epidemiology and of medicine and pharmacology, University of Pennsylvania School of Medicine, Philadelphia; March 28, 2003, Morbidity and Mortality Weekly Report; March 27, 2003, St. Petersburg Times
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