Heart Problems Reported in Smallpox Vaccine Recipients

Published May 1, 2003

Two women, both first-responder health care workers in their 50s, have died of heart attacks suffered after receiving vaccinations against the smallpox virus. A 55-year-old National Guardsman with a history of coronary artery disease also died of a heart attack days after receiving the vaccine.

Five other individuals have developed heart-related conditions after receiving the smallpox vaccine, including one additional heart attack, two cases of angina or chest pain, and two cases of myopericarditis, an inflammation of the heart muscle or sac surrounding the heart. In addition, 10 military personnel are known to have developed myopericarditis after being vaccinated.

None of the reported heart problems has been linked directly to the vaccinations, although research is ongoing. Dr. Walt Orenstein, director of the National Immunization Program of the U.S. Centers for Disease Control and Prevention, says the evidence may suggest 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,” says Orenstein, “and from the cases of angina are within what we might have expected from chance alone.”

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, Florida, was 57 and also had a history of hypertension and smoking. Jorgensen had undergone a previous cardiac catheterization, during which she had suffered a mini-stroke.

First-time Recipients

All of the cases of myopericarditis occurred among individuals who had never before been vaccinated against smallpox, indicating 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,” the CDC’s Orenstein said. All have recovered, Orenstein said, and are back at their regular duties.

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 its smallpox vaccination program, which calls for voluntary vaccination of all nationwide health care and public safety workers such as firefighters and police.

Warnings Expressed

The Advisory Committee on Immunization Practices, which advises the CDC, has recommended the list of people who should not take the vaccination be expanded to include heart patients and persons at risk of heart disease.

The Institute of Medicine (IOM) 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 report recommended a pause between the first and second phases of the vaccination program.

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

Federal officials had planned to offer the vaccine on a voluntary basis to at least 450,000 civilians in the program’s first month. After two months, only about 25,000 have been vaccinated, with many hospitals opting out of the program.

The CDC is working to improve the numbers, but after learning of the first death, officials decided anyone with a history of heart disease should not get the vaccine. The Pentagon adopted the same policy.

Conrad F. Meier is managing editor of Health Care News. His email address is [email protected].

For more information …

on the smallpox vaccination program, visit the CDC Web site at http://www.cdc.org and the Department of Health and Human Services’ Web site at http://www.hhs.gov.