Click Here For CDC's Smallpox Vaccination Adverse Events Report

Posted: 28-March-2003
By Mary Ellen Butler
ATLANTA-Officials at the Centers for Disease Control and Prevention recently recommended that people with heart disease be temporarily deferred from participation in the ongoing federal smallpox vaccination plan of health workers.

The announcement, made March 25, came after seven people who had been vaccinated, experienced heart problems, including one person who died.

The healthcare worker who died worked in Maryland and had volunteered to be vaccinated against smallpox on March 18. She died on March 23, and preliminary autopsy reports indicate that a heart attack was the cause of death.

The Maryland Department of Health and Mental Hygiene, the Virginia Department of Health and CDC are investigating the death to see if it is linked to her smallpox vaccination.

The six other cases that prompted concern from health officials included two other heart attacks, two cases of angina, and two cases of myopericarditis (inflammation of the heart muscle or sac surrounding the heart).

All of these cases have been reviewed by the Advisory Committee on Immunization Practices' (ACIP) Smallpox Vaccine Safety Review Board. CDC continues to investigate the cases, looking at individual medical histories, including risk factors for heart disease. CDC is also starting research projects aimed at identifying associations between smallpox vaccine and heart problems.

In five of the cases-the three patients who suffered heart attacks and the two with angina-there were clear risk factors for coronary artery disease, said CDC director Dr. Julie Gerberding.

"Coronary artery disease is a very common condition in our society, and people who have strong risk factors for coronary artery disease do develop angina and have heart attacks all the time," Dr. Gerberding said. "So we cannot say that what we've observed in these vaccine volunteers is a greater frequency of this problem, greater than what we would expect under other circumstances. But we will certainly do everything we can to get to the bottom of this issue."

CDC is recommending that persons with known cardiac disease, such as cardiomyopathy, a previous heart attack, history of angina, or other evidence of coronary artery disease, should not be vaccinated at this time. Officials from CDC are providing states with screening questions to use before vaccination.

This temporary deferral is expected to affect less than ten per cent of vaccine recipients, and possibly less than five percent, according to Dr. Gerberding.

"We promised to closely monitor this program and to put safety first, so we are exercising exceptional caution," she said. "If our investigation shows this precautionary measure should become permanent or [that there is a] need for other changes or enhancements in the civilian smallpox vaccination program, we will take immediate action."

CDC and state health departments are currently involved in vaccinating health workers who could treat and vaccinate others in the event of a smallpox attack. To date, more than 25,000 people have been vaccinated.