ATLANTA, March 26 (UPI) -- The Centers for Disease Control and Prevention issued an advisory Wednesday notifying health officials that people with certain heart conditions should be temporarily deferred from receiving the smallpox vaccine due to several reports of heart problems, including one death, in healthcare workers and military personnel who have been vaccinated.
Although it remains unclear if the vaccine caused the heart problems, CDC officials said they are taking the action as a precaution.
"We promised to closely monitor this program and to put safety first, so we are exercising exceptional caution," CDC director Dr. Julie Gerberding said in a written statement.
The smallpox vaccine is one of the riskiest vaccines and can cause severe side effects including serious immune reactions and even death in rare cases. Heart problems generally are not considered a side effect of the vaccine but the CDC noted heart inflammation was reported in some people who received the vaccine in the 1960s and 1970s.
Despite the concern, Gerberding said during a news briefing from Atlanta Tuesday night the vaccination program will continue.
"Certainly we are at a time in the history of our country where the potential for terrorism has probably never been higher," she said. "And we recognize that we must continue to be prepared to deal with a threat of smallpox in our nation. And so we are going to continue the program."
Of more than 25,000 civilian healthcare personnel who have been vaccinated against the deadly smallpox virus, three women subsequently suffered heart attacks. One of the heart attack patients -- a healthcare worker in Maryland -- died Sunday and another remains on life support.
All three of the women were older than age 50 and had "very clear risk factors" for heart disease, Gerberding said.
"So we are not talking about people with no unknown reasons to have (a heart attack)," she said. "And that's why we cannot necessarily ascribe any relationship of vaccination to these events. It could be entirely coincidental."
Two other women, who also had risk factors for heart disease, developed angina or chest pain after receiving the vaccine.
There also have been two cases in civilians and 10 cases in military personnel of inflammation of the heart or the sac around the heart, which now is considered a potential complication of the vaccine. Well over 108,000 members of the military have been vaccinated.
In the health advisory, the CDC recommends, "persons receiving smallpox vaccine should be informed that (inflammation of the heart or sac around the heart) is a potential complication of smallpox vaccination and that they should seek medical attention if they develop chest pain, shortness of breath, or other symptoms of cardiac disease within two weeks after vaccination."
The CDC also recommends persons with a history of heart problems, including cardiomyopathy, heart attack, angina or heart disease, temporarily defer from receiving the vaccine. Questionnaires will be used to screen out people with heart problems before they are vaccinated.
Heart problems were not seen in the 1970s when the smallpox vaccine was given routinely prior to the global eradication of the disease. However, the surveillance ability of health officials during that time was limited and side effects could have gone unnoticed, Dr. William Schaffner, who is chairman of Vanderbilt University's Department of Preventive Medicine in Nashville, Tenn., told United Press International.
"It is likely, even if (the vaccine) were causal, we would not have detected it back then," said Schaffner, who is a member of the CDC's Advisory Committee on Immunization Practices.
Some doctors in charge of administering the smallpox vaccine might decide to err on the side of caution and not give the vaccine to anyone with any of the various risk factors for heart disease, including diabetes, obesity, smoking, high blood pressure and high cholesterol, Schaffner said.
"Some physicians may be ... conservative and say you know for the moment if you have some of these conditions associated with heart disease maybe you ought to wait a little bit until this is all sorted out," he said.
Schaffner noted the CDC has scheduled the ACIP panel to meet by teleconference Friday to discuss the heart problems and their relationship to the vaccine.
The agency might change its recommendation for deferring people with heart conditions as it investigates the matter, Gerberding said.
"If our investigation shows this precautionary measure should become permanent or the need for other changes or enhancements in the civilian smallpox vaccination program, we will take immediate action," she said.
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(Reported by Steve Mitchell, UPI Medical Correspondent, in Washington)
