- The Washington Times - Friday, March 28, 2003

ATLANTA, March 28 (UPI) — Despite a very low fatality rate, a panel of experts recommended Friday that people with a history of heart disease or risk factors for the condition should not receive the smallpox vaccine.

The Centers for Disease Control and Prevention convened the panel after several reports of heart problems and two deaths from heart attacks among vaccinated civilian and military personnel raised concern about the effect of the vaccine on the heart.

The panel's recommendations came as the U.S. Army said a 50-year-old National Guardsman died from a heart attack Wednesday, raising the number of heart attack deaths to three among the more than 350,000 military personnel and civilians who have been vaccinated thus far.

Col. John Gravenstein, the science director for the Department of Defense smallpox vaccination program, said the heart attack death was considered "unlikely to be due to smallpox vaccine" because the man had a history of smoking, high cholesterol and evidence of heart disease.

Given that the other individuals who suffered heart attacks also had pre-existing heart conditions prior to vaccination, the CDC's Advisory Committee on Immunization Practices concluded the deaths were probably coincidental and not due to the smallpox vaccine.

The vaccine does appear to play a role in causing inflammation of the heart or the membrane around the heart, the panel said. Their conclusion was based on several cases of inflammation of the heart and the heart membrane in vaccinees who did not have underlying heart conditions.

"Everybody's estimation at the moment … is it is unlikely there's a cause and effect relationship between smallpox vaccine and sudden death from coronary artery disease," Dr. John Modlin, chairman of ACIP and professor of pediatrics and medicine at Dartmouth Medical School, told United Press International.

On the other hand, Modlin noted, "We have enough information to suggest there is a relationship with" inflammation of the heart and the membrane around the heart.

The CDC made the temporary recommendation earlier this week that people with a history of heart disease should avoid the vaccine while the agency investigates the issue to determine which if any groups of people are most at risk of developing a heart problem.

However, most of the ACIP members decided it would be prudent to go one step further and also exclude people with three major risk factors for heart disease from being vaccinated. Risk factors for heart disease include smoking, obesity, high blood pressure and high cholesterol. The panel's recommendations are not binding on the CDC.

Screening out these individuals would probably do little to eliminate those who might develop heart inflammation since heart disease and risk factors for heart disease do not indicate a risk for inflammation.

The panel members concluded that people with heart problems should be screened out because there is a small possibility that the vaccine could exacerbate underlying heart conditions or cause heart inflammation and increase the risk of a heart attack, Modlin said.

"There was general agreement (among the panel) that there is a biologically plausible mechanism that could link the two but the likelihood there could be a link continues to be low," he said. But "for safety purposes" the panel is obligated "to look into this more carefully," he said.

One member said he thought the vaccination program should be suspended. Dr. Paul Offit, chief of the section of infectious diseases at The Children's Hospital of Philadelphia, said the small possibility of the vaccine itself or heart inflammation caused by the vaccine causing a heart attack was enough to warrant temporarily halting the program.

"We should consider temporarily suspending the vaccination program until we better understand this," Offit said.

(Reported by Steve Mitchell, UPI Science News, in Washington)

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