Heart inflammation problems cause worries for smallpox vaccination program


A Florida nurse is the second health care worker to die of a heart attack after being vaccinated against smallpox, and an additional 10 people have experienced heart inflammation and chest pain, the Centers for Disease Control and Prevention said Thursday.
The first casualty, a Maryland nurse, died Sunday.

The newly disclosed cases, which bring to 17 the tally of post-vaccination heart problems, are focusing attention on unanticipated risks in a program that has already met with public reluctance.

Simultaneously, a federal panel again asked the CDC to halt the program and evaluate its progress before proceeding with planned vaccinations of health workers, first responders and law enforcement that are scheduled for later this year.

“Focus on protecting the safety of the vaccine recipients and the public is paramount,” said Dr. Brian Strom, a professor at University of Pennsylvania’s School of Medicine who chaired the Institute of Medicine panel evaluating the smallpox vaccination program.

In the first round, which started Jan. 24, 25,645 public health workers and emergency room staff have been vaccinated. The campaign could eventually involve 10 million Americans.

Seven civilians who have been vaccinated have had heart problems: three heart attacks, two of them fatal; two cases of angina, or chest pain; and two cases of inflammation of the heart or surrounding membranes.

About 350,000 members of the military also have been vaccinated, according to the Department of Defense. Ten of those reported chest pain about a week after their vaccinations; they also were diagnosed with inflammation of heart muscle or the membrane surrounding the heart. All 10 have recovered.

Health authorities took pains Thursday to distinguish the inflammation cases from the more serious cardiac events.

When smallpox vaccination was routine in the 1950s and 1960s, the CDC said, a few cases of heart muscle inflammation were reported in Europe and Australia, which used a different virus in its vaccine than America does.

“The evidence is somewhat suggestive that vaccine is playing a role in . . . the inflammation side of this,” said Dr. Walt Orenstein, director of the CDC’s National Immunization Program. “[But] the heart attacks and the cases of angina . . . are within what we might have expected by chance alone.”

Since the first death was reported Tuesday evening, the CDC has argued that Americans’ rate of heart disease is so high that there are apt to be heart attacks within two months in any group of 25,000.

Backing up that assertion, the three heart attack patients — all women in their 50s — are known to have had serious health problems before being vaccinated. All three had high blood pressure, two smoked, one was obese, and another was diabetic. All are conditions that would make heart attacks more likely.

Nevertheless, health experts said Thursday it was possible the vaccine could encourage a heart attack in someone with serious coronary disease. Because the vaccine uses a live virus and creates a brief but acute infection, the body’s response could tip the balance toward a heart attack, they said.

The CDC has temporarily banned anyone with previously diagnosed heart disease from getting the smallpox vaccine. The agency also must evaluate whether to exclude anyone with a condition that might indicate heart disease, such as diabetes, obesity or high blood pressure.

“If we look at all known risk factors for coronary artery disease, we would potentially get to very, very large numbers of the population,” Orenstein said. “What we’ve tried to do is pick out people with the very highest of risk factors, in the absence, at this point, of any known causal rela- tionship.”

The CDC is consulting cardiologists and will hold a meeting today of outside advisers from academic medical centers, professional organizations and the military to discuss the cases.

So far, the CDC said, over two-thirds of those vaccinated have been 45 or older. Those over 30 are apt to have been vaccinated as children, possibly reducing the risk of serious side effects.

Because age is the greatest heart disease risk factor, the program could opt to vaccinate younger people, cutting the risk of heart problems but increasing the risk of the heart inflammation suffered by the younger military members, as well as other side effects.


M.A.J. McKENNA writes for the Atlanta Journal-Constitution.