After the first such death was confirmed Tuesday, the Centers for Disease Control and Prevention advised that people with known heart disease not receive the vaccine until an investigation into any possible link has been completed. The Defense Department said Friday that such people are deferred from the vaccination program.
Dr. Bill Winkenwerder, assistant secretary of defense for health-related affairs, said the soldier who died also smoked and had high cholesterol, and an autopsy showed that he had coronary disease. Because of those findings, Winkenwerder said, it appears unlikely that the vaccine was the cause of death.
Winkenwerder said military personnel have had few serious side effects from the vaccine program. Two cases of encephalitis had been reported previously. So far about 300,000 military personnel have been vaccinated, he said, with the aim of reaching about 500,000.
He said there have been about 10 cases of heart inflammation reported in those vaccinated, but none was severe. Some people have been hospitalized for one to three days and then returned to duty. Those cases involved people in their 20s and 30s, he said.
The vaccine was administered to 25,645 health care and public health workers between January 24 and March 21, seven of those individuals had heart problems after being innoculated, including two who died of heart attacks.
The vaccine carries well-documented side effects, but they have never included heart problems. However, the past data was gathered years ago during a time when most people being vaccinated were young children not likely to have heart trouble.
Federal officials see some evidence that the vaccine is playing a role in these inflammation cases, said Walter Orenstein, director of the CDC’s National Immunization Program. He said reports from decades ago in Europe suggested similar problems with another strain of smallpox vaccine. The CDC is not convinced that the heart attacks and chest pain cases are related, he said.
“This very well could be coincidental,” Orenstein said.
The CDC is consulting with cardiac experts on whether something in the vaccine might be triggering heart problems in people who already have risk factors.
In Florida, where a health care worker died this week after a heart attack, officials suspended their smallpox vaccination program while the issue is investigated. New York put its program on hold earlier in the week.
Meanwhile, an expert panel advising the CDC raised questions about the government’s vaccination program.
The Institute of Medicine suggested Thursday that the CDC was moving too quickly beyond its first stage of vaccinations, which include public health and hospital workers, into a second stage, which includes a large group of emergency responders.
Responding to the Institute of Medicine report, Dr. Orenstein said Thursday that the CDC is not recommending a pause between the two stages because “of the need to get prepared, particularly with the other events going on in the world at the moment.”