Federal health officials today plan to reveal details of the death Sunday of a Maryland nurse who suffered a heart attack after being vaccinated against smallpox.
Late Tuesday, leaders of the vaccination program at the U.S. Centers for Disease Control and Prevention ordered that, for now, anyone with a history of heart disease not be vaccinated against smallpox. Six other people have experienced adverse cardiac events after smallpox vaccinations, one of whom is on life support.
CDC officials said yesterday studies are being conducted to determine if the complications are related to the vaccine.
Kristine Smith, spokeswoman for the New York State Department of Health, said none of the reported complications occurred in New York. “There have been no reports of that kind here,” Smith said.
Von Roebuck, a CDC spokesman, said an autopsy has been conducted on the Maryland woman to determine if vaccinia, the live virus in the vaccine, somehow figured in her death. The woman died of a heart attack, apparently the result of coronary artery disease, Roebuck said.
Preliminary findings from the autopsy are to be published today in the CDC publication Morbidity and Mortality Weekly Report.
As of yesterday, Roebuck said, CDC officials had not determined whether the seven cases are related, or whether smallpox vaccination plays a role. The CDC has no plans to halt the vaccination program in which President George W. Bush has called for the inoculation of 500,000 health care workers, and another 10 million first responders.
Vaccinating a large number of emergency responders, Bush said, would provide a cadre of protected health care workers in the event of a bioterrorist attack with the smallpox virus. The Institute of Medicine, which advises the government on health and science policy, has convened a panel of experts to review the CDC’s administration of the smallpox vaccination program. Its first report is expected today.
The vaccination program has come under attack from critics who say the vaccine poses too many dangers, especially in a time when there is no evidence worldwide of smallpox, a highly infectious and deadly disease.
Smallpox was wiped from the planet in an aggressive vaccination program overseen by the World Health Organization in the 1960s and ’70s, and routine vaccinations ceased in 1972. The last case occurred in Somalia in 1977.
Dr. Richard Zane, a smallpox vaccine expert, said it has been known since at least the 1960s that vaccinia can cause inflammatory cardiac conditions, such as pericarditis and myocarditis.
The CDC said two of the patients who developed complications had pericarditis, an inflammation of the membrane that encases the heart. Two others experienced the chest pain known as angina and three others suffered heart attacks.
“It is not clear whether the complications being reported by the CDC are related to the smallpox vaccine,” said Zane, medical director for emergency preparedness and biodefense at Brigham and Women’s Hospital in Boston. “Right now, this is a good epidemiologic question: Are these events related to the vaccine or are they random events?”
The CDC estimates that more than 25,600 people have gotten smallpox vaccinations so far. The agency’s computer models, using epidemiologic data from the 1960s, suggested before the vaccination campaign began that at least one death per every 1 million vaccinations was possible. A study by the Rand institution concluded that if 10 million health care workers were vaccinated, about 25 would die.
“I was well aware of myocarditis and pericarditis being complications,” Zane said. “Nowhere in the medical literature has it been mentioned that cardiac sudden death can be caused by the vaccine. It very well may not be related.”
Cheryl Peterson, senior policy fellow at the American Nurses Association in Washington, said the report of heart problems underscores the vaccine’s potential for danger.
While the association is not urging nurses to refrain from being vaccinated, the group is asking them to be cautious and to educate themselves about the vaccine before agreeing to undergo inoculation.
“This is a completely different population with a completely different set of risk factors than the people who vaccinated in the 1950s and ’60s,” she said. “A half century ago only children and young adults were routinely vaccinated. Now the demographics have changed.
“We don’t know what the risk factors are in people who are in their 40s, 50s and 60s. These are the people who are getting the vaccine now.”