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Second Worker Dies After Smallpox Vaccine

Mar 28, 2003 | AP A second health care worker has died of a heart attack after receiving the smallpox vaccine, and officials are investigating whether vaccinations are to blame for cardiac problems seen in 17 people who have been inoculated.

The vaccine has never been associated with heart trouble, but as a precaution, the Centers for Disease Control and Prevention is advising people with a history of heart disease not to be vaccinated until further investigation is complete.

CDC officials said Thursday there was some evidence the smallpox vaccine has played a role in heart inflammation. They were less certain whether three recent heart attacks were related to the vaccine.

Meanwhile, an expert panel advising CDC raised questions Thursday about the government's smallpox vaccination program.

The Institute of Medicine suggested 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. The report, released Thursday, also called on the federal government to compensate people injured by the vaccine.

On Capitol Hill, lawmakers struggled to do just that, but a House vote scheduled for Thursday was abruptly canceled amid questions about whether Republicans had enough votes to beat back a somewhat larger Democratic compensation plan.

The issue of smallpox vaccine safety gained new urgency this week after a Maryland nurse died Sunday of a heart attack, and the CDC launched an inquiry on a possible connection between heart disease and the vaccine.

The second death came Wednesday to Virginia Jorgensen, 57, of St. Petersburg, Fla., who was a nurse's aide at a local hospital. She suffered a heart attack about two weeks after being vaccinated against smallpox.

Like the other vaccine recipients with heart troubles, Jorgensen had a history of high blood pressure and other factors that put her at risk for heart attack.

"She's been having heart problems for almost a year," her husband, Robert Jorgensen, said in an interview Thursday. After the vaccination, he said, "within a few days she was feeling like she had a cold coming on and then it got bad."

The recent deaths "display a sense of urgency" and make it plain the legislation is needed, said Rep. Richard Burr, R-N.C., the chief sponsor of a Republican legislative package that would pay $262,100 in cases where a person dies or is permanently and totally disabled by the vaccine. Those less severely injured could receive up to $50,000 in lost wages plus unpaid medical expenses. Democrats want more for lost wages and want funding for the program guaranteed.

On the question of heart problems, CDC officials are investigating 17 cases, including seven civilians and 10 people vaccinated in the military program. The civilian cases include three women who had heart attacks two of whom died and two with angina, or chest pain. The last two suffered heart inflammation, and all 10 military vaccinees suffered heart inflammation.

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 there were reports from decades ago in Europe of similar problems with another strain of smallpox vaccine. They are less convinced that the heart attacks and angina cases are related, he said.

"This very well could be coincidental," Orenstein said.

The vaccine carries well-documented side effects, but they have never included heart problems. Still, the data were gathered years ago during a time when most people being vaccinated were young children not likely to have heart trouble.

The CDC was consulting with cardiac experts on to consider whether something in the vaccine might be triggering heart problems in people who already have risk factors.

Existing guidelines already screen out people with conditions that are known to increase the chances of side effects, including people with HIV, pregnant women, organ transplant recipients and people with a history of skin disorders.

The smallpox vaccination program has gotten off to a slow start. As of March 21, states had vaccinated just over 25,000 civilians, mostly in public health departments and hospitals. Concerns about the vaccine's risk have helped keep the numbers well below the 450,000 initially expected.

Several hundred thousand military personnel have been vaccinated.

Based on studies in the late 1960s, experts estimate that one or two people out of every million being vaccinated for the first time will die. The death rate for those being revaccinated was lower: Two people died out of 8.5 million who were revaccinated in a 1968 study.

Additionally, 14 to 52 people out of every million being vaccinated for the first time are expected to suffer life-threatening side effects.

That's because the smallpox vaccine is made with a live virus called vaccinia, a cousin to smallpox which can cause illness if it escapes the inoculation site and infects another part of the body. Vaccinia can also infect those who touch someone else's vaccination site.

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