-Caveat Lector-

Posted on Fri, Mar. 28, 2003

http://www.centredaily.com/mld/centredaily/news/5500258.htm



Two states suspend smallpox vaccinations in wake of deaths

BY JEREMY MANIER AND PETER GORNER
Chicago Tribune

CHICAGO - (KRT) - Health officials in Illinois and New York suspended all
smallpox vaccinations
Thursday while investigators review the deaths of two health care workers
who suffered fatal heart attacks after being immunized.

The states moved more quickly than the federal Centers for Disease
Control and Prevention, where the only recommendation experts gave
Thursday morning was that people with a history of heart disease should
not get vaccinated against smallpox.

Federal officials also are looking at 15 other civilians and military personnel
who have had non-fatal heart problems after being immunized.

The new problems are the most serious setback yet for the federal
smallpox vaccination program, started by the Bush administration to
protect a contingent of doctors, nurses and other emergency workers in
the event of a biological attack with the deadly virus.

The vaccine had not been known to cause heart problems among
Americans who were vaccinated as children. But concerns about liability
and other known side effects have led many hospitals and counties to opt
out of the program, resulting in just 27,000 civilians being vaccinated - far
fewer than the 450,000 government planners had projected.

Virginia Jorgensen, 57, a nurse from St. Petersburg, Fla., died of a heart
attack she suffered 17 days after getting the vaccine. Jorgensen's husband
Robert said he had asked his wife, who had a history of heart disease, not
to take the vaccine.

"She was in the first group to volunteer," Jorgensen said. "I tried to talk
her out of it, but she said `No way.'"

The CDC has not changed its smallpox vaccination plans in response to
Thursday's action by the states. Smallpox program officials will meet with
the agency's Advisory Committee on Immunization Practices on Friday to
discuss how vaccine clinics should screen for heart patients, said CDC
spokesman Curtis Allen.

"The states are obviously concerned," Allen said. "We're trying to provide
guidance as quickly as possible. There may be states that are
uncomfortable going forward until this is resolved."

An independent panel of experts from the Institute of Medicine released a
report on the vaccination campaign on Thursday recommending that the
CDC proceed with care, possibly including a temporary halt to assess the
vaccine's safety.

"What we're saying is what we have said all along - is that a pause would be
useful," said committee chairman Dr. Brian Strom, a professor of
biostatistics and epidemiology at the University of Pennsylvania School of
Medicine.

The CDC on Wednesday said it was recommending that people diagnosed
with heart disease not be vaccinated until its investigation was completed.

The agency said it was taking the action after receiving "several reports of
heart-related problems" among the volunteers vaccinated in the first phase
of the program.

The seven cases that prompted Wednesday's precautionary action
included three cases of myocardial infarction (heart attacks), two of which
were fatal; two cases of angina (chest pain); and two cases of
myopericarditis (inflammation of the heart muscle or the sac surrounding
the heart).

"Myocarditis is usually caused by a virus. The smallpox vaccine is a live
virus, so this is a side effect you might expect," said Dr. David Faxon, chief
of cardiology at the University of Chicago Medical Center.

"But there is no direct correlation to a heart attack, except if you have
pre-existing heart disease. That's bad because the two conditions will
aggravate each other."

Cases of heart inflammation following smallpox vaccinations were reported
in Europe in the 1960s and 1970s, the CDC said.

However, the strain of vaccine used in the U.S. is different and had not
been associated with any heart problems.

Illinois public health officials said they would stop administering the
vaccine until at least April 7.

"We're concerned about the safety of those who volunteer and want to
make sure they're informed," said Tammy Leonard, of the Illinois
Department of Public Health.

So far, the state has vaccinated only 116 people. Additionally, about 30
people have been vaccinated in Chicago, where the smallpox program is
run separately from the state's program.

City health officials said they have halted vaccinations but hope to begin
again next week.

The possible link between the smallpox vaccine and reported heart
problems remains unclear. Some patients suffered inflammation that
seemed related to the vaccine, while others had heart attacks that may
simply have been caused by the history of heart problems, said Dr. Walter
Orenstein, head of the CDC's immunization program.

"We are working to try to maintain this program … (but) the issue of
women is very important," he acknowledged Thursday.

"Women are not only disproportionately represented in the cases. They're
disproportionately represented in the vaccines. About two-third of the
vaccinees are women and women make up a larger proportion of the
health care worker task force."

Despite such questions, Orenstein said the CDC wanted the program to
continue.

"We would not recommend a pause (in vaccinations) because of the
concern about the need to get prepared, particularly with other events in
the world at this moment," Orenstein said.

---

© 2003, Chicago Tribune.

Visit the Chicago Tribune on the Internet at
http://www.chicago.tribune.com

Distributed by Knight Ridder/Tribune Information Services.







© 2003 KRT Wire and wire service sources. All Rights Reserved.



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