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Press Release from CDC Media Relations
For Immediate Release
March 25, 2003
Temporary Deferral Recommended for Heart Patients Volunteering for
Smallpox Vaccination
The Centers for Disease Control and Prevention today took
the precautionary step of
adding a temporary medical deferral to the smallpox vaccination program
for persons
who have been diagnosed with heart disease. CDC is investigating whether
there is any association between smallpox vaccination and reports of heart
problems in seven health care workers who have been vaccinated.
CDC added the temporary measure to the existing list of deferral criteria
based on
information from its real-time monitoring system, which showed a small
number of
heart-related incidents among health care workers following smallpox
vaccination. It is
not clear whether this number is greater than would be expected normally
in this
population, CDC scientists said.
"We promised to closely monitor this program and to put safety first, so
we are
exercising exceptional caution," said Julie Gerberding, M.D., CDC
director. "If our
investigation shows this precautionary measure should become permanent or
the need for other changes or enhancements in the civilian smallpox
vaccination program, we will take immediate action."
"We continue to believe that it is important and necessary to vaccinate
health care
workers to prepare our nation in the event we have to respond to a
smallpox outbreak," Dr. Gerberding said.
CDC is recommending that persons with known cardiac disease - such as
cardiomyopathy, previous heart attack, history of angina, or other
evidence of coronary artery disease – be temporarily deferred from
receiving smallpox vaccination. CDC will provide states with simple
questions about heart problems to use in screening people volunteering for
smallpox vaccination.
In pursuing its promise of safety, last week CDC asked the
Advisory Committee on
Immunization Practices' (ACIP) Smallpox Vaccine Safety Review Board to
examine
reports of heart-related adverse events occurring in connection with the
smallpox
vaccination program. CDC is also beginning research projects aimed at
identifying and understanding any associations that may exist between
smallpox vaccine and heartrelated problems.
"A major part of our monitoring program involves regularly
sharing information about
adverse events with experts such as those on the ACIP. They can help
assess whether the smallpox vaccine is, indeed, associated with the
medical conditions described in the adverse event reports," said Walter
Orenstein, M.D., director of CDC's National Immunization Program.
CDC has received several reports of heart-related problems
among the 25,645 people who have been vaccinated in the civilian program.
The seven cases prompting today's precautionary action include three cases
of myocardial infarction (heart attack), one of which resulted in death;
two cases of angina (chest pain); and two cases of myopericarditis
(inflammation of the heart muscle or sac surrounding the heart). In each
case the individual's medical history, including risk factors for heart
disease, is being studied.
Cases of heart inflammation following smallpox vaccination
were reported in the 1960s and 1970s. However, the information from these
reports does not provide any
information about the types of people who may be at higher risk for
heart-related
problems following smallpox vaccination.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Division of Media Relations
1600 Clifton Road, MS D-25
Atlanta, GA 30333
404.639.3286
404.639.7394 (fax)
Wednesday, March 26, 2003
1 dead, 6 ill after smallpox vaccination
Maryland nurse dies; recipients report heart problems, CDC says
One health worker vaccinated against smallpox has died of a heart attack,
one is on life support, and five others also have developed a variety of
heart problems, prompting the Centers for Disease Control and Prevention
to bar anyone with known heart disease from receiving the vaccine.
The CDC announced late Tuesday that, of the 21,698 health care workers and
public
health employees vaccinated against smallpox since Jan. 24 as part of
national
bioterrorism preparations, three have had heart attacks, two have had
chest pain and two have developed inflammation in or around their hearts.
The CDC would not identify the patients by name or location, though it
described the
three heart attack patients as women in their 50s. According to the
Maryland Department of Health and Mental Hygiene, the heart attack patient
who died was a Maryland nurse who was vaccinated March 18 and died March
23. It was the first death associated with the smallpox vaccination.
The CDC said the vaccine recipients, all volunteers, had health problems
that could have predisposed them to heart attacks. "We cannot say that
what we have observed in these vaccine volunteers is a greater frequency
of [heart disease] than what we would expect under other circumstances,
but we will do everything we can to get to the bottom of this issue," said
Dr. Julie Gerberding, the CDC's director.
In the 1960s, when smallpox vaccination was routine, there were one to
three deaths and 14 to 52 serious complications for every 1 million
vaccinations given. Almost none of those adverse events, however, were
heart problems. The CDC is consulting with experts to search for a link
between the vaccine and heart problems, as well as issuing an alert to
those who already have been vaccinated and asking volunteers who know they
have heart conditions to step back from participating until more research
can be done, Gerberding said.
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