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Published Date: 2003-03-29 23:50:00
Subject: PRO> Smallpox vaccination adverse events - USA (09)
Archive Number: 20030329.0781

SMALLPOX VACCINATION ADVERSE EVENTS - USA (09)
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International Society for Infectious Diseases
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[1]
Date: 29 Mar 2003
From: George Robertson <geo456@comcast.net>
Source: Washington Post 29 Mar 2003 [edited]
<http://www.washingtonpost.com/wp-dyn/articles/A44240-2003Mar28.html>

At least 2 states suspended smallpox immunizations, and the Pentagon
reported its first fatal post-inoculation heart attack yesterday, even as
federal scientists struggled to figure out whether the vaccine was
triggering a series of cardiac-related problems.
Also yesterday, the government's leading vaccine experts recommended that
the Centers for Disease Control and Prevention take additional precautions
in the beleaguered program by screening out anyone volunteering for
inoculation with known heart disease or risk factors such as hypertension,
diabetes, or high cholesterol.
Altogether, federal health experts are investigating at least 18 cases of
possible cardiac reactions, including 3 fatal heart attacks in recently
immunized military personnel and civilian health care workers. But William
Winkenwerder Jr., assistant secretary of defense for health affairs, said
the heart attack death of a 55-year-old National Guardsman was more likely
related to the man's high cholesterol and smoking than the vaccination.
"That is very noteworthy in this case," Winkenwerder said in an interview.
The evidence at this point, "indicates smallpox vaccination was not likely
to be the cause of his death." More than 350 000 Defense Department
employees have been inoculated since December [2002].
Although historically the smallpox vaccine has not been linked to heart
attacks or angina, the recent cases have added to widespread reluctance in
the medical community to be immunized against a disease that has not been
seen in 3 decades.
In the District, only 3 of the 11 health department workers scheduled for
inoculation yesterday showed up, said Michael Richardson, the city's senior
deputy director of medical affairs.
Illinois and New York suspended immunizations entirely, as did some
individual hospitals such as Dartmouth Medical Center in New Hampshire.
Other states, such as Florida, postponed inoculations until they could
update volunteers on new safety measures relating to heart risks.
At the CDC offices in Atlanta, staffers were fielding nervous phone calls
from people who had been vaccinated and worried they may be at risk for
heart failure, said Dixie Snyder, associate director for science at CDC.
At the 2-month mark, the Bush administration's effort to immunize millions
is stalled, hampered by fears of the vaccine itself, doubts about the risk
of a smallpox attack and the lack of compensation for people who suffer
complications from the vaccine.
So far, 25 000 people have responded to President Bush's call for medical
personnel to be inoculated, a tiny fraction of the 450 000 that state
officials estimated they would need to set up mass vaccination clinics in
the event of a bioterrorism attack. The House has rescheduled a vote on a
compensation proposal for Monday, although Democrats complain the
Republican bill falls far short.
"I think it's time to stop the program," said one early skeptic, Richard
Wenzel, chief of internal medicine at the Virginia Commonwealth University
Medical Center in Richmond. "Now is the time to say let's err on the side
of caution until this is really sorted out."
A safety subcommittee of CDC's Advisory Committee on Immunization Practices
recommended screening out anyone over age 50 and people under 50 with risk
factors for heart problems, said John Neff, cochair of the smallpox
vaccination safety working group and a physician at Children's Hospital in
Seattle. "This would provide the maximum degree of safety for the
population," he said. "That is our major concern."
In an emergency 2-hour meeting, however, the full committee stopped short
of that position yesterday, in part because it fears the vaccination
program would come to a standstill.
Eliminating everyone over 50 would make it "unfeasible to develop the
numbers we need for preparedness," said Guthrie Birkhead, a committee
member and director of the Center for Community Health at the New York
State Department of Health. "We are taking extraordinary precautions
because of a theoretical concern."
A few committee members said they preferred to wait for more data before
proceeding with the program.
"You can make the case the risks of this vaccine may be outweighing its
benefits, and at least for the moment, we should temporarily suspend this
program," said Paul Offit, chief of infectious diseases at Children's
Hospital in Philadelphia. But his proposal for a temporary halt to the
program was quickly dismissed.
CDC spokesmen said they did not know whether officials would adopt the
committee's recommendation or stick to its decision this week to only weed
out people with known heart disease, such as a previous heart attack.
While experts study the recent cases in hospital workers, growing evidence
suggests that the 10 cases of heart inflammation in healthy, young Defense
Department employees were related to the vaccine military and CDC experts
said. In every case, the sharp heart pains subsided after patients received
painkillers, and physicians do not expect any long-term damage.
That discovery raised another challenge for administration officials trying
to refine the civilian vaccination program. Until now, states have targeted
older volunteers because research has shown the rate of serious reactions
is much lower in people who had been previously vaccinated. But if the
cardiac cases result in fewer older volunteers and more younger, first-time
vaccinees, it is likely the number of heart inflammation cases is likely to
rise, experts said.
Whatever the CDC decides, many physicians, hospitals and health departments
are charting their own course. David Pearle, a cardiologist at Georgetown
University Hospital, said he would err on the side of caution.
"The worry would be not so much the 35-year-old who smokes, but perhaps the
55-year-old who smokes and has a family history," he said, describing the
complex set of factors to consider in deciding who could safely get the
vaccine. "If there is a strong constellation of symptoms, I certainly would
withhold vaccine until we know more."
[Byline: Ceci Connolly]
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ProMED-mail
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[2]
Date: 29 Mar 2003
From: ProMED-mail <promed@promedmail.org>
Source: BayInsider.com 29 Mar 2003 9:16 AM PST [edited]
<http://www.ktvu.com/news/2073447/detail.html>

State Suspends Smallpox Vaccinations
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The director of the California health department has temporarily cancelled
the state's smallpox vaccination program following widespread concern that
the vaccine caused heart problems in some of the people who received it.
Friday's move by State Health Director Diane M. Bonta came on the same day
that health officials in Illinois and New York suspended all smallpox
vaccinations while investigators review the deaths of 2 health care workers
and a National Guardsman who suffered fatal heart attacks after being
immunized.
Earlier in the day, the California Nurses Association had called on the
state to end its smallpox program. Although participation is voluntary for
nurses and doctors, the nurses' group said it was irresponsible for the
state to administer the program when at least a dozen health care workers
and military personnel across the country who received the vaccine
experienced heart troubles.
Bonta ordered local health departments throughout the state to postpone
their smallpox vaccination clinics until at least 7 Apr 2003, saying the
delay would give the federal Centers for Disease Control time to study
possible links between preexisting heart conditions and adverse vaccine
reactions.
"For those who volunteer for smallpox vaccination, safety must be our first
concern," Bonta said. "This delay will allow the smallpox vaccination
program to resume in a manner that is safe and effective."
As of Mar 2003, 18 989 Californians had received the smallpox vaccine,
according to the Department of Health Services.
--
ProMED-mail
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[3]
Date 29 Mar 2003
From: ProMED-mail <promed@promedmail.org>
Source: CDC Smallpox website - Interim smallpox fact sheet [Accessed 29
Mar 2003] [edited]
<http://www.bt.cdc.gov/agent/smallpox/vaccination/heartproblems.asp>

Smallpox Vaccine and Heart Problems
-----------------
Careful monitoring of smallpox vaccinations given over recent months has
suggested that the vaccine may cause heart inflammation (myocarditis),
inflammation of the membrane covering the heart (pericarditis), and/or a
combination of these 2 problems (myopericarditis). Experts are exploring
this more in depth.
Heart pain (angina) and heart attack also have been reported following
smallpox vaccination. However, it is not known at this time whether
smallpox vaccination caused these problems or whether they occurred by
chance alone (heart problems are very common). Experts are investigating
this question also. Reported events are not necessarily caused by the
vaccine, and some or all of these events might be coincidental.
As a precautionary step, people who have been diagnosed by a doctor as
having heart disease with or without symptoms should not get the smallpox
vaccine at this time, while experts continue their investigations.
These include heart conditions such as: previous myocardial infarction
(heart attack); angina (chest pain caused by lack of blood flow to the
heart); congestive heart failure; cardiomyopathy. These may be temporary
exclusions and may change as more information is gathered. The presence of
these conditions in a close contact is not a reason to defer vaccination.
Anyone who has received the smallpox vaccine should see a health care
provider right away if they develop chest pain, shortness of breath, or
other symptoms of cardiac disease after vaccination.
Anyone who has been diagnosed by a doctor as having heart disease and has
already received the smallpox vaccine should contact their heart disease
specialist or their regular health care provider if they have questions.
--
ProMED-mail
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[The temporary suspension of vaccination activities on the part of several
states until more information is known about the possible association of
vaccination with myocardial infarction (heart attack) is known is not
totally surprising. In the original postings of reports on cardiac
complications following smallpox vaccination (see ProMED-mail posting
Smallpox vaccination adverse events - USA (08) 20030327.0772), data on the
expected number of cardiac deaths in these age groups were presented
(available in the MMWR report
<http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5212a2.htm>): "By using the age
distribution for these persons, using year 2000 age-specific death rates
from all causes, and assuming that the age distribution is the same for
persons whose age is unknown, 2-3 deaths are expected to occur within 3
weeks of vaccination among persons aged 45-54 years and an additional 2-3
deaths among vaccinees aged 55-64 years. Among vaccinees aged 45-64 years,
1-2 cardiac-associated deaths are expected to occur within 3 weeks of
vaccination." Hence, the occurrence of 3 deaths following receipt of
smallpox vaccine may not represent a statistically significant event.
One should keep in mind that information on adverse events following
smallpox vaccination with calculations of expected reaction rates is based
on data from vaccination activities 30-40 years ago, when the overwhelming
majority of primary vaccinees were in the childhood population, with
revaccinations occurring primarily for those in military service (usually
ages 18-30 years and in excellent health). A review of the available
literature base (see ProMEDmail posting Smallpox vaccination adverse events
- USA (07) 20030326.0749) revealed a series of case reports (primarily from
European countries) of myopericarditis and the occasional myocardial
infarct. Again, these were case reports, representing small numbers of
observations. The current vaccination effort underway in the USA is the
first major activity with large numbers of primary vaccinees of young
adults (in the military) and proposed large numbers of revaccinees over the
age of 30 (in the civilian population). Most of the prior discussions
concerning potential adverse reactions associated with smallpox vaccination
were focused on today's environment, with larger numbers of potentially
immune compromised individuals being exposed to the vaccine either directly
or indirectly through contact with recent vaccinees and concerns for
adverse events associated with immune-compromised hosts. Myopericarditis
and possibly myocardial infarction did not factor into earlier discussions
as predominant serious adverse events.
For interested parties there is a vaccination adverse reactions fact sheet
for clinicians revised 28 Mar 2003, with brief information related to
possible association with myopericarditis, available at:
<http://www.bt.cdc.gov/agent/smallpox/vaccination/reactions-vacc-clinic.asp>
Information on the official recommendations resulting from the emergency
session of the Advisory Committee for Immunization Practices (ACIP) held
yesterday was not available for review at the time of preparation of this
posting. According to the newswire, the recommendation was to suspend
vaccination of individuals over the age of 50 and those younger than 50
with a history of risk factors for heart disease. Given the remaining
questions regarding a true association with myocardial infarction, this
seems a prudent recommendation. As a reminder, the original recommendation
of the ACIP on 20 Jun 2002 was to vaccinate between 15 000 and 20 000
potential first responders. At present there have been approximately 25
000 first responders and 350 000 military personnel vaccinated. We await
further information on the investigation of this event. - Mod.MPP]

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