The
connection between smallpox vaccination and heart disease
strengthens as ten previously unvaccinated military people develop
myopericarditis and second
civilian healthworker heart attack
victim dies.
Meanwhile, some areas are already entering Phase 2, the expanded
program for healthworkers and other public safety workers, despite a
second
phase before proceeding, and perhaps re-evaluate the entire program.
The IOM reports the vaccination program was modified three weeks ago
to merge phase 1 and phase 2.
Health Scout, Thu Mar 27,11:46 PM ET
Second Heart Death Tied to Smallpox Vaccine
By Amanda Gardner HealthScoutNews Reporter
THURSDAY, March 27 (HealthScoutNews) -- Two women have now died
apparently as a result of heart attacks suffered in the wake of
receiving vaccinations against the smallpox virus.
Five other individuals have developed heart-related conditions,
including one additional heart attack, two cases of angina (news -
web sites) (chest pain), and two cases of myopericarditis, or
inflammation of the heart muscle or sac surrounding the heart.
In addition, 10 military personnel are known to have
developed
myopericarditis after being vaccinated.
It is not yet clear which, if any, of these cases are a direct result
of the vaccinations.
"While the evidence is somewhat suggestive that the vaccine is playing
a role in the myopericarditis, particularly based on the military
data, the data from the civilian side from the heart attacks and from
the cases of angina are within what we might have expected from chance
alone," Dr. Walt Orenstein, director of the
Control and Prevention (news - web sites)'s (CDC) National
Immunization Program, said at a news briefing on Thursday.
One of the civilian women was 50 years old and had a history of
hypertension and smoking. She was vaccinated on March 18, developed
chest tightness, dizziness, nausea and vomiting on March 22, and died
24 hours later. A preliminary autopsy indicated a heart attack.
The second woman, identified by the St.
Jorgensen, a nurse's aide in St.
had a history of hypertension and smoking. She first went to an
emergency room on March 4, six days after her vaccination, and was
diagnosed with an exacerbation of chronic obstructive pulmonary
disease and dehydration. She was hospitalized again on
March 16 after
a sudden cardiopulmonary arrest at her home, and died on Wednesday.
Jorgensen had had a previous cardiac catheterization during which she
had suffered a transient ischemic attack, or "mini-stroke."
At least in the civilian population, the heart conditions may be
consistent with what would occur naturally in the population, health
officials say.
The military cases appear more suspicious. All of the cases of
myopericarditis occurred among individuals who had never
before been
vaccinated against smallpox, indicating that they were born after
1972, when smallpox vaccinations for the general population were
halted. There have been no reports of adverse events among military
personnel who were previously vaccinated.
"It's only in the first
vaccination group that this is occurring," Orenstein said. From a
biological perspective, experts might expect to see some kind of
increased inflammation, he added.
Roughly two-thirds of the civilians vaccinated are over the age of 45,
Orenstein said.
Orenstein indicated that all of the military personnel have
recovered
and are back at their regular duties, but this could not be confirmed.
Even though the exact relationship between the heart ailments and the
vaccine is unclear, health officials are recommending that people with
cardiac disease be excluded from the program. The CDC also advises
anyone who develops shortness of breath or other symptoms of cardiac
disease after the smallpox vaccination seek medical attention.
There have been reports of myopericarditis following smallpox
vaccination in the past, but the majority of the reports came from
used. "Heart problems were not scientifically accepted
adverse events
of the smallpox vaccine," Orenstein said. "Certainly there may
be
occasional reports of this but not enough to support a role for the
vaccine."
Meanwhile, the CDC appears to be proceeding with the second phase of
the smallpox vaccination program, which calls for voluntary
vaccination of all health-care and public safety workers such as
firefighters and police nationwide. Although official guidelines will
not be released to states until mid-April, according to Orenstein,
indications are that some jurisdictions may already be proceeding.
However, the
the CDC to take a more careful look before continuing. The
institute's Smallpox Vaccination Program Committee, in a report
released to the CDC on Thursday, recommends the CDC "comprehensively
evaluate the program and its outcomes in order to improve its
implementation and to protect the vaccinees and the public." The
committee's first report recommended a pause between the first and
second phases.
"Efforts from here on in should be focused on what is needed for
preparedness," said Dr. Brian Strom, chairman of the IOM committee.
"This is an opportunity to recalibrate and redirect the program to
make sure the focus is on what is really needed in the future."
More information
Read the committee's letter at the
smallpox, visit the
or the
The Boston Globe (
smallpox vaccination, and that the two civilian healthworkers
developing angina also had heart inflammation.
The Salt Lake Tribune (
emergency meeting today to evaluate the vaccination-heart disease
link, because avoiding vaccination of persons with known heart disease
may be an insufficient precaution. Brian Strom, chairman
of the
it may be time for the Bush administration to reassess the entire plan.
http://www.sltrib.com/2003/Mar/03282003/nation_w/42731.asp
The Baltimore Sun (3-28-03) reports the CDC program director saying
that the restrictions against vaccinating health workers with cardiac
disease will not include those with cardiac risk factors such as high
blood pressure or smoking because ""If you looked at all known risk
factors ... it would be very difficult to enhance our preparedness."
"We are not recommending a pause because of concern for the need to
get prepared, especially with events going on around the world."
CDC's Orenstein also dismissed yesterday's recommendation by an
Institute of Medicine committee that the CDC and state and local
health departments stop, evaluate the program's progress and figure
out exactly how to prepare to respond to a smallpox attack before
continuing to vaccinate greater numbers and additional groups of
people. The statement by the IOM program chairman said, in part:
"The focus should be not on fixed numbers ... but on their
distribution and the ability to mobilize them" to isolate and treat
smallpox victims and prevent the spread of the deadly virus, said Dr.
Brian Strom. He is chairman of the institute's
committee on the
smallpox program, which was created at the CDC's request.
"It is important to define the goal of the program as preparedness and
to avoid exposing more people than necessary to the vaccine's risks,"
he said.
But within two or three weeks, the CDC plans to tell states they can
go ahead with Phase 2 of the program and begin vaccinating police,
fire and emergency personnel in addition to frontline health workers.
IOM's program chairman Brian Strom also said "The
committee believed
that it was important to emphasize again in its second report the need
for evaluation. Evaluation is extremely important for ensuring that
the program is implemented in the safest and most
effective manner
possible. The course of the program has been modified
from the way it
was originally envisioned. Because the program is moving past phase I
more rapidly than originally expected, the committee acknowledges that
it is now more difficult to pause between phases to conduct an
evaluation. However, this does not mean that an evaluation should not
be conducted. On the contrary, it makes an evaluation more
critical,
to determine what lessons can be learned from phase I, as we enter
phase II. Furthermore, such a pause may occur naturally, for reasons
such as reluctance of state and local health departments to proceed,
an inability to obtain more volunteers, the continuing lack of a
compensation plan, or a lack of financial resources. Regardless, this
evaluation could be conducted concurrent with the program expansion."
"The committee still has some concerns related to informed consent.
Informed consent is dependent upon a potential vaccine recipient's
understanding of the risks and benefits of the vaccine. The
indeterminate risk of smallpox is one reason many potential recipients
question whether to receive the vaccine. People are basing their
decision to be vaccinated partly on the risk of attack
being
communicated by the leaders in the administration. Because the threat
assessment of a smallpox attack is a critical component of informed
consent, it is important that any change in the threat assessment --
whether higher or lower -- be communicated to the American public."
http://www4.nationalacademies.org/news.nsf/isbn/sNI000498?OpenDocument
On the merging of phases 1 and 2, and the rapid expansion of the
smallpox vaccination program, the IOM's press release said,
"Originally conceived as proceeding in distinct phases, the national
smallpox immunization campaign was revised on March 6 to allow the
vaccination of a wider group of health care workers and
emergency-response personnel to begin before completing the first
phase involving only a small group of key personnel. While the
campaign expansion may result in vaccinating greater numbers of
individuals more quickly, the committee worried that it hinders the
ability of CDC and its partners to evaluate and learn from the early
stages and improve later efforts." ... "The decision to proceed to
the
next phase of the program was not accompanied by assurance of
sufficient additional funding for states and localities to carry out
the inoculations. Some public health agencies and hospitals
participating in the initial phase have reported difficulties in
stretching limited resources to cover the costs of the smallpox
program, overall bioterrorism preparations, and their core public
health responsibilities, such as childhood vaccinations and disease
surveillance. Some of these organizations report shifting substantial
resources from other public health activities to the smallpox
initiative."
http://www4.nationalacademies.org/news.nsf/isbn/NI000498?OpenDocument