More Smallpox Vaccine
Concerns
WASHINGTON, D.C., May 27, 2003


(CBS) There is new concern about the government's
already troubled smallpox vaccination program. Few of the
half-million healthcare workers eligible for innoculation
under phase one of the program chose to get vaccinated.
And some healh experts are warning -- not so fast.
Some states, including Florida and Virginia, are already
moving ahead with phase two of the government's smallpox
vaccination program, to include as many as three million
firefighters, police and paramedics.
But a new report issued by an Institute of Medicine panel says
all civilian vaccinations should temporarily stop, and that
the federal government should actively get out the word to
states, CBS News Correspondent Sharyl Attkisson
reports.
The Committee on Smallpox Vaccine Implementation earlier
recommended a "pause" in civilian smallpox vaccination, in
part due to unexpected adverse events emerging in what was
already known to be the most toxic vaccine on the market.
The head of the committee, Dr. Brian Strom, says the Centers
for Disease Control, which advises states on their vaccine
programs, recently accepted the idea of a pause. Yet, Strom
says, the CDC didn't explicitly notify states of this change
of heart. Tuesday's report encourages the CDC to take more
action.
"What we're asking is one step further that they go out of
their way to make it easy for those states who want to pause
to make it easy for them to be able do that," says Strom.
"We think that it's better for public health, we think it's
better for the campaign, that all information be learned about
to the degree possible before launching into phase two in a
large-scale way. We thought that it was very important that
people stop, they take stock of where they are, look to learn
from the experience gained today before proceeding onward with
the rest of the campaign."
The report says several issues should be resolved "before
deciding whether and how to proceed with vaccination."
On the issue of safety, the report says a "pause" is needed to
collect and evaluate adverse event reports. Although every
civilian who receives the smallpox vaccine is supposed to be
individually tracked, only 34 percent of vaccinees have made
it into the surveillance system so far; two-thirds have not.
"Some adverse events might not arouse concern on a state
level, but aggregated nationally, new patterns could emerge,"
says the report. "Cardiac complications were unexpected
adverse events, and there may be others."
Says Strom: "At this point only about one-third of the
civilian patients who've gotten the vaccination are in the
surveillance system. And one of the things we'd like know
about is the outcomes in the other two-thirds of the
patients."
The report also says the consent forms and educational
materials should be revised with updated material and
information that can be understood clearly by firefighters,
police and paramedics instead of the health care workers who
were targeted in phase one.
"In many ways, the most important message we have is that
maximum preparedness doesn't require huge numbers; it requires
it be done very safely and very carefully. That's what's been
done so far. The CDC has done a terrific job. And the CDC
should use (a pause in the state's vaccination programs) as an
opportunity to learn maximally from the experience to date, in
order to be sure that as we launch into phase two it's given
to the right people, it's the right size and it's done as
safely as possible," says Strom.
The panel that issued the new report was created by the
Institute of Medicine to advise the federal government on
implementing the smallpox vaccine program.
But it's unclear whether the federal government will take the
committee's advice to publicly encourage states to "pause."
Doing so would highlight touchy subjects in some political
circles: unexpected adverse events, and what some view as the
lackluster response to President Bush's smallpox vaccine
program. Out of roughly 500,000 eligible health care workers,
only a small fraction, 30,000, volunteered to receive the
vaccine in phase one.
Many who refused the vaccine were concerned about the
vaccine's risks. Some states have already stopped their
smallpox vaccination programs on their own, others are
"skipping" phase two altogether.
The inherent conflict involved in this issue is apparent.
Strom, chair of the committee that wrote the new report, told
CBS News it was issued quickly because of its
importance and urgency. Yet a spokesman for the Institute of
Medicine told reporters, in advance, there would be nothing
particularly newsworthy in the committee's report.
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