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- WASHINGTON (Reuters) - The
Pentagon said on Monday it was delaying the planned vaccination of all
2.4 million active and reserve U.S. troops against the deadly anthrax disease
until the government approves a new facility built to produce the vaccine.
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- But officials stressed that troops being sent to South
Korea and the Gulf would continue to get anthrax immunization shots begun
last year with previously produced vaccine because of the danger of biological
attack by North Korea or Iraq.
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- The problem, they said, is that the Food and Drug Administration
has so far refused to give production approval for vaccine at a new high-tech
BioPort Corp. plant in Lansing, Michigan.
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- A total of 383,000 U.S. troops rotating to the Gulf and
Korea have received mandatory anthrax shots to date, but Assistant Defense
Secretary for Health Affairs Sue Bailey said the start of shots for all
troops -- previously scheduled to begin next month -- might now wait six
months to a year.
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- Anthrax spores are odorless and invisible, but following
initial, flu-like symptoms, the death rate for victims is higher than 80
per cent.
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- ``It's important that all military personnel have confidence
in the safety of this vaccine,'' Bailey told a news conference. ''It is
not a question of if we will have confidence, but when we will have confidence.''
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- Defense officials said the department planned to spend
an additional $8 million to $10 million to help address production problems
linked to the new plant.
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- ``We currently have enough (previously produced) vaccine
to continue Phase One of the program, the vaccination of all of those troops
deploying to the high-threat areas of the Gulf and Korea,'' Bailey said.
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- ``We had hoped to begin the broader Phase Two vaccinations
earlier next year. However, Secretary (of Defense William) Cohen directed
that Phase Two not start until BioPort had achieved assured production
of this new vaccine.''
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- Vaccine Only Defense Against Anthrax
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- She noted that she, Cohen and others had safely received
inoculations of the old vaccine produced by BioPort and that there had
been no deaths or serious reactions among the tens of thousands of troops
who have taken the series of six shots.
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- Despite Pentagon warnings that the vaccine is the only
defense against the deadly toxin, a small number of American troops have
refused to take the shots.
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- David Oliver, Principal Deputy Undersecretary of Defense
for Acquisition, Technology and Logistics, told reporters that the FDA
had raised questions over some 40 issues at the new plant. But he voiced
confidence that approval would be granted in coming months.
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- Oliver said defense officials ``underestimated'' the
time needed to tear down BioPort's old plant on the Lansing site and to
build and get approval for the new facility.
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- ``The plant has not yet begun production and we will
not launch Phase Two vaccinations until we and the FDA are completely satisfied
that the BioPort plant meets the highest possible safety standards,'' Bailey
told reporters.
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- She said it was difficult to estimate how long that might
be, but that ``it could be in the range of six to 12 months.''
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- The Pentagon agreed in August to more than double the
price that it was paying to BioPort for the vaccine, renegotiating the
contract to pay more than $10 per dose from an originally agreed $4.36.
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- Anthrax is contracted mainly in warm weather by animals
often grazing near areas contaminated by the burial of large numbers of
infected animals. The disease can kill infected animals in a matter of
hours but is also fatal to humans who inhale its spores.
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