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The manufacturer of the anthrax vaccine, BioPort Corp. of Lansing, Mich.,
has failed to properly track or investigate serious adverse reactions
by people being inoculated, a recent federal study reveals.
The company is required under a federal regulation to monitor adverse
reactions not on the vaccine's label, the U.S. Food and Drug Administration
(FDA) said in the inspection report. The FDA said that many complaints
of adverse reactions to the vaccine from members of the armed services
were not being tracked or investigated by BioPort.
One of those complaints involved a servicewoman who died in June
of aplastic anemia and invasive aspergillosis, which is an infection
caused by a specific type of mold. It is not clear what triggered
the death of the woman, who had received all six anthrax inoculations
and whose family had noted her complaints of adverse reactions to
the shots.
The FDA report said inoculations that appear to have come from
three particular lots of the vaccine - FAV030, FAV041 and FAV020
- resulted in complaints. The symptoms included:
- blackouts
- nausea
- diarrhea
- vomiting
- double vision
- dizziness
- memory loss
- shortness of breath
The company investigated none of these patient reports,
the FDA said.
A spokeswoman for BioPort, Kim Brennen Root, said the company has
been working on a new system to review and investigate adverse-vaccine
reactions.
One frequent critic of the military's inoculation program, U.S.
Rep. Christopher Shays, (R-Connecticut), said the results of the
inspection are not surprising.
"The firm's entrenched incuriosity about adverse [vaccine]
events shared by the Pentagon means the health effects of the vaccine
program on U.S. military readiness are still not being acknowledged,''
said Shays, who is among a group of congressmen urging the program
be halted. "As a result, good men
and women willing to serve and die for their country are being made
needlessly ill.''
James Turner, a Pentagon spokesman, disputes claims of safety problems
with the vaccine, stating "The FDA and Centers for Disease
Control have not found any indication of unexpected side effects
related to the anthrax vaccine and, in fact, has found such reactions
to occur at a decreased rate to that of most other vaccines."
The vaccine has come under controversy since the military began
a mandatory inoculation program for all 2.4 million enlistees in
early 1998. More than 1,200 soldiers have complained of adverse
reactions of varying length and severity, while scores
more have been disciplined for refusing to take the inoculation
or have resigned rather than take it.
The two successive manufacturers of the anthrax vaccine - BioPort
and previously the State of Michigan's Health Department - have
been cited for many violations at the plant in Lansing. The FDA
has allowed BioPort to use only older batches of the vaccine created
by its predecessor.
The Hartford
Courant November 11, 2000
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