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Servicemen Sue US Government Over Anthrax Vaccine Program
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Washington, May 2 (Bloomberg) -- Two servicemen are suing the U.S. government
over the anthrax vaccine, claiming immunization against the world's deadliest
biological agent isn't approved by the U.S. Food and Drug Administration.
A former Air Force major, Sonnie Bates, and Capt. John Buck, both refused to
have the shots, which have been administered 500,000 military personnel,
according to the lawsuit.
The inoculations are protection against the virus, that the U.S. believes
could be produced by North Korea, Iraq and Iran. The government's goal is to
inoculate all 2.4 million active and reserve troops by 2006.
``There's never been a lawsuit specifically challenging the FDA's lawful role
in the program,'' said Mark Zaid, an attorney for one of the plaintiffs,
citing a pending application of the drug's maker, BioPort Corp., for use
specifically against inhaled anthrax.
The anthrax vaccine was approved years ago by the FDA for general use,
according to Mark Ellengold, deputy director of the Center for Biologics at
the agency.
``The dispute arises because the labeling approved says `for prevention of
anthrax' and doesn't specify anthrax via skin, inhalation, food or
whatever,'' he said.
Since its inception in 1998, the Pentagon's anthrax vaccine program has been
cited for management, efficacy and safety flaws, as well as its reliance on a
single manufacturer, privately held BioPort of Lansing, Michigan.
The budget proposal for the U.S. Department of Defense this year includes $52
million to stockpile drugs for use in a terrorist attack with biological
weapons such as anthrax.
May/02/2001 17:26 ET
(C) Copyright 2001 Bloomberg L.P.
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