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    Controversy Surrounds Anthrax Vaccine

    Manufacturing Woes

    This week, the military announced that it will be giving anthrax vaccinations only to troops considered most at risk of a bioterrorism attack because its supply of vaccine is limited. And though health officials recently said criminal investigators, decontamination crews, and others working closely with anthrax investigations should be vaccinated, it is unclear whether that is happening.

    No one is quite sure how much anthrax vaccine is available or will be available in the near future. That is because the FDA forced the sole U.S. manufacturer of anthrax vaccine to stop distribution two years ago after an inspection found 30 violations at the manufacturing plant. Those violations included vaccine safety and sterility problems.

    BioPort Corp. of Lansing, Mich., has actually been making and stockpiling the vaccine again for over a year, but the reserves can not be used or distributed until it passes another FDA inspection. That could be as early as Thanksgiving, but there are no guarantees, officials say.

    If BioPort does pass inspection, some 5.4 million doses of anthrax vaccine will be available for immediate distribution, Health and Human Services secretary Tommy G. Thompson said late last week. But Rep. Christopher Shays, R-Conn., who has held hearings on the anthrax vaccine, says it is unclear if the stockpiled doses are safe.

    Military Discord

    The anthrax vaccine used in the United States was developed during the 1950s and '60s and was licensed by the FDA in 1970. It is given as a series of six injections over 18 months and poses no risk of developing the disease because it is a killed vaccine.

    Critics say there is no guarantee that the vaccine is effective against all strains of anthrax and that terrorists could conceivably manufacture vaccine-resistant strains to use as weapons. The only human study ever done in the U.S. evaluated the vaccine during an outbreak of anthrax among New Hampshire mill workers 40 years ago. It was found to be 93% effective in workers who got the vaccine, and studies in monkeys have shown similar rates of protection.

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