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U.S. Federal Judge Expresses Doubt Over Government Information on Safety of Anthrax Vaccine

Global Security Newswire

U.S. District Judge Emmet Sullivan said yesterday that he had doubts as to whether the U.S. government could prove that the anthrax vaccine required for military personnel is safe, according to the Washington Post (see GSN, Jan. 8).

Last year, six servicemembers filed a lawsuit seeking an end to mandatory anthrax vaccinations on the basis that the inoculations posed health risks. In late December, Sullivan determined that the U.S. Food and Drug Administration had never approved the vaccine used to protect against inhalational anthrax and temporarily suspended the vaccination program. The program has since been restarted.

During a hearing on the lawsuit yesterday, Sullivan described the government’s review of the anthrax vaccine as “one of the most jumbled, confusing” processes that he had ever seen, the Post reported. He also questioned why the FDA ruled that the vaccine was safe for use against inhalational anthrax 18 years after it was first proposed for that use, but just one week after the vaccination program was suspended, according to the Post.

John Michels, a lawyer for the six servicemembers, said during yesterday’s hearing that the FDA only issued the ruling to protect the vaccination program. Deputy Associate Attorney General Brian Boyle said, however, that the agency’s ruling was based on science (Carol Leonnig, Washington Post, May 26).