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FDA Rules Anthrax Vaccine “Effective” Against Inhalational Anthrax
The U.S. Food and Drug Administration announced yesterday that the current anthrax vaccine has been determined to be effective in preventing both the skin form and the inhaled version of anthrax (see GSN, Dec. 29). Last week, a U.S. federal judge issued a preliminary injunction to halt the U.S. Defense Department’s use of the vaccine in inoculating military personnel. In his injunction, the judge, who described the vaccine as an “investigational drug,” said the FDA had approved the vaccine for use in preventing skin exposure to anthrax, but not against the inhaled version (Thom Shanker, New York Times, Dec. 31). In a press statement yesterday, however, the FDA said the vaccine, known as Anthrax Vaccine Adsorbed, “is safe and effective for the prevention of anthrax disease — regardless of the route of exposure.” The agency also said that it did not regard the vaccine as “investigational” for protecting against inhalational anthrax, and that such a determination is “relevant and should be considered in any further litigation in this matter” (U.S. Food and Drug Administration release, Dec. 30). Yesterday, the U.S. Justice Department filed an emergency motion asking a federal judge to remove last week’s injunction, the New York Times reported (Shanker, New York Times). A Pentagon spokesman said that the department would continue its temporary suspension of the anthrax vaccination program “until legal issues are resolved” (Maggie Fox, Reuters, Dec. 30).
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