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FDA Calls Anthrax Vaccine Safe, Effective
The U.S. Food and Drug Administration yesterday announced that the existing anthrax vaccine remains safe and effective for use against the pathogen, the Associated Press reported (see GSN, Dec. 5). The announcement regarding Anthrax Vaccine Adsorbed was made in a Federal Register notice, AP reported. “We believe the vaccine is safe and effective for intended use, which would include (prevention of) inhalation anthrax,” said FDA spokeswoman Julie Zawisza. Six military personnel sued the Defense Department over the mandatory anthrax vaccinations. A federal judge last year faulted the FDA drug-approval process and ordered the Pentagon to halt the vaccination of military personnel (see GSN, Oct. 28, 2004). The Pentagon earlier this year was allowed to administer the vaccine on a strictly voluntary basis; it is appealing the decision that barred mandatory inoculations. The Food and Drug Administration review of its earlier findings was required under a court order, according to AP. The military will “review program options” following the FDA announcement, William Winkenwerder, assistant defense secretary for health affairs, said in a statement. The voluntary vaccination program will also continue. “The threat of anthrax as a weapon remains real. It is very important to provide our service members with maximum protection against this threat, particularly when operating in certain areas of the world,” Winkenwerder said (Associated Press/Yahoo!News, Dec. 16).
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