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The manufacturer of the anthrax vaccine used by the Defense Department for inoculating service members has filed an appeal of a court order that rejected its status as a "safe and effective" treatment under Food and Drug Administration standards, the Frederick News-Post reported last week.

"We were licensed as a protection from anthrax, all forms of anthrax," said Kim Brennan Root of BioPort, the Frederick, Md.-based maker of Biothrax. "But because we weren't specific as to the types, the judge saw a problem."

Last year, U.S. District Court Judge Emmet Sullivan barred mandatory anthrax vaccinations and ordered the Food and Drug Administration to withdraw its category 1 classification for Biothrax. The Pentagon this month invoked emergency provisions in the Project Bioshield Act to restart the program.

The public comment period on the BioPort case is expected to close at the end of next month, according to the News-Post. Once that information has been examined, the Food and Drug Administration could restore the vaccine's category 1 classification as a "safe and effective" drug.

With Pentagon approval, BioPort is simultaneously seeking emergency-use authorization, and Sullivan is scheduled to hear that argument on March 28.

A third option would be to continue the military immunization program on a voluntary basis, Root said.

"We could deliver it in a voluntary way," she said. "Right now it's mandatory. It has always been mandatory."

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