Judge OKs military anthrax vaccinations
From Jamie McIntyre
CNN Washington Bureau
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HEALTH LIBRARY
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WASHINGTON (CNN) -- A federal judge cleared the way Wednesday for the Pentagon to resume vaccinating military personnel against anthrax after lifting his injunction against the mandatory inoculation program.
U.S. District Judge Emmet Sullivan granted a motion from Defense Department attorneys to limit the effect of his vaccine ban to the six plaintiffs who are suing the government.
They claim the mandatory administration of the anthrax vaccines to U.S. military personnel without the informed consent of the patient is unlawful.
Sullivan ruled December 22 that the vaccine must be considered experimental against inhaled anthrax, because it was initially developed and tested to protect against skin exposure. (Full story)
In response a week later, the Food and Drug Administration published a "final rule" that said "the efficacy of the vaccine includes all cases of anthrax disease regardless of the route of exposure."
Lawyers for the six plaintiffs said they would appeal and attempt to make the case a "class action" lawsuit when they return to court next week.
"In the absence of a proven correlate of immunity between humans and animals, specific to anthrax infection, the FDA's Final Rule's reliance on animal data is illegal, and reflects an arbitrary and capricious decision. Therefore, the government's victory today may only be fleeting," said attorney Mark Zaid.
The Pentagon insists the anthrax vaccine is "safe and effective" and that adverse reactions are similar to other approved vaccines.
