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Policy

ANTHRAX SHOTS

U.S. judge lifts ban, allows Pentagon inoculation program to resume

by LOIS EMBER
January 12, 2004 | APPEARED IN VOLUME 82, ISSUE 2

A federal judge last week lifted his December temporary injunction that had stopped the Pentagon's mandatory anthrax vaccination program in its tracks.

In his Dec. 22, 2003, order, U.S. District Judge Emmet G. Sullivan sided with six plaintiffs who had sued the Pentagon and FDA challenging the legality of the anthrax vaccine. The plaintiffs argued that the vaccine was still investigational for protection against inhalation anthrax. Sullivan agreed it was "being used for an unapproved purpose" and members of the armed services and defense contractors could not be inoculated without their informed consent or a presidential waiver.

Shortly after Sullivan's order, FDA made final a rule it had proposed 15 years ago. Although the proposal noted that the vaccine's effectiveness against inhalation anthrax was not "well documented," FDA's final rule declared the vaccine effective against inhalation anthrax.

On the basis of FDA's final rule, the Bush Administration went back to the district court seeking a stay of the December order, which Sullivan granted in part. The Pentagon may resume its vaccination program but cannot require the six plaintiffs to take part.

Undersecretary of Defense for Personnel & Readiness David S. C. Chu said the Pentagon would "immediately resume the anthrax vaccination program."

Mark S. Zaid, an attorney for the plaintiffs, said the Administration's "victory ... may only be fleeting." He said FDA's final anthrax rule is flawed, "arbitrary, and capricious," and he plans to ask Sullivan to reissue the injunction against mandatory vaccinations pending the upcoming trial challenging the legality of the vaccine.

Nearly 1 million service members have been vaccinated since the Pentagon's mandatory program began in 1998. More than 200 who have refused to take the shots have been court-martialed, and Zaid said they "were unjustly punished, as the order to take the vaccine was unlawful."

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