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Emergency OK sought to resume anthrax vaccine for troops

WASHINGTON -- The Pentagon is seeking emergency authority to resume administering the anthrax vaccine, saying troops in South Korea and the Middle East are at risk.

Deputy Defense Secretary Paul D. Wolfowitz made the request in a Dec. 10 letter to Health and Human Services Secretary Tommy Thompson. Wolfowitz, second in command at the Pentagon, cited "a significant potential for a military emergency involving a heightened risk to United States military forces of attack with anthrax."

Wolfowitz did not describe a specific threat but noted a classified intelligence assessment from November 2004 regarding anthrax. He did not detail the assessment.

Health and Human Services is considering the request, a department spokesman said.

Anthrax vaccinations by the military have been suspended since late October, when a federal judge ordered the military to stop requiring personnel to take the vaccine. The judge, responding to a lawsuit by six members of the armed forces, found fault in the Food and Drug Administration process for approving the drug.

The military's request for emergency authority comes under the Project BioShield Act of 2004, which says that in response to a terrorist attack or other emergency, Health and Human Services can allow the use of drugs that had not finished the FDA process, officials said.

"We are concerned for the health and safety of our service members, particularly in worldwide operations involving the war on terrorism," said William Winkenwerder Jr., assistant secretary of defense for health affairs, in a statement provided by the Pentagon. "Intelligence indicates an ongoing threat of anthrax against our military forces."

An official of Health and Human Services, speaking on condition of anonymity, said the BioShield law was envisioned to be used after an attack has occurred to protect the American public from an outbreak, not to preemptively protect a part of the US government.

US District Judge Emmet G. Sullivan first ordered a halt to the mandatory vaccinations a year ago, saying the vaccine was being used for an unapproved purpose. Soon after, the FDA issued an order intended to give the vaccine final approval for use to prevent inhaled anthrax.

Sullivan later lifted the ban, except for the six plaintiffs, who asked Sullivan to reinstate the prohibition. He agreed, finding fault in the government's process for approving the vaccine.

With the FDA's final approval overruled, the anthrax vaccine is considered investigational. Congress has prohibited the military from giving investigational drugs to soldiers without their consent unless there is a presidential waiver.

Since 1998, 1.2 million troops have been vaccinated against anthrax. Before the shots were stopped, hundreds of service members had been punished or discharged for refusing them, according to the Pentagon.

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