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Biotech / Medical : Bioterrorism

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From: scaram(o)uche2/2/2005 12:31:33 AM
   of 891
 
seattlepi.nwsource.com

Pentagon gets OK for anthrax vaccines

By MARK SHERMAN
ASSOCIATED PRESS WRITER

WASHINGTON -- Federal health officials have granted emergency authority for U.S. military personnel to receive the anthrax vaccine, and the Pentagon said Tuesday it plans to ask a federal judge to allow vaccinations to resume.

The military would be allowed to vaccinate U.S. forces for six months, but could not punish people who refused a shot, under the authority granted last week by the Food and Drug Administration, according to a court filing Tuesday. Defense officials say military forces are at heightened risk of an anthrax attack.

But the Pentagon must first get U.S. District Judge Emmet G. Sullivan to agree. "This step could take some time," a Pentagon official said.

Ruling in a lawsuit by six members of the armed forces, Sullivan suspended anthrax vaccinations in late October after he found fault in the FDA's process for approving the drug.

The government, however, acknowledged that 931 people were "mistakenly vaccinated" after Sullivan ordered the halt on Oct. 27, including about 150 in January. The Defense Department "recognizes and takes seriously its obligations to cease all inoculations and is redoubling its efforts" to comply with the court order, said the Justice Department filing.



Defense officials have insisted the vaccine is safe and noted the judge has not disagreed. The lawsuit argued the vaccine was experimental and that it was being improperly used for inhalation anthrax as well as exposure to the bacteria through the skin.

The Pentagon sought emergency authority under the Project BioShield Act of 2004, which says the Health and Human Services Department, in response to a terrorist attack or other emergency, can allow the use of drugs that have not finished the FDA process, officials said.

Tommy Thompson signed the emergency use declaration late last month, shortly before stepping down as HHS secretary, said HHS spokesman Bill Pierce.

The FDA told the Pentagon vaccinations could resume, with one important condition: Military personnel can refuse a shot without fear of punishment.

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