FDA issues emergency order on military anthrax shots

Feb 2, 2005 (CIDRAP News) – Asserting that US troops face an increased risk of anthrax attacks, the Food and Drug Administration (FDA) has issued an emergency order to help the Pentagon reverse a court ruling that stopped its anthrax vaccination program last fall.

The order means the Department of Defense (DoD) now can petition US District Judge Emmet G. Sullivan to lift the injunction he issued against the vaccination program on Oct 27, 2004, DoD officials said in statements issued today. It could take several weeks for that to happen, officials said.

Before the court ruling, anthrax shots were required for troops serving in the Middle East and certain other areas. But the FDA's emergency order allows troops to refuse the vaccine, according to DoD.

In his ruling, Sullivan said the FDA did not follow proper procedures in approving the anthrax vaccine for use against inhalational anthrax, as opposed to cutaneous anthrax. The FDA responded Dec 29 by publishing a proposal to reaffirm the vaccine's approval and inviting the public to comment within 90 days.

But before that, on Dec 10, DoD had asked the Department of Health and Human Services (HHS) for emergency authority to resume the vaccination program. Under the Project Bioshield Act of 2004, the FDA can, in an emergency, authorize the use of a medical product that has not gained ordinary FDA approval.

In response to the DoD request, HHS Secretary Tommy Thompson declared an emergency on Jan 14, according to FDA and DoD statements today. The FDA followed up by publishing an "Emergency Use Authorization" (EUA) in the Federal Register today.

The order authorizes use of anthrax vaccine adsorbed (AVA) to prevent inhalational anthrax in people between the ages of 18 and 65 if DoD considers them to face a risk of anthrax attacks, the notice says. The authorization is effective for 6 months and can be extended if the state of emergency continues.

DoD said, "Granting the EUA is one step in the process that DoD must pursue in order to continue vaccinating its personnel at highest risk. The next step is to petition the District Court to modify its injunction to allow DoD to resume vaccinations with the EUA. This step could take several weeks."

The emergency order includes "a provision allowing DoD vaccinees an option to refuse the vaccine," the DoD statement said.

About 1.25 million military personnel have received anthrax shots since the vaccination program started in 1998, according to DoD. Some troops have refused the shots because of concern about side effects, and some have been disciplined or forced out of the service as a result. Sullivan's ruling came in response to a lawsuit filed by six military members and civilian contractor personnel.

See also:

FDA Federal Register notice on anthrax vaccine emergency order
http://edocket.access.gpo.gov/2005/pdf/05-2028.pdf

DoD questions and answers on the authorization
http://www.vaccines.mil/default.aspx?cnt=resource/qaCategories&dID=21

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