« Home | Next Generation Smallpox Vaccine In Trials » | Soldiers Fear the NeedleThe Pentagon still fights ... » | British Scientist to Receive $3.5 Million U.S. Gra... » | Ecstasy trials for combat stress » | Anthrax Vaccine Manufacturer Challenges Court Ruling » | FDA Approves VIGIV For Side Effects Of Smallpox Va... » | U.S. Judge Warns Rumsfeld Could Face Contempt for ... » | Honor Betrayed: Chemical Veterans » | National Vaccine Information Center Calls 'Anti-Te... » | US military stretched too thin? »

Anthrax Vaccinations Expected to Resume

By David Ruppe
Global Security Newswire

WASHINGTON — The U.S. Defense Department could soon resume anthrax vaccinations of U.S. military personnel pending a court decision expected this week or following a Food and Drug Administration decision sometime later, according to a lawyer for soldiers who sued to stop mandatory anthrax vaccinations (see GSN, Feb. 25).


A federal judge suspended the required shots last October, after finding that the FDA had not properly reviewed the vaccine before declaring it safe and effective against inhalation anthrax.

U.S. District Judge Emmet Sullivan, however, is expected to rule this week that his injunction does not bar vaccination using the unlicensed drug voluntarily, if authorized under a declared state of emergency.

Following a request from Deputy Defense Secretary Paul Wolfowitz, then-Health and Human Services Secretary Tommy Thompson declared such an emergency in January and issued an “emergency use authorization” for the voluntary vaccinations.

Although the vaccinations would be voluntary, soldiers could still be pressured into taking vaccine, which is believed to have some rare but severe side effects, said attorney Mark Zaid, representing military and civilian personnel in a lawsuit that pushed for the suspension. Without the emergency authorization, the law requires service-members to be informed about an unlicensed drug’s possible side effects and to consent to be vaccinated, unless that requirement is waived by the president.

Zaid said he expects Sullivan to allow the vaccinations to take place under the emergency authorization. The Defense Department has said it would provide vaccine recipients with a tri-fold brochure providing information on the vaccine and on options to accept or refuse the vaccine.

Zaid said, though, that several nongovernmental organizations in an “amicus curiae” brief are pressing Sullivan to require the Pentagon to offer potential recipients more information than the brochure now offers about the vaccine’s risks, to give that information prior to vaccination, and to have recipients sign a form indicating their consent to the vaccination.

“All I want is for them to be able to make an informed choice,” he said.

The government has argued that consideration of the brief is outside the court’s jurisdiction regarding the case.

FDA Ruling Pending

In addition, a 90-day comment period preceding a FDA determination on whether to license the vaccine for inhalation anthrax — a type anticipated in warfare or from terrorism — ended yesterday.

FDA licensing of the vaccine would allow the resumption of mandatory vaccinations without informed consent.

An FDA spokeswoman said yesterday there is no set date for the decision and that it would follow a review of the public comments.

Zaid expects the FDA to license the vaccine. It previously attempted to do so without full public comment in December 2003 after determining the vaccine is effective against skin and inhalation anthrax.

The plaintiffs contend there is insufficient research showing the drug is effective against inhalation anthrax, and so the drug should remain investigational and be administered either with the informed consent of the vaccine recipient or following a presidential order.

“You need to have an expert panel consider all of the evidence and make a recommendation to the FDA,” Zaid said.

Archives