Apr 7, 2005 (CIDRAP News) – A federal judge who stopped the US military's compulsory anthrax vaccination program last October has ruled that the Pentagon can resume giving anthrax shots, but only on a voluntary basis.
District Judge Emmet G. Sullivan in Washington, DC, said yesterday the Pentagon can administer the shots to volunteers under the terms of an emergency authorization granted in January by the Department of Health and Human Services (HHS). Military officials had asked for the emergency authority on grounds that troops in some regions face a risk of anthrax attack.
The Department of Defense (DoD) said it was pleased with the ruling but did not predict when vaccinations will resume. In a brief statement provided by e-mail, DoD officials said, "No vaccinations will be offered until the Defense Department issues detailed implementing instructions in the near future."
Sullivan had ruled last October that the mandatory vaccination program was illegal because the Food and Drug Administration (FDA), in his opinion, did not follow proper procedures in approving the vaccine for inhalational anthrax, as opposed to cutaneous anthrax. He said troops could not be required to take the vaccine, called Anthrax Vaccine Adsorbed (AVA), without their informed consent or a special presidential waiver.
In December, military officials responded to the ruling by asking 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, in a declared emergency, can authorize the use of a medical product that has not gained ordinary FDA approval.
Then-HHS Secretary Tommy Thompson granted the Department of Defense (DoD) request on Jan 14. But the "Emergency Use Authorization" (EUA) said DoD had to make the vaccinations optional.
DoD subsequently asked Sullivan to modify his injunction to allow for anthrax vaccinations under the emergency authority. Sullivan granted that motion yesterday, stipulating that the shots have to be voluntary.
In his ruling, Sullivan left the door open to challenges to the legality of the emergency authorization granted by HHS. He said his ruling signaled no "prejudice to a future challenge to the validity of any such EUA," adding, "The court expressly makes no finding as to the lawfulness of any specific EUA that has been or may be approved by the Department of Health and Human Services."
More than 1.3 million people have received anthrax shots in the DoD program since 1998, according to the Pentagon. Hundreds of troops have refused the shots out of concern about side effects, and some have been punished or forced out of the military as a result.
Sullivan's ruling came in a suit filed by six military members and DoD civilian contractor employees. In an initial ruling in December 2003, the judge ordered DoD to stop requiring the shots on the ground that the FDA had never specifically approved the vaccine for inhalational anthrax. (The vaccine was originally licensed in 1970.)
The FDA responded a week later with a declaration that the vaccine was safe and effective for all forms of anthrax. Sullivan then lifted his injunction in January 2004, little more than 2 weeks after he had issued it.
But in his subsequent ruling in October 2004, Sullivan said the FDA had failed to follow its own rules in declaring the vaccine safe for all forms of the disease. Those rules, set up after the FDA took over drug licensing from another federal agency in 1972, included gathering public comments. Sullivan said that the FDA's declaration relied partly on evidence on which the public never had a chance to comment.
Last December, the FDA quietly published a Federal Register notice inviting the public to comment on a proposal to confirm the vaccine's approval for all forms of anthrax. The deadline for comments was Mar 29.
AVA requires six shots over a period of 18 months, followed by annual boosters. Last November HHS awarded an $877 million contract for a new anthrax vaccine that officials hope will require fewer doses and have fewer side effects. The contract went to VaxGen Inc., Brisbane, Calif., for 75 million doses, which are destined for the Strategic National Stockpile of drugs and medical supplies to protect the public. AVA is derived from whole anthrax microbes, whereas the new vaccine contains a purified form of just one anthrax component, called protective antigen.
See also:
Feb 2 CIDRAP News story "FDA issues emergency order on military anthrax shots"
Nov 4, 2004, CIDRAP News story "HHS to spend $877 million on new anthrax vaccine"
