The Pentagon has taken a major step toward reviving its controversial program of giving anthrax vaccine to service members, invoking emergency provisions of the Project BioShield Act that allow use of unapproved drugs and vaccines.
The Department of Defense said use of the vaccine will be voluntary for now, in contrast with the mandatory program that was blocked by a federal judge in October on the grounds that the vaccine was never properly cleared for use by the Food and Drug Administration.
Angelita Kisena of Compton, Calif., administers an anthrax vaccine to a crew member aboard the USS Mount Whitney. For now, the Defense Department says the vaccine will be voluntary.
(Sean Gallup -- Getty Images)
The special authorization follows determinations by the Defense Department and former Health and Human Services secretary Tommy G. Thompson that a formal anthrax emergency exists for troops stationed in some nations abroad.
"The Department's current intelligence community assessments establish that there is a heightened risk for U.S. military forces of attack with anthrax," a DOD official said. He said the assessment applies to Iraq, Afghanistan and North Korea in particular.
The emergency measure marks a dramatic turn in the Defense Department's long-running efforts to establish and maintain a mandatory vaccination program to protect against inhaled anthrax. Six former or current service members sued the department in 2003 over the program, and U.S. District Judge Emmet G. Sullivan ruled last fall that the vaccinations were illegal and permanently enjoined their use.
In an order posted online Monday, however, acting FDA Commissioner Lester M. Crawford said that after conferring with the National Institutes of Health and the Center for Disease Control and Prevention, he had authorized the use of the vaccine under the BioShield Act. The order set several conditions -- that troops be educated about the vaccine and given the opportunity to refuse -- but did not present any other obstacles to renewing the program.
Crawford wrote that the "known and potential benefits of the [vaccine] outweigh the known and potential risks," and that there is no adequate substitute for it.
A DOD official said yesterday the issue will be revisited in Sullivan's courtroom before the vaccination program resumes. The process, he said, "could take some time."
That assessment was reinforced yesterday by the six service members' lawyer, who said he would go to court to oppose any effort to quickly revive the program. John J. Michels said the injunction remains in force despite the emergency authorization and despite the department's new willingness to accept a voluntary vaccination program.
Michels also argued that the emergency provisions of the BioShield Act were being misused. "The emergency here is that the department lost the case in court, and invoking an emergency on that basis is a terrible precedent," he said.