Anthrax vaccination policy dropped after court ruling

Court rules against forced military vaccinations

The Department of Defense (DoD) has halted mandatory anthrax vaccinations of military personnel after a ruling by the U.S. District Court for the District of Columbia. The injunction cited a congressional "prohibition on forced inoculations with investigational drugs" in issuing a permanent injunction.

Until the Food and Drug Administration (FDA) certifies that the vaccine is safe and effective, the DoD "may no longer subject military personnel to involuntary anthrax vaccinations absent informed consent," the court ruled. Six plaintiffs, known as John and Jane Doe No. 1 through No. 6, brought the action to challenge the lawfulness of the government’s anthrax vaccination program.

They all are military personnel and civilian contract employees of the DoD who have submitted or have been instructed to submit to anthrax vaccinations without their consent. The ruling also cited an expert panel on finding that "no meaningful assessment of the [the vaccine’s] value against inhalation anthrax is possible."

Moreover, interested parties who originally were invited to comment on the vaccine in 1985 "could not have anticipated that FDA would permit the vaccine to be used for inhalation anthrax as a result of exposure through a biological attack," the court found. "Now for the first time, 18 years later, FDA’s Final Rule and Order asserts the FDA does not agree with the panel report,’ and believes that the vaccine is indicated for active immunization against [anthrax], independent of the route of exposure,’ and that the vaccine will protect humans against . . . inhalation anthrax.’"

The court ruled that the FDA position was a significant post-comment expansion of the scope of the original inquiry and it deprived the public of a meaningful opportunity to submit comments and participate in the administrative process mandated by law.

In a press release, the DoD pointed out that the ruling does not question the safety and effectiveness of the anthrax vaccine.

"The injunction centered on FDA procedural issues stating that additional public comment should have been sought before the FDA issued its final rule in December of 2003," the DoD stated. "DoD remains convinced that the anthrax immunization program complies with all the legal requirements and that the anthrax vaccine is safe and effective."