FDA: Anthrax vaccine 'safe and effective'
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WASHINGTON (CNN) -- The Food and Drug Administration Tuesday declared the anthrax vaccine "safe and effective" in response to a federal judge's injunction against mandatory vaccinations of what he said was an experimental drug.
The anthrax vaccine is routinely administered to U.S. military personnel.
The FDA said its "final rule and order" is that the vaccine is "safe and effective for the prevention of anthrax disease -- regardless of the route of exposure."
The FDA also cited an independent review of the vaccine by the Institute of Medicine, which concluded that it was safe.
U.S. District Judge Emmet G. Sullivan ruled December 22 that the Department of Defense must stop forcing soldiers and civilian employees to get the anthrax vaccine, saying the vaccine is an experimental drug not licensed by the FDA.
Sullivan issued a preliminary injunction against the Pentagon in a lawsuit brought by six Department of Defense employees -- including active duty personnel, civilian contractors and National Guardsmen -- who objected to orders to take the shots.
In its Tuesday statement, the FDA said its final rule on the vaccine makes "it clear that (the) FDA does not regard the approved anthrax vaccine as 'investigational' for protection against inhalation anthrax."
Late Tuesday, Defense Secretary Donald Rumsfeld, Health and Human Services Secretary Tommy Thompson and others fielded an emergency motion asking that the December 22 injunction against giving the anthrax vaccine be stayed, following the FDA's ruling.
"The Defendants respectfully ask this Court to vacate its injunction in light of an FDA Order... that confirms and conclusively determines that AVA [Anthrax Vaccine Adsorbed] is safe and effective to protect humans against inhalation anthrax," says the motion.
"There can be no doubt that the FDA Order removes the legal basis upon which relief was sought and granted in this case," the motion continues.
Lawyers for the plaintiffs in the lawsuit issued a statement saying that the FDA's ruling is nothing more than "after-the-fact gamesmanship to overrule the Court's findings."
Attorney Mark Zaid cited research from an FDA panel in 1985 -- which was also mentioned in the FDA statement Tuesday -- that said that "no meaningful assessment of [the vaccine's] value against inhalation anthrax is possible," Zaid said.
Shortly after the September 11, 2001, terrorist attacks in the United States, five people died after anthrax-laced letters were mailed to politicians and various media outlets.
Six other people were also stricken with inhalation anthrax but survived, while seven people contracted anthrax through skin contact.
