Anthrax Vaccine Safe, FDA Says
Wednesday, December 31, 2003; Page A04
The Food and Drug Administration made it official again yesterday: The anthrax vaccine is safe and effective, no matter how the infection is spread.
The ruling comes a week after a federal judge halted the military's anthrax inoculations, saying he thought the vaccine was experimental if used to prevent inhaled anthrax instead of the through-the-skin form.
The Justice Department, citing the FDA's ruling, asked U.S. District Judge Emmet G. Sullivan to set aside his preliminary ban, except for the six plaintiffs who filed a class-action suit against the Defense Department to stop the vaccinations. As an alternative, the department asked that the court set aside its ruling pending an appeal.
"The longer such an injunction remains in place, the greater is the danger to the men and women of our armed forces and to our military preparedness," the department said. "Prolonged cessation of the inoculation program would gravely threaten the safety of more and more service members."
Mark Zaid, one of the lawyers representing the service members who sued the government, said the FDA rule "is nothing more than after-the-fact gamesmanship to overrule the court's findings."
The vaccine has been government-approved for sale since 1970, and its label says it protects regardless of the route of anthrax exposure, which FDA officials have repeatedly stressed. The agency published a formal regulation yesterday restating the approval -- a bureaucratic step decades in the making that does not change the vaccine's sales status.
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