FDA Rules Anthrax Vaccine Safe, Effective
The Justice Department, citing the FDA order, 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. It appears reflective of policy duress than independent analysis."
The vaccine actually has been government-approved for sale since 1970 and its label says it protects regardless of the route of anthrax exposure, something FDA officials have repeatedly stressed.
The agency published a formal regulation Tuesday restating the approval -- a bureaucratic step decades in the making that doesn't change the vaccine's sales status.
The FDA in 1972 gained jurisdiction over vaccines and related products from the National Institutes of Health and began double-checking that they met the agency's requirements. In 1985, FDA proposed the rule codified today, re-certifying the safety of the anthrax vaccine and some other vaccines against bacterial infections. That proposal had never been finalized as the FDA moved on to jobs it considered more important.
The anthrax attacks of 2001 reminded the FDA that it needed to formally finish the job, and the rule was moving through final review by the Bush administration when the judge ruled last week.
It wasn't clear if the FDA rule would have any effect on suspended military vaccinations. The Associated Press
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