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Federal Court Orders Pentagon to Stop Anthrax Immunization Program

Global Security Newswire

For a second time, a federal judge has ruled that the U.S. Defense Department must stop administering the anthrax vaccine to military personnel, concluding that the Food and Drug Administration did not meet the required review standards before allowing use of the vaccine, the Washington Post reported (see GSN, Sept. 9).

The Defense Department’s mandatory vaccination program, under which more than 1.2 million troops have been inoculated since 1998, must stop until the FDA reviews the anthrax vaccine properly for safety and effectiveness, according to a ruling yesterday by U.S. District Judge Emmet Sullivan.

Sullivan was particularly critical of the FDA for forgoing public comment before the agency first approved the vaccine last year, the Post reported.

“The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all — public scrutiny. This is the process the FDA in its expert judgment has outlined, and this is the course this court shall compel FDA to follow,” Sullivan wrote.

U.S. President George W. Bush, however, retains the power to waive the standard review process if he determines emergency circumstances exist, according to the ruling.

Sullivan initially ruled late last year, according to the Post, that the FDA had never approved the vaccine and ordered the inoculation program stopped. The FDA, however, approved the vaccine eight days later based on an application made 18 years earlier, and the program continued.

“As a result of the injunction, the Department of Defense will pause giving anthrax vaccinations until the legal situation is clarified,” the department said in a press release. “[The department] remains convinced that the anthrax immunization program complies with all the legal requirements and that the anthrax vaccine is safe and effective.” (Marc Kaufman, Washington Post, Oct. 28).