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Judge's Ruling Pauses Anthrax-Vaccination Program

By Samantha L. Quigley
American Forces Press Service

WASHINGTON, Nov. 2, 2004 – The Defense Department has temporarily paused the anthrax vaccination program because of an injunction issued by the U.S. District Court for the District of Columbia.

Assistant Secretary of Defense for Health Affairs Dr. William Winkenwerder emphasized the injunction was not related to the safety or effectiveness of the vaccine, but rather to a technical issue as to whether the Food and Drug Administration followed a proper procedure when it issued a rule about the vaccine one year ago.

"I just would like to reassure everyone that the vaccine is safe and effective," Winkenwerder said. "The most definitive study was one that was independent, apart from the Department of Defense, done two years ago by the National Academy of Sciences.

"They looked at all the evidence," he said. "They said the vaccine is safe and effective against all forms of anthrax."

The vaccination program was also paused briefly in late 2003. That ruling was reversed roughly two weeks after being handed down. Officials hope that, as in 2003, the current legal issues will be resolved quickly and the program will restart in the near future, he said.

Winkenwerder said he didn't want to speculate what would be required of the Food and Drug Administration to work through these matters.

"Those really are legal issues that are being worked on by lawyers by the Department of Defense, from the Justice Department, from the FDA working together to address the concerns that have been raised by this opinion," he said.

The results of the pause are unclear at this time, but Winkenwerder said DoD expects no more than a delay.

"Obviously attorneys have to get together to look at these issues and respond," he said. "We'll be able to say more about what will happen after that's done."

Despite the pause in the program, those servicemembers who have begun the vaccination program will continue with it once the injunction is lifted, Winkenwerder said.

However, because of the wording of the judge's opinion, servicemembers wanting to participate in the program voluntarily are unable to do so. After fulfilling government contracts, little of the current vaccine is available to the general public.

"We're hoping and planning to have a new anthrax vaccine with large amounts available," Winkenwerder said. "And maybe within a couple years' time, vaccine would be available to the general public."

Winkenwerder said the new vaccine is under development with the project being led by the Department of Health and Human Services. The department's plan is to have 75 million doses produced within the next year, however, it would still have to go through testing and FDA licensing.

The concerted effort to produce and develop large quantities of the vaccine is being made to not only protect the troops, Winkenwerder said, but also the American public. That effort is necessary because there is still a threat of an attack using anthrax as a weapon, despite the fact that no weapons of mass destruction were found in Iraq, he said.

"There's clearly a continuing threat," he said. "We know from intelligence information and also from comments that have been made by the leaders of the intelligence community that the terrorists have expressed an avowed interest in biological and chemical and nuclear weapons.

"They've spoken specifically about anthrax," Winkenwerder added. "With that kind of threat out there, it's really important that we take the steps that we must take to protect our people."

The vaccine is not the only way the government is working to protect the public from these threats. Winkenwerder named post-exposure antibiotic treatment and early-warning systems that can sample the air for an exposure as alternative protective measures.

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Biographies:
Assistant Secretary of Defense for Health Affairs Dr. William Winkenwerder

Related Sites:
Anthrax Vaccine Information Program



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