DoD Examines Anthrax Court Decision, Calls Vaccine Safe

 

Tuesday  December 23, 2003

By Jim Garamone
American Forces Press Service

WASHINGTON, Dec. 23, 2003 – Defense officials and lawyers with the Justice Department are examining a decision handed down by a federal judge in Washington Dec. 22 that ordered DoD to stop anthrax vaccinations for U.S. service members without their consent, Pentagon officials said today.

No one would comment on the ruling beyond saying the appropriate people are studying it. "The lawyers are examining it," Defense Secretary Donald H. Rumsfeld said during a Pentagon press conference today. "And at the appropriate time, they will be making a recommendation as to the way forward."

Pentagon officials said the anthrax vaccination program continues. Service members set to receive shots should report for them. The court case is limited to service members who do not want to receive the shot, Defense officials said. How the decision affects those individuals remains to be worked out.

DoD considers anthrax vaccination for service members deploying to high-threat areas as crucial. "We don't send soldiers into battle without helmets," said a Defense official.

The chairman of the Joint Chiefs of Staff also stressed the military need for the vaccinations. "This drug that we're using, the vaccine has been around for 40 years," said Chairman of the Joint Chiefs of Staff Air Force Gen. Richard B. Myers during a press conference. "It is not experimental. It's approved by the FDA (Food and Drug Administration).

"And from a military standpoint, I think it's extremely important. As you know, when we went into Iraq, we had all the troops in their chemical protective gear, because we thought there was a very real threat of either chemical or biological weapons, and in particular, anthrax was a big worry."

Anthrax is still a worry in many parts of the world, Myers said. "The one thing you can do to protect people is this vaccine," the chairman said. "From a military standpoint, I think it's very important we have this capability to protect our troops and enable them to do their job."

Dr. William Winkenwerder, the assistant secretary of defense for health affairs, said the vaccines are needed to protect American troops. The FDA guides everything the department does, he noted. "We follow FDA regulations scrupulously in the use of the anthrax vaccine and all medically regulated products," Winkenwirder said during an interview.

The FDA has licensed the product for all use, the doctor said. Other independent groups agree with the FDA assessment.

Winkenwirder said DoD was surprised about the decision. He said it was out of step with current science and out of keeping with the need for force protection.

The doctor said about 1 million American service members have received the vaccinations since the program started in 1998. Some 650,000 service members have received the six-shot series since June 2002. Of that number, only around 10 service members have refused to get the shots. "Most people realize and appreciate the threat that we face and are persuaded by the scientific evidence regarding the safety and effectiveness of the vaccine," Winkenwirder said.

The FDA approved the vaccine in 1970. The District Court decision questioned the FDA contention that the vaccine was effective against aerosolized anthrax – the most likely bioterror weapon. This judge's decision is counter to the FDA's own decisions, the opinion of the National Academy of Sciences' Institute of Medicine and the judgment of the most eminent experts on this topic.

Winkenwirder stressed that the department's paramount concern is for the safety of service members. The vaccine has been put through the most rigorous testing, he said. The vaccine has very few side effects, similar to other vaccines, and these are mild and temporary, officials said.

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