FDA reaffirms worth of DoD anthrax vaccine

Dec 19, 2005 (CIDRAP News) – In a new chapter in a 2-year legal battle over the US military's anthrax vaccination program, the Food and Drug Administration (FDA) has reaffirmed its earlier finding that the anthrax vaccine used by the military is safe and effective for preventing all forms of anthrax.

It was not immediately clear whether the FDA decision announced last week would help the Department of Defense (DoD) revive its mandatory anthrax vaccination program, which was stopped by a federal judge in October 2004.

DoD has been giving the vaccine, called Anthrax Vaccine Adsorbed (Biothrax), to military personnel on a voluntary basis since April of this year.

"In light of the [FDA's] Final Order, the Department will review program options," Dr. William Winkenwerder, assistant secretary of defense for health affairs, said in a Dec 16 statement. "The military services will continue anthrax vaccinations as they have since April 2005 on a voluntary basis for eligible service members with the option to refuse."

More than 1.3 million service members serving in the Middle East and other areas have received anthrax shots since 1998. But some have objected to the shots out of concern about side effects.

In a lawsuit filed by military and civilian contractor personnel, a federal judge ordered DoD to stop requiring the shots because the FDA, in his view, had never specifically approved the vaccine for inhalataional anthrax.

The FDA quickly responded with a statement that the vaccine was for safe and effective for all forms of anthrax disease. District Judge Emmet G. Sullivan in Washington, DC, then lifted his injunction. But in October 2004 he stopped the vaccinations again, ruling that the FDA had not followed proper procedures in issuing the new approval.

In January 2005, the FDA granted DoD's request for emergency authority to resume the vaccination program, but said the shots had to be voluntary.

Also in January, the FDA, to satisfy Sullivan's objections about procedures, proposed a new approval of safety and effectiveness for the vaccine and asked for public comments. In its 73-page final order issued last week, the agency lists and responds to the public comments.

Winkenwerder said experts have consistently found the vaccine to be safe and effective. "The threat of anthrax as a weapon remains real," he said. "For people at increased risk of exposure, the benefits of the vaccine far outweigh the risks when all factors are considered. Vaccination against anthrax is the best round-the-clock protection available to protect our forces at risk."

See also:

FDA final order on anthrax vaccine
http://www.anthrax.mil/documents/853continuation.pdf

Dec 16 DoD statement
http://www.defense.gov/releases/release.aspx?releaseid=9168

Jan 13, 2005, CIDRAP News article "FDA seeks comments on controversial anthrax vaccine"

May 4, 2005, CIDRAP News article "DoD to resume giving anthrax shots"

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