FDA says anthrax vaccine prevents inhalational anthrax

Dec 31, 2003 (CIDRAP News) – The Food and Drug Administration (FDA) formally stated yesterday that the licensed anthrax vaccine is safe and effective for preventing all forms of anthrax, including inhalational anthrax, thereby undermining the rationale of a recent court injunction that halted the Pentagon's anthrax vaccination program.

In a news release, the FDA said it concluded that Anthrax Vaccine Adsorbed "is safe and effective for the prevention of anthrax disease—regardless of the route of exposure."

On Dec 22 US District Judge Emmet G. Sullivan of Washington, DC, ordered the Pentagon to stop its mandatory immunization program on grounds that the FDA never specifically approved the vaccine to prevent inhalational anthrax. He said the vaccine amounted to an investigational drug with respect to that form of the disease.

The FDA stated, "Today's final rule and order make it clear that FDA does not regard the approved anthrax vaccine as 'investigational' for protection against inhalation anthrax." The agency said its conclusions on the safety and effectiveness of the vaccine "are relevant and should be considered in any further litigation on this matter."

The US Justice Department immediately responded to the FDA statement by filing a motion asking a federal judge to cancel Sullivan's injunction, according to a New York Times report today. The report said the motion asked the court to stay the effects of the injunction for all military service members except the six plaintiffs who sued to stop the vaccination program.

The FDA said it made its determinations about the vaccine long before the Dec 22 court ruling. Its ruling, the agency said, marks the completion of a review of biologic products that were licensed before 1972, when the FDA took over licensing responsibility from the National Institutes of Health (NIH). The anthrax vaccine was originally licensed in 1970. The review included some other "bacterial vaccines and toxoids" besides the anthrax vaccine.

After taking over the licensing responsibility, the FDA gave expert panels the job of reviewing biologic products that had been licensed by the NIH, the FDA statement explained. The panel that reviewed the anthrax vaccine recommended in 1985 that the FDA classify it as safe and effective and continue to license it.

"FDA agreed with the Expert Panel's general recommendation categorizing the vaccine at that time and continues to support that conclusion in this final rule and order," the agency stated. It acknowledged that the controlled clinical trial that showed the effectiveness of the vaccine included "too few cases of inhalation anthrax to support an independent statistical analysis." But all the inhalational cases that did occur in the trial were in unvaccinated people, the agency said.

"Therefore, the FDA-approved labeling for the anthrax vaccine does not specify the route of exposure, and the vaccine is indicated for active immunization against Bacillus anthracis, independent of the route of exposure," the FDA said.

The Times report quoted John J. Michels, Jr., an attorney for the plaintiffs seeking to stop the vaccination program, as saying, "The FDA pronouncement is not retroactive and, at best, means that the FDA has issued a ruling that makes the vaccine properly licensed from this point forward."

After the Dec 22 court ruling, the Department of Defense said it would stop the immunization program pending clarification of the legal situation. Close to a million military personnel have received anthrax shots since DoD launched the immunization program in 1998. Citing concerns about alleged long-term side effects, hundreds of soldiers have quit the military or sought transfers to other units to avoid the shots, and some have been disciplined or court-martialed for refusing them.

The anthrax vaccine is given in six doses over 18 months, with annual boosters thereafter.

See also:

"Prepublication" version of the FDA final rule and order covering anthrax vaccine and certain other bacterial vaccines and toxoids licensed before July 1972
http://www.fda.gov/OHRMS/DOCKETS/98fr/80n-0208-nfr0001.pdf

Dec 23, 2003, CIDRAP News story on the injunction against the DoD anthrax vaccination program

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