DoD resumes anthrax shots after judge lifts ban

Jan 8, 2004 (CIDRAP News) – The Department of Defense (DoD) yesterday ordered the resumption of its mandatory anthrax vaccination program after a federal judge in Washington, DC, lifted an injunction that had halted the program Dec 22.

An order for immediate resumption of the inoculations was issued by David S. C. Chu, undersecretary of defense for personnel and readiness, and was posted on a DoD Web site.

US District Judge Emmet G. Sullivan had issued a preliminary injunction against the vaccination program on grounds that the Food and Drug Administration (FDA) had never specifically approved Anthrax Vaccine Adsorbed to prevent inhalational anthrax, as opposed to cutaneous anthrax. Sullivan said the vaccine amounted to an investigational drug in relation to inhalational anthrax.

But on Dec 30 the FDA formally stated that the vaccine is safe and effective for preventing anthrax regardless of the route of exposure. The agency said it had made that determination long before Sullivan's injunction. The US Justice Department immediately asked Sullivan to stay the injunction except as it affected the six military and contractor personnel who had filed suit against the immunization program.

In lifting the injunction yesterday, Sullivan called the timing of the FDA's ruling on anthrax vaccine "highly suspicious," according to Associated Press (AP) and Washington Post reports. Nonetheless, "the rule has been issued and the principal reason for the issuance of the injunction has been addressed by the government," Sullivan was quoted as saying in his written order. The order still forbids vaccination for the six plaintiffs in the lawsuit.

The Post reported that Mark S. Zaid, a Washington lawyer for the plaintiffs, said he would ask Sullivan to stop the immunization program again on the ground that the FDA (according to Zaid) approved the vaccine only on the basis of animal research.

According to the Post, Zaid also said he has evidence that DoD is administering the vaccine improperly. The vaccine requires six doses over 18 months, followed by annual boosters. But Zaid alleged that the military often gives only two or three shots.

Chu, in his memo ordering resumption of the program, stated, "The Department of Defense remains convinced that the AVIP [Anthrax Vaccine Immunization Program] complies with all legal requirements."

More than a million military personnel have received anthrax shots since the current vaccination program began in 1998. Hundreds have refused the shots out of concern about alleged serious side effects, and some have been punished or forced out of the military.

See also:

Memo from David S. C. Chu on resumption of anthrax vaccination program
http://www.defenselink.mil/news/Jan2004/d20030107anthrax.pdf

Dec 31 CIDRAP News story about the FDA statement on the anthrax vaccine

Dec 23 CIDRAP News story about Sullivan's injunction against the anthrax vaccination program

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