Anthrax Vaccination Resumption

U.S. District Court Stays Injunction;
DoD Resumes Anthrax Vaccinations;
FDA Rules Anthrax Vaccine Protective Regardless of Route

Anthrax Vaccine Immunization Program Resumption
On January 7, 2004, the Court issued a stay of that preliminary injunction. The DoD remains convinced that the AVIP complies with all legal requirements, and there is now no judicial restraint on the AVIP implementation. Therefore, you should immediately resume the anthrax vaccination program.

DoD and the Anthrax Vaccine
I want to address the recent controversy created by a U.S. District Court decision December 22. 2003 to order a preliminary injunction against our anthrax program and the subsequent lifting of that injunction, January 7, 2004.

FDA Issues Final Rule and Final Order Regarding Safety and Efficacy of Certain Licensed Biological Products Including Anthrax Vaccine
The final order states FDA's conclusion that the licensed anthrax vaccine, Anthrax Vaccine Adsorbed, is safe and effective for the prevention of anthrax disease - regardless of the route of exposure.

A recent ruling by a United States District Court for the District of Columbia gave the opinion that the anthrax vaccine should be classified as "investigational" with regard to protecting against inhalation anthrax. 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. FDA's final determination of the safety and effectiveness of the anthrax vaccine, independent of route of exposure, as well as its conclusions regarding the Expert Panel's report, being announced today in the final order, are relevant and should be considered in any further litigation in this matter.

CNN
Judge OKs military anthrax vaccinations
Washington Post
Judge Reverses Anthrax Ruling
CNN
FDA: Anthrax vaccine 'safe and effective'
Washington Post
Anthrax Vaccinations Temporarily Stopped Program for Military on Hold While Legalities Explored

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DOD Temporarily Stops Anthrax Vaccinations Pending Legal Clarification

Anthrax Vaccination Stoppage
On December 22, 2003, the United States District Court for the District of Columbia issued a preliminary injunction against the current operation of the Anthrax Vaccine Immunization Program. In response, the Department, in concert with other agencies, is evaluating possible litigation and program actions. Pending further notice, the Deputy Secretary has decided that DoD will stop giving anthrax vaccinations until the legal situation is clarified.