DoD and the anthrax vaccine

  • Published
WASHINGTON (ACCNS) --    I want to address the recent controversy created by a Dec. 22 U.S. District Court decision to order a preliminary injunction against our anthrax vaccination program and the subsequent lifting of that injunction on Jan. 7.

Although the litigation has not been resolved, were pleased the court lifted the preliminary injunction. The Defense Department is once again vaccinating service members to protect them against the threat of anthrax.

The facts, the best medical science and the Food and Drug Administrations Dec. 30 Final Rule, fully support all of DoDs actions and speak for themselves.

The anthrax vaccination program is important for the safety and welfare of our service members because it protects against a deadly biological agent. The program is based on sound scientific information and verified by experts, both inside and outside of DoD. My message to our troops throughout the world is this: your health and safety is our top priority. The purpose of military vaccination programs is to keep you protected and healthy so you can return home safely.

On Dec. 22, 2003, the U.S. District Court for the District of Columbia placed a preliminary injunction on the anthrax vaccination program for service members. The Court expressed the opinion that the FDA had not clearly determined the vaccine is approved to protect against inhalation anthrax and therefore DoD had to comply with rules for using investigational drugs. In response to that court order, DoD stopped giving anthrax vaccinations to service members until the legal situation was clarified.

On Dec. 30, 2003, FDA issued a Final Rule that had been under development for more than a year that addressed a number of vaccines and biologic products. This rule made explicitly clear the finding that the anthrax vaccine prevents all forms of anthrax, including inhalation disease.

The rule appeared in the Federal Register Jan. 5, 2004. In the Final Rule, FDA makes clear a fact that FDA, DoD and other federal government agencies such as the Centers for Disease Control and Prevention and the National Institutes of Health have known for years: that use of anthrax vaccine is firmly rooted in the best available science.

One example is the National Academy of Sciences Institute of Medicine report of March 2002. That report, compiled by the worlds best scientists states unequivocally that anthrax vaccine is an effective vaccine for the protection of humans against anthrax, including inhalation anthrax. In field studies, no one who received the vaccine series got inhalation anthrax, but five people who did not receive the vaccine series did get this deadly disease. Additionally, in a series of controlled experiments in 65 Rhesus monkeys exposed to inhalation anthrax and provided the vaccine, more than 95 percent survived whereas, among 18 exposed Rhesus monkeys without the vaccine, none survived.

Based on the FDA Final Rule, the court lifted the preliminary injunction, except as it applies to six individual John Doe plaintiffs in the case, whose identities are not known to DoD.

Now that the preliminary injunction is lifted, DoD is proceeding with anthrax vaccinations, which are safe and effective to protect service members. Because the litigation is continuing, additional legal proceedings will be required to bring final resolution to the matter. DoD hopes this can be achieved soon and that inflammatory and inaccurate statements the litigation has spawned can be clearly put to rest.

I want to reiterate that the health and safety of all service members is the top concern of myself and the service surgeons general.

Our vaccination program to protect you from this deadly biological disease is based on the best medical and scientific information available as well as by independent review of the worlds best experts in the field.

The program is supported in FDA regulations and consistent with all legal requirements. It has my full support and that of the DoD military and civilian leadership.