I want to address the recent controversy created by a U.S. District Court decision December 22 to order a preliminary injunction against our anthrax program and the subsequent lifting of that injunction, January 7. Although the litigation has not been finally resolved, we are pleased the Court lifted the preliminary injunction. DoD is now vaccinating service members again to protect them against the threat of anthrax. The facts, the best medical science, and the FDA’s December 30 final rule, fully support all of DoD’s 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 outside of the Department of Defense. 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 our troops protected and healthy so that they return home safely.

On December 22, 2003, the United States 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 Food and Drug Administration (FDA) had not clearly determined that the vaccine is approved to protect against inhalational 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 December 30, 2003, FDA issued a Final Rule that had been under development for more than one year that addressed a number of vaccines and biologic products. This rule made explicitly clear the finding that anthrax vaccine prevents all forms of anthrax, including inhalational disease. The Rule appeared in the Federal Register on January 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 world’s best scientists states unequivocally that anthrax vaccine is “an effective vaccine for the protection of humans against anthrax, including inhalational anthrax.” In field studies, no one who received the vaccine series got inhalational 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 inhalational anthrax and provided the vaccine, over 95% survived whereas among 18 exposed Rhesus monkeys without the vaccine, 0% 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 the Service Surgeons General and me. 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 world’s 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.

- William Winkenwerder, Jr., MD, Assistant Secretary of Defense for Health Affairs