The Anthrax Vaccine and the United States Military: The Ethics of Anthrax Vaccine Administration and Informed Consent
Creators: name: Warren, Tara D.
Publisher: name: The University of North Carolina at Chapel Hill University Libraries
Year: 2003

description: The anthrax bacterium, when converted into a biological weapon, poses a serious threat to the United States military forces in battle. In order to counteract this threat, the Department of Defense (DoD) instituted the Anthrax Vaccine Immunization Program (AVIP), which mandates that all military forces take the anthrax vaccine shot series. There has been a wave of controversy over this program, because the vaccine has not been proven as safe and effective against the strains of anthrax that would potentially be encountered in warfare. The controversy over the program has been surrounded by discussions of whether or not the military should be required to sign an informed consent form when given the vaccine, in order to ensure that they fully understand the potential benefits and risks associated with the vaccine and still choose to take the shot. The DoD maintains that the vaccine is completely safe and efficacious, and that because the vaccine is licensed, no informed consent is required. The military and civilians counter this argument by stating that the vaccine is not being used for the condition that it was tested for, and is therefore still considered to be an investigational drug. In order to administer an investigational drug, and informed consent must be obtained. Many legal battles are being fought, both by military men and women wishing to reverse their discharges because of refusing the vaccine, and by military men and women who have experienced serious side effects as a result of the vaccine. There are also legislative actions being proposed, but nothing thus far has been approved. A reasonable solution would be to make the AVIP program voluntary until a better vaccine is developed and the long-term effects are more fully understood. This would allow the military personnel to make the personal decision of what medication they want to put into their bodies, and to be fully informed of the benefits and risks associated with that medication before the vaccine is administered. Though countries have been studying and developing biological weapons for years, the events of September 11, 2001 introduced the threat to the entire world. Letters infested with the anthrax bacterium began to surface around the United States, causing a newfound fear in American citizens regarding biological and chemical warfare. By this time, however, the military had already put an anthrax vaccine program into place and was in the process of trying to vaccinate all of the troops against this bioweapon. A controversy and outcry from the military personnel ensued, due to the fact that many troops that took the anthrax vaccine experienced adverse health effects, varying in severity. Troops continue to refuse the vaccine and suffer the consequences, and so the debate continues on whether it is ethical to have a mandatory anthrax vaccination program for the United States military forces, especially when the long-term effects of the vaccine are unknown and have not been conclusively studied. In addition, the vaccine is currently only tested and approved for cutaneous anthrax, not the inhalation form that would be experienced in combat (Nicolson, Nass, and Nicolson, 2000) The issues surrounding this controversy will be discussed, including an overview of the anthrax bacterium, the history of the vaccine's development, safety and efficacy, the history of the military's adoption of the vaccine, and current issues involving the military officials, troops, scientists, and pending legislation. The existing problem is that there is not enough hard evidence to support giving this vaccine to our troops without knowing all of the potential consequences. Because the administration of the vaccine for inhalation anthrax is still investigational, it should be treated as such by the Food and Drug Administration (FDA) and the military and informed consent should be obtained from the recipients of the vaccine. If the vaccine is continually administered as is, the military risks losing more soldiers to side effects of the vaccine and also to the fear of taking the vaccine in the first place. In a time as crucial as this, we cannot afford to lose troops, but should provide them with the latest information on the vaccine and its known side effects, then let them make their own decision on whether or not they will take the vaccine.