Vaccines and Immunizations

Vaccines are common health interventions that broadly benefit populations and individuals. Because of its unique, diverse mission, the military employs vaccines as critical countermeasures against infectious diseases and biological warfare agents. The military services' different vaccination policies reflect variations in their respective training cycles, missions, and expected levels of exposure. Military planners also constantly update vaccine programs to incorporate advances in preventive medicine and in response to changing health threats.

During the Gulf War, anthrax and botulinum toxoid vaccines protected US forces from the threat of Iraq's biological weapons. Anthrax is a serious livestock disease that also can infect humans who inhale the bacteria, causing a pneumonia-like disease fatal in 90 percent of cases; by the time symptoms appear, it is too late to save the patient. Botulism is a paralytic disease with a 25 percent incidence of mortality from respiratory failure caused by a bacterium-produced toxin, "the most potent poison known to man," according to the American Medical Association. Both produce symptoms extremely swiftly, and anthrax spores and the botulinum bacterium are easy to grow and weaponize.

The Food and Drug Administration licensed the anthrax vaccine in 1970; thus, some veterinarians, researchers, and people who worked with animal hides had used it for 20 years by the time of the Gulf War. Botulinum toxoid, used in occupational settings where workers were at risk of contracting botulism, had not been licensed, but the Food and Drug Administration approved its use as an investigational new drug.

A recent Institute of Medicine (IOM) report evaluates the published scientific research on these vaccines' health effects. This report states the evidence to link Gulf War veterans' long-term health problems with vaccines they received before or during the Gulf War is insufficient. The IOM specifically focused on anthrax and botulinum toxoid vaccinations and could not determine whether they are associated with long-term health effects. The IOM said published, peer-reviewed studies have not systematically evaluated their long-term health effects, and that few vaccines have been monitored for adverse effects over long periods of time.

Some of these vaccines' short-term effects, such as swelling and tenderness at the injection site, have been documented. Some study subjects also experienced a one- or two-day fever and other systemic effects commonly associated with other vaccinations. Serious events, such as those requiring hospitalization, are uncommon reactions to the anthrax vaccine. Severe allergic reactions occur even less frequently.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices has recommended anthrax vaccination for several at-risk groups, including military personnel deployed to areas with a high risk of exposure to the organism, as when it is used as a biological warfare weapon.

Several civilian committees, including the FDA's Panel on Review of Bacterial Vaccines and Toxoids (1985), the Armed Forces Epidemiological Board (1990 to present), the CDC's Anthrax Vaccine Expert Committee (1998 to present), and the Working Group on Civilian Biodefense at Johns Hopkins University (1999) have independently reviewed the anthrax vaccine's safety and effectiveness.

The Department of Defense has established an anthrax vaccination program designed to protect all deployable servicemembers from weaponized anthrax. Due to short supply, currently only DoD personnel deployed to Southwest Asia for more than 30 consecutive days continue to receive anthrax vaccine. Military medical treatment facilities are required to report serious reactions related to a vaccination to the Food and Drug Administration's Vaccine Adverse Event Reporting System (VAERS). According to VAERS statistics, 502,000 servicemembers have received 2,015,000 doses of the anthrax vaccine as of February 2001. Of these recipients, 54 have been hospitalized (0.011%); 11 hospitalizations were due to allergic reactions at the injection site. The Army is conducting a long-term study of 600 soldiers stationed at Tripler Army Medical Center in Honolulu to identify side effects that may occur over time from anthrax vaccinations.

Investigational drugs like botulism toxoid may be used only with the informed consent of those receiving them. Under current laws, the Department of Defense may issue the vaccine without informed consent if the threat of combat is immediate, but the President of the United States must agree in writing to such use.

More detailed information on vaccines and other research projects of the Office of the Special Assistant is available on the Internet at GulfLINK.