Hundreds of service members were compelled to leave the military (some of them court-martialed) for resisting the inoculations during the first six years of the program. Adverse events following AVA administration were assessed in several studies conducted by the DoD in the context of the routine anthrax vaccination program. Between 1998 and 2000, at U.S. Forces, Korea, data were collected at the time of anthrax vaccination from 4,348 service personnel regarding adverse events experienced from a previous dose of anthrax vaccine. Most reported events were localized, minor, and self-limited. After the first or second dose, 1.9% reported limitations in work performance or had been placed on limited duty. Only 0.3% reported >1 day lost from work; 0.5% consulted a clinic for evaluation; and one person (0.02%) required hospitalization for an injection-site reaction. Adverse events were reported more commonly among women than among men. A second study, also between 1998 and 2000, at Tripler Army Medical Center, Hawaii, assessed adverse events among 603 military health-care workers. Rates of events that resulted in seeking medical advice or taking time off work were 7.9% after the first dose; 5.1% after the second dose; 3.0% after the third dose; and 3.1% after the fourth dose. Events most commonly reported included muscle or joint aches, headache, and fatigue.
Under the plan all military personnel, including new recruits, would begin receiving what was then a six-shot series of inoculations in the following fashion: Phase 1: Forces assigned now, or soon rotating, to high threat areas in Southwest Asia and Korea; Phase 2: Early deploying forces into high threat areas; Phase 3: Remainder of the force and new recruits; and Phase 4: Continuation of the program with annual booster shots. The AVIP and initial mandatory military use (1997-2000)
There were no published studies of AVAs safety in humans until the advent of the Anthrax Vaccine Immunization Program (AVIP). This program, initiated by the Clinton administration and announced by Secretary of Defense William Cohen in 1997, made the vaccine mandatory for active duty US service personnel. Vaccinations began in March 1998 with personnel sent to high-risk areas, such as South Korea and Southwest Asia. Also in 1998, MBPI was purchased by BioPort Corporation of Lansing, Michigan (jointly with former MBPI laboratory directors) for approximately $24 million. The same year, a particularly damning FDA report was issued resulting in the temporary suspension of AVA shipments from the production plant. Much controversy ensued due to the FDA infractions, the mandatory nature of the program, and to a public perception that AVA was unsafe — possibly causing sometimes serious side effects — and might be contributing to the highly politically charged malady known as "Gulf War syndrome".