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".
The same year (as later revealed) MBPI changed both the fermenters and the filters used in manufacturing AVA without notifying the FDA, thus reportedly causing a 100 fold increase in the PA levels present in vaccine lots.Only several thousand people had ever received the vaccine up to 1991 when — coincident with Saddam Husseins invasion of Kuwait and the subsequent Gulf War — MBPI and the U.S. Army entered into an agreement for the manufacture of the vaccine. Later that year, the Army awarded MBPI the Commanders Award for Public Service for their efforts in supplying the US military with increased amounts of AVA for use during the conflict in which the use of anthrax bio-weapons by Iraq had been anticipated. Initial use in US military (1991-1997)
Use of AVA expanded dramatically in 1991, when the US military, concerned that Iraq possessed anthrax bioweapons, administered it to some 150,000 service members deployed for the Gulf War. Hussein never deployed his bio-weapons, but subsequent confirmation of an Iraqi bioweapons program — including 8,500 liters of concentrated anthrax spores (6,500 liters of it filled into munitions) — came in 1995 and later when the Iraqi government began to fully disclose the scope and scale of the effort, which it had pursued since the 1980s. Meanwhile, MBPI fell afoul of FDA inspectors and reviewers when it failed inspections (1993, 1997) and received warning letters (1995) and Notices of Intention to Revoke (1997) from the agency.