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.
The FDAs incomplete rulemaking from 1985 effectively rendered the anthrax vaccine program illegal. The basis was the never finalized FDA Proposed Rule. In that rulemaking the FDA published, but never finalized, a licensing rule for the anthrax vaccine in the Federal Register, which included an expert review panels findings. Those findings included the fact that the "Anthrax vaccine efficacy against inhalation anthrax is not well documented," and that "No meaningful assessment of its value against inhalation anthrax is possible due to its low incidence," and that "The vaccine manufactured by the Michigan Department of Public Health has not been employed in a controlled field trial. "On December 15, 2005, the FDA re-issued a Final Rule & Order on the license status of the anthrax vaccine. After reviewing the extensive scientific evidence and carefully considering comments from the public, the FDA again determined that the vaccine is appropriately licensed for the prevention of anthrax, regardless of the route of exposure. Also in 2005, the George W. Bush administration established a policy to ensure that the Strategic National Stockpile retains a current unexpired inventory of 60 million doses of AVA. (The US GAO reports that 4 million doses of the inventory will expire every year, requiring vaccine destruction services.) These would be used for pre- or post-exposure vaccination — of emergency first responders (police, firefighters), federal responders, medical practitioners, and private citizens — in the event of a bioterrorist anthrax attack.