The academy considered more than a dozen studies using various scientific designs, and heard personally from many concerned US military service members. Development of a replacement vaccine
While effective in protecting against anthrax, the licensed vaccine schedule is not very efficient, involving a cumbersome five (previously six) dose injection series. Typically, five injections are given over a period of 18 months in order to induce a protective immune system response. In addition, in 2004 the US Department of Health and Human Services contracted with Vaxgen Inc. to supply up to 75 million doses of a recombinant anthrax vaccine, for $877 million. To be acceptable to HHS, this vaccine was to be protective against anthrax in three doses or less. On December 19, 2006, HHS voided the contract, because of stability problems with the vaccine, and a failure to start a Phase 2 clinical trial on time. In May 2008, Emergent Biosolutions, the Maryland-based successor to BioPort, both controlled by former Lebanese banker Faud el Hibri, acquired rights to Vaxgens patents and processes.On 30 October 2012, the US National Institute of Allergy and Infectious Diseases agreed to provide $6.5 million to the United Kingdoms Health Protection Agency for initial work on a potential future anthrax vaccine that could be delivered through the nasal passage instead of via a needle. The HPA has long produced the UKs AVP anthrax vaccine. Research is being continuously done to develop and test new improved candidate anthrax vaccines.
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.