BioPort Corporation is the only licensed supplier of the anthrax vaccine BioThrax® in the United States. Bioport acquired the assets of the Michigan Biologic Products Institute, which historically produced the vaccine, from the State of Michigan in 1998. Bioport was founded with this acquisition as its sole purpose. Along with the anthrax vaccine, BioPort acquired the sole and exclusive customer for the vaccine, the U.S. Department of Defense. Since this time, the United States Department of Health and Human Services has purchased doses of the vaccine for the Strategic National Stockpile.
BioPort Corporation is a subsidiary of Emergent BioSolutions, headquartered in Gaithersburg, Maryland. In addition to BioPort, Emergent BioSolutions owns three other subsidiaries including Emergent ImmunoSolutions (U.S. R&D, Gaithersburg, MD), Emergent Europe (European R&D, Reading, England), and Emergent BioLogics (manufacturing plant, Frederick, MD). Emergent Biosolutions is developing vaccines and antibody-based therapies for infectious diseases for both biodefense and commercial markets. Emergent has approximately 500 employees worldwide, the majority of whom are at the BioPort manufacturing site in Lansing, Michigan. The principal owner, and CEO of Emergent BioSolutions is Fuad El-Hibri.
The anthrax vaccine was originally licensed in 1970 by the US Food and Drug Administration. In 1997, the Clinton Administration initiated the Anthrax Vaccine Immunization Program, under which active U.S. service personnel were to be immunized with the vaccine. Much controversy has surrounded the program since its inception, since vaccination was mandatory, and a perception developed that the anthrax vaccine was unsafe, causing sometimes serious side effects. Mandatory vaccination was halted due to an injunction which was put into place on October 27, 2004. The injunction did not question the safety and effectiveness of the anthrax vaccine or the immunization program in the Defense Department, but rather centered on FDA procedural issues stating that additional public comment should have been sought before the FDA issued its Final Rule declaring the vaccine safe and effective, in December of 2003. On December 15, 2005, the FDA re-issued a Final Rule & Order on the license status of the anthrax vaccine. After reviewing extensive scientific evidence and carefully considering comments from the public, the FDA again determined that the vaccine is licensed for the prevention of anthrax, regardless of the route of exposure. At present vaccination is optional for active duty personnel. Approximately 50% of service men and women are voluntarily taking the vaccine according to a recent disclosure by the Department of Defense.