BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) for pre-exposure protection against anthrax infection.

To date, more than 10 million doses of BioThrax have been administered to more than 2.5 million individuals, says Emergent BioSolutions on its Website. “BioThrax is indicated for the active immunization of individuals between 18 and 65 years of age at high risk of exposure to anthrax,” says the company. “BioThrax is not licensed for use in a post-exposure setting. The safety and efficacy of BioThrax have not been established in pregnant women, nursing mothers, pediatric populations or geriatric populations.

“Emergent is proud to be able to contribute to the U.S. government’s program of protecting the nation from the threat of anthrax,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “This 5-year award provides for uninterrupted supply of this critical biodefense countermeasure while addressing the government’s mandate to reduce spending across all programs. In coming to agreement, Emergent and the Centers for Disease Control and Prevention worked diligently to establish business terms that incorporate substantial price concessions.”

Initial deliveries under this award are expected to commence in 2011 with 8.5 million doses scheduled to be delivered during the first contract year. Deliveries are scheduled to continue, subject to availability of funding, through September 2016. The company retains the ability to modify the timing of deliveries depending on manufacturing yields and other factors.

The company explains on its Website how its product functions. “Anthrax bacteria produce three proteins known as protective antigen (PA), lethal factor (LF), and edema factor (EF),” explains the company. “If the PA protein interacts with LF or EF on the surface of human or animal cells, the resultant toxins could be lethal to anyone who became infected with the bacteria.

“BioThrax (Anthrax Vaccine Adsorbed) stimulates the immune system to produce protective antibodies against PA. When PA is blocked, LF and EF are not able to interact with PA and the toxins are thereby neutralized.”