The FDA has approved a change to the administration schedule of BioThrax (anthrax vaccine adsorbed) to a three-dose primary series of IM injections at 0, 1, and 6 months. The booster series consists of IM injections at 12 and 18 months after initiation of the primary series, and at 1-year intervals thereafter for those who remain at risk. Individuals are not considered protected until they have completed the three-dose primary immunization series. BioThrax is the only FDA-licensed vaccine for pre-exposure protection of adults against anthrax disease.

The sBLA was based on a Final Study Report from a large multi-center study initiated by the CDC in 2002. This study was designed to evaluate whether as few as three doses of BioThrax administered over six months, with booster doses to follow, would confer an adequate immune response. CDC completed the study in 2009, and Emergent submitted the sBLA in 2010.

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