The decision follows a review of data including the clinical, scientific, and epidemiological data establishing the safety and efficacy of the vaccine.
“This decisive ruling marks an important decision for members of the US military and appropriate at-risk populations outside the federal government,” said Robert Kramer, CEO of BioPort Corporation, the Emergent subsidiary that manufactures BioThrax.
BioThrax is the only FDA-licensed vaccine for protection against anthrax, a deadly disease caused by exposure to the anthrax bacteria or anthrax spores.
BioPort has provided more than 5 million doses of the vaccine to the Department of Defense for the protection of military personnel and is delivering five million doses to the Department of Health and Human Services for the strategic national stockpile, which is available to protect the civilian population in the event of a bioterrorist attack.