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Proper Name
Anthrax Vaccine Adsorbed
For the active immunization for the prevention of disease caused by Bacillus anthracis in persons between 18 and 65 years of age at high risk of exposure.

It is a sterile, milky-white suspension for intramuscular or subcutaneous injections made from cell-free filtrates of microaerophilic cultures of an avirulent, non-encapsulated strain of Bacillus anthracis.

Key Regulatory Milestones

1970s - BioThrax originally approved

12/11/2008 approved a change to an intramuscularly (IM) administered five-dose primary series (Week 0 and 4; and Month 6, 12, and 18) followed by an annual booster thereafter.

05/17/2012 - change in dosing schedule for BioThrax was approved

04/11/2014 received orphan drug-designation for the indication of “post-exposure prophylaxis of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis.”

11/23/2015 - FDA approval date

11/29/2015 - PDUFA Goal Date

Advisory Committee

The question of which immune response and what study design should be used to determine protective antibody levels in the animals that could be extrapolated to humans for a postexposure prophylaxis indication was discussed at the VRBPAC held on November 16, 2010. At that meeting, a scientific strategy for bridging animal protection data to humans for PA-based vaccines, including BioThrax, was agreed upon.

Advanced Facts