Licensure strategy for pre- and post-exposure prophylaxis of biothrax vaccine: the first vaccine licensed using the FDA animal rule

摘要

Introduction: The availability of a licensed anthrax vaccine that is safe, effective, and easy to administer for both pre- and post-exposure prophylaxis is critical to successfully manage and prevent potential anthrax attacks. BioThrax (R) (Anthrax Vaccine Adsorbed; AVA) is the only licensed anthrax vaccine in the US.