Major areas of responsibility include the development, licensing, stockpiling and testing of BD vaccines. Background Anthrax is a major biological warfare threat faced by United States forces. More than ten countries, including Iraq, have or are suspected of developing a biological warfare capability. Anthrax is the biological weapon most likely to be encountered because it is highly lethal, easy to produce in large quantities, and relatively easy to develop as a weapon due to the stability of its spore stage. If anthrax is used as a biological weapon, disease will most likely occur by inhalation of anthrax spores.
Death is the usual outcome once clinical symptoms appear regardless of any post-exposure treatment.
Death from anthrax, however, is preventable by immunization with the licensed vaccine. I am not aware of any MOUs between DoD and FDA that specifically deal with the licensed Anthrax Vaccine. This MOU formalized agreements that DoD would comply with Federal regulations for DoD sponsored clinical research as pertains to 21 CFR 312 or 21 CFR 812. FDA agreed to special expedited review for DoD requirements to meet national defense conditions including stockpiling considerations for future use. FDA also agreed to maintain a cadre of personnel who have appropriate security clearances if research projects involve potential security issues.