The plague vaccine is being developed as an important component of the DoD's medical countermeasures portfolio against bioterrorism agents. Drugs and biologics developed for this vaccine must receive orphan status through the FDA's Orphan Drug Designation program. The orphan status applies to those drugs and biologics intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. Currently, no licensed vaccines against plague are available for human use in the US. The vaccine is intended to be administered to individuals considered to be at high risk for exposure to aerosolized Y. pestis.
Plague is an acute, and often fatal, disease caused by infection with Y. pestis, a gram-negative bacterium. Historically, the disease has resulted in three pandemics over the last 1,700 years. It is estimated to have caused 200 million deaths worldwide. Plague is currently viewed as a possible agent of bioterrorism. As such, it has been classified as a Category A priority pathogen by both the National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention (CDC). The rF1V vaccine was originally developed by scientists at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID).
This work was funded by the Medical Countermeasures Systems-Joint Vaccine Acquisition Program (MCS-JVAP), Department of Defense (DoD) Contract DAMD17-98-C-8024 and does not represent official DoD positions, policies or decisions.
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