FDA Grants Orphan Drug Status to Plague Vaccine
The Food and Drug Administration (FDA) has granted Orphan Drug designation to the recombinant rF1V plague vaccine (CSRA/DynPort) for pre-exposure prophylaxis of Yersinia pestis infection, also known as, the plague.
Plague is an often fatal disease caused by the gram-negative bacterium, Y. pestis. In the past, three pandemics of plague occurred and an estimated 200 million deaths worldwide were associated with the disease. Plague is presently viewed as a possible bioterrorism agent and has currently no licensed vaccines available for human use in the US.
The rF1V plague vaccine is being developed on behalf of the U.S. Department of Defense (DoD) as a component of its medical countermeasures portfolio against bioterrorism agents. It was originally developed by scientists at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). DynPort has further developed the vaccine and sponsored its Investigational New Drug Application.
The rF1V plague vaccine is intended for administration in persons considered to be at high risk for exposure to aerosolized Y. pestis.
For more information visit csra.com.