FDA Grants Orphan Drug Designation for Plague Vaccine

3D rendering of Y. pestis. Credit: Shutterstock, modified.

DynPort Vaccine Company LLC, a subsidiary of CSRA Inc., this week announced it has been granted Orphan Drug Designation for its recombinant rF1V plague vaccine from the U.S. Food and Drug Administration (FDA).

DynPort is developing the biodefense countermeasure on behalf of the U.S. Department of Defense (DoD). The vaccine will be used for pre-exposure prophylaxis to combat infection with Yersinia pestis, the causative agent of plague.

Historically, the disease has resulted in three pandemics over the last 1,700 years. It is estimated to have caused 200 million deaths worldwide. Yersinia pestis is currently 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).

DynPort is a contractor for the Medical Countermeasure Systems Joint Vaccine Acquisition Program (MCS-JVAP) and the sponsor of the associated Investigational New Drug Application for the plague vaccine.

“We are excited the FDA has granted Orphan Drug status for rF1V vaccine,” said Gary S. Nabors, Ph.D., President of DynPort. “Orphan Drug Designation provides important incentives to support the development of products for rare diseases. These incentives include the waiving of prescription drug user fees and the ability to market the vaccine exclusively in the U.S. for seven years following approval.”

The FDA’s Orphan Drug Designation program 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.

The rF1V vaccine was originally developed by scientists at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). Current development is funded by the Medical Countermeasures Systems-Joint Vaccine Acquisition Program (MCS-JVAP), Department of Defense (DoD) Contract DAMD17-98-C-8024.

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