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The Threat

A radiological or nuclear attack on the U.S. homeland could take a number of forms, including: contamination of food or water with radioactive material; placement of radiation sources in public locations; detonation of radiological dispersal devices that scatter radioactive material over a populated area; an attack on a nuclear power plant or a high-level nuclear waste storage facility; or detonation of an improvised nuclear device. Other scenarios of concern include accidents at nuclear power plants or nuclear fuel reprocessing facilities; and accidents involving the loss or dispersion of industrial or clinical radiography sources. A large-scale radiological or nuclear incident in a sizable metropolitan setting would result in an immediate critical need to assess potentially dangerous radiation exposures in up to tens of thousands of people in order to determine the priority of victim's treatments based on the severity of harmful radiation doses. The acquisition and ready availability of medical countermeasures for radiation-induced illnesses is essential to our Nation's preparedness and response capabilities.

On September 23, 2004, the Secretary of Homeland Security determined that radiological and nuclear agents present a material threat to the U.S. population sufficient to affect national security.

About Radiation Exposure

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BARDA’s near-term strategy for anthrax vaccines leverages funding to support improvements in the utility and capability of BioThrax®. Significant progress toward this goal includes delivery of BioThrax® to the Strategic National Stockpile (SNS) under PBS funding and submission in late 2014 of the Supplemental Biologics License Application (sBLA) for post-exposure prophylaxis (PEP) indication, with anticipated FDA licensure in 2015. Projects are ongoing to expand the vaccine’s label indication for post-exposure prophylaxis, increase the current U.S. manufacturing production capacity and support the development of an enhanced vaccine formulation candidate with adjuvant (NuThrax®) that may produce a more rapid immune response with fewer doses required for protection. NuThrax® will enter Phase 3 clinical development in 2015 and potentially transition to procurement under PBS later in the decade. Successful execution of this near-term strategy may have a significant impact on U.S. preparedness against an anthrax attack and provide a substantial reduction in costs across the PHEMCE.

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Advanced Development and Procurement of Radiological and Nuclear Medical Countermeasures

The goal of the Rad/Nuc efforts within CBRN is to address the advanced development needs required to respond to an improvised nuclear device (IND) incident, radiological (dirty bomb) attack, and the acute and chronic effects that would result from these threats. Currently there are 10 programs in advanced research and development in the Rad/Nuc area. These cover a wide range of disease states, including the various manifestations of acute radiation syndrome (GI, neutropenia, lung, skin) and decorporation agents for radionuclides.

To improve and progress in the development of medical countermeasures for radiological and nuclear threats, BARDA has:

  • Released (in conjunction with NIAID ) a RFP for research on medical countermeasures to treat or mitigate ionizing radiation-induced pulmonary and cutaneous injury
  • Released a RFP for medical countermeasures to treat the neutropenia (loss of white blood cells) component of Acute Radiation Syndrome (ARS). The treatment of neutropenia post radiation exposure is one of the most pressing needs for survivors
  • Issued a Broad Agency Announcement (BAA) for advanced development of therapies for hematopoietic syndrome, bone marrow stromal cell loss, and vascular injury resulting from acute exposure to ionizing radiation
  • Supported facilities for research using radionuclides for development of medical countermeasures for radiation exposure
  • Released Special Instructions to the BAA to address advanced development needs for definitive care of thermal burns that would result from an IND incident.

The Strategic National Stockpile (SNS) has large quantities of pharmaceuticals and medical supplies to protect the American public against known threats. The SNS current inventory of medical countermeasures for radiation incidents includes

  • the chelating agent Prussian blue, which treats internal absorption of Cesium-137 (a possible component of a dirty bomb)
  • the decorporation agents Ca- and Zn-DTPA (diethylenetriaminepentaacetate) for the chelation of isotopes curium, plutonium and americium
  • cytokine growth factor, G-CSF (granulocyte-colony stimulating factor), which may be useful for addressing life-threatening neutropenia associated with acute radiation syndrome (ARS)
  • medical supplies to treat the complex array of medical problems following a radiological or nuclear attack, including antibiotics, anti-nausea drugs, and supplies to treat burn and blast injuries

Industry partners are encouraged to visit the BARDA BAA and sign up for a TechWatch meeting.