CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR (CBRN) THREAT PROGRAMS
The Pandemic and All Hazards Preparedness Act (PAHPA) (PDF - 248 KB) established BARDA as the focal point within HHS for the advanced development and acquisition of medical countermeasures to protect the American civilian population against CBRN and naturally occurring threats to public health. PAHPA was reauthorized in 2013 by the signing of Pandemic and All Hazards Preparedness Reauthorization Act (PAHPRA) (PDF - 284 KB). CBRN accomplishes this by supporting advanced research and development of medical countermeasures against CBRN threats and establishing stockpiles of vaccines, drugs and diagnostics against these threats. Ultimately, these medical countermeasures are used to help the Nation prepare to respond to and recover from public health emergencies. Using its advanced research and development authority, BARDA strengthens HHS efforts to bridge the valley of death funding gap that exists between the early stages of product development and the acquisition of approved or approvable medical countermeasures for the Strategic National Stockpile.
The CBRN programs within BARDA span a number of threat and focus areas:
Anthrax is an acute infectious disease caused by the spore-forming bacterium Bacillus anthracis, which can cause human disease via gastrointestinal, cutaneous, or inhalational (pulmonary) routes.
Smallpox is a potentially deadly infectious disease and is considered a high-priority biological threat agent.
Botulism is a serious paralytic illness caused by neurotoxins produced by several Clostridium botulinum strains.
Chemical threats include nerve agents, chemical burn agents, pulmonary agents, and blood /metabolic agents, as well as toxic industrial chemicals and toxic industrial materials.
The thermal burn program aims to improve burn treatment across the burn care spectrum.
Medical consequences of a nuclear detonation result in radiation-induced illness, thermal and radiation burns, and trauma. The acquisition and ready availability of medical countermeasures to address the multitude of injuries is essential to our Nation's preparedness and response capabilities.
Broad Spectrum Antimicrobials program was established in January 2010 and is focused on developing novel antibacterial and antiviral drugs for the treatment or prevention of disease caused by currently defined and future biological threats.
The Ebola MCM strategy for development, manufacturing and evaluation of monoclonal antibody and antiviral drug therapeutic candidates has several goals.
The CBRN investments include funding for the advanced research and development of anthrax vaccines and therapeutics; smallpox vaccines and antivirals; broad spectrum antimicrobials; biodosimetry/diagnostics; radiological/nuclear countermeasures; and countermeasures to a variety of chemical threats. As part of a comprehensive strategy, the CBRN division is not only developing pipelines of products for each of these health threats but has also begun support for multi-use MCMs that may be used for a variety of other health threats (e.g. community acquired pneumonia) while providing a source of effective countermeasures in the event of a public health emergency response.
BARDA's CBRN Advanced Development and Procurement Programs
BARDA uses the authorities granted under PAHPA to enhance the overall medical countermeasure portfolio of CBRN candidate products and is now managing a portfolio of over 70 contracts and grants for the development of these countermeasures.
Advanced research and development funds support products through the "valley of death" with the intent to build a sustainable medical countermeasure pipeline for potential, future, Project BioShield procurements. BARDA has awarded numerous contracts for the advanced research and development of these products and has successfully stockpiled 14 medical countermeasure products against 4 CBRN threats. These include an anthrax vaccine for post-exposure prophylaxis, anthrax therapeutics, a novel smallpox vaccine, a smallpox antiviral drug, a botulinum antitoxin, and radiation countermeasures. As of 2016, BARDA is supporting 21 different medical countermeasures under Project BioShield with additional, promising, candidates to transition to Project BioShield in the coming years to address remaining gaps in preparedness.
BARDA uses Project BioShield funding to support its acquisition programs. Project BioShield institutes a secure funding source for the late-stage development and purchase of critical medical countermeasures, such as vaccines, therapeutics, and diagnostics.