BARDA’s CBRN Advanced Development Programs

Since the passage of Project BioShield Act of 2004, BARDA has awarded 9 contracts for development and acquisition of Chemical, Biological, Radiological, and Nuclear (CBRN) medical countermeasures, and has successfully stockpiled 17 medical countermeasure products against 6 CBRN threats. Over the past year, the CBRN program has advanced in the development of its medical countermeasure portfolio for CBRN agents that pose a major risk to medical and public health preparedness.

Biological Programs: Advanced Development of Medical Countermeasures

To improve and progress in the development of the medical countermeasures for Biological Threats, BARDA has awarded contracts in support of the following programs:

• Continued to support the advanced development of a heptavalent equine botulism antitoxin. To date, over 30,000 vials of the botulism antitoxin have been delivered to the Strategic National Stockpile (SNS);
• Contracted for the acquisition of two anthrax therapeutic agents with deliveries to the SNS already initiated for one therapeutic agent and anticipated for the other therapeutic agent;
• Entered into a contract to develop 20 million doses (10 million treatment courses) of smallpox vaccine for individuals with weakened immune systems. In 2008, the manufacturer conducted Phase II safety studies in both healthy and immunocompromised individuals. Initial results for the immunocompromised are positive.
• Used its advanced development authority to award three advanced development contracts worth $27 million for novel anthrax therapeutics.

BARDA has also announced a number of funding opportunities that have not yet been awarded:

• Issued a Request for Proposals (RFP) to acquire a second-generation anthrax vaccine based on recombinant protective antigen technology with awards expected in FY 2009.
• Issued a Sources Sought notice for emergency responder anthrax antimicrobial kits. These kits will contain antibiotics to protect first responders in the event of an anthrax attack;

Chemical Programs: Advanced Development of Medical Countermeasures

• Transferred advanced development funding of $7 million in FYs 2007 and 2008 to NIAID for continued development of midazolam as an improved antidote against seizures caused by chemical nerve agents;
• Continued to support the CHEMPACK program, which pre-positions nerve agent antidotes for use by state, local, and/or tribal officials throughout the U.S.

Radiological and Nuclear Programs: Advanced Development of Medical Countermeasures

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.