Project BioShield:

Medical Countermeasure Acquisition Programs

Project BioShield Act of 2004

On July 21, 2004, President George W. Bush signed into law the Project BioShield Act of 2004 (Public Law 108-276) as part of a broader strategy to defend the United States against chemical, biological, radiological, and nuclear (CBRN) threats. The purpose of Project BioShield is to accelerate the research, development, purchase, and availability of effective medical countermeasures for CBRN agents.

Medical Countermeasures Acquisition Programs under Project BioShield

In the three years since the Project BioShield Act was signed into law, contracts using the $5.6 billion BioShield Special Reserve Fund have been awarded for the purchase and delivery of eight medical countermeasures. These medical countermeasures will be used to protect the nation from threats posed by anthrax, smallpox, botulism, and radiological or nuclear agents.

Future Project BioShield medical countermeasure acquisitions will be made in accordance with the priorities outlined in the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Implementation Plan for Chemical, Biological, Radiological, and Nuclear (CBRN) Threats.

Anthrax

HHS is pursuing a comprehensive strategy to address the threat of anthrax which includes the appropriate acquisition of antibiotics, vaccines, and therapeutics to meet immediate public health needs in the event of an attack. The following progress has been made under Project BioShield:

Therapeutic Products for Inhalational Anthrax: Contracts have been awarded for the purchase of 20,000 treatment courses of ABthrax Monoclonal Antibody and 10,000 treatment courses of Anthrax Immune Globulin (AIG).
Licensed Anthrax Vaccine: 10 million doses of the FDA-licensed anthrax vaccine, Anthrax Vaccine Adsorbed (AVA) have been delivered to the SNS. A Sole-Source notice has been issued for the purchase of an additional 10.4 million doses, with options to purchase 8.35 million doses more.
Next-Generation Anthrax Vaccine: HHS has a need for 25 million doses of an anthrax recombinant Protective Antigen (rPA) vaccine. A Sources Sought Notice for an rPA vaccine was issued on May 14, 2007. BARDA is currently reviewing responses received by the closing date of June 11, 2007. A Request for Proposals (RFP) for rPA vaccine is expected in the fall of 2007.

Smallpox

On June 4, 2007, a contract was awarded for the acquisition of 20 million doses of a Modified Vaccinia Ankara (MVA) smallpox vaccine. This is the first BioShield contract to allow two types of advance (pre-delivery) payments: one under the Project BioShield Act of 2004, and the other under the Pandemic and All-Hazards Preparedness Act of 2006. Under the Project BioShield Act, a company can get an advance payment based on a determination that it is necessary to the success of development, before delivery of product to the SNS. Under the Pandemic and All-Hazards Preparedness Act, the company can get payments as it reaches certain milestones in product development.

Botulism

Botulinum antitoxins block the action of circulating neurotoxins in the bloodstream. Use of the appropriate antitoxin within 12 to 36 hours of intoxicationcan prevent worsening of the effects of botulinum toxin. Separate antitoxins for the seven known subtypes of toxin produced by Clostridium species already exist. A combination of all seven antitoxins (heptavalent antitoxin) is effective against all these subtypes. On May 30, 2006, a contract was awarded for the acquisition of 200,000 doses of Heptavalent Botulism Antitoxin.

Radiation Exposure

The acquisition and ready availability of medical countermeasures for radiation-induced illnesses are essential to our Nation’s preparedness and response capabilities; however, the development of medical countermeasures against radiological and nuclear threats poses a unique set of scientific challenges. HHS maintains a comprehensive strategy for addressing the threat posed by radiological and nuclear agents and under Project BioShield has pursued:

Liquid Formulation of Potassium Iodide (KI): KI blocks absorption of radioactive iodide in the thyroid gland. The SNS maintains a supply of KI oral tablets. To facilitate the delivery of KI to small children, a liquid pediatric formulation was developed for and acquired by HHS. Contracts have been awarded for 4.3 million bottles of liquid KI.
Calcium- DTPA and Zinc-DTPA: Calcium-DTPA and Zinc-DTPA are two forms of a decorporation agent which help remove transuranic radioactive particles from the body. More than 480,000 doses of DTPA have been delivered to the SNS.
Treatments to Address Acute Radiation Syndrome: (ARS) HHS issued a Sources Sought Notice on May 30, 2007 for therapeutics to treat neutropenia resulting from exposure to ionizing radiation. BARDA is currently reviewing responses received by the closing date of June 29, 2007. HHS anticipates pursuing the initial acquisition of 100,000 treatment courses of a medical countermeasure for neutropenia arising as a consequence of ARS.