HHS Releases Project BioShield Annual Report

The U.S. Department of Health and Human Services issued a progress report this week on its implementation of Project BioShield, a program that gives the department authorities to support, facilitate, and expedite the research, development, acquisition, and availability of medical countermeasures to respond to the adverse effects of public health emergencies involving chemical, biological, radiological and nuclear (CBRN) threats.

"Emergency preparedness and response is a responsibility we all share as individuals, as family members, and as citizens of our communities," said Assistant Secretary for Preparedness and Response (ASPR) W. Craig Vanderwagen. "Our goal is to foster involvement by private and public stakeholders in the emergency preparedness process, working to make the process transparent while safeguarding national security. This report reflects our progress in that regard not only as an agency but also as a nation."

The Project BioShield Act of 2004 was enacted as part of a national strategic effort to prepare for threats to public health from CBRN events. The Pandemic and All-Hazards Preparedness Act (PAHPA), enacted in December 2006, provided additional authorities to support advanced development of medical countermeasures, including Project BioShield acquisitions. PAHPA also established the new offices of the ASPR and of the Biomedical Advanced Research and Development Authority (BARDA).

"This report demonstrates significant accomplishments of Project BioShield toward increasing public health emergency preparedness. The breadth and depth of the medical countermeasure portfolio for chemical, biological, radiological, and nuclear threats is growing securely and steadily based upon the solid foundation established since 2004," said Dr. Robin Robinson ASPR deputy assistant secretary and director of BARDA.

HHS has a comprehensive strategy to mitigate and treat the health effects associated with a potential anthrax emergency, including antibiotics, vaccines, and therapeutics. During the reporting period of August 2006 to July 2007, delivery to the Strategic National Stockpile of Anthrax Vaccine Adsorbed (AVA) was completed in February 2007 under a previously awarded $242.7 million contract. A contract for $448 million for additional AVA was subsequently awarded in September 2007, and delivery under that contract has begun. In addition, HHS released a Sources Sought Notice in May 2007 to initiate a recombinant anthrax vaccine program.

Using the new authorities under PAHPA, HHS for the first time made milestone payments in a $500 million Project BioShield contract for development of a new smallpox vaccine, Modified Vaccinia Ankara (MVA). The new vaccine is expected to be effective for people with compromised immune systems. In addition, delivery to the Strategic National Stockpile of a pediatric formulation of potassium iodide under a $17.5 million contract was completed in July 2007. Potassium iodide can be used to protect the thyroid gland after a nuclear or radiological event that disperses radioactive iodine. HHS also released a Sources Sought Notice in May 2007 for therapeutic agents to mitigate and treat a type of blood disorder, neutropenia, associated with acute radiation syndrome.

During the reporting period, HHS awarded five research grants in August and September 2006, for which review had been expedited under Project BioShield authorities. These grants, worth approximately $4 million and awarded to national laboratories and universities, were for research on decorporation agents, which can reduce exposure to radioactive substances by aiding their elimination from the body. Review was also expedited for research grant applications for medical countermeasures to restore gastrointestinal function after radiation exposure.

The report notes that improving public health preparedness is an ongoing process as science advances, innovations mature, and the threat scope changes. To achieve this goal, HHS will continue to use Project BioShield and other authorities to research, develop, acquire, store, maintain, deploy, and utilize medical countermeasures to enhance public health preparedness.

The HHS Public Health Emergency Countermeasures Enterprise (PHEMCE) is an interagency organization through which HHS coordinates Project BioShield and other public health preparedness efforts, with participation of other federal departments and offices, to assure efficiency and effectiveness in the development and acquisition of emergency medical countermeasures. The HHS PHEMCE Strategy and the HHS PHEMCE Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats (online at www.hhs.gov/aspr/barda/phemce/enterprise/strategy) express the priorities and plans for pursuing these goals over near-, mid-, and long-term time frames. The annual report is available online at www.hhs.gov/aspr/barda/bioshield/annualreport.

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