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Annual Report on Project BioShield Released to Congress

By Kunal Rambhia, July 11, 2008

On July 9, 2008, the U.S. Department of Health and Human Services (HHS) announced¹ that the Annual Report to Congress on Project BioShield² had been released. The Project BioShield Act, passed in 2004, gives HHS “authorities to expedite research, development, acquisition, and availability of priority medical countermeasures for public health emergencies caused by terrorist attacks.”² This Congressionally mandated report covers progress on the uses of those authorities for the period from August 2006 through July 2007.² Furthermore, the report places “the uses of [HHS’s] authorities in the context of a broader view of [HHS’s] activities in support of and surrounding public health emergency medical countermeasure preparedness.”²

According to the report, HHS used only one of the Project BioShield authorities that are subject annual reporting requirements during the report period when it exercised the authority to expedite peer review procedures for countermeasure research proposals. All medical countermeasures acquisitions were carried out using normal procedures. In the news release, Dr. Robin Robinson, Director of the HHS Biomedical Advanced Research and Development Authority (BARDA), commented that “this report demonstrates significant accomplishments of Project BioShield toward increasing public health emergency preparedness” for chemical, biological, radiological and nuclear threats.¹ Specific progress against biological threats is reported in the following areas:

1. Delivery of 10 million doses of Anthrax Vaccine Absorbed (AVA) to the Strategic National Stockpile (SNS) with Notice of Intent to acquire 10.4 million additional doses;
2. Initiation of a second generation recombinant anthrax vaccine program and cancellation of previous contract with VaxGen;
3. Development of anthrax therapeutic antitoxin, by means of 2 contracts, with delivery in 2007 and expected in 2009;
4. Delivery of antibiotics to SNS for use following anthrax exposure;
5. Development and delivery of 200,000 doses of botulinum antitoxin to SNS;
6. Support of research and development for next generation medical countermeasure for treatment of botulism; and
7. Support of development of 20 million doses of Modified Vaccinia Ankara (MVA) vaccination against smallpox for immuno-compromised individuals.²

Additionally, research and development of medical countermeasures for chemical, radiological, and nuclear threats has also been supported under BioShield, including:²

1. Radionuclide decorporation agents for radiation/nuclear emergencies;
2. Restoration of gastrointestinal function after radiation exposure;
3. Liquid potassium iodide for pediatric use to treat thyroid gland upon radiation exposure;
4. Placement options for stockpiled calcium and zinc DTPA for treating internal contamination from plutonium, americium, or curium; and
5. Medical countermeasures for Acute Radiation Syndrome.

References

1. HHS releases Project BioShield annual report to Congress on public health emergency preparedness for chemical, biological, radiological and nuclear threats [news release]. Washington, DC: U.S. Department of Health and Human Services; July 9, 2008. http://www.hhs.gov/news/press/2008pres/07/20080709b.html. Accessed July 11, 2008.
2. U.S. Department of Health and Human Services. Project BioShield annual report to Congress. July 9, 2008. http://www.hhs.gov/aspr/barda/documents/bioshieldannualreport2006.pdf. Accessed July 11, 2008.