HHS offers plan for defense against biological threats

Apr 25, 2007 (CIDRAP News) – The US Department of Health and Human Services (HHS) recently unveiled its plan for developing and buying medical countermeasures against a range of biological, chemical, and other threats, with new anthrax and smallpox vaccines among the near-term priorities.

The 21-page implementation plan, released Apr 20 on the HHS Web site and in the Federal Register, details how the agency will acquire countermeasures against 14 threats on its priority list, which include nine category A biological agents, two category B biological agents, typhus, certain volatile nerve agents, and radiological and nuclear agents.

HHS Secretary Mike Leavitt said in an Apr 18 press release that since the Sep 11 terrorist attacks the United States has made significant progress in securing medical countermeasures against a number of threats, but much more work remains.

"This plan lays out our path forward in the coming years and will take advantage of our new authorities under the Pandemic and All-Hazards Preparedness Act to move forward with Project BioShield," he said.

Project BioShield, a $5.6 billion program, was established in 2004 to speed the development of medical treatments for the effects of biological and other unconventional weapons. But major drug companies showed little interest in the program. In passing the All-Hazards Preparedness Act last December, Congress tried to revitalize the program by authorizing partial payments to companies working under BioShield contracts before final delivery of their products.

The HHS plan identifies acquisitions the agency will make under the remaining 5 years of Project BioShield, a 10-year program, as well as those the agency will pursue through fiscal year 2023.

The report says the maturity of the product development pipeline and estimated costs guided HHS decisions and placement of items on near-term, mid-term, and long-term development lists. The agency focused on the countermeasures that offer the greatest opportunity to improve emergency preparedness across a range of threats.

Priority is placed on countermeasures that involve "post-event prophylaxis" or postexposure treatment, the HHS report said. Though single treatments are appropriate for some of the biological threats—a "one bug, one drug" approach—HHS aid it wants to focus its efforts to more efficiently address groups of threats, using tools such as broad-spectrum antibiotics and broad-spectrum antivirals.

The centerpiece of the HHS report is two tables: one that plots the priority countermeasures for each threat and another that lists the proposed funding sources for each countermeasure.

Diseases listed among the priority threats include anthrax, botulism, glanders, meliodosis, Ebola and Marburg hemorrhagic fevers, tularemia, Argentine hemorrhagic fever, typhus, smallpox, and plague.

Countermeasures that HHS would like to acquire in the near term, meaning in fiscal years 2007 and 2008, include broad-spectrum antibiotics and anthrax and smallpox vaccines. The report notes that HHS recently canceled a contract for a recombinant anthrax vaccine (a reference to a vaccine that was under development by VaxGen Inc.), but the agency "remains committed to acquiring next-generation anthrax vaccines."

HHS is also working to acquire a smallpox vaccine that would be safe for immunocompromised people, the report notes. The agency "is well advanced in the pre-award stage" of a program to buy one such vaccine, called modified vaccinia Ankara, it says.

The list of products for mid-term acquisition—in fiscal years 2009 through 2013—includes broad-spectrum antibiotics, diagnostic tests for all biological agents, an anthrax antitoxin, filovirus countermeasures, and smallpox antivirals, as well as measures for diagnosing and treating radiological and nuclear agents and improving the distribution of nerve agent antidotes.

Longer-term projects, beyond fiscal year 2013, would include broad-spectrum antivirals and a single, easy-to-use antidote effective against several volatile nerve agents.

In its press release, HHS said it was seeking public comments on the implementation plan, which can be made through the Federal Register. The agency will also hold a stakeholders meeting for those involved in developing medical countermeasures, scheduled July 31 through Aug 2 in Washington, DC.

See also:

Apr 18 HHS press release

Apr 18 CIDRAP News story "Danish firms expects to sell smallpox vaccine to US"

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