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Contract For New Anthrax Vaccine To Be First Use Of Project BioShield Money

This article was originally published in The Pink Sheet Daily

Executive Summary

Next-generation smallpox vaccine and botulinum antitoxin also are on HHS' list of required countermeasure procurements for the FY 2004 budget cycle; BioShield may be authorized within weeks, Senate GOP leader Frist says.

The Bush Administration hopes to commit all $890 mil. earmarked for Project BioShield in fiscal 2004 toward procuring several bioterrorism countermeasures, starting with an updated vaccine for anthrax, an HHS official told the Secretary's Council on Public Health Preparedness May 3.

Philip Russell, MD, acting director of the Office of Research & Development Coordination within HHS' public health emergency preparedness office, reported that the department is preparing the imminent release of a request for proposals for a second-generation anthrax vaccine. The department expects to have the vaccine on hand in the Strategic National Stockpile by next year, Russell added.

"We believe that we'll have a large-scale acquisition of 75 mil. doses beginning to be delivered into stockpile by the middle of 2005," Russell told the advisory panel.

The agreement to purchase a new anthrax vaccine would mark the first use of BioShield funds by the White House. The priorities for the program are being drafted by an inter-departmental Weapons of Mass Destruction Medical Countermeasures panel.

HHS has moved forward with its plans to obtain new vaccines and treatments for potential biological agents under BioShield despite the fact that the legislation authorizing the program has not yet been approved by Congress. Appropriations for the current fiscal year, however, have been signed into law; Project BioShield was conceived as a $5.6 bil, five-year program to shore up biodefense capabilities.

Senate Majority Leader Bill Frist (R-Tenn.) told reporters May 4 that he hopes to bring the authorization for BioShield to the floor "in the next couple of weeks." The senator would not specify what form the leadership bill will take; members in the upper chamber have drafted several differing versions in addition to the House-passed measure form last session (HR 2122).

The department soon will begin to review the responses it received to an initial request for information from vaccine researchers, Russell said. The impending request for proposals will be derived from those findings, and a contract winner will be selected from among the applicants.

Russell also outlined the Administration's other near-term acquisition targets under BioShield. Second in priority to the new anthrax vaccine are adjuncts to antibiotic treatments for anthrax exposure, a next-generation smallpox vaccine and a botulinum antitoxin, he said.

Bush Administration officials already are making plans for BioShield spending in upcoming fiscal years, Russell indicated. Future goals include the acquisitions of a recombinant plague vaccine, botulinum vaccine, anti-radiation drugs and chemical antidotes. Further out in the five-year period, Russell said, HHS is eyeing a third-generation vaccine for anthrax; vaccines for ebola-Marburg and Rift Valley fever; novel antibiotics, anti-infectives and antivirals; and polyclonal anthrax and botulinum anti-toxins.

- Jeffrey Young

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