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New Anthrax Vaccine Delayed
The company working on the next-generation anthrax vaccine has reported a major setback that will delay delivery of the drug in the United States by at least a year, the Washington Post reported (see GSN, Nov. 2, 2005). VaxGen Inc. of California, which was awarded a $1 billion vaccine contract two years ago under Project Bioshield, said it has identified the problem and is working on a solution. The company said it will default on the contract to deliver 25 million doses of the vaccine by November unless the government grants an extension. The delay confirms fears on Capitol Hill that the small firm could not meet the deadline to produce 75 million doses of the vaccine, the Post reported. Health and Human Services Department officials would not comment on details of the VaxGen contract, but said that despite setbacks, defenses against anthrax are being put in place. They noted that there are enough antibiotics in the U.S. stockpile to treat 40 million people. “I think overall we are certainly making progress in our anthrax preparedness program,” said Gerald Parker, chief deputy for the department’s emergency preparedness office. To compensate for the delay, the United State purchased 5 million doses of an older vaccine. This would be enough to inoculate fewer than 2 million people, and more is expected to be ordered, according to the Post. The problems with the VaxGen contract are representative of difficulties with Bioshield, the Bush administration’s bioterrorism defense program. Many of the countermeasures promised by the White House when Congress created Bioshield will not be ready for some time. Health and Human Services Secretary Michael Leavitt said yesterday that “more can and must be done to aggressively and efficiently implement Project Bioshield” and that changes to the office that runs the program are forthcoming. The $5.6 billion in federal money set aside for the program has drawn the interest of some biotechnology companies. However, analysts said that the research needed to produce the new bioterrorism countermeasures is moving slowly. Also, larger drug companies have ignored the program, seeing little upside of developing a risky product. Smaller, less established firms have filled the gap. Health and Human Services, however, cannot provide large amounts of money to the companies before the product is delivered. Only 10 percent of the contract value can be delivered before the product is complete, a small amount that many times does not cover expenses to get production rolling, according to the Post. Companies can receive research subsidies early on and can look forward to large government paychecks once the product is complete. However, they must pay for the middle stages of product development. Biotechnology companies call this gap the “Valley of Death” and it is not yet known if this period can be crossed and a Bioshield contract delivered, the Post reported. Companies have aired their grievances to lawmakers, complaining that the government has not issued contracts quickly and has done a bad job of outlining project requirements. “There should be a sense of expediency and urgency to get these products developed and stockpiled,” said Richard Hollis, head of Hollis-Eden Pharmaceuticals Inc. The company has spent $70 million on developing a radiation countermeasure, only to see its stock price drop on the news that the government has delayed purchase of the drug. Department spokesman William Hall said the government is aware of the companies’ complaints and is trying to move quickly. However, terrorist threats must be analyzed and needed countermeasures must be carefully chosen. Funding for Bioshield projects “is not a bottomless pit,” Hall said. VaxGen is an example of how Bioshield is supposed to work. The small company was expected to produce enough vaccine to inoculate the entire populations of New York and Washington. The product was supposed to be fully delivered by next year, but now will not be ready until 2008 or 2009, nearly a decade after the anthrax attacks of 2001. Shaky finances bring VaxGen’s ability to survive as a company long enough to deliver the vaccine into doubt, the Post reported. Problems with the strength of VaxGen’s vaccine are behind the delay. Testing found that the drug remained potent only for a few months, making it useless as the treatment could sit in the national stockpile for years. VaxGen researchers attempted to solve this problem by adding an additional ingredient, but the effectiveness of that fix is not yet known. Health and Human Services would not comment on the problems but said a stable product was expected from VaxGen (Justin Gillis, Washington Post, March 17).
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