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GAO critiques anthrax vaccine procurement, management

first_imgOct 31, 2007 (CIDRAP News) – The US government’s attempt to add a next-generation anthrax vaccine to its stockpile failed because of a premature contract award, unrealistic expectations, and confusion about how the vaccine would be used, according to the Government Accountability Office (GAO), the investigative agency of Congress. Dissecting a failed procurementHHS awarded its first contract to VaxGen for the rPA vaccine at a very early development stage, before critical issues such as stability could be addressed, the GAO says. The award also interrupted an existing development contract VaxGen had with the National Institute for Allergy and Infectious Diseases (NIAID). GAO investigators assert that VaxGen took several “unrealistic” risks in accepting the HHS contract: the delivery deadline was too aggressive, the company lacked in-house technical expertise to address vaccine stability and formulation issues, and it had few resources to pay for additional testing to meet regulatory requirements. The GAO’s second concern about management of the existing anthrax vaccine stockpile is that HHS planned to use vaccine that had expired in 2006 and 2007, which would violate FDA rules. “The failure of this procurement effort raised larger questions regarding the country’s ability to develop a new anthrax vaccine and robust and sustainable biodefense medical countermeasure industry,” the GAO report states, adding that the problems cast doubt on the government’s ability to clearly spell out the requirements of future contracts with its pharmaceutical and biotechnology industry partners. HHS officials told the GAO that they felt an urgency to tell the public an improved anthrax vaccine was on the horizon and that they were 80% to 90% confident in VaxGen’s ability to successfully develop and produce the vaccine. Both HHS and DoD generally concurred with the investigators’ findings, the report says, but each added detailed technical responses to the report. “If this is not done, the government risks future interest and participation of the biotechnology industry,” the report says. The VaxGen vaccine was based on a recombinant form of protective antigen (rPA), a key anthrax protein. It was expected to provide immunity in 3 doses, rather than the 6 doses required for the licensed vaccine, and to cause fewer side effects. Avecia, a biotechnology company based in Manchester, England, is also developing an rPA anthrax vaccine with grant support from the National Institutes of Health. Industry experts told the GAO that, given the early stage of development, the expectation that VaxGen could deliver 75 million doses of the vaccine was unrealistic, and would have been so even for a large pharmaceutical firm. The GAO said using expired vaccine could undermine the public’s confidence and that HHS should destroy the expired lots. Oct 23 GAO report on anthrax vaccine procurementhttp://www.gao.gov/cgi-bin/getrpt?GAO-08-88 VaxGen announced in May that it hoped to license its rPA vaccine to another company in hopes that the product could someday be added to the national stockpile.center_img The contract, awarded in 2004, was the first under Project BioShield, a program meant to spur the development and production of medical countermeasures for chemical, biological, and radiological weapons. Licensed vaccine going to wasteIn examining how the government manages the current anthrax vaccine in the national stockpile—anthrax vaccine adsorbed (AVA), developed in the 1950s—investigators raised two main concerns. One is that HHS doesn’t have a strategy to minimize wasted vaccine. The report says $12 million worth of vaccine has already expired, and without an effective management plan, $100 million more per year could be lost as vaccine lots in the stockpile expire. Another problem was that HHS did not tell VaxGen how it planned to use the vaccine, because at the start of the contract the Food and Drug Administration (FDA) was still defining the data and testing requirements for the rPA anthrax vaccine as part of its new guidance on emergency use authorization for unlicensed products in the Strategic National Stockpile. HHS recently announced that it awarded the manufacturer of the AVA vaccine, Emergent BioSolutions, based in Gaithersburg, Md., a contract worth up to $448 million for 18.75 million doses of the AVA vaccine, which would allow the agency to maintain a 10 million-dose stockpile through 2011. Dec 20, 2006, CIDRAP News story “HHS cancels VaxGen anthrax vaccine contract” The findings were detailed in a 41-page report the GAO released on Oct 23. Four members of Congress had requested the investigation after the Department of Health and Human Services (HHS) cancelled an $877 million contract with VaxGen, a small biotechnology company based in Brisbane, Calif., last December. The company had failed to meet certain project milestones. See also: The GAO says HHS has announced that it will issue another rPA anthrax vaccine proposal but has not formally reviewed what went wrong with the VaxGen contract. “They may repeat their mistakes in the absence of a corrective plan,” the report says. Sep 26 CIDRAP News story “HHS orders 18 million doses of anthrax vaccine” The GAO also concluded that the government lacks a strategy for preventing waste and duplication in managing its stockpile of the existing anthrax vaccine, which could result in annual $100 million losses as stored vaccine lots expire. The GAO report says HHS could minimize the waste by developing a single inventory that can be shared with the Department of Defense (DoD), which has a mandatory anthrax vaccination program. However, HHS responded in the report that it explored the vaccine rotation option in 2004, but identified funding, legal, and logistical obstacles.last_img read more

Iowa State Defeats Drake, 75-67

first_img Full Schedule Roster Drake was plagued by tough shooting in the final quarter at 33.3 percent. The Bulldogs missed all seven three-pointers they took in the period and finished 7-of-32 behind the arc in the contest. Story Links The Bulldogs limited the Cyclones to just 32.8 percent shooting. Iowa State went 21-of-28 at the free throw line as Drake was whistled for 24 fouls to just 10 for the Cyclones. ISU capitalized on 13 turnovers by Drake and scored 23 points off the Bulldogs’ miscues. Next Game: HTML Box Score Sophomore Sammie Bachrodt (Wichita, Kan.), a game after scoring a then career-high of 16 points at Creighton Thursday night, set her new mark with 17 points. Bachrodt added six rebounds, two assists and one steal. Fellow sophomore Sara Rhine (Eldon, Mo.) just missed a double-double with nine points and a game-high 13 rebounds Drake had a five-point advantage at the start of the fourth quarter, but a turnover by Ingle led to a three-pointer by Carleton. The teams then traded points until the score was tied for the seventh and final time at 65-65 after Ingle made the second of two-straight layups with 2:26 to play in the game. However, Drake would score just two more points as Iowa State’s Jada Buckley scored seven-consecutive points to help pull out the comeback win. AMES, Iowa – Iowa State defeated the Drake University women’s basketball team, 75-67, Sunday, Nov. 20 evening at Hilton Coliseum. Preview Buy Tickets Live Stats 1350 ESPN DES MOINES THE VALLEY ON ESPN3 Listen Live Watch Live Iowa State (3-0) had four players hit double figures led by Bridget Carleton with 19 points. Following a three-game road trip to start this season, Drake will finally return to the Knapp Center on Nov. 27 when the Bulldogs welcome Wyoming. Tipoff is scheduled for 2 p.m. Print Friendly Version PDF Box Score Photo Gallery Drake (1-2) was led in scoring by senor Lizzy Wendell (Blue Springs, Mo.) with a game-high 20 points. Wendell added six rebounds, four assists, two steals and one block as she recorded her 50th career 20-plus scoring performance. Senior Caitlin Ingle (Runnells, Iowa) finished with 16 points, six assists and three rebounds.  Ingle surpassed the 1,000 career-point mark in the loss. She is the 29th player in program history to reach the scoring milestone. Wyoming 11/27/2016 – 2 PMlast_img read more