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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

“Maybe I should have gone to Barcelona instead of Real Madrid”

first_imgShortly before the winter of 98, his return to Porto was planned, after going to play there with Real Madrid. “We came to play a Champions League match in Porto and speaking with President Pinto da Costa he asked me if I wanted to return. I did not look back. There were people at Real Madrid who told me not to go out, that we were going to be champions of Europe, as then happened, but I left because I could not reject the offer of Porto. I was in time to win the League five times, “he said.The Portuguese played just 17 games for Real Madrid throughout his brief journey as a white player. In Porto, he added many more titles to his achievements in addition to the League with Real Madrid: six Portuguese Leagues, five Cups, one UEFA Cup and three national Super Cups.Nowadays, Carlos Secretary is coach of the US Creteil-Lusitanos of the French Championnat National, equivalent to the Second Spanish B. Before the stoppage due to coronavirus, the Parisian club occupied half of the table with 35 points, 13 of the head and 11 of the promotion slots. “All of this happened after the Euro Cup in England. My representative called me to go to Lisbon because we had to make a contract with a club but I did not know what it was and suddenly saw that it was Real Madrid. When I was going to sign for them, Vítor Baía called me and told me about Barcelona. Bobby Robson was there and he wanted me to go too. But I had already committed to Real Madrid. Maybe it would have been better for my career to have gone to Barça, because there I had the support of my teammates but, that day, I was already signing for Real and I couldn’t reject it. Things did not go well, but we ended up winning LaLiga. The following year, after leaving in winter, Real Madrid was champion of Europe “, he assured the one who was a white winger in the TV program ‘FC Porto em casa’. Carlos Secretary was one of Fabio Capello’s requests to Lorenzo Sanz for Real Madrid. The Italian wanted to reform the squad with a reinforcement on the right side and looked at the Portuguese, then a Porto player and starter in the Portuguese team.The Secretary’s journey was not as successful as they expected and now, the former madridista admits in an interview in his country that Vitor Baía tried to take him to Barça and that in perspective, he may have chosen poorly and should have been inclined to dress in blaugrana.last_img read more

Walstra to leave Port of CamasWashougal post

first_imgScot Walstra, director of planning and development for the Port of Camas-Washougal, will leave his post at the end of today under a plan by the port to consolidate its economic-development efforts into a new partnership with the cities of Camas and Washougal.His salary will be routed to a new nonprofit, tentatively named the Camas Washougal Economic Development Association, which will also receive funding from both of those cities.David Ripp, executive director of the Port of Camas-Washougal, said the new group will neither overlap nor conflict with Clark County’s chief economic development agency, the nonprofit Columbia River Economic Development Council.“We’re not taking anything away from CREDC,” Ripp said. “We’re going to continue to support that group as well.”The Camas Washougal Economic Development Association will be expected to promote the east Clark County to employers, recruit companies to the area, create jobs and diversify the region’s economy, Ripp said. A priority will include attracting new industries to Washougal, which has traditionally been dependent on timber.“Our big picture is to create and jobs and have diversification,” Ripp said. One key will be to get a handle on which industries are up-and-coming and should be focused on as soon as possible. “What’s next in line?” Ripp said. “You don’t want to jump in after it’s started.”last_img read more