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Salvage of Chiron flu vaccine unlikely

first_imgOct 9, 2004 (CIDRAP News) – Lester Crawford, acting director of the US Food and Drug Administration (FDA), appearing before the House Committee on Government Reform yesterday, said he was pessimistic about the possiblility that any of the 48 million doses of influenza vaccine expected in the United States from Chiron Corp. can be salvaged for use this flu season, according to new service reports. FDA experts remain in England this weekend to make the final determination, with visits planned to the Liverpool plant whose manufacturing license was revoked earlier in the week, effectively cancelling half the US’s supply.Several lots of Chiron’s vaccine, Fluvirin, were found to be contaminated, leading to suspension of Chiron’s manufacturing license by Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA). It came out this week that the organism implicated in the contamination is Serratia, a bacterium that lives in water, soil, plants, and animals and is not dangerous if encountered on environmental surfaces.When Serratia is harbored in medical equipment, however, it can cause illness and has been documented in numerous outbreaks (see link below for example of bronchoscope contamination). In commenting on the Chiron situation, Dr. Robert Belshe, director of the division of infectious diseases and immunology at St. Louis University, conjectured that it may have come from bottles, vials, or rubber stoppers, according to a Wall Street Journal story.Aventis Pasteur, the other large supplier of inactived flu vaccine for the United States, has said it will be able to supply 55.4 million doses of its Fluzone, according to an Associated Press story. This is somewhat more than it had originally commited to, but doses beyond that cannot be made in time for this year’s flu season.MedImmune, makers of FluMist, an inhalable form of flu vaccine, was asked by the Center for Disease Control and Prevention to provide more than the 1.5 million doses promised. The company has said it can provide nearly 1 million extra doses by late November, according to the Associated Press. The doses will come from already-produced frozen bulk vaccine.FluMist is FDA-approved for use only in people aged 5 to 49, which is the group least in need of vaccination. Four million doses were produced for the 2003-2004 flu season but much of that supply went unused, partly because of its higher cost in comparison with injected vaccines. MedImmune has cut the cost of FluMist this year and is also working on a new formulation it expects to be available in 2007.Public health officials are working quickly to track down the doses of vaccine that are already in the hands of distributors and providers to ascertain how the unexpectedly limited supply can best be made available to the populations most in need of vaccinations (see link below to interim guidelines).See also:2003 New England Journal of Medicine article on Serratia contamination of brochoscopes [Abstract]CDC interim recommendations for flu vaccinehttp://www.cdc.gov/mmwr/preview/mmwrhtml/mm5339a6.htmlast_img read more

USC’s schedule pays off for now

first_imgNo matter how hard Pete Carroll tries to turn the focus forward to the upcoming game against Washington, Saturday’s classic against Ohio State might be the only thing USC fans talk about for some time.The tilt between top-10 teams was a rarity on a number of levels.Earlier in the fall, Carroll mused on how few last-minute thrillers he had been involved in as a college coach. Redshirt sophomore linebacker Chris Galippo noted in the locker room after the game that it may have been the first instance of a close win that USC has experienced since he joined the team.But to the rest of the college football world, the primetime matchup was a ballad of a dying breed of intersectional regular-season games between top teams.There’s a simple reason why ESPN and ABC hyped the last two matchups between the Trojans and Buckeyes so heavily — top-tier non-conference games are an endangered species.Take a look at the non-conference schedules of the other top-five teams. Charleston Southern, Florida International and Louisiana-Monroe don’t exactly constitute a murderers’ row of opponents for powerhouse teams.With strength of schedule no longer a component of the Bowl Championship Series, most teams would prefer to pay a small directional school a hefty payday in exchange for an easy win. And with the rise of giant-killers like Boise State, Utah and BYU, few teams want to even take a risk in jeopardizing their postseason hopes by scheduling a solid opponent.San Jose State hardly made for a high-powered opener, but the Trojans still deserve credit for their courage in scheduling since Carroll’s arrival. USC is one of the few schools that has never played against a Division I Football Championship Subdivision (formerly known as Division-IAA) school. Moreover, the team has given its fans chances to see some of college football’s best and brightest, including then-powerhouses Kansas State, Auburn and Virginia Tech.And that annual date with Notre Dame has made for some fun games, too.“These difficult road games early in the year help make us,” Carroll said after Saturday’s win. “You build from there if you learn the lessons.”It’s easy to say that the high reward of scheduling tough out-of-conference opponents outweighs the high risk after USC came away with yet another critical road win. But if the Trojans’ final drive had stalled, most fans probably would be bemoaning the strategy and wishing that Cal Poly had come to town for a guaranteed win before conference play.And it’s not certain that the Trojans will parlay their success against Ohio State into wins in conference. The celebrations following last year’s romp against the Buckeyes were brought to a halt when Oregon State upended the Trojans the following Thursday.But Carroll’s condition of “if you can learn the lessons” is the key to the rest of the season and whether anything will grow from the team’s experience in the Midwest. The Trojans were outplayed for long stretches of the game and have plenty to take away from the game in ways to improve.How they respond to the flaws they showed Saturday will ultimately determine how far the Trojans can go during the rest of the season. The 2004 team took more than just a win away from its contest with Virginia Tech and only experienced a couple more close calls on their way to the national championship.But no matter how far USC goes from this point forward, fans should be grateful to the school and team for giving them arguably the most entertaining game of the last three and a half years.“This is the most intense college football game I’ve ever been a part of,” Galippo said.USC doesn’t look like it will be changing its scheduling philosophy anytime soon. Tennessee Athletic Director Mike Hamilton announced last week that his school had reached a verbal agreement with USC for a home-and-home in 2021 and 2022.To give you an idea of how far off that is, both Carroll and current Tennessee head coach Lane Kiffin could be long gone by the time that series comes to fruition — if it ever does. There’s no guarantee that both programs will still be competitive come kickoff. I will be 34 when the second game is played and the future USC student who will hold my current position at the Daily Trojan is probably only eight years old right now.But I’m sure we’ll both be watching the game.“Tackling Dummy” runs Tuesdays. To comment on this article, visit dailytrojan.com or email Michael at middlehu@usc.edu.last_img read more

2014 Fifa World Cup: Germany to build training complex in Brazil

first_imgThree-time World Cup winners Germany will use a purpose-built training base in Brazil during next summer’s finals.The under-construction venue, which will be developed by a Munich property firm, will cover 15,000 square metres and will have 60 bedrooms, a training pitch as well as a fitness centre.AnalysisStephen EvansBBC News, Berlin”Campo Bahia, as the German football authorities are calling it, has all the comforts of a seaside holiday village.”It is still under construction amid the palms on the sand-dunes of north eastern Brazil but the basic structures are there: a circle of white buildings for accommodation around a pool, a press centre plus a training pitch for the national side. It is well located for an airport to give short flights to Germany’s initial fixtures.”According to the German association, the work is being organised by a German entrepreneur who said the facilities would be “optimal” for the team. There’s been a lot of controversy about whether facilities will be adequate for the World Cup. In November, a crane collapsed at one stadium still being built. “The Germans are leaving nothing to chance. They’ve been to Brazil, decided what they need and are now building it themselves.”The German Football Association (DFB) said it is not funding the project.A football youth academy and an orphanage will also be built on the site, 30km north of Porto Seguro.The DFB said the Campo Bahia base is within two hours’ flight of the three cities – Salvador, Fortaleza and Recife – where Germany will play their Group G games at the tournament.Joachim Low’s team face Portugal on 16 June, Ghana on 21 June and the United States on 26 June. “Bearing in mind the size of the country and the considerable distances between each tournament venue, it was important for us to minimise the strain of travelling to and from matches as much as possible,” said Germany national team manager Oliver Bierhoff.”Acclimatisation and recovery will also play a major role at this World Cup, and our camp offers ideal conditions in these respects.”Due to the early kick-off times and the heat and high humidity expected in Salvador, Fortaleza and Recife, we looked for a base where the players could adapt effectively to the kind of things they can expect to encounter during each match.”last_img read more

Jurors proclaim suspected spy guilty

first_imgProsecutors alleged the systems were sensitive and labeled NOFORN, or barred from the view of foreign nationals. Defense attorneys argued that Mak had given presentations on the information on the disks at symposiums that were open to foreigners. Defense attorney Marilyn Bednarski, who called the government’s case against Mak “an alarmist overreaction,” argued that the government did not place restrictions on the information on the disks until several months after Mak’s arrest, so he could not have known about it. Staples said a person must first apply to the State Department for a license to send out the information, and Mak never did, despite his intensive training in how to handle classified and sensitive information. Staples told jurors that in 1989, the State Department barred the export of any military technology to China, and that “barely nothing on these disks could be sent to China.” After the verdicts, Staples said that Mak never sought permission for the presentations. SANTA ANA – A naturalized U.S. citizen from China was convicted Thursday of sending sensitive information on submarine technology that he worked on at a defense contractor job in Orange County. Chi Mak, 66, of Downey was found guilty of five counts of conspiracy to violate export control laws and other charges. He also was convicted of two counts of attempting to send sensitive material to China, acting as a foreign agent without notifying the U.S. government and making false statements to federal agents. Mak faces up to 35 years in prison, said Assistant U.S. Attorney Greg Staples. Under sentencing guidelines, that amount would probably be less, but it will still be “a substantial” prison term, he said. The eight-woman, four-man panel deliberated less than three days. Mak, an electrical engineer at Power Paragon in Anaheim, was accused of conspiring with his relatives to send an encrypted computer disk to China in October 2005 that contained information on the Quiet Electric Drive power system designed to make submarines quieter, as well as a solid state power switch for ships. Mak and his wife, Rebecca Chiu, were arrested in their Downey home shortly after his brother, Tai Mak, and his wife, Fuk Li, were arrested on Oct. 28, 2005, at Los Angeles International Airport, as they prepared to board a plane. Prosecutors allege that Tai Mak had an encrypted disk so that the information within would not be found. Mak told agents who later questioned him that he had given documents relating to research for the U.S. Navy to his brother so that Tai Mak could select engineering books for Chi Mak while his brother was in Hong Kong, according to the indictment. Tai Mak’s son, Billy Yui Mak, who is accused of encrypting the material, was arrested later. The other family members are scheduled to go to trial on June 5. 160Want local news?Sign up for the Localist and stay informed Something went wrong. Please try again.subscribeCongratulations! You’re all set!last_img read more