None of Chiron’s flu vaccine is safe, FDA says

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None of Chiron’s flu vaccine is safe, FDA says

first_imgOct 15, 2004 (CIDRAP News) – Federal health officials today ruled out using any of Chiron Corporation’s influenza vaccine in the United States this year, following the completion of inspections at the company’s plant in Liverpool, England.Shipment of Chiron’s 48 million doses of vaccine was halted last week when the British government shut down the plant because of concerns about contamination. US officials had held out little hope that any of the Chiron vaccine could be used, and today’s announcement confirmed the bad news.”Today we’re announcing that none of the flu vaccine made by Chiron for the US market is safe,” Food and Drug Administration (FDA) Acting Commissioner Lester Crawford said at a news briefing late this afternoon. The announcement confirms the disappearance of nearly half of the previously projected US supply of 100 million doses.Crawford said FDA officials who finished inspecting Chiron’s Liverpool plant this afternoon found violations of “good manufacturing practices.” “We did enough testing to conclude that we couldn’t guarantee the safety of any of the vaccine,” he said. “The contamination appears to be from the filling of the vials; that has to be done in a sterile way, and we’re not sure that was the case.” He said the contamination involved the bacterial species Serratia marcescens.About a million doses of Chiron vaccine that had already been shipped to the United States probably can’t be used either, Crawford said. “Our inclination and intention here is to test and retest those lots and see if some of it can be used. We are not optimistic about that and in fact do not believe it can be used,” he said.The Chiron disaster has left Aventis Pasteur as the only supplier of injectable vaccine for the US market. Aventis has produced 55.4 million doses, about 33 million of which have already been shipped to customers, according to the Centers for Disease Control and Prevention (CDC).Because of the shortage, the CDC has recommended that healthy people forgo flu shots so the doses can be saved for people at high risk for flu complications, such as the elderly, infants, and people with chronic illness. The agency is working with Aventis to assure that the remaining doses go to those groups.Crawford said the Department of Health and Human Services is hunting everywhere for more vaccine. “Literally every flu vaccine manufacturer in the world is being contacted, and some progress is being made,” he said, without giving specifics.The CDC said today that Aventis shipped more than 2 million doses of flu vaccine this week to providers serving high-risk groups, including the Veterans Administration, long-term care facilities, hospitals, state public health agencies, the Vaccines for Children Program, and private providers who care for young children.”More doses of vaccine will be going out over the next 6-7 weeks so there will be more opportunity for those who need this vaccine to get it in time for this year’s influenza season,” CDC Director Julie Gerberding said in a news release.Amplifying this message at the news briefing, Gerberding said, “We recommend that people not wait in long lines [for vaccine] but rather call ahead to make an appointment. . . . We have very limited flu activity in the US right now, so there is still time for us to get these vaccine doses out and for people to receive them without having to wait in long lines.”Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, urged providers not to give flu shots to healthy people in low-risk groups. “It’s a numbers issue,” he said. Roughly 45 million people in the high-risk groups are expected to seek flu shots, which means there are just enough doses for them, he explained.Gerberding said the CDC has a stockpile of antiviral drugs that can help the nation cope with the vaccine shortage. “We’ve gotten 5 million doses of rimantadine for the stockpile. . . . We also have a stockpile of oseltamivir which would be used for treating influenza,” she said. She added that the CDC will be providing more information soon and will look into whether production of antivirals can be increased.In other developments, reports of exorbitant prices for scarce flu vaccine prompted HHS Secretary Tommy Thompson yesterday to urge states to prosecute price gougers.”I am encouraging the attorney general of each state to thoroughly investigate reports of price gouging and prosecute those engaging in this immoral and illegal activity to the full extent of the law,” Thompson said in a letter he sent to attorneys general and released publicly.At the same time, Thompson said it was “doubtful” that the United States would be able to buy significant supplies of flu vaccine from Canada or other foreign sources, according to the Associated Press (AP) and other news services.The FDA has been talking with two companies that sell flu vaccine in Canada and other countries and have “a few million” unsold doses, the AP reported. But the vaccines are not licensed in the United States, and Thompson said it was unlikely the producers could meet FDA requirements in time for this season, according to the report.Thompson’s comments came a day after President Bush, in the Oct 13 presidential debate, said Canadian supplies might ease the US vaccine shortage.According to the AP, hospitals have reported distributors offering flu vaccine for as much as $100 per shot, compared with normal retail prices of $12 to $20. In his letter to attorneys general, Thompson said the CDC is collecting reports of price gouging and sharing them with the National Association of Attorneys General and state prosecutors.One sign of the surging demand for flu vaccine came from Denver, where someone stole 780 doses from a clinic in suburban Aurora, according to a report in yesterday’s Denver Post. The doses were taken from a refrigerator at Kids Aurora, a private, two-doctor pediatric clinic, the story said.last_img read more

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Coming off disappointing season, pressure-free Syracuse expects to climb back to winning ways

first_imgLaughter echoed throughout the Carrier Dome as players posed for pictures at the Syracuse men’s lacrosse team’s media day. Eric DeJohn looked out into the distance as his teammates chuckled and shouted to the attack in approval.It’s already evident—this year’s team is going to be different.“The camaraderie’s huge,” midfielder JoJo Marasco said. “You look just as they’re doing interviews right away all the guys are laughing, and joking around and getting loud. And I think we’re very close as a team since the past couple of years and I think that’s why we’re going to have such a great season.”The Orange enters the 2013 campaign in an unfamiliar position. For years, and essentially the entirety of John Desko’s career as head coach, SU has been among the favorites to win the national championship. This season, though, the same expectation isn’t necessarily there.After a disappointing 9-8 season a year ago ending with a first-round exit from the NCAA Tournament, Syracuse begins the season ranked 14th in the country—a far cry from its usual spot in the top five.AdvertisementThis is placeholder textBut it has led to a different type of attitude. Usually there’s a certain swagger about the Orange as the team plays with a target on its collective back, but 2013 is different.SU is playing angry. Angry with its preseason ranking. Angry with how last season ended.“That season is always stuck in the back of everyone’s minds, so I think it’s something kind of motivating everyone is we don’t want to have another season like that,” defender Brandon Mullins said. “… Being ranked 14 is nothing we settle for.”For Desko, this new attitude was evident even before the first practice of the season. Before the first practice, Syracuse takes a running test that Marasco said is difficult for the players who fail to workout enough during the offseason.“A high percentage of them came back, made the runs,” Desko said. “So that in itself says they’ve been working in the offseason between where we were in the fall and where they are today.”The 2013 season also represents the first time the Orange will play without a target on its back. Even after missing the NCAA Tournament in 2007, SU had lofty expectations the next year with one of the top recruiting classes of all time.Instead of being chased, the 2013 team will have the luxury of playing as the underdog chasing the powers that Syracuse is usually lumped with in the preseason.“It’s awesome,” attack Derek Maltz said. “You know you don’t have as much pressure usually – you know there’s always pressure when you play for Syracuse lacrosse – but it’ll be a great year.”Still, there is no wavering of confidence. The swagger that often defined the Orange in the past and the knowledge that SU has more talent than any opponent it faces may be more subdued as opposed to past seasons. But the positivity is still there, even if it’s quieter.Syracuse knows it has more to prove this preseason than it has in the past, but the expectation is still that the Orange will be there in the end. And when it is, the doubt that clouded the preseason will make the satisfaction that much sweeter.“We have the talent, we have the team, and I think we’re really going to shock the world a little bit this year,” Marasco said. “We’re really excited about this season. With just the guys on this team, the motivation, the captains, the leaders, I think we’re ready to go out there and show people why we should be in the Top 10, why we should be there.” Comments Published on January 8, 2013 at 5:26 pm Contact David: dbwilson@syr.edu | @DBWilson2 Facebook Twitter Google+last_img read more

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