first_imgSep 28, 2007 (CIDRAP News) – The Food and Drug Administration (FDA) today announced the approval of an Australian-made influenza vaccine called Afluria for use in adults, raising the number of US-licensed flu vaccines to six.The vaccine, made by CSL Limited, based in Parkville, Australia, was approved for protecting people aged 18 and older from type A and B influenza viruses.Like most flu vaccines, Afluria contains inactivated (killed) flu viruses grown in chicken eggs. People who are allergic to eggs should not receive the vaccine, the FDA said in a news release.The vaccine is given as a single injection in the upper arm. It will be available in single dose, preservative-free syringes and in multiple-dose vials containing thimerosal, a mercury compound, as a preservative, the FDA said.CSL expects to supply up to 2 million doses of the vaccine in the United States this season, according to Paul Perreault, executive vice president of commercial operations for the company’s US division, CSL Biotherapies, based in King of Prussia, Pa. Plans call for delivering all the doses to the United States by the end of October, the company said in a news release today.The FDA said the Centers for Disease Control and Prevention (CDC) has estimated that the six vaccine makers will supply a record total of 132 million doses of flu vaccine in the United States this year. The CDC had cited the same figure at a news conference last week, without mentioning the CSL vaccine.”The licensure of this additional flu vaccine contributes to having an adequate supply of seasonal influenza vaccine for Americans, one of FDA’s highest priorities,” said Jesse L. Goodman, MD, MPH, director of the FDA’s Center for Biologics Evaluation and Research, in the agency news release.CSL Biotherapies announced its filing for FDA approval of Afluria in April. The application included the results of a phase 3, randomized, placebo-controlled clinical trial that involved 1,357 volunteers at nine US sites, the company news release said. Sponsored by the National Institutes of Health, the study evaluated the safety and immunogenicity of thimerosal-free and thimerosal-containing formulations of the vaccine.The FDA used its accelerated approval pathway in evaluating the vaccine. “The manufacturer demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza,” the agency said. “As part of the accelerated approval process, the manufacturer will conduct further studies to verify that the vaccine decreases seasonal influenza disease after vaccination.”CSL-branded flu vaccines are approved and sold in 16 countries, and the company provides bulk antigen for flu vaccines sold in 24 countries, according to the CSL news release. Officials said the company has been making flu vaccines for 40 years.Perreault told CIDRAP News that the bulk antigen for the vaccine is made in Australia, and this year the product will be finished and packaged in a facility in Germany. But in the future the finishing and packaging will be moved to a CSL plant in Kankakee, Ill., he said.In August, CSL announced plans to expand the Kankakee plant by adding a line to fill single-dose syringes. The company plans to start operating the line and packaging flu vaccine at the plant in 2010, according to the August announcement.Last year CSL announced it would spend $60 million to double the capacity of the company’s Melbourne, Australia, plant to 40 million doses per year, making it one of the largest flu vaccine production facilities in the world.Other injectable flu vaccines licensed in the United States, with their manufacturers, are FluLaval, ID Biomedical; Fluarix, GlaxoSmithKline; Fluzone, Sanofi Pasteur; and Fluvirin, Novartis. The other licensed product is FluMist, the nasal-spray vaccine made by MedImmune.See also: Sep 28 FDA news release 28 CSL Biotherapies news releaseOct 5, 2006, CIDRAP News story “FDA approves 5th flu vaccine”last_img read more

first_img Published on December 28, 2014 at 4:18 pm After a slow start, Syracuse outpaced Long Beach State by 18 points on Sunday in the Carrier Dome thanks to Michael Gbinije and Rakeem Christmas. Here are three observations from the Orange’s win over the 49ers.Wing players stepping upSyracuse’s early-season offense has been centered around Rakeem Christmas and Chris McCullough throughout the better part of the nonconference season. Trevor Cooney made just 13 of his first 46 3s on the season and Michael Gbinije made three of his first 21.But on Sunday, that duo combined for 40 points and played the entire game in the 85-67 win. Gbinije’s 24 were a career high, and Cooney continued his resurgence after an atrocious start to his season.With Syracuse down 21-17 early, the pair hit three 3s — two by Cooney — in the span of 65 seconds to give the Orange a 26-21 advantage, a lead it would hold the rest of the way.AdvertisementThis is placeholder textThe press paid dividends Jim Boeheim has been known to employ the press in times of desperation — mainly when SU is down big to teams it shouldn’t be — and he did again today. After a Gbinije jump shot cut the 49ers lead to 14-8, the Orange press forced David Samuels into an errant pass and Christmas turned it into a three-point play.Cooney forced a turnover just seconds later, and it would turn into a Gbinije layup. Kaleb Joseph converted on a McCullough steal right after as SU completed an 11-0 run.Tyler Roberson coming up bigThe sophomore didn’t get a chance to make much of a difference in the first half, missing his only shot. But when his number got called in the second frame, he played well.The forward connected on 3-of-6 from the field, including a slam dunk on an outlet pass from Gbinije to put the Orange up 12 with 4:34 to play and on its way to an 18-point victory. Comments Facebook Twitter Google+last_img read more