Sep 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 releasehttp://www.fda.gov/bbs/topics/NEWS/2007/NEW01714.htmlSep 28 CSL Biotherapies news releaseOct 5, 2006, CIDRAP News story “FDA approves 5th flu vaccine”
Brendan Rodgers’ former Swansea colleague Neil Taylor says he does not envy young British managers following the sacking of the Liverpool boss. But he feels Liverpool’s decision to sack Rodgers and probably go foreign, with Jurgen Klopp and Carlo Ancelotti among the early front-runners to land the Anfield job, paints a bleak picture for ambitious British managers. “This is modern football and I don’t envy young British managers coming through,” Taylor said. “I am shocked because it seemed like they had a long-term plan at that football club. “Brendan is a good manager and whether they changed their train of thought that they needed to bring someone in to have immediate success I don’t know. “They gave him money to spend this summer and maybe they felt they haven’t started well enough this year. “But the key for young managers is they’ve got to be given time to build their own team.” In the 2013/14 season, fuelled by the brilliance and goals of Luis Suarez, Rodgers almost steered Liverpool to their first English title for 24 years. But Liverpool failed to hit those heights again after Suarez’ departure to Barcelona in the summer of 2014 and Rodgers came under increasing scrutiny before his three-year reign was ended in the wake of Sunday’s 1-1 draw away to Merseyside rivals Everton. “I think it all goes back to the year they didn’t win the title,” Taylor said. “They were very close to it and if they’d won it then maybe Suarez and Raheem Sterling stay and it’s a different story. “Daniel Sturridge has had some long injures as well and any football club losing those players would be in quite a lot of trouble. “When you lose three players like that what are you supposed to do as a manager? “As a manager you’ve got to manage expectations, but you also need a little bit of realism in football.” But Taylor has no doubts that Rodgers will return better for his Liverpool experience and land another big job sometime in the future. “I’m disappointed for him but he’s had three good years at a big club and has gained loads of experience as a manager,” Taylor said. “Sometimes your name has to fit as well and maybe Brendan’s didn’t. “I feel for him, but I’m sure he’ll get another good job and move on quickly from this.” Taylor worked with Rodgers as the Northern Irishman won promotion with Swansea from the Championship and established them in the Premier League before he moved on to Liverpool in 2012. The Wales defender considers Rodgers a fine manager and believes he will soon find another job following his departure from Anfield on Sunday evening. Press Association
In the center of USC’s Health Sciences Campus Wednesday, a crowd of red-shirted demonstrators stood with picket-signs, chanting over the din of cars driving past, which occasionally honked in support. These health care workers participated in a one-day strike to demand better wages and more equitable treatment.In negotiations that have been ongoing for over a year, Keck School of Medicine of USC staff represented by the National Union of Healthcare Workers has been trying to reach an agreement on a contract with USC-Keck.Their primary complaints are short-staffing that strains adequate patient care, low wages that force workers to go on government assistance and a discriminatory lack of retirement and tuition benefits afforded to other USC employees.Striking alongside NUHW workers were cafeteria employees working for Sodexo, a multinational food services company that employs 133,000 workers nationwide. Also picketing in solidarity was the California Nurses Association.“It is not okay to short staff all of the departments: nursing, respiratory, PCT. At the end of the day we are running around, and really not taking care of the patients the way they deserve,” said Adela Rea, a respiratory therapist at Keck, during a midday rally. “This is a place of healing. If we rush that process and short staff, we’re not really healing, we’re just rushing them through.”Keck administration has refuted these claims of short-staffing and poor treatment.“This strike has nothing to do with patient care. It is a purely economic strike,” said Rod Hanners, chief operating officer of Keck.Hanners emphasized the importance of remaining affordable and competitive with comparable health institutions such as Cedars-Sinai and the UCLA Health system.The crux of the labor dispute, according to Hanners, amounted to three articles of negotiation out of 27 others that were agreed upon.“We either enhanced a benefit or kept it the same. There were no takebacks,” Hanners said.According to Hanners, Keck offered the NUHW workers a 9 percent wage increase over the life of the upcoming contract, providing the first wage increase of 3 percent last week, in addition to a $500 bonus.“We offered a market-competitive increase,” Hanners said.He also mentioned that the healthcare workers represented by the NUHW also receive a zero premium health care plan that other unions do not, the Anthem-Blue Cross HMO.Following the one-day strike, the Keck Hospital of USC responded to the strike with a press release, stating that only a fraction of the represented workers participated in picketing and that treatment of patients continued as usual.