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 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”last_img read more

first_imgMargot Robbie talks about filming ‘Bombshell’s’ disturbing sexual harassment scene Jake says relationship with Shaina ‘goes beyond physical attraction’ Carpio hits red carpet treatment for China Coast Guard PLAY LIST 02:14Carpio hits red carpet treatment for China Coast Guard02:56NCRPO pledges to donate P3.5 million to victims of Taal eruption00:56Heavy rain brings some relief in Australia02:37Calm moments allow Taal folks some respite03:23Negosyo sa Tagaytay City, bagsak sa pag-aalboroto ng Bulkang Taal01:13Christian Standhardinger wins PBA Best Player award Speaking to reporters after the Lakers’ victory against the Brooklyn Nets over the weekend, Ball’s eccentric father, LaVar, urged his son to beat the funk by taking more shots.“You’ve got to shoot the ball,” Lavar, who witnessed his son tally 6 points, 5 boards and 7 assists, told Bleacher Report. “You’re not going to make it if you don’t take it.”FEATURED STORIESSPORTSRedemption is sweet for Ginebra, Scottie ThompsonSPORTSMayweather beats Pacquiao, Canelo for ‘Fighter of the Decade’SPORTSFederer blasts lack of communication on Australian Open smogThe Ball patriarch also made it known that he wants more consistent minutes in the rotation for his eldest son.“Let him play the whole fourth quarter and bet you’ll always win. He’ll get into a better flow,” he said. “The in and out, sitting out six to 10 minutes? He’s not going to take no shots because he’s not in the flow. He don’t want to hurt the team by shooting.” It’s too early to present Duterte’s ‘legacy’ – Lacson LATEST STORIES Sports Related Videospowered by AdSparcRead Next View comments Jo Koy: My brain always wants to think funny OSG plea to revoke ABS-CBN franchise ‘a duplicitous move’ – Lacson Ball, meanwhile, has proven his ability to score in the grand stage, where he poured in 29 points in his second regular-season against the Phoenix Suns.Since then, the 20-year-old point guard has struggled to crack double digits in the scoring department, punctuated by a scoreless game against the Portland Trailblazers where he only took two shots.  Khristian Ibarrola /raRELATED STORY:Coach Luke Walton: It ‘would be silly’ to tinker with Lonzo Ball’s shooting styleADVERTISEMENT MOST READ Los Angeles Lakers guard Lonzo Ball, front, passes the ball past Detroit Pistons forward Stanley Johnson defending during the second half of an NBA basketball game Tuesday, Oct. 31, 2017, in Los Angeles. The Lakers won, 113-93.  AP/Kyusung GongThe youthful Los Angeles Lakers currently hold a 5-5 record, thanks to their uptempo offense led in part by the team’s sensational facilitator, Lonzo Ball.But as much as the former UCLA Bruin has dazzled distributing the rock, this year’s second overall pick has mightily struggled to make a basket—shooting a drastic 29.9 percent from the field in his first 10 games.ADVERTISEMENT Danny Seigle named as Alab team consultant Coco’s house rules on ‘Probinsyano’ set Kiss-and-tell matinee idol’s conquests: True stories or tall tales? Steam emission over Taal’s main crater ‘steady’ for past 24 hours Don’t miss out on the latest news and information. Jake says relationship with Shaina ‘goes beyond physical attraction’last_img read more