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”
Topics : As many as 33 rivers in China have risen to their highest levels in history during the current wave of floods, a senior water ministry official said on Monday, as regions across the country brace for another “grim” week of torrential rain.Ye Jianchun, vice minister of water resources, told a briefing that 433 rivers – as well as major lakes like the Dongting, the Poyang and the Tai – have all risen beyond their warning levels since the flood season began in June.”Going into the key flood-prevention period of late July to early August, the current trends remain grim on the Yangtze and the Lake Tai basins,” he said, adding that the belts of heavy rain that have lashed central China would eventually head north. Average rainfall has been at its highest since records began in 1961. The emergency ministry said last Friday that 141 people were dead or missing, with economic losses at around 60 billion yuan ($8.57 billion).Flood-control authorities throughout the Yangtze basin have already declared “red alerts” that cover major population centers such as Xianning, Jiujiang and Nanchang.A red alert has also been declared at the Poyang lake, where water levels are more than 3 meters higher than normal, another record high.In some flood-stricken regions, soldiers filled sandbags to shore up riverbanks and stave off more damage. Town streets were inundated, and rescue workers waded through hip-deep water with inflatable boats to reach people trapped in homes turned into islands.According to water ministry data, warning levels were breached at more than 70 flood-monitoring stations on Monday. Water levels at the Three Gorges reservoir, which cut its discharge volumes for a fifth time on Saturday to ease downstream water levels, have now hit 153.2 meters, 6.7 meters higher than the warning level.China’s weather bureau said that although some regions in the southwest would see a temporary respite from the heavy rain on Monday, central and eastern China would continue to bear the brunt of the storms.