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Community Info Health News
 How To Reach Us: St. Louis Front Page Community News P.O. Box 1354 St. Louis, MO 63188 http://www.slfp.com Voice: 314-771-0200 Fax: 314-771-0300 To submit news, contact: editor@slfp.com  |
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Chiron Will Not Supply Flu Vaccine for Upcoming Influenza Season ST. LOUIS, (SLFP.com), October 5, 2004 - The UK regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA), has temporarily suspended Chiron's license to manufacture Fluvirin® influenza virus vaccine in its Liverpool facility, preventing the company from delivering an estimated total of 50 million doses to the U.S. market this season. In a statement released today, Howard Pien, president and CEO of Chiron, said, "Chiron deeply regrets that we will not be able to meet public health needs this season. We take our responsibility to protect human health very seriously. Chiron believes in the value of influenza vaccination, and we are committed to taking all necessary actions to ensure an adequate vaccine supply for the 2005-2006 influenza season." On September 28, Mr. Pien testified to the value of influenza vcaccination before the U.S. Senate Special Committee on Aging. Mr. Pien reiterated Chiron's expectation, as stated in the company's August 26, 2004, press release, that it will supply between 46 million and 48 million Fluvirin® influenza virus vaccine doses to the U.S. market for the 2004-2005 influenza season, beginning in early October. October and November are the primary months when influenza vaccine is given. Influenza, a contagious disease caused by the influenza virus, affects the respiratory tract, often resulting in symptoms in the nose, throat and lungs, as well as fever, headache, tiredness and body aches. It can also lead to complications such as pneumonia, bronchitis, or sinus and ear infections or exacerbate chronic conditions. According to the U.S. Centers for Disease Control and Prevention (CDC), about 10 to 20 percent of the U.S. population contracts influenza each year. CDC statistics show that, in an average year in the United States, influenza causes 114,000 hospitalizations and kills 36,000 people, primarily in persons 65 and older. Vaccination not only decreases the risk of illness for the vaccine recipient but also helps prevent the spread of the influenza virus and limits its role in the potential development of life-threatening complications. CDC statistics show that, in an average year in the United States, influenza causes more than 200,000 hospitalizations and kills 36,000 people, primarily in ages 65 and older. In August, Chiron announced a delay in providing Fluvirin for the 2004-2005 influenza season. Chiron has communicated regularly with the U.S. Food and Drug Administration (FDA), which has regulatory oversight for vaccines marketed in the United States, and the U.S. Centers for Disease Control and Prevention (CDC), which makes recommendations for influenza vaccination through its National Immunization Program (NIP) and the Advisory Committee on Immunization Practices (ACIP). Chiron had previously expected to provide nearly half the U.S. supply for the 2004-2005 influenza season and is discussing potential impact with the FDA and CDC. In the United Kingdom, where Fluvirin typically accounts for approximately 20 percent of the influenza vaccine market, Chiron plans to make up a significant proportion of this supply with vaccines that are produced at its other European sites and approved for use in the United Kingdom (but not the United States). Chiron plans to continue to work with the CDC and the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) in preparation for the 2005-2006 influenza season. "Our manufacturing and quality staff have worked hard to resolve what we viewed as a problem limited in scope to a few batches, and we believe our quality assurance confirmatory testing demonstrates that the Fluvirin doses we anticipated releasing are safe. While the MHRA's conclusions are unexpected, we respect the regulatory authority's judgment," said John Lambert, president of Chiron Vaccines. "We apologize unreservedly to the public and our customers for being unable to meet our commitments this year." Brown & Williamson wins Mash: Individual Smoker Suit in Missouri ST. LOUIS, (PRNewswire), October 4, 2004 - In the first individual smoker case to be tried since the merger of R.J. Reynolds Tobacco Company and the U.S. tobacco business of Brown & Williamson Tobacco Corporation (B&W), a Missouri jury today returned a verdict, September 30, in favor of B&W. The jury concluded that B&W was not responsible for the illness of Stella Hale, a smoker who died allegedly from lung cancer caused by smoking the company's products. The jury unanimously agreed with B&W that there was ample evidence that Ms. Hale had long been aware of the potential health risks of smoking, and that she, nevertheless, chose to smoke. The Honorable Thomas C. Mummert, III, United States Magistrate Judge, presided over the trial that began with jury selection on September 20, 2004. "This verdict showed that the jury thought that people who choose to smoke in the face of these known risks should not be financially rewarded," said Jeff Raborn, senior counsel for R.J. Reynolds, in a statement. "The verdict also confirms yet again the strength of the defenses in individual lawsuits," Raborn said. "The jury evaluated all of the evidence in this case and concluded that the plaintiffs' claims lacked merit. "The trial was held in the United States District Court for the Eastern District of Missouri in St. Louis. This lawsuit was filed by Tracey A. Mash and Anjanetta Lingard on March 6, 2003 in state court in Missouri. It was later removed to federal court. The plaintiffs are the daughters of Stella Hale who died on Aug. 16, 2001. Plaintiffs allege Ms. Hale died from lung cancer caused by KOOL cigarettes. This is the only individual smoking and health case to go to trial against either B&W or R.J. Reynolds this year. Archived Stories: Merck Announces Voluntary Worldwide Withdrawal of VIOXX® Classroom Triggers for Asthma and Allergies Obesity is Not a Disease Memory Study Gives New Hope in the Fight Against Alzheimer's Eating Apples and Drinking Apple Juice Today May Protect Brain Health Tomorrow Chamber Study Shows Obesity Lawsuits Are No Diet Aid Summer Season Sizzles With Potential for Injuries Around the Home  The SLFP.com - Community Info is presented in conjunction with the St. Louis Front Page and Southwest Illinois News. The sites are owned and maintained by the Moore Design Group for the sole purpose of disseminating news and information about the Metropolitan St. Louis area. Text or graphics may not be copied, rewritten or distributed in any manner whatsoever without written permission. For more information, contact editor@slfp.com All rights reserved world wide © 1996 - 2008 Moore Design Group . |
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