CSL Biotherapies announces FDA marketing approval of Afluria(R).New influenza vaccine influenza vaccine Flu vaccine A vaccine recommended for those at high risk for serious complications from influenza: > age 65; Pts with chronic diseases of heart, lung or kidneys, DM, immunosuppression, severe anemia, nursing home and other chronic-care available for distribution in time for the 2007/2008 season Global biopharmaceutical company with strong vaccine heritage affirms commitment to help address critical U.S. public health need KING OF PRUSSIA King of Prussia, industrialized suburban area (1990 pop. 18,406), Montgomery co., SE Pa. It has glass and steel fabricating, food processing, printing and publishing, and varied manufacturing (textiles, liquified petroleum gas, water-treatment and electrical , Pa. -- CSL (Computerese as a Second Language) Said of people who love to speak high-tech words even though they often use them erroneously. See TLA. 1. CSL - Computer Structure Language. A computer hardware description language, written in BCPL. Biotherapies, a subsidiary of one of the world's leading manufacturers of influenza vaccine, announced today that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has approved Afluria([R])(influenza virus vaccine influenza virus vaccine n. A vaccine containing influenza virus, usually several strains of the virus, prepared in chick embryos and used to immunize against influenza. ) for active immunization Active immunization Treatment that provides immunity by challenging an individual's own immune system to produce antibody against a particular organism, in this case the rabies virus. Mentioned in: Rabies of persons age 18 years and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. Today's approval marks the company's first entry into the U.S. vaccine market. Afluria will be made available in both single-dose, thimerosal-free, pre-filled syringes and in multi-dose vials to provide choice and convenience to caregivers who administer it. CSL Biotherapies intends to deliver all shipments to the U.S. before the end of October, 2007, an objective that affirms the company's commitment to helping address a critical U.S. public health need. "CSL Biotherapies is proud to bring our 40-year heritage in influenza vaccines to the U.S. market, where boosting the supply of available flu vaccine and increasing vaccination rates is a priority public health goal," said Paul Perreault, Executive Vice President of CSL Biotherapies Worldwide Commercial Operations. "In addition, we are particularly pleased to be offering Afluria in a thimerosal-free formulation in pre-filled syringes, representing a greater degree of choice for patients and healthcare professionals." "Health authorities continue to emphasize the importance of flu vaccination as a front-line defense against a common and serious public health threat that still claims lives every year in the U.S.," said Kathryn M. Edwards, MD, of Vanderbilt School of Medicine in Nashville, Tennessee, and principal investigator in the National Institutes of Health-funded clinical trial that assessed the CSL influenza vaccine in the U.S. "With today's approval of Afluria, we welcome the expanded diversity of vaccine suppliers and applaud CSL Biotherapies' efforts to increase the availability of thimerosal-free flu vaccine in the U.S. Now, healthcare professionals have the ability to offer flu vaccination to more people and significantly decrease the burden of this preventable disease in America." About Afluria The Afluria market application was granted priority review status by the FDA in April, 2007. CSL-branded influenza vaccines are approved and marketed in 16 countries worldwide. The company also provides bulk antigen for influenza vaccine sold in 24 countries. CSL's influenza vaccine is a purified, inactivated inactivated rendered inactive; the activity is destroyed. inactivated viruses treated so that they are no longer able to produce evidence of growth or damaging effect on tissue. , trivalent trivalent /tri·va·lent/ (tri-va´lent) having a valence of three. tri·va·lent adj. Having valence 3. tri·va influenza vaccine propagated in embryonated chicken eggs. Each dose contains the required dose of influenza virus hemagglutinin hemagglutinin /he·mag·glu·ti·nin/ (-gloo´ti-nin) an antibody that causes agglutination of erythrocytes. cold hemagglutinin one which acts only at temperatures near 4° C. antigens from the influenza strains recommended and prioritized by FDA's Vaccine and Related Biological Products Advisory Committee for the 2007-2008 flu season. Previous international flu vaccine studies sponsored by CSL Limited, and a clinical trial conducted by the National Institutes of Health (NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. ), formed the basis for CSL Biotherapies' biologics licensing application submission. The NIH-supported clinical trial that led to U.S. licensure enrolled 1,357 volunteers at nine clinical sites in the U.S. in a pivotal, Phase III, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind, placebo-controlled study. The study evaluated the safety, tolerability and immunogenicity immunogenicity /im·mu·no·ge·nic·i·ty/ (-je-nis´it-e) the property enabling a substance to provoke an immune response, or the degree to which a substance possesses this property. of thimerosal-free and thimerosal-containing formulations of influenza vaccine in healthy adults aged 18 to less than 65 years. Last year, CSL, parent company to CSL Biotherapies, announced a $60 million (U.S.D.) investment in plant and equipment to double the manufacturing capacity of the company's Melbourne facility to 40 million doses per season, making it one of the largest vaccine manufacturing plants in the world. Recently, CSL also announced its intention to expand its fill and finish activities with installation of a new facility in Illinois. Important Safety Information Afluria([R]) is indicated for active immunization of persons age 18 and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. The indication is based on the immune response elicited by Afluria; no controlled clinical studies have demonstrated a decrease in influenza disease after vaccination with Afluria. Afluria should not be administered to individuals with hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to eggs or chicken protein or other components of Afluria, and in anyone who has had a life-threatening reaction to previous influenza vaccination. The most common injection-site adverse reactions were tenderness, pain, redness and swelling. The most common systemic adverse reactions were headache, malaise and muscle aches. Vaccination with Afluria may not protect all individuals. Immunocompromised immunocompromised /im·mu·no·com·pro·mised/ (-kom´pro-mizd) having the immune response attenuated by administration of immunosuppressive drugs, by irradiation, by malnutrition, or by certain disease processes (e.g., cancer). persons may have a diminished immune response. If Guillain-Barr[R] syndrome has occurred within six weeks of receipt of prior influenza vaccine, the decision to give Afluria should be based on careful consideration of the potential benefits and risks. Full prescribing information on Afluria can be found at www.Afluria.com. About Influenza The "flu" is a contagious respiratory illness caused by influenza viruses. It can cause mild to severe illness, and at times can lead to death. According to CDC's Advisory Committee on Immunization Practices The Advisory Committee on Immunization Practices (ACIP) consists of fifteen advisors to the Centers for Disease Control and Prevention (CDC), selected by the Secretary of the United States Department of Health and Human Services, to provide advice and guidance on the most effective (ACIP ACIP Cardiology A clinical trial–Asymptomatic Cardiac Ischemia Pilot Study that evaluated 3 therapeutic strategies2 for ↓ myocardial ischemia during exercise testing. ), the single best way to prevent the flu is by getting vaccinated every year. About CSL Biotherapies The U.S. headquarters of CSL Biotherapies are located in King of Prussia, Pa. Its parent company, CSL Limited, in Melbourne, Australia, operates one of the world's largest influenza vaccine facilities for global markets. CSL Biotherapies, which shares its U.S. headquarters with its sister company, CSL Behring, is commercializing influenza vaccine products globally. At CSL Biotherapies, delivering vaccines is our mission, protecting lives our passion. The CSL Group, which also includes CSL Research & Development, CSL Bioplasma, and CSL Behring, has more than 8,500 employees and operates in 21 countries worldwide. For more information, visit us at www.cslbiotherapies-us.com, or call 1-888-435-8633. |
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