Flu Vaccine Strains For 2006-2007 Season To Be Selected By FDA Cmte.

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"FDAAdvisoryCommittee.com" <fdaadvisorycommittee.com@...> wrote: Date: Wed, 25 Jan 2006 19:37:30 -0500 (EST)From: "FDAAdvisoryCommittee.com"<fdaadvisorycommittee.com@...>redhead60707@...Subject: Flu Vaccine Strains For 2006-2007 Season To Be Selected By FDA Cmte. "The Pink Sheet""The Tan Sheet"Health News DailyNDA PipelinePharmaceutical Approvals Allergenic Products Anesthetic and Life Support Drugs Anti-Infective Drugs Pediatric Subcommittee Antiviral Drugs

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Pharmacology Orally Inhaled & Nasal Drug Products Pharmacy Compounding Psychopharmacologic Drugs Public Meetings Pulmonary-Allergy Drugs Reproductive Health Drugs Science Board Transmissible Spongiform Encephalopathies Vaccines and Related Biological Products A D V E R T I S E M E N T Flu Vaccine 2006-2007 Strains To Be Determined By Advisory Cmte. Feb. 17 Influenza virus strains to be included in the vaccine for the 2006-2007 flu season will be discussed by FDA’s Vaccines & Related Biological Products

Advisory Committee Feb. 17. During last February’s deliberations for the 2005-2006 flu season, the committee recommended retaining the previous flu season’s A/New Caledonia/20/99 (H1N1)-like strain and switching to an A/California/7/2004 (H3N2)-like strain from the previous A/Fujian/411/2002-like strain. The committee also recommended keeping the same influenza B strain, the Yamagata lineage B/Shanghai/361/2002-like strain. The committee also suggested the development of a bivalent B strain vaccine for pediatric patients, who do not get cross protection from a single B strain. Since last year’s advisory committee meeting, two companies have entered the U.S. influenza vaccine market. GlaxoKline could launch two vaccines for the 2006-2007 season. FDA

approved GSK’s flu vaccine Fluarix in August. A month later, the firm announced plans to buy Fluviral maker ID Biomedical; the company has said it hopes to have the vaccine approved by the 2007 flu season. Novartis also entered the flu vaccine market with its acquisition of U.K.-based Chiron, which manufactures the flu vaccine Fluvirin. Fluvirin manufacturing was halted in 2004 due to good manufacturing practice deviations at its Liverpool facility. Chiron was cleared to recommence manufacture of the vaccine in September.Other flu vaccines include Sanofi Pasteur’s Fluzone and Medimmune’s intranasal FluMist. To watch a webcast of this meeting, click the button below. To arrange for live videoconferencing, or to order videotapes & DVDs, email FDATV@... or call 800-627-8171. Sign up to view this meeting. This meeting will be held February 17, 2006 at the National institutes of Health, Bldg. 29B in Bethesda, Md. beginning at 1 p.m. Click HERE to remove your name from this email list. A D V E R T I S E M E N T Copyright and Privacy Policy __________________________________________________