GlaxoSmithKline announces FDA approval ...( lth care Garnier said. GSK worked q...),Health

lth care," Garnier said. "GSK worked quickly with government officials to make FLUARIX available and increase supply at a critical time. We appreciate the spirit of cooperation and commitment on the part of the FDA and US Department of Health and Human Services. Now we look forward to working with health authorities to encourage vaccination among those who are most vulnerable."

FLUARIX™ [Influenza Virus Vaccine] Clinical Trials
The FDA reviewed safety and immunogenicity data from a Phase III clinical trial which studied FLUARIX in approximately 1,000 adults in the United States aged 18 to 64. This randomized, double-blind, placebo-controlled study showed FLUARIX to be safe and immunogenic.

FLUARIX has been in use outside the United States since 1992. More than 150 million doses of FLUARIX have been distributed worldwide since that time. Because the prevalent strains of influenza can change from season to season, the composition of the vaccine is adjusted yearly to match the recommendations of the FDA and the Centers for Disease Control and Prevention (CDC). As a result of these changes in the influenza virus, the CDC recommends annual vaccination, particularly for groups at high risk of complications.

ABOUT INFLUENZA
Many respiratory diseases occur every winter, but influenza is one of the most severe. The illness is easily passed from one person to another through the air by tiny droplets released when an infected individual coughs or sneezes. Most people recover fully within a week or two, but the risk of complications is elevated in very young, very old and chronically ill persons.

Although epidemics of flu happen in most years, the beginning, severity and length of the epidemic can vary widely from year to year. Before a season begins, it is not possible to accurately predict the features of any season. While October or November is the best time to get vaccinated, getting influenza vac
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Contact: Michael Fleming
919-483 2839
Cohn & Wolfe
31-Aug-2005

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