FDA gives clearance for GlaxoSmithKline’s flu vaccine

The introduction of GSK’s Fluarix, indicated for adults 18 and older against influenza disease, is the next immediate step in that commitment. Fluarix, currently distributed in 79 countries, will be available exclusively in prefilled Tip-Lok syringes.

US stocks of flu vaccines have been depleted after vaccine maker Chiron was forced to suspend production of its Fluvirin jab in October, 2004 amid regulators concerns about the potential for contamination at the company’s manufacturing facility

“The introduction of Fluarix is a vital step in the effort to improve vaccination rates in the US and protect against this highly communicable infection that threatens young and old alike,” said Dr John Treanor, associate professor of Medicine, Infectious Diseases Unit, University of Rochester Medical Center, N.Y. “Influenza can be a serious health threat, so the increased availability of this vaccine is critical to help keep the virus at bay and to potentially avoid epidemics.”

Influenza is a highly contagious and potentially fatal virus that affects five to 20 percent of the total US population during each influenza season. Between 1990 and 1999, approximately 36,000 people died in the US each year from complications of influenza infection; more than 90% of these deaths occurred in persons 65 years of age and older.