The US Food and Drug Administration has approved GlaxoSmithKline’s influenza vaccine, Fluarix (Influenza Virus Vaccine) for distribution in time for the 2005-2006 influenza season.

Fluarix, currently distributed in 79 countries, will be available exclusively in prefilled Tip-Lok syringes, said a GSK release.

"The introduction of Fluarix is a vital step in the effort to improve vaccination rates in the United States 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 Centre, Rochester, N.Y.

Jean-Pierre Garnier, CEO of GlaxoSmithKline, said that it could bolster the country's supply of flu vaccine in time for the 2005/2006 flu season. "The shortage of flu vaccine last year was a reminder of the importance of vaccines in health care," Garnier said adding, "GSK worked quickly with government officials to make Fluarix available and increase supply at a critical time."

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, the release added.

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