GSK Begins Shipments of Fluarix and FluLaval to U.S. Customers for 2008-2009 Influenza Season

PHILADELPHIA – GlaxoSmithKline (GSK) today announced that it will begin shipment of FLULAVAL(R) [Influenza Virus Vaccine] and FLUARIX(R) [Influenza Virus Vaccine] to U.S. customers for the 2008-2009 influenza season. The U.S. Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research (CBER) released the first lots of FLULAVAL and FLUARIX, allowing distribution to begin. GSK plans to supply the U.S. market with approximately 35 million doses of the two products combined -- an increase from last year, when GSK contributed approximately 33 million doses.

GSK anticipates delivery of at least half of its influenza vaccines by the end of August and the vast majority to be shipped to customers by the end of September.

"GSK is committed to continually raising awareness of the role of influenza vaccination in helping to keep people healthy," said David Pernock, senior vice president at GlaxoSmithKline. "We are excited to play an integral part in helping adults protect themselves against this serious infection."

FLUARIX is available for purchase on GSKVaccinesDirect.com. FLULAVAL is available for purchase on GSKVaccinesDirect.com or through three distributors -- Henry Schein, Inc., McKesson Medical-Surgical and ASD Specialty Healthcare.

FLUARIX and FLULAVAL are indicated for active immunization of adults (18 years of age and older) against influenza disease caused by influenza virus subtypes A and type B contained in the vaccines. These indications are based on immune response, and there have been no controlled trials demonstrating a decrease in influenza disease after vaccination with these products. FLUARIX and FLULAVAL are not indicated for use in children.

FLUARIX and FLULAVAL should not be administered to anyone with known systemic hypersensitivity reactions to eggs, egg products, egg or chicken proteins, or any component of the vaccines. FLUARIX and FLULAVAL should not be administered to anyone who has had a life-threatening reaction to previous administration of any influenza vaccine. Immunization should be delayed in anyone with an acute evolving neurologic disorder, but should be considered when the disease process has been stabilized.

In a clinical trial with FLUARIX, adverse events included pain and redness at the injection site, muscle aches and fatigue. In clinical trials with FLULAVAL, the most common adverse events were pain, redness, and/or swelling at the injection site and headache, fatigue, myalgia, fever and malaise. Most adverse events in clinical trials were mild and self-limited. (See adverse reactions section of the Prescribing Information for each product for other potential adverse events.)

Vaccination with FLUARIX or FLULAVAL may not protect 100 percent of susceptible individuals. If Guillain-Barre syndrome has occurred within six weeks of receipt of prior influenza vaccine, the decision to give FLUARIX or FLULAVAL should be based on careful consideration of the potential benefits and risks.

Source: GlaxoSmithKline