GSK begins shipments of Fluarix and FluLaval to U.S. customers for 2008-2009 flu season

Aug 11 2008

GlaxoSmithKline has announced that it will begin shipment of Flulaval [Influenza Virus Vaccine] and Fluarix [Influenza Virus Vaccine] to U.S. customers for the 2008-2009 influenza season.

The U.S. Food and Drug Administration's (FDA) 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, 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.

Influenza, or the flu, is primarily passed from one person to another through the air by droplets released when an infected individual coughs or sneezes, but may also be spread by direct contact with flu virus-contaminated surfaces.

According to the U.S. Centers for Disease Control and Prevention (CDC), annual flu vaccination is the most effective method for preventing flu virus infection and its complications. The CDC recommends an annual flu vaccination for anyone who wishes to reduce their risk of contracting the flu -- especially adults over 50 years of age, women who will be pregnant during the flu season and anyone with chronic health conditions, such as heart disease, asthma, chronic obstructive pulmonary disease (COPD) and diabetes. The CDC also recommends annual vaccination for caregivers and household contacts of these high-risk groups, such as relatives and healthcare workers. In fact, approximately 83 percent of the U.S. population is included in one or more of the target groups that the CDC recommends to receive the vaccination; however, less than 40 percent of the U.S. population received a flu vaccination during 2007-2008.

The beginning, severity and length of the flu season can vary widely from year to year. According to CDC data, the peak in flu activity between the years 1976 and 2008 frequently occurs after December, most commonly in February. In general, healthcare providers should begin offering vaccination soon after the vaccine becomes available and if possible by October. The CDC recommends an extended vaccination effort, with vaccination offered at every opportunity throughout the flu season.

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.