PHILADELPHIA, Aug. 11 /PRNewswire-FirstCall/ -- GlaxoSmithKline 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’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.
About Influenza
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.
About FLUARIX and FLULAVAL
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.
Important Safety Information
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.
GlaxoSmithKline: A Leader in Flu
GlaxoSmithKline has an active research and development program targeted at both seasonal and pandemic flu and has recently invested more than $2 billion to expand capacity for manufacturing its flu vaccines FLUARIX and FLULAVAL and its antiviral flu medication Relenza(R) (zanamivir for inhalation). GlaxoSmithKline -- one of the world’s leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline at www.gsk.com.
GlaxoSmithKline: A Leader in Vaccines
GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research Triangle Park, NC, is one of the world’s leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. GSK Biologicals (GSK Bio), one of the world’s leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline’s activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world -- an average of three million doses a day. Of those vaccine doses, approximately 136 million were doses of combination pediatric vaccines which protect the world’s children from up to six diseases in one vaccine.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’s operations are described under ‘Risk Factors’ in the ‘Business Review’ in the company’s Annual Report on Form 20-F for 2007.
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