FDA Approves GlaxoSmithKline's four-strain seasonal influenza vaccine for use in the U.S.

LONDON, Dec. 17, 2012 /PRNewswire/ -- GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved FLUARIX® QUADRIVALENT (Influenza Virus Vaccine) for the immunisation of children (three years and older) and adults to help prevent disease caused by seasonal influenza (flu) virus subtypes A and type B contained in the vaccine. Fluarix Quadrivalent  is the first intramuscular vaccine to cover against four influenza strains.

Scientists classify the influenza strains that cause seasonal flu as A or B strains. Currently administered trivalent (three-strain) flu vaccines help protect against the two A virus strains most common in humans and the B strain expected to be predominant in a given year. But since the year 2000, two B virus strains (Victoria and Yamagata) have co-circulated to varying degrees each season. Various degrees of mismatch have occurred between the B strain included in trivalent vaccines and the B strain that actually circulated, causing an increased risk of influenza-related morbidity across all age groups – children, adults and the elderly. Fluarix Quadrivalent helps protect against the two A strains and adds coverage against a second B strain.   

"Trivalent influenza vaccines have helped protect millions of people against flu, but in six of the last 11 flu seasons, the predominant circulating influenza B strain was not the strain that public health authorities selected," said Dr. Leonard Friedland, V.P. and Head, GSK North America Vaccines Clinical Development and Medical Affairs. "Fluarix Quadrivalent will help protect individuals against both B strains and from a public-health standpoint, can help decrease the burden of disease."

GSK will make Fluarix Quadrivalent available in time for the 2013-14 flu season and and also plans to fulfill orders for its trivalent vaccines. Healthcare providers traditionally order flu vaccines about a year in advance of each flu season.

Fluarix Quadrivalent is not currently approved or licensed in any country outside of the U.S. The full U.S. Prescribing Information will be available on http://www.gsk.com/products/index.htm.

About Seasonal Influenza

Seasonal influenza may cause three to five million cases of severe illness and up to 500,000 deaths per year worldwide. Vaccination against influenza is considered one of the most effective ways of preventing mortality, complications, and hospitalisations. The  U.S. Centers for Disease Control and Prevention (CDC)  recommends that children six months of age and older and adults receive a flu shot annually.  More information about seasonal influenza can be found at http://flu.gov and http://www.cdc.gov/flu/about/season/flu-season-2012-2013.htm.

Important Safety Information for Fluarix Quadrivalent  

Fluarix Quadrivalent is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluarix Quadrivalent is approved for use in persons 3 years of age and older.

• Do not administer Fluarix Quadrivalent to anyone with known severe allergic reactions (anaphylaxis) to any component of the vaccine, including egg protein, or a life-threatening reaction to previous administration of any influenza vaccine.
• If Guillain-Barre syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give Fluarix Quadrivalent should be based on careful consideration of the potential benefits and risks.
• The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.
• If Fluarix Quadrivalent is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons.
• Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.
• In clinical trials with Fluarix Quadrivalent, the most common adverse reactions in adults were pain at the injection site, muscle aches, headaches and fatigue.  In children 3 years to less than 18 years of age, the most common adverse reactions were pain at the injection site, redness and swelling.  In children 3 years to less than 6 years of age, the most common adverse reactions were drowsiness, irritability, and loss of appetite.  In children 6 to less than 18 years of age, the most common systemic adverse reactions were fatigue, muscle aches, headache, arthralgia and gastrointestinal symptoms.  (See Adverse Reactions section of the Prescribing Information for Fluarix Quadrivalent for other potential adverse reactions and events).
• Vaccination with Fluarix Quadrivalent may not result in protection in all vaccine recipients.

About GlaxoSmithKline Vaccines

GlaxoSmithKline Vaccines, a division of GlaxoSmithKline group, is the world's leading vaccine company and a leader in innovation. The company is active in vaccine research, development and production with over 30 vaccines approved and 20 more in development - both in the prophylactic and therapeutic fields. Headquartered in Belgium, GSK Vaccines has 14 manufacturing sites strategically positioned around the globe. In 2011, GSK Vaccines distributed 1.1 billion doses to 173 countries in both the developed and the developing world.  Through its accomplished and dedicated workforce, GSK Vaccines applies its expertise to the discovery of innovative vaccines that contribute to the health and well-being of people of all generations around the world.

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 further information, go to us.gsk.com, follow us on twitter.com/GSKUSor visit our U.S. company blog.  

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 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.

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SOURCE GlaxoSmithKline