GlaxoSmithKline shipping U.S. flu vaccine with new strain coverage recommended for 2012-2013

PHILADELPHIA, July 31, 2012 /PRNewswire/ -- GlaxoSmithKline [NYSE: GSK] announced today it has begun shipping the first lots of 2012-2013 FluLaval® (Influenza virus vaccine) and Fluarix® (Influenza Virus Vaccine) to CDC distribution centers and U.S. healthcare providers. This follows approval of this season's GSK seasonal influenza vaccines by the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research.

FLULAVAL is approved for use in adults (18 years of age and older) to help protect against influenza disease caused by the virus subtypes A and B contained in the vaccine. FLUARIX is approved for use in adults and also children (3 years of age and older).

"The three strains of influenza virus in the seasonal influenza vaccine can change from year-to-year based on estimates of the strains that will circulate in the upcoming season," said Dr. Leonard Friedland, VP and Head, Clinical/Medical Affairs, GSK North America Vaccine Development. "This is a key reason why the CDC recommends everyone six months of age and older gets an influenza vaccination every year. For the 2012-2013 influenza season, two of the three strains have been changed compared to last year's formulation."

Beginning with today's initial shipments, GSK flu vaccine will be available to most healthcare providers in time to address back-to-school immunization needs of parents and children. Subsequently, the company anticipates being able to supply its seasonal flu vaccines to the US marketplace well into 2013.

More information about seasonal influenza and flu vaccination can be found at http://flu.gov and http://www.cdc.gov/flu/about/season/flu-season-2012-2013.htm.

Indication for FLUARIX

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

Important Safety Information for FLUARIX

• Do not administer FLUARIX to anyone with known severe allergic reactions to egg proteins (a vaccine component) or a life-threatening reaction to previous administration of any influenza vaccine
• If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUARIX 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 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, the most common adverse events in adults included injection site pain and redness, muscle aches, fatigue, and headache. In children 5 years to <18 years of age, the most common adverse events were similar to those in adults but also included injection site swelling. In children 3 years to <5 years of age, the most common adverse events included pain, redness, and swelling at the injection site, irritability, drowsiness, and loss of appetite. (See Adverse Reactions section of the Prescribing Information for FLUARIX for other potential adverse events).
• Vaccination with FLUARIX may not result in protection in all vaccine recipients.

Complete Prescribing Information for FLUARIX.

Indication for FLUAVAL

FLULAVAL is a vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLULAVAL is approved for use in persons 18 years of age and older.

This indication is based on immune response elicited by FLULAVAL, and there have been no controlled trials adequately demonstrating a decrease in influenza disease after vaccination with FLULAVAL.

Important Safety Information For FLULAVAL

• Do not administer FLULAVAL to anyone with known severe allergic reactions (eg, anaphylaxis) to any component of the vaccine including egg protein or to a previous dose of any influenza vaccination
• If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLULAVAL should be based on careful consideration of the potential benefits and risks
• If FLULAVAL 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 comparator-controlled clinical trials with FLULAVAL, adverse events included pain, redness, and swelling at the injection site; headache; fatigue; and myalgia. (See Adverse Reactions section of the Prescribing Information for FLULAVAL for other potential adverse events)
• Vaccination with FLULAVAL may not result in protection in all vaccine recipients.

Complete Prescribing Information for FLULAVAL.

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/GSKUS or 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.

SOURCE GlaxoSmithKline