This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.

GlaxoSmithKline begins distribution of flu vaccine to U.S. customers for 2011-2012 flu season

Issued: Friday 15 July 2011, Philadelphia, PA

GlaxoSmithKline [NYSE: GSK] announced today that the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research has released the first lots of FluLaval® [Influenza Virus Vaccine], allowing distribution in the United States to begin for the 2011-2012 flu season. GSK anticipates distribution of Fluarix® [Influenza Virus Vaccine] to follow in the next several days.

GSK expects to supply 35-37 million doses combined of FLULAVAL and FLUARIX this flu season.  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 children (3 years of age and older).

“Each year, curbing the spread of seasonal flu remains a top public health concern,” said Mike Thomas, Vice President, U.S. Vaccines, GlaxoSmithKline.  â€śGSK is committed to helping protect adults and children 3 years of age and older from this serious infectious disease.  By providing millions of doses of the vaccine to customers in advance of this year’s flu season, we are helping to ensure that people can be vaccinated as early as possible.”

Important Safety Information for FLULAVAL

  • Do not administer FLULAVAL to anyone with known severe allergic reactions (e.g. anaphylaxis) to any component of the vaccine including egg protein or to a previous dose of any influenza vaccination.
  • If FLULAVAL is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons.
  • If Guillain-BarrĂ© 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.
  • In comparator-controlled clinical trials with FLULAVAL, adverse events included pain, redness, and swelling at the injection site; headache; fatigue; and myalgia.  Most adverse events in clinical trials were mild and self-limited.  (See adverse reactions section of the Prescribing Information for FLULAVAL for other potential adverse events.)
  • Vaccination with FLULAVAL may not protect all susceptible individuals.


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 FLUARIX is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons.
  • If Guillain-BarrĂ© 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.
  • In clinical trials with FLUARIX, the most common adverse events in adults included injection site pain and redness, muscle aches, fatigue, and headache.  Most adverse events in adult clinical trials were mild and self-limited.  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, loss of appetite, and fever.  (See adverse reactions section of the Prescribing Information for FLUARIX for other potential adverse events.)
  • Vaccination with FLUARIX may not protect all susceptible individuals.


Please see complete Prescribing Information.

GlaxoSmithKline:  A Leader in Influenza Vaccine Manufacturing
GlaxoSmithKline has an active research and development program targeted at both seasonal and pandemic flu and has invested more than $2 billion to expand capacity for manufacturing its flu vaccines FLUARIX and FLULAVAL and its antiviral flu medication RELENZA® (Zanamivir).

GlaxoSmithKline:  A Leader in Vaccines
GlaxoSmithKline Biologicals (GSK Biologicals), GlaxoSmithKline’s vaccines business, is one of the world’s leading vaccine companies and a leader in innovation.   The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing around the world and 20 more in development.

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 blog (www.morethanmedicine.us.gsk.com/blog/).

 

GlaxoSmithKline 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 2010.

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GlaxoSmithKline 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 2010.

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