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GlaxoSmithKline (GSK) Begins Shipping 2014-15 U.S. Flu Vaccines


7/16/2014 8:37:19 AM

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Expected 28 - 33 million doses of four-strain and three-strain flu shots will help meet U.S. public health needs

GSK [LSE/NYSE: GSK] announced today it has begun shipping FLUARIX® QUADRIVALENT (Influenza Vaccine) doses to U.S. healthcare providers. This is the first shipment of GSK’s U.S. flu vaccine supply for the flu season, following licensing and lot-release approval from the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER).

GSK also has received 2014-15 U.S. license approvals for its other flu vaccines formulations -FLUARIX® (Influenza Vaccine), FLULAVAL® (Influenza Vaccine) and FLULAVAL®QUADRIVALENT (Influenza Vaccine). Pending additional FDA lot releases, GSK expects to begin shipping FluLaval Quadrivalent and FluLaval [trivalent] in early August. GSK anticipates supplying a combined total of approximately 28-33 million doses, across all four vaccines, to the U.S. for the upcoming 2014-15 flu season.

“Consumers today have more options than ever to help protect themselves against the flu,” said Deborah Waterhouse, Senior Vice President and Business Unit Head, U.S. Vaccines, GSK. “Since introducing our own four-strain vaccines last year, we’ve seen a strong uptake. It’s important for consumers to discuss these options with their physicians and get early seasonal protection as the nature and severity of flu seasons can be unpredictable.”

Four-strain flu shots (quadrivalent) are designed to protect against two different types of “A” flu strains and two types of “B” flu strains, while trivalent flu shots are designed to protect against three-strains: two different types of “A” flu strains and one “B” flu strain. Each year, the World Health Organization recommends which strains will be most likely to circulate in a given season, in consultation with health partners. For more information on strains and vaccine composition for the 2014-15 flu season, visit the U.S. Centers for Disease Control and Prevention (CDC) 2014-15 Flu Season page.

The CDC recommends most Americans over the age of six months get a flu vaccination each year as the first and most important step in protecting against this disease. GSK’s flu vaccines are indicated for use in persons three years and older. For many vaccine recipients, more than one type of vaccine may be appropriate. The CDC does not recommend four-strain flu shots over three-strain flu shots. Consumers should speak to their physician about which flu shots may be most appropriate.

About seasonal flu

Seasonal flu is a contagious respiratory illness, caused by flu viruses. There are two main types of flu viruses, A and B that spread between people and can cause mild to severe illness. Most flu activity in the U.S. occurs from October-May, and it usually peaks in January and February. According to the CDC, each year approximately 5-20% of U.S. residents get the flu and more than 200,000 people are hospitalized for flu-related complications. For more information about the flu, visit www.flu.gov and www.cdc.gov/flu.

About GSK flu vaccine manufacturing

Fluarix® and Fluarix® Quadrivalent are manufactured in Dresden, Germany. FluLaval® and FluLaval® Quadrivalent are manufactured in Ste-Foy, Quebec, Canada. The supply for the U.S. market represents approximately half of all GSK flu vaccines distributed worldwide.

The following Important Safety Information is based on the Highlights section of the Prescribing Information for FluLaval® Quadrivalent (Influenza Vaccine) and Fluarix® Quadrivalent (Influenza Vaccine). Please consult the full Prescribing Information for all the labeled safety information for t FluLaval Quadrivalen and Fluarix Quadrivalent .

Professional indication(s) and ISI indication for FluLaval Quadrivalent

FluLaval 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. FluLaval Quadrivalent is approved for use in persons 3 years of age and older.

Indication 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.

Important safety information for FluLaval Quadrivalent and Fluarix Quadrivalent

• Do not administer FluLaval Quadrivalent or 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-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FluLaval Quadrivalent or Fluarix Quadrivalent should be based on careful consideration of the potential benefits and risks
• 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
• If FluLaval Quadrivalent or Fluarix Quadrivalent is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons
• In clinical trials with FluLaval Quadrivalent, the most common solicited local adverse reaction in adults was pain. The most common solicited systemic adverse reactions in adults were muscle aches, headache, fatigue, and arthralgia. In children 3 through 17 years of age, the most common solicited local adverse reaction was pain. In children 3 through 4 years of age, the most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite. In children 5 through 17 years of age, the most common solicited systemic adverse reactions were muscle aches, fatigue, headache, arthralgia, and gastrointestinal symptoms. (See Adverse Reactions section of the Prescribing Information for FluLaval Quadrivalent for other potential adverse reactions and events)
• In clinical trials with Fluarix Quadrivalent, the most common injection site adverse reaction in adults was pain. The most common systemic adverse reactions in adults were muscle aches, headache, and fatigue. In children 3 through 17 years of age, injection site adverse reactions were pain, redness, and swelling. In children 3 through 5 years of age, the most common systemic adverse reactions were drowsiness, irritability, and loss of appetite. In children 6 through 17 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 FluLaval Quadrivalent or Fluarix Quadrivalent may not result in protection in all vaccine recipients

The following Important Safety Information is based on the Highlights section of the Prescribing Information for FluLaval® (Influenza Vaccine) and Fluarix® (Influenza Vaccine). Please consult the full Prescribing Information for all the labeled safety information for FluLaval and Fluarix .

Professional Indication(s) and ISI

Indication for FluLaval

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

Indication for Fluarix

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

Important Safety Information FluLaval and Fluarix

• Do not administer FluLaval or Fluarix 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-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FluLaval or Fluarix should be based on careful consideration of the potential benefits and risks
• 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
• If FluLaval or Fluarix is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons
• In clinical trials with FluLavl, the most common solicited local adverse reactions in adults included pain, redness, and/or swelling. The most common solicited systemic adverse reactions in adults were fatigue, headache, and muscle aches/arthralgia. The most common solicited local adverse reaction in children 3 through 17 years of age was pain. In children 3 through 4 years of age, the most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite. In children 5 through 17 years of age, the most common solicited systemic adverse reactions were muscle aches, headache, and fatigue. (See Adverse Reactions section of the Prescribing Information for FluLaval for other potential adverse reactions and events).
• In clinical trials with Fluarix, the most common local and general adverse reactions in adults included pain and redness at the injection site, muscle aches, fatigue, and headache. In children 5 through 17 years of age, the most common local and general adverse reactions were similar to those in adults but also included swelling at the injection site. In children 3 through 4 years of age, the most common local and general adverse reactions included pain, redness, and swelling at the injection site, irritability, loss of appetite, and drowsiness,. (See Adverse Reactions section of the Prescribing Information for Fluarix for other potential adverse reactions and events).
• Vaccination with FluLaval or Fluarix may not result in protection in all vaccine recipients

About GSK – GSK is 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/).

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