GSK begins shipping 2015-16 US flu vaccines with focus on customer needs, volume, and speed

PHILADELPHIA, July 16, 2015 /PRNewswire/ -- GSK (LSE/NYSE: GSK) announced today it has begun shipping FLUARIX^® QUADRIVALENT (Influenza Vaccine) doses to US healthcare providers, following licensing and lot-release approval from the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research.

"To help our customers meet the flu immunization needs of their patients, GSK has shifted our flu vaccine supply to four-strain (quadrivalent) flu vaccine," said Patrick Desbiens, Senior Vice President, US Vaccines. "This decision gives patients the opportunity for broader protection since it covers a fourth flu virus strain compared to trivalent vaccines that only cover three strains. With flu a priority focus of our portfolio, we have made a significant investment in customer service upgrades, designed to accelerate delivery timelines to customers."

GSK also has received 2015-16 US license approval for its other quadrivalent flu vaccine FLULAVAL^® QUADRIVALENT (Influenza Vaccine). Pending additional FDA lot releases, GSK expects to begin shipping FLULAVAL^® QUADRIVALENT in August. This means that two different presentations of the four-strain vaccines will be available to customers. FLUARIX^® QUADRIVALENT comes in a 0.5-mL, single-dose, prefilled syringe while FLULAVAL^® QUADRIVALENT comes in a 5-mL, multidose vial containing 10 doses (0.5mL each).

GSK expects to supply an estimated 32-38 million doses across both vaccines for the US market for the 2015-16 season. The company shipped approximately 27 million doses for the 2014-15 season --19 million quadrivalent and eight million trivalent. This year's anticipated volume of quadrivalent doses is nearly double the amount shipped last year. GSK made the decision to switch to 100% quadrivalent following customer demand from the 2014-15 flu season and early pre-booking for the 2015-16 season.

Quadrivalent vaccines are designed to help protect against two different types of "A" flu strains and two types of "B" flu strains. Influenza A and Influenza B are the viruses that spread between people and can cause mild to severe illness, leading to seasonal flu. Most flu activity in the US occurs from October-May, and it usually peaks in the US between December-February. According to the US Centers for Disease Control and Prevention (CDC), each year approximately 5-20% of people in the US get the flu and more than 200,000 people are hospitalized for flu-related complications.

For this year's flu season, the World Health Organization (WHO) and FDA's Vaccines and Related Blood Products Advisory Committee recommended that quadrivalent vaccines include an A/California/7/2009 (H1N1)pdm09-like virus, an A/Switzerland/9715293/2013 (H3N2)-like virus, a B/Phuket/3073/2013-like (B/Yamagata lineage) virus, and a B/Brisbane/60/2008-like (B/Victoria lineage) virus (2). This represents a change in the influenza A (H3) and influenza B (Yamagata lineage) components compared with the composition of the 2014-15 influenza vaccines.

The CDC has a routine recommendation for Americans over the age of six months to 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.

The CDC does not make preferential recommendations about which flu vaccine an individual should receive. Individuals should speak with their healthcare professional about flu vaccines and which one may be most appropriate for them.

For more information about the flu, visit ChooseMoreChooseFour.com.

About GSK flu vaccine manufacturing

FLUARIX^® QUADRIVALENT is manufactured in Dresden, Germany. FLULAVAL^® QUADRIVALENT is manufactured in Ste-Foy, Quebec, Canada.

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 FluLaval Quadrivalent and Fluarix Quadrivalent.

Professional Indication(s) for FluLaval^® Quadrivalent (Influenza Vaccine) and Fluarix^® Quadrivalent (Influenza Vaccine)

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.

Combined Important Safety Information for FluLaval^® Quadrivalent (Influenza Vaccine) and Fluarix^® Quadrivalent (Influenza Vaccine)

• 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-Barre 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

GSK -- 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 please visit www.gsk.com.

Cautionary statement regarding forward-looking statements
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. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2014.

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