GSK ships 2016-17 seasonal influenza vaccines for US market

First-to-market with quadrivalent vaccine
Company to deliver up to 40 million doses

GSK [LSE/NYSE: GSK] announced today it has begun shipping quadrivalent 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. It is the first company to ship quadrivalent vaccine for the 2016-17 flu season.

The US Centers for Disease Control and Prevention (CDC) recommends flu vaccination as the single best measure for flu prevention. 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.1,2 GSK’s flu vaccines are indicated for use in persons three years and older.

“Our goal is to be a reliable partner in the annual flu immunization campaign by developing and manufacturing high quality quadrivalent influenza vaccines for the US population,” said Patrick Desbiens, Senior Vice President, US Vaccines. “This year we introduced new functionality to our eCommerce platform, www.GSKDirect.com, to allow those who stock and administer our vaccines to further accelerate delivery of their flu vaccines when they order directly from us. We believe this enhancement supports healthcare providers by helping to ensure that their patients have access to the vaccines they need.”

Two different options of the four-strain vaccines will be available to customers. FLULAVAL® QUADRIVALENT comes in a 5-mL, multidose vial containing 10 doses (0.5mL each), while FLUARIX® QUADRIVALENT comes in a 0.5-mL, single-dose, prefilled syringe.

GSK expects to supply up to 40 million doses across both vaccines for the US market in the 2016-17 season. One hundred percent of GSK supply is quadrivalent doses.

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 typically peaks in the US between December-February. According to the CDC, each year approximately 5 to 20 percent of people in the US get the flu and more than 200,000 people are hospitalized for flu-related complications. 3,4,5

For this year’s flu season, the World Health Organization (WHO) and FDA’s Vaccines and Related Blood Products Advisory Committee recommended including the A/California/7/2009 (H1N1)pdm09-like virus, A/Hong Kong/4801/2014 (H3N2)-like virus, and B/Brisbane/60/2008-like virus (B/Victoria lineage), with the addition of B/Phuket/3073/2013-like virus (B/Yamagata lineage), for the quadrivalent vaccine. 6,7

For more general 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 (InfluenzaVaccine) 

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 (InfluenzaVaccine)

  • 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

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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1. The US Centers for Disease Control and Prevention (CDC): “Preventing the Flu: Good Health Habits Can Help Stop Germs,” Available at: http://www.cdc.gov/flu/protect/habits.htm. Accessed June 2016.

2. The US Centers for Disease Control and Prevention (CDC): “Vaccination: Who Should Do It, Who Should Not and Who Should Take Precautions,” Available at: http://www.cdc.gov/flu/protect/whoshouldvax.htm#annual-vaccination. Accessed June 2016. 

3. The US Centers for Disease Control and Prevention (CDC): “Key Facts About Seasonal Flu Vaccine,” Available at: http://www.cdc.gov/flu/protect/keyfacts.htm. Accessed June 2016.

4. The US Centers for Disease Control and Prevention (CDC): “What You Should Know for the 2015-2016 Influenza Season,” Available at: http://www.cdc.gov/flu/about/season/flu-season-2015-2016.htm. Accessed June 2016. 

5. The US Centers for Disease Control and Prevention (CDC): “Information for Schools.” Available at: http://www.cdc.gov/flu/school/qa.htm. Accessed June 2016.

6. World Health Organization (WHO): “Recommended Composition of Influenza Virus Vaccines for use in the 2016-

2017 Northern Hemisphere Influenza Season,” Available at: http://www.who.int/influenza/vaccines/virus/recommendations/201602_recommendation.pdf?ua=1. Accessed June 2016.

7. U.S. Food and Drug Administration (FDA): “Influenza Virus Vaccines 2016-2017 Strain Selection,” Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM497026.pdf. Accessed June 2016.