GSK ships 2017-18 seasonal influenza vaccines for US market

According to the CDC, the flu is more dangerous than the common cold for children. Severe flu complications are most common in children under the age of 2 years. Each year, millions of children get sick with seasonal influenza and some of those illnesses result in death. The CDC estimates that flu-related hospitalizations among children under the age of 5 have ranged from 7,000 to 26,000 since 2010 and flu-related deaths reported to CDC during regular flu seasons from 37 to 171 since the 2004-2005 flu season.⁶

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/Michigan/45/2015 (H1N1) pdm09-like virus, A/Hong Kong/4801/2014 (H3N2)-like virus and B/Brisbane/60/2008-like (B/Victoria lineage) virus, with the addition of B/Phuket/3073/2013-like virus (B/Yamagata lineage) for the quadrivalent vaccine.^7,8

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.

Prescribing 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 aged 6 months 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 aged 3 years 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-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 in adults, the most common solicited local adverse reaction was pain and the most common solicited systemic adverse reactions were muscle aches, headache, fatigue, and arthralgia. In children aged 6 through 35 months of age, the most common local adverse reaction was pain and the most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite. 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.

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 2017.
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 2017. 
³ The US Centers for Disease Control and Prevention (CDC): Types of Influenza Viruses. Available at: https://www.cdc.gov/flu/about/viruses/types.htm. Accessed June 13, 2017.
⁴ The US Centers for Disease Control and Prevention (CDC): The Flu Season. Available at: https://www.cdc.gov/flu/about/season/flu-season.htm. Accessed July 5, 2017.
⁵ The US Centers for Disease Control and Prevention (CDC): Estimated Influenza Illnesses, Medical Visits, Hospitalizations, and Deaths Averted by Vaccination in the United States. Available at: https://www.cdc.gov/flu/about/disease/2015-16.htm. Accessed June 2017.
⁶ The US Centers for Disease Control and Prevention (CDC): Children, the Flu, and the Flu Vaccine. Available at: http://www.cdc.gov/flu/protect/children.htm. Accessed June 13, 2017. 
⁷ World Health Organization (WHO): Recommended Composition of Influenza Virus Vaccines for use in the 2017-2018 northern hemisphere influenza season. Available at: http://www.who.int/influenza/vaccines/virus/recommendations/201703_recommendation.pdf?ua=1. Accessed June 13, 2017.
⁸ U.S. Food and Drug Administration (FDA): Influenza Virus Vaccine 2017-2018 Strain Selection. Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM547273.pdf. Accessed June 13, 2017.

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SOURCE GSK