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FDA Expands Indication for Influenza Vaccine

GSK news release; 2018 Jan 11

The FDA has approved an expanded indication for Fluarix Quadrivalent (influenza vaccine) for persons aged 6 months and older.

Indications: Fluarix Quadrivalent is a vaccine for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

Dosage and administration: Providers should use the same dose of Fluarix Quadrivalent (15 ug of hemagglutinin per virus strain in 0.5 mL) to cover all eligible persons aged 6 months and older.

Adverse reactions:

  • In children aged 6 through 35 months, the most common solicited adverse reactions were pain and redness; the most common systemic adverse reactions were irritability, loss of appetite, and drowsiness.
  • In children aged 3 through 17 years, solicited local adverse reactions were pain, redness, and swelling.
  • In children aged 3 through 5 years, the most common systemic adverse reactions were drowsiness, irritability, and loss of appetite.
  • In children aged 6 through 17 years, the most common systemic adverse reactions were fatigue, muscle aches, headache, arthralgia, and gastrointestinal symptoms.

Citation:

GSK receives FDA approval for expanded indication for FLUARIX QUADRIVALENT (influenza vaccine) for persons 6 months and older. [news release]. January 11, 2018. GSK; Philadelphia, PA. http://us.gsk.com/en-us/media/press-releases/2017/gsk-receives-fda-appro.... Accessed January 16, 2018.

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