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.
- 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.
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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