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FDA Approves Expanded Indication for FluLaval

GSK news release; 2016 Nov 18

The FDA has granted approval for the expanded indication of FluLaval quadrivalent (influenza vaccine) (GSK) for infants 6 months and older. Prior, the vaccine was only approved for active immunization against influenza A subtype viruses and type B viruses in persons aged 3 years and older.

Indication: 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. It is approved for use in persons aged 6 months and older.

Dosage and administration:

  • In children aged 6 months through 8 years not previously vaccinated with influenza vaccine, administer 2 doses (0.5 mL each) at least 4 weeks apart.
  • In children aged 6 months through 8 years vaccinated with influenza vaccine in a previous season, administer 1 or 2 does (0.5 mL each).
  • In persons aged 9 years and older, administer 1 dose (0.5 mL).

Adverse reactions:

  • In adults, the most common (≥10%) solicited local adverse reaction was pain (60%); most common solicited systemic adverse events were muscle aches (26%), headache (22%), fatigue (22%), and arthralgia (15%).
  • In children aged 6 through 35 months, the most common (≥10%) solicited local adverse reaction was pain (40%); most common solicited systemic adverse events were irritability (49%), drowsiness (37%), and loss of appetite (29%).
  • In children aged 3 through 17 years, the most common (≥10%) solicited local adverse reaction was pain (65%).
  • In children aged 3 through 4 years, the most common (≥10%) solicited systemic adverse events were irritability (26%), drowsiness (21%), and loss of appetite (17%).
  • In children aged 5 through 17 years, the most common (≥10%) solicited systemic adverse events were muscle aches (29%), fatigue (22%), headache (22%), arthralgia (13%), and gastrointestinal symptoms (10%).

Citation:

GSK receives FDA approval for expanded indication for FluLaval® quadrivalent (influenza vaccine) for infants 6 months and older. [news release]. Philadephia, PA: GSK; November 18, 2016. http://us.gsk.com/en-us/media/press-releases/2016/gsk-receives-fda-appro.... Accessed November 21, 2016.