GSK submits Biologics License Application for influenza vaccine

Fluarix Quadrivalent was approved in 2012 in the United States to prevent influenza.
Fluarix Quadrivalent was approved in 2012 in the United States to prevent influenza. | File photo

GSK has submitted a supplemental Biologics License Application (sBLA) for Fluarix Quadrivalent (influenza vaccine) to the U.S. Food and Drug Administration.

While the vaccine is approved for influenza A subtype viruses and type B viruses, it must be used on people 3 years of age or older. The new application seeks to expand the indication to include children ages 6 months to 35 months of age. If approved, health care providers can use the same dose for all eligible people 6 months old or older.

Fluarix Quadrivalent was approved in 2012 in the United States to prevent influenza, and is also approved in 30 additional countries across the globe. It should not be administered to anyone with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine.

GSK is a leading research-focused pharmaceutical and health care company. It is dedicated to improving the quality of life for humans around the world.

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