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Fluad Quadrivalent FDA Approval History

FDA Approved: Yes (First approved February 21, 2020)
Brand name: Fluad Quadrivalent
Generic name: influenza vaccine, adjuvanted
Dosage form: Injection
Company: Seqirus
Treatment for: Influenza Prophylaxis

Fluad Quadrivalent (influenza vaccine, adjuvanted) is an inactivated influenza virus vaccine approved for the prevention of seasonal influenza in adults 65 years and older.

  • Fluad Quadrivalent is indicated for the active immunization against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. This indication is approved under accelerated approval based on the immune response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Fluad Quadrivalent is administered as a single intramuscular injection prior to the winter influenza season.
  • Fluad Quadrivalent contains the MF59® adjuvant to help strengthen, broaden and lengthen the body's immune response against the influenza strains contained in the vaccine.
  • Fluad Quadrivalent is contraindicated in anyone who has had an allergic reaction to any component of the vaccine, including egg protein, or after a previous dose of any influenza vaccine. Fluad Quadrivalent should be used only after weighing up the risks versus the benefits when Guillain-Barré Syndrome (GBS) has occurred within six weeks of a previous influenza vaccination.
  • Common (≥ 10%) side effects in elderly subjects 65 years of age and older include injection site pain (16.3%), headache (10.8%) and fatigue (10.5%).

Development Timeline for Fluad Quadrivalent

DateArticle
Feb 24, 2020ApprovalFDA Approves Fluad Quadrivalent (influenza vaccine, adjuvanted) for Influenza Prophylaxis in Adults 65 Years and Older

Further information

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