Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere
Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs
Advisory Board:
This BLA was not discussed at a VRBPAC meeting because review of this submission did not identify concerns or issues for which the Agency would have benefited from an advisory committee discussion
Indications: Fluzone High-Dose Quadrivalent, Fluzone Quadrivalent, Fluzone Quadrivalent Southern Hemisphere-For active immunization for the prevention of influenza disease caused by influenza virus subtypes A & type B viruses contained in the vaccine. Fluzone Intradermal Quadrivalent: For active immunization of persons 18 through 64 years of age for the prevention of influenza disease caused by influenza A subtype viruses & type B viruses contained in the vaccine.
Key Regulatory Milestones:
06/07/2013 – Fluzone-QIV formulation was first approved under STN 103914/5574 for use in persons 6 months of age and older.
01/28/2019 – PDUFA Goal Date
07/02/2019 – FDA approval date