Influenza Virus Vaccine (Trivalent, Types A and B)
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.
Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs
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
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