Flublok Quadrivalent

Proper Name: Influenza Vaccine (Quadrivalent)

Flublok Quadrivalent [Quadrivalent Influenza Vaccine] is a sterile, clear, colorless solution of recombinant hemagglutinin (HA) proteins from four influenza viruses for intramuscular injection. It contains purified HA proteins produced in a continuous insect cell line (expresSF+®) that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda (which is related to moths, caterpillars and butterflies), and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts.

Advisory Board:

A VRBPAC meeting was held on November 19, 2009, for the original Flublok licensing application (STN 125285/0) and there were no issues associated with this supplement that required a new Advisory Committee meeting

Indications: For active immunization against disease caused by influenza A subtype viruses and influenza type B viruses contained in the vaccine.

Key Regulatory Milestones:

01/16/2013 – Flublok (trivalent formulation) was licensed in the United States (STN 125285/0)

10/29/2014 – Accelerated approval was granted (STN 125285/78) to extend the use of Flublok

10/07/2016 – PDUFA Goal Date

07/02/2020 – FDA approval date

Package Insert