FluQuadri Description

FluQuadri (Quadrivalent Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton X-100), producing a "split virus". The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The FluQuadri process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation.
FluQuadri suspension for injection is clear and slightly opalescent in color.
Neither antibiotics nor preservative are used in the manufacture of FluQuadri.
The FluQuadri prefilled syringe presentations are not made with natural rubber latex.
FluQuadri is standardized according to United States Public Health Service requirements and is formulated to contain 60 micrograms (mcg) HA per 0.5 mL dose in the recommended ratio of 15 mcg HA of each of the following four influenza strains recommended for the 2020 Southern Hemisphere influenza season: A/Brisbane/02/2018 IVR-190 (H1N1), A/South Australia/34/2019 IVR-197 (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Washington/02/2019 (B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 1. (See Table 1.)

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