Fluzone®, Influenza Virus Vaccine, (Zonal Purified, Subvirion) for intramuscular use, is a sterile suspension prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing fluids are 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 nonionic surfactant, octoxinol-9, (Triton® X-100 - A registered trademark of Union Carbide, Co.) producing a “split virus.” The split virus is then further purified by chemical means and suspended in sodium phosphate-buffered isotonic sodium chloride solution. Fluzone vaccine has been standardized according to USPHS requirements for the 2007-2008 influenza season and is formulated to contain 45 micrograms (µg) hemagglutinin (HA) per 0.5 mL dose, in the recommended ratio of 15 µg HA each, representative of the following three prototype strains: A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004.¹ Gelatin 0.05% is added as a stabilizer. Fluzone vaccine is supplied in four different presentations: a 5 mL vial of vaccine which contains the preservative thimerosal [(mercury derivative), (25 µg mercury/dose)]; a 0.25 mL prefilled syringe (No Preservative: Pediatric Dose, for 6 - 35 months of age) distinguished by a pink syringe plunger rod; a 0.5 mL prefilled syringe (No Preservative, for 36 months of age and older); and a single dose vial (No Preservative, for 36 months of age and older). There is no thimerosal used in the manufacturing process of the No Preservative unit dose presentations of Fluzone vaccine. Fluzone vaccine, after shaking syringe/vial well, is essentially clear and slightly opalescent in color.

ANTIBIOTICS ARE NOT USED IN THE MANUFACTURE OF FLUZONE VACCINE.

ALL PRESENTATIONS OF FLUZONE VACCINE ARE LATEX-FREE.

REFERENCES

1. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2004;53: 1-40.

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