Influenza Virus Vaccine Fluzone

DESCRIPTION Fluzone, Influenza Virus Vaccine, (Zonal Purified, Subvirion) for intramuscular use, is a sterile suspension prepared from influenza viruses propagated in chicken embryos. 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 Polyethylene Glycol p-Isooctylphenyl Ether (Triton X-100 – A registered trademark of Rohm and Haas, Co.) producing a “split-antigen.” The split-antigen is then further purified by chemical means and suspended in sodium phosphate-buffered isotonic sodium chloride solution. Fluzone has been standardized according to USPHS requirements for the 2002-2003 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/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2) (an A/Moscow/10/99-like strain) and B/Hong Kong/1434/2002 (a B/Hong Kong/330/2001-like strain). Gelatin 0.05% is added as a stabilizer. Fluzone is supplied in two unit dose preservative-free presentations distinguished by a pink syringe plunger rod: a 0.25 mL prefilled syringe (for pediatric use) and a 0.5 mL prefilled syringe; both are formulated without preservatives but contain a trace amount of thimerosal [(contains 49.6% mercury), (≤ 0.5 μg Hg/0.25 mL dose) (≤ 1.0 μg Hg/0.5 mL dose)] from the manufacturing process. Fluzone is also supplied in two other presentations: a 0.5 mL prefilled syringe and 5 mL vial of vaccine, of which both contain the preservative thimerosal [(mercury containing compound), 25 μg mercury/0.5 mL dose]. Fluzone, after shaking syringe/vial well, is essentially clear and slightly opalescent in color.