IIS Data Code Sets | CDC The information provided in this resource is for informational purposes only. Products: Comirnaty (COVID-19 vaccine) Sanofi U.S. 55 Corporate Drive Bridgewater, NJ 08807 Vaccines and biologics A developmental and reproductive toxicity study was performed in female rabbits given a 0.5 mL/dose of Fluzone Quadrivalent prior to mating and during gestation (a single human dose is 0.5 mL). Afluria is approved by the Food and Drug Administration for intramuscular administration with the PharmaJet Stratis Needle-Free Injection System for persons age 18 through 64 years. Each of the trivalent formulations contained an influenza type B virus that corresponded to one of the two type B viruses in Fluzone Quadrivalent (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). (See ref. Requires Refrigeration. Vaccine update: issue 337, April 2023 - GOV.UK Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trial(s) of a vaccine cannot be directly compared to rates in the clinical trial(s) of another vaccine and may not reflect the rates observed in practice. Study 4 included 602 subjects 50 through 64 years of age for safety analysis, randomized to receive Flublok (n=300) or another U.S.-licensed trivalent influenza vaccine (Fluzone, manufactured by Sanofi Pasteur, Inc.) as an active control (n=302). The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Vaccine. The HI antibody GMT following Fluzone Quadrivalent was higher than that following TIV-1 for B/Florida but not higher than that following TIV-2 for B/Brisbane, based on pre-specified criteria (the lower limit of the 2-sided 95% CI of the ratio of the GMTs [Fluzone Quadrivalent divided by TIV] >1.5 for each B strain in Fluzone Quadrivalent compared with the corresponding B strain not contained in each TIV). The preferred site for infants and young children is the anterolateral aspect of the thigh. Syncope (fainting) has been reported following vaccination with Fluzone Quadrivalent. The new facility building at Swiftwater has had an investment of $150m. Adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Fluzone (trivalent) or Fluzone Quadrivalent. Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent are vaccines indicated for immunization against disease caused by influenza A and B strains contained in the vaccine. Multi-dose vial, 5 mL (NDC 49281-637-78) (not made with natural rubber latex). You can review and change the way we collect information below. Vaccine efficacy of Fluzone against all influenza viral types and subtypes is presented in Table 9. The single-dose, pre-filled syringe (0.5 mL) and the single-dose vial (0.5 mL) are manufactured and formulated without thimerosal or any other preservative. A maximum of ten doses can be withdrawn from the multi-dose vial. It is not known whether Fluzone Quadrivalent is excreted in human milk. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. 3) Multi-dose vial, 5 mL, for persons 6 months of age and older. If a prefilled syringe of Fluzone Quadrivalent is used for a child in this age group, the dose volume will be 0.5mL per dose. Vaccine Product Information - Order Vaccines and Contact Manufacturers About 16,000. employees globally, 65% of them dedicated to manufacturing and quality operations. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. COVID-19 Vaccine Lot Number and Expiration Date Tool. Prefilled Syringes Single-dose vial, 0.5 mL (NDC 49281-422-58) (not made with natural rubber latex). Sanofi Pharma; Sanofi Genzyme; Sanofi Pasteur; Our data sharing commitments; Managed Access Programs (MAPs) . Fluzone Quadrivalent: Package Insert - Drugs.com Tuberculin Purified Protein Derivative (Mantoux) - Food and Drug ** Fluzone Quadrivalent is currently licensed for ages 6 through 35 months at either 0.25 mL or 0.5 mL per dose; however, .25-mL prefilled syringes are not expected to be available for the 2020-21 influenza season. IM-administered influenza vaccines should be given by needle and syringe only, with the exception of the MDV presentation of Afluria Quadrivalent, which may alternatively be given by the PharmaJet Stratis jet injector for persons aged 18 through 64 years only. Accounts Receivable 800.453.5180 For intramuscular injection only, Afluria, Afluria Quadrivalent, Flucelvax Quadrivalent, Fluad, +7 more, Tamiflu, oseltamivir, Fluzone, Xofluza, Afluria, influenza virus vaccine, inactivated. Influenza - Sanofi

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