Available at: Izikson R. et al. Sanofi Pasteur Inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes following vaccination with Fluzone Quadrivalent during pregnancy. Participants were monitored for unsolicited adverse events and SAEs during the 28 days following vaccination. Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. We aim to ensure these vaccines, supported by a high level of evidence, are available to protect as many people as possible each flu season., Sandrine Samson, PhD The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Products: Comirnaty (COVID-19 vaccine) Sanofi U.S. 55 Corporate Drive Bridgewater, NJ 08807 Vaccines and biologics Need help with SupplyManager? The preservative thimerosal is only in the multi-dose vial of Fluzone Quadrivalent. Requires Refrigeration. For information on flu vaccine distribution schedules, please contact the manufacturers directly. For infants, Fluzone Quadrivalent is a shot given into the muscle of the thigh. In Study 1 (NCT01240746) [see Adverse Reactions (6.1)], 1419 children 6 months through 35 months of age and 2101 children 3 years through 8 years of age were included in the per-protocol immunogenicity analysis. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Fluzone Quadrivalent and any potential adverse effects on the breastfed child from Fluzone Quadrivalent or from the underlying maternal condition. ", About the Composition of Sanofi's 2022-2023 Licensed and Approved Influenza Vaccines, Each year, the FDA, World Health Organization (WHO), Centers for Disease Control and Prevention, and other partners collaborate by collecting and reviewing data on the circulating strains of influenza from around the world to identify those likely to cause the most illness in the upcoming flu season.9 Once strains are selected, flu vaccine manufacturers include the newly selected flu strains in their FDA-approved vaccines, and then submit applications to the FDA to include the new flu strains in their FDA-approved vaccines, including for Fluzone High-Dose Quadrivalent, Flublok Quadrivalent and Fluzone Quadrivalent.9 Today those requests for licensure were approved for the upcoming 2022-2023 flu season.5, About Fluzone Quadrivalent (Influenza Vaccine), Flublok Quadrivalent (Influenza Vaccine) and Fluzone High-Dose Quadrivalent (Influenza Vaccine). E, 10 Single-Dose ever had a severe allergic reaction after getting any flu vaccine. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. A randomized, double-blind, placebo-controlled study was conducted at a single US center during the 1999-2000 (Year 1) and 2000-2001 (Year 2) influenza seasons. Cases of influenza were identified through active and passive surveillance and confirmed by cell culture and/or real-time polymerase chain reaction (PCR). This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. Vaccine 2021; 39: A24-A35. ACIP General Best Practice Guidelines for Immunization. Single-dose vial, 0.5 mL (NDC 49281-422-58) (not made with natural rubber latex). The most commonly reported unsolicited non-serious adverse events were cough, vomiting, and pyrexia. Pregnant women are at increased risk of complications associated with influenza infection compared to non-pregnant women. They help us to know which pages are the most and least popular and see how visitors move around the site. Fluzone Quadrivalent is given to people 6 months of age and older. With protection against four flu strains, Fluzone High-Dose is the only influenza vaccine licensed for use in adults 65 years of age and older to have demonstrated superior efficacy in a randomized controlled trial versus a standard dose influenza vaccine for the prevention of laboratory-confirmed influenza illness and the only influenza . If you have questions or would like more information, please talk with your healthcare provider. There were no adverse effects on pre-weaning development or vaccine-related fetal malformations noted in this study. MacIntyre CR, et al. N Engl J Med. Fluzone Quadrivalent: Package Insert - Drugs.com Fluzone Quadrivalent stimulates the immune system to protect against influenza, but does not prevent other respiratory infections. Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. Throughout the study period, a total of 41 (1.4%) recipients in the Fluzone Quadrivalent group, 7 (1.0%) recipients in the TIV-1 group, and 14 (1.9%) recipients in the TIV-2 group, experienced at least one SAE. In adults 18 years and older, the most common (10%) injection-site reaction was pain (47%); the most common solicited systemic adverse reactions were myalgia (24%), headache (16%), and malaise (11%). The preferred site for infants and young children is the anterolateral aspect of the thigh. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of Fluzone Quadrivalent. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk. Available at: https://www.cdc.gov/flu/highrisk/65over.htm. Call your healthcare provider for advice about any side effects that concern you. Sanofi flu vaccines licensed and approved for 2022-2023 influenza season, including CDC preferred higher-dose vaccines for adults 65+ * Fluzone High-Dose Quadrivalent (Influenza. 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. Thank you for taking the time to confirm your preferences. Vaccination with Fluzone Quadrivalent may not protect all recipients. In Study 3 (NCT00988143, see http://clinicaltrials.gov), a multi-centered randomized, open-label trial conducted in the US, adults 18 years of age and older received one dose of either Fluzone Quadrivalent or one of two formulations of comparator trivalent influenza vaccine (TIV-1 or TIV-2).

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