Accessed, https://www.cdc.gov/flu/spotlights/2021-2022/specific-vaccines-seniors.htm, https://www.cdc.gov/flu/highrisk/index.htm, https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-22-23/03-influenza-grohskopf-508.pdf, https://www.cdc.gov/flu/prevent/vaccine-selection.htm, https://www.nejm.org/doi/full/10.1056/nejmoa1315727. DO NOT FREEZE. Vaccine sales in Q1 were up 15% due to strong travel and dynamic vaccine sales as they continue to recover and have now . Store all Fluzone Quadrivalent presentations refrigerated at 2 to 8C (35 to 46F). Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. 1) If GBS has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone Quadrivalent should be based on careful consideration of the potential benefits and risks. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. 2) (See ref. Influenza - Sanofi J Diabetes Sci Technol. Influenza vaccination can reduce the risk of heart attacks by up to 45% [15-45%]7, Vaccination is especially important for people most at risk1, People over 65, children under 5, pregnant women and people with chronic medical conditions, Flu and Covid-19 vaccines can be administered at the same time8per a recent Sanofi study9, With our influenza vaccines, we seek to not only prevent influenza but also protect against its severe complications like heart attack and pneumonia. Fluzone Quadrivalent contains 4 killed flu virus strains. Data for 2022 shows an average uptake across England of 61.5% . 2009;200(2):172-180. doi:10.1086/599790, Sanofi flu vaccines licensed and approved for 2022-2023 influenza season, including CDC preferred higher-dose vaccines for adults 65+, 2005-2023 sanofi-aventis U.S. LLC - All rights reserved, https://doi.org/10.1016/j.vaccine.2020.09.004, https://www.cdc.gov/flu/highrisk/65over.htm. Three SAEs were considered to be possibly related to vaccination: croup in a Fluzone Quadrivalent recipient and 2 episodes of febrile seizure, 1 each in a TIV-1 recipient and a TIV-2 recipient. In Study 4 (NCT01218646) [see Adverse Reactions (6.1)], 660 adults 65 years of age and older were included in the per-protocol immunogenicity analysis. For participants who received two doses, the doses were administered approximately 4 weeks apart. FLUZONEHigh-Dose is indicated for active immunization against influenza caused by the specific strains of influenza virus contained in the vaccine in adults 65 years of age and older. 2021 Mar;69(3):696-703. ACIP General Best Practice Guidelines for Immunization. TABLE 1. Influenza vaccines United States, 2020-21 influenza season* It's an infectious disease that does more damage than most people realize. Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. The most commonly reported unsolicited non-serious adverse events were headache, cough, and oropharyngeal pain. Vaccination with Fluzone Quadrivalent may not protect all recipients. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. (2019). If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Inform the vaccine recipient or guardian: Vaccine Information Statements must be provided to vaccine recipients or their guardians, as required by the National Childhood Vaccine Injury Act of 1986 prior to immunization. The site is secure. The most commonly reported adverse events were oropharyngeal pain, rhinorrhea, injection-site induration, and headache. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. Healthcare providers are encouraged to enroll women who receive Fluzone Quadrivalent during pregnancy in Sanofi Pasteur Inc.'s vaccination pregnancy registry by calling 1-800-822-2463. The 1976 swine influenza vaccine was associated with an elevated risk of Guillain Barr syndrome (GBS). In this study, children 6 months through 35 months of age received one or two 0.25 mL doses of either Fluzone Quadrivalent or one of two formulations of a comparator trivalent influenza vaccine (TIV-1 or TIV-2), and children 3 years through 8 years of age received one or two 0.5 mL doses of either Fluzone Quadrivalent, TIV-1, or TIV-2. Fluzone High-Dose Quadrivalent: Package Insert - Drugs.com 2) Single-dose vial, 0.5 mL, for persons 6 months of age and older. Influenza virus strains were selected based on the influenza vaccine production method; egg-based and cell- or recombinant based. Do not use after the expiration date shown on the label. Single-dose vial, 0.5 mL (NDC 49281-422-58) (not made with natural rubber latex). For adults and older children, the recommended site for intramuscular influenza vaccination is the deltoid muscle. Requires Refrigeration. Manufactured by: A maximum of ten doses can be withdrawn from the multi-dose vial. Protection from influenza virus infection has not been correlated with a specific level of hemagglutination inhibition (HI) antibody titer post-vaccination. In the follow-up period, there were two SAEs, 1 (0.5%) in the Fluzone Quadrivalent group and 1 (0.5%) in the TIV-2 group. ACIP Flu Meeting Update: Flu Vaccines Worked Better than Reported & ACIP Recommends Specific Vaccines for Seniors. (See ref. Strength. 0.5-mL Dose of Fluzone Quadrivalent in Children 6 Months through 35 Months of Age. Call your healthcare provider for advice about any side effects that concern you. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Available at: Warren-Gash C, et al. Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction to any component of the vaccine (including eggs or egg products for Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent) or after previous dose of the vaccine. L Generic name: influenza vaccine Antibodies against one influenza virus type or subtype confer limited or no protection against another. For information on flu vaccine distribution schedules, please contact the manufacturers directly. Syncope (fainting) has been reported following vaccination with Fluzone Quadrivalent. Product Dating. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. NDC Number. Participants were monitored for unsolicited adverse events and SAEs during the 28 days following vaccination. Influenza Vaccine for the 2021-2022 Season | FDA Product: Influenza (FluMist Quadrivalent) Bavarian Nordic A/S Hejreskovvej 10A DK-3490 Kvistgaard Phone: 1-800-675-9596 Email: info@bavarian-nordic.com Product: . 47823. Safety and immunogenicity of Fluzone Quadrivalent were evaluated in adults 65 years of age and older. The dose and schedule for Fluzone Quadrivalent are presented in Table 1. 60 mcg / 0.5 mL. 0.5 mL each, For 6 months of age and older Fluzone Quadrivalent is approved for use in persons 6 months of age and older. The safety analysis set included 570 recipients, half aged 18-60 years and half aged 61 years or older. (2021) Efficacy and effectiveness of high-dose influenza vaccine in older adults by circulating strain and antigenic match: An updated systematic review and meta-analysis. Antibody responses to Fluzone Quadrivalent are lower in persons 65 years of age than in younger adults. Vaccine Product Information - Order Vaccines and Contact Manufacturers Withdraw one dose of vaccine from the single-dose vial using a sterile needle and syringe. During this meeting, the advisory committee reviewed and evaluated the surveillance data related to epidemiology and antigenic characteristics of recent influenza isolates, serological responses to 2020-2021 vaccines, and the availability of candidate strains and reagents. 2019 Sep 16;37(39):5825-5834. In the first year of the study the influenza B component of the vaccine and the majority of influenza B cases were of the Victoria lineage; in the second year the influenza B component of the vaccine and the majority of influenza B cases were of the Yamagata lineage: Any type/subtype# 227 (1.43) 300 (1.89) 24.2 (9.7; 36.5) Influenza A: 190 (1.20) Study 2 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) (2) (see Clinical Studies ). History of severe allergic reaction (e.g., anaphylaxis) to egg is a labeled contraindication to the use of most IIVs and LAIV4. Vaccines are the best public health tool available to prevent flu and its serious complications. Swiftwater, PA: Sanofi3Lee JKH, Lam GKL, Shin T, et al. In children 3 years through 8 years of age, the most common (10%) injection-site reactions were pain (67%), erythema (34%), and swelling (25%); the most common solicited systemic adverse reactions were myalgia (39%), malaise (32%), and headache (23%). 1 This was the impetus for the 1994 federal. Flublok Quadrivalent STN: 125285 Proper Name: Influenza Vaccine Tradename: Flublok Quadrivalent Manufacturer: Protein Sciences Corporation Indication: For active immunization against. The safety analysis set included 1841 children 6 months through 35 months of age and 2506 children 3 years through 8 years of age. Procedures should be in place to avoid injury from fainting. Seroconversion rates following Fluzone Quadrivalent were higher than those following TIV for the B strain not contained in each respective TIV, based on pre-specified criteria (the lower limit of the two 2-sided 95% CI of the difference of the seroconversion rates [Fluzone Quadrivalent minus TIV] >10% for each B strain in Fluzone Quadrivalent compared with the corresponding B strain not contained in each TIV). It is provided for information only. Influenza Vaccine for the 2020-2021 Season | FDA For intramuscular injection only, Afluria, Afluria Quadrivalent, Flucelvax Quadrivalent, Fluad, +7 more, Tamiflu, oseltamivir, Fluzone, Xofluza, Afluria, influenza virus vaccine, inactivated. Chang LJ, et al. Sanofi has led the way with the first human vaccine in the US against the H5N1 virus. * Fluzone High-Dose Quadrivalent (Influenza Vaccine) and Flublok Quadrivalent (Influenza Vaccine) are the only two flu vaccines proven to help prevent more cases of flu in older adults, compared to their standard-dose flu vaccine comparators as assessed in randomized controlled trials, the gold standardin evaluating clinical evidence for vaccine licensure1,2* FluzoneHigh-Dose (Influenza Vaccine) is the first and only influenza vaccine with superior flu protection and 10 years of evidence in preventing flu-related hospitalizations in adults aged 65+2,3,a,b* As the leaders in flu, Sanofi is committed to protecting patients most at-risk for the flu and its related complications, including hospitalizations due to pneumonia & cardiovascular events4.
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