ever had a severe allergic reaction after getting any flu vaccine. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Fluzone Quadrivalent is approved for use in persons 6 months of age and older. We believe we must protect beyond the influenza infection to help reduce the risks of its severe complications, which too often bring people to hospital. Prefilled Syringes The 1976 swine influenza vaccine was associated with an elevated risk of Guillain Barr syndrome (GBS). For infants, Fluzone Quadrivalent is a shot given into the muscle of the thigh. Sanofi assumes no responsibility for the information presented on this website. CDC twenty four seven. Store all Fluzone Quadrivalent presentations refrigerated at 2 to 8C (35 to 46F). These cookies may also be used for advertising purposes by these third parties. Do not use after the expiration date shown on the label. 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. A world leader. * 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. Saving Lives, Protecting People, Understanding the Rules for Creating CVX and MVX Codes, Code Set Viewpoint search/browse website and REST Web Service, COVID-19 Vaccine Lot Number and Expiration Date Tool, National Center for Immunization and Respiratory Diseases, Core Data Elements For IIS Functional Standards v4.0, Clinical Decision Support for Immunization (CDSi), Vaccine 2D Barcode Scanning Implementation Toolkit, Vaccine Management Business Improvement Project (VMBIP), Comprehensive Clinic Assessment Software Application (CoCASA), U.S. Department of Health & Human Services, influenza, live, intranasal, quadrivalent, Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use, influenza, injectable, quadrivalent, preservative free, Influenza virus vaccine, quadrivalent (IIV4), split virus, preservative free, 0.5 mL dosage, for intramuscular use, Influenza, injectable, quadrivalent, preservative free, Influenza virus vaccine, quadrivalent (IIV4), split virus, 0.25 mL dosage, for intramuscular use, Influenza virus vaccine, quadrivalent (IIV4), split virus, 0.5 mL dosage, for intramuscular use, influenza, injectable, quadrivalent, contains preservative, Influenza, injectable, MDCK, preservative free, quadrivalent, Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0.5 mL dosage, for intramuscular use, influenza, recombinant, quadrivalent,injectable, preservative free, Influenza virus vaccine, quadrivalent (RIV4), derived from recombinant DNA, hemagglutinin (HA) protein only, preservative and antibiotic free, for intramuscular use, Influenza, injectable, MDCK, quadrivalent, preservative, Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, antibiotic free, 0.5 mL dosage, for intramuscular use, FLUZONE High-Dose Quadrivalent Northern Hemisphere, Influenza virus vaccine (IIV), split virus, preservative free, enhanced immunogenicity via increased antigen content, for intramuscular use, Influenza vaccine, quadrivalent, adjuvanted, Influenza virus vaccine, quadrivalent (aIIV4), inactivated, adjuvanted, preservative free, 0.5 mL dosage, for intramuscular use, influenza, Southern Hemisphere, pediatric, preservative free, influenza, Southern Hemisphere, preservative free, influenza, Southern Hemisphere, quadrivalent, with preservative, influenza, Southern Hemisphere, high-dose, quadrivalent, FLUZONE High-Dose Quadrivalent Southern Hemisphere, Centers for Disease Control and Prevention. For adults and older children, the recommended site for intramuscular influenza vaccination is the deltoid muscle. Thank you, Bill. California Compliance Law - Sanofi Pasteur, 2023 Health Equity Accelerator Awards: Application Guidelines, 2022 Health Equity Accelerator Award Winners, Health Equity Accelerator Awards Aim to Expand Solutions for Bigger Impact, A Million Conversations: Addressing Disparities in Healthcare, Independent Medical Education (IME/CME) Grants, Prescribing Information - NDC #49281-562-10, Prescribing Information - NDC #49281-564-10/15. Vaccination of female rabbits with Fluzone Quadrivalent revealed no evidence of impaired female fertility [see Animal Data (8.1)]. 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. Pregnant women who contract influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery. Accounts Receivable 800.453.5180 Available at: https://www.cdc.gov/flu/highrisk/65over.htm. The committee recommended that the quadrivalent formulation of egg-based influenza vaccines for the U.S. 2021-2022 influenza season contain the following: The committee recommended that the quadrivalent formulation of cell- or recombinant based influenza vaccines for the U.S. 2021-2022 influenza season contain the following: For trivalent influenza vaccines for use in the U.S. for the 2021-2022 influenza season, depending on the manufacturing method of the vaccine, the committee recommended that the A(H1N1) pdm09, A(H3N2) and B/Washington/02/2019-like virus (B/Victoria lineage) viruses recommended above for the quadrivalent vaccines be used. Fluzone Quadrivalent has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color. People at Higher Risk for Flu Complications. The latest UKHSA data on the maternal whooping cough vaccine programme shows that uptake has dropped to its lowest level in 7 years. You should not get Fluzone Quadrivalent if you: Tell your healthcare provider if you or your child have or have had: Fluzone Quadrivalent is a shot given into the muscle of the arm. They help us to know which pages are the most and least popular and see how visitors move around the site. Vaccination with Fluzone Quadrivalent may not protect all recipients. The following events have been spontaneously reported during the post-approval use of Fluzone (trivalent) or Fluzone Quadrivalent. This approval is the final step toward the company's complete transition to quadrivalent influenza vaccines in the U.S. Fluzone High-Dose Quadrivalent will be made available for immunization efforts during the 2020-2021 influenza season. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. 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. The dose volume for Afluria Quadrivalent is 0.25 mL for children aged 6 through 35 months and 0.5 mL for persons aged 3 years. Available at https://www.cdc.gov/flu/prevent/vaccine-selection.htm. Questions: Toll-free: 877-2Get-VFC (877-243-8832) Vaccine 2021; 39: A24-A35. It can lead to severe complications, increasing the risk of heart attack and pneumonia. The safety analysis set included 675 recipients. Participants were monitored for unsolicited adverse events for 28 days after each dose and serious adverse events (SAEs) during the 6 months following the last dose. (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. Furthermore, antibodies to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. Cases of influenza were identified through active and passive surveillance and confirmed by cell culture and/or real-time polymerase chain reaction (PCR). We comply with the HONcode standard for trustworthy health information. 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. Most participants were White (91.2% and 89.7%), followed by Black (6.8% and 8.0%), and Hispanic (2.8% and 2.6%) in the Fluzone High-Dose Quadrivalent and Fluzone High-Dose groups, respectively. 2018 Mar 29;51(3):1701794. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY, Media RelationsEvan Berland| + 1 215 432 0234 | evan.berland@sanofi.comSally Bain| + 1 781 264 1091 | sally.bain@sanofi.comKate Conway| + 1 617 981 2738 | kate.conway@sanofi.com, Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delpine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+1 617 764 6418| priya.nanduri@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com. For preventive vaccines, the underlying maternal condition is susceptibility to the disease prevented by the vaccine. Available for Android and iOS devices. Please refer to the full Prescribing Information forFluzone High-Dose Quadrivalent, Flublok Quadrivalent, orFluzone Quadrivalent. Non-inferiority of the 0.5 mL dose(s) relative to the 0.25 mL dose(s) of Fluzone Quadrivalent was demonstrated for all four strains based on pre-specified criteria (lower limit of the 2-sided 95% CI of the ratio of GMTs between groups > 0.667; lower limit of the 2-sided 95% CI of the difference in seroconversion rates >-10%). Supplied as package of 1 (NDC 49281-637-15). Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Product: Influenza (FluMist Quadrivalent) Bavarian Nordic A/S Hejreskovvej 10A DK-3490 Kvistgaard Phone: 1-800-675-9596 Email: info@bavarian-nordic.com Product: . Table 6 summarizes solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards. In this study, children 6 months through 35 months of age received one or two doses of either 0.25 mL or 0.5 mL of Fluzone Quadrivalent. For Flublok Quadrivalent, in adults 18 through 49 years of age, the most common side effects were tenderness, and/or pain where you got the shot; headache, tiredness, muscle aches, and joint pain. Study 2 (NCT02915302 see http://clinicaltrials.gov) was a randomized, observer-blinded, 2-arm, multi-center safety and immunogenicity study conducted in the US. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. 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. NDC Number. Chang LJ, et al. Available data with Fluzone Quadrivalent use in pregnant women are insufficient to inform vaccine-associated risk of adverse developmental outcomes. HI antibody geometric mean titers (GMTs) and seroconversion rates 28 days following vaccination with Fluzone Quadrivalent were non-inferior to those following each TIV for all four strains, based on pre-specified criteria (see Table 10 and Table 11). problems with your immune system as the immune response may be diminished. The table shows the patterns for the different lot numbers for the six VFC vaccines this difference impacts. 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%). Last updated on Nov 1, 2022. In Study 3 (NCT00988143) [see Adverse Reactions (6.1)], 565 adults 18 years of age and older who had received one dose of Fluzone Quadrivalent, TIV-1, or TIV-2 were included in the per-protocol immunogenicity analysis. J Diabetes Sci Technol. We take your privacy seriously. This new format includes all seasonal influenza vaccines for the 2022/2023 season in a single Excel crosswalk table that provides the CVX, MVX, NDC Unit of Sale, NDC Unit of Use, and CPT (*) codes for each vaccine. Products: Comirnaty (COVID-19 vaccine) Sanofi U.S. 55 Corporate Drive Bridgewater, NJ 08807 Vaccines and biologics The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. WHO. Global surveillance of influenza identifies yearly antigenic variants. Fluzone Quadrivalent, an inactivated influenza vaccine that contains the hemagglutinins of two influenza A subtype viruses and two influenza type B viruses, is manufactured according to the same process as Fluzone. A maximum of ten doses can be withdrawn from the multi-dose vial. Antibiotics are not used in the manufacture of Fluzone Quadrivalent. In children 3 years through 8 years of age, the most common side effects were pain, redness, and/or swelling where you got the shot; muscle aches, general discomfort, and headache. During the 28 days following vaccination, a total of 16 (0.6%) recipients in the Fluzone Quadrivalent group, 4 (0.5%) recipients in the TIV-1 group, and 4 (0.6%) recipients in the TIV-2 group, experienced at least one SAE. Cookies used to make website functionality more relevant to you. It's an infectious disease that does more damage than most people realize. The dose and schedule for Fluzone Quadrivalent are presented in Table 1. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. NDC Number. In this study, 1950 children 6 months through 35 months of age were randomly assigned to receive Fluzone Quadrivalent administered in either a volume of 0.25 mL (Group 1) or 0.5 mL (Group 2). 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. Safety and immunogenicity of Fluzone Quadrivalent were evaluated in adults 65 years of age and older. If any of these defects or conditions exist, Fluzone Quadrivalent should not be administered. Flu impacts people's lives and puts a considerable strain on already stretched health systems during the winter season. in influenza and pediatrics vaccines, first worldwide . This summary is not intended to take the place of talking with your healthcare provider. 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. 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). Table 2 and Table 3 summarize solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards. (2022) Safety and immunogenicity of a high-dose quadrivalent influenza vaccine administered concomitantly with a third dose of the mRNA-1273 SARS-CoV-2 vaccine in adults aged 65 years: a phase 2, randomised, open-label study. 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. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. Evidence for a causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated. Sanofi Pasteur Inc. is collecting information on pregnancy outcomes and the health of newborns following vaccination with Fluzone Quadrivalent during pregnancy. Influenza illness and its complications follow infection with influenza viruses. Selecting Viruses for the Seasonal Influenza Vaccine. Flublok Quadrivalent STN: 125285 Proper Name: Influenza Vaccine Tradename: Flublok Quadrivalent Manufacturer: Protein Sciences Corporation Indication: For active immunization against. Those who report having had reactions to egg involving symptoms other than urticaria (e.g., angioedema or swelling, respiratory distress, lightheadedness, or recurrent emesis) or who required epinephrine or another emergency medical intervention should be vaccinated in an inpatient or outpatient medical setting (including, but not necessarily limited to, hospitals, clinics, health departments, and physician offices) supervised by a health care provider who is able to recognize and manage severe allergic reactions, if a vaccine other than ccIIV4 or RIV4 is used. Flublok Quadrivalent is given to people 18 years of age and older. The site is secure. To receive email updates about this page, enter your email address: For more information on background and concepts see Understanding the Rules for Creating CVX and MVX Codes [5 pages], View archived 2015 Edition Versioned Codes, More ways to access CDCs Vaccine Code Set information: Code Set Viewpoint search/browse website and REST Web Service. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. With the increased risk of H5N1 bird flu being passed by . Among all randomized participants in both years, the mean age was 13.8 months; 52.5% were male, 50.8% were Caucasian, 42.0% were Black, and 7.2% were of other racial groups. Product Dating. For Fluzone High-Dose Quadrivalent, in adults 65 years of age and older, the most common side effects were pain, redness, and/or swelling where you got the shot; muscle aches, headache, and general discomfort. Available at: Izikson R. et al. Availability and characteristics of specific products and presentations might change and/or differ from what is described in this table and in the text of the full report.
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