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. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Thank you, Bill. Flu & People 65 Years and Older. Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. Before administering a dose of vaccine, shake the prefilled syringe or vial. Anyone can catch and spread flu. 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. Discard if vaccine has been frozen. 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 Flu vaccine lots that have been released by FDA and are available for distribution by the manufacturers. Not every flu vaccine is created equal and we are pleased with ACIP's acknowledgment that Fluzone High-Dose Quadrivalent & Flublok Quadrivalent have demonstrated improved protection from flu & its related complications through randomized controlled trials and real-world evidence.8 Of note ACIP recognized that Fluzone High-Dose Quadrivalent had the most data available, including evidence favoring its use over standard dose for all the benefit outcomes within the GRADE analysis; influenza illnesses, outpatient/ER visits, hospitalizations, and deaths.8 Nevertheless, we believe even more can be done to provide healthcare providers with clearer guidance. 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. Forward-looking statements are statements that are not historical facts. The Fluzone Quadrivalent prefilled syringe and vial presentations are not made with natural rubber latex. The 1976 swine influenza vaccine was associated with an elevated risk of Guillain Barr syndrome (GBS). Drug class: Viral vaccines. Clin Infect Dis. Women who receive Fluzone Quadrivalent during pregnancy are encouraged to contact Sanofi Pasteur Inc. directly or have their healthcare provider contact Sanofi Pasteur Inc. at 1-800-822-2463. ever had a severe allergic reaction to eggs or egg products. Pregnant women who contract influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery. Dosing for infants and children age 6 through 35 months: Afluria 0.25 mL Fluarix 0.5 mL Flucelvax 0.5 mL FluLaval 0.5 mL Fluzone 0.25 mL or 0.5 mL 4. Call your healthcare provider for advice about any side effects that concern you. Available at: Warren-Gash C, et al. FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Silver Spring, Maryland, on March 5, 2021, to select the influenza viruses for the composition of the influenza vaccine for the 2021-2022 U.S. influenza season. Additional guidance regarding site selection and needle length for intramuscular administration is available in the ACIP General Best Practice Guidelines for Immunization.pdf icon. Participants were monitored for unsolicited adverse events and SAEs during the 28 days following vaccination. * Vaccination providers should consult FDA-approved prescribing information for 202021 influenza vaccines for the most complete and updated information, including (but not limited to) indications, contraindications, warnings, and precautions. 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. Tell your health care provider if you have ever had Guillain-Barr syndrome (severe muscle weakness) after a previous influenza vaccination. Need help with SupplyManager? Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. Supplied as package of 1 (NDC 49281-637-15). The dose and schedule for Fluzone Quadrivalent are presented in Table 1. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. We are pursuingnext generationinfluenza vaccines with multiple vaccine technologies to develop and bring forward tomorrows vaccines to people around the world as fast as possible. Product Dating. Cases of influenza were identified through active and passive surveillance and confirmed by cell culture and/or real-time polymerase chain reaction (PCR). 8Grohskoph L. Influenza Vaccines for Persons Aged 65 Years: Evidence to Recommendations (EtR) Framework. 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. You can ask your healthcare provider for a list of other side effects that is available to healthcare professionals. The most commonly reported unsolicited non-serious adverse events in both groups were cough and rhinorrhea. This summary is not intended to take the place of talking with your healthcare provider. Participants were 18 through 49 years of age (mean age was 23.3 years); 63.3% were female, 83.1% were Caucasian, and 16.9% were of other racial/ethnic groups. L In adults 50 years of age and older the most common side effects were tenderness, and/or pain where you got the shot; headache and tiredness. For information on flu vaccine distribution schedules, please contact the manufacturers directly. The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Based on that information and on the recommendations of the FDAs Vaccines and Related Biological Products Advisory Committee, the FDA selects the different influenza strains each year that. Women who receive Fluzone Quadrivalent during pregnancy are encouraged to contact Sanofi Pasteur Inc. directly or have their healthcare provider contact Sanofi Pasteur Inc. at 1-800-822-2463. 2021 Dec 6;73(11):e4288-e4295. For intramuscular injection only, Afluria, Afluria Quadrivalent, Flucelvax Quadrivalent, Fluad, +7 more, Tamiflu, oseltamivir, Fluzone, Xofluza, Afluria, influenza virus vaccine, inactivated. 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. If Fluzone Quadrivalent is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained. References1Flublok Quadrivalent [Prescribing Information]. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines). 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. About 16,000. employees globally, 65% of them dedicated to manufacturing and quality operations. 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. Of these participants, 49.7% were female, 74.3% were Caucasian, 19.2% were Black, 6.5% were of other racial groups, and 22.0% were Hispanic/Latino. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of Fluzone Quadrivalent. Questions: Toll-free: 877-2Get-VFC (877-243-8832) Sanofi Pasteur will continue to deliver and offer the trivalent formulation of Fluzone High-Dose through . Single-dose, prefilled syringe (clear plunger rod), without needle, 0.5 mL (NDC 49281-422-88) (not made with natural rubber latex). Medical professionals, medical facility employees 855.571.2100. See FDA-approved patient labeling (Patient Information). These cookies may also be used for advertising purposes by these third parties. Influenza virus strains were selected based on the influenza vaccine production method; egg-based and cell- or recombinant based. Available at: WHO - Coadministration of seasonal inactivated influenza and COVID-19 vaccines. For participants who received two doses, the doses were administered approximately 4 weeks apart. Please read this information sheet before getting Fluzone Quadrivalent. 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. Do not use after the expiration date shown on the label. 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. 2014;371(7):635-645 https://www.nejm.org/doi/full/10.1056/nejmoa131572711Falsey AR, Treanor JJ, Tornieporth N, Capellan J, Gorse GJ. Fluzone Quadrivalent contains 4 killed flu virus strains. To receive weekly email updates about Seasonal Flu, enter your email address: We take your privacy seriously. Participants received one dose of either Fluzone vaccine (N = 813), an active comparator (N = 814), or placebo (N = 325). With the increased risk of H5N1 bird flu being passed by . The most commonly reported unsolicited non-serious adverse events were headache, cough, and oropharyngeal pain. Available at https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-22-23/03-influenza-grohskopf-508.pdf. 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. 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. Sanofi has led the way with the first human vaccine in the US against the H5N1 virus. Product Dating. However, in some human studies, antibody titers 1:40 have been associated with protection from influenza illness in up to 50% of subjects. (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. Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. Withdraw one dose of vaccine from the single-dose vial using a sterile needle and syringe. They help us to know which pages are the most and least popular and see how visitors move around the site. Generic Drug Name. Fluzone is a registered trademark of Sanofi Pasteur Inc. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation. 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). The preservative thimerosal is only in the multi-dose vial of Fluzone Quadrivalent. ** 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. Fluzone Quadrivalent contains killed viruses and cannot cause influenza. Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color. 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. Antibiotics are not used in the manufacture of Fluzone Quadrivalent. in influenza and pediatrics vaccines, first worldwide . Non-inferiority immunogenicity criteria based on HI antibody GMTs and seroconversion rates were also met when age subgroups (6 months to <36 months and 3 years to <9 years) were examined. The intent-to-treat analysis set included a total of 786 children 6 through 24 months of age. NDC Number. FDA-approved patient labeling (Patient Information), "-" Indicates information is not applicable, Not previously vaccinated with influenza vaccine or unknown vaccination history, Previously vaccinated with influenza vaccine, If two doses, administer at least 4 weeks apart, Sodium phosphate-buffered isotonic sodium chloride solution, INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/WASHINGTON/02/2019 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED). Products: Comirnaty (COVID-19 vaccine) Sanofi U.S. 55 Corporate Drive Bridgewater, NJ 08807 Vaccines and biologics (2019). We take your privacy seriously. This study revealed no adverse effects to the fetus or pre-weaning development due to Fluzone Quadrivalent [see Animal Data (8.1)]. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. Vaccine efficacy of Fluzone against all influenza viral types and subtypes is presented in Table 9. If Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent are given to people with a compromised immune system, including those receiving therapies that suppress the immune system, the immune response may be lower than expected. Not all formulations are available from the VFC Program. 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. Guillain Barr syndrome (severe muscle weakness) after getting a flu vaccine. 60 mcg / 0.5 mL. Animal Data: In a developmental and reproductive toxicity study female rabbits were administered a 0.5 mL/dose of Fluzone Quadrivalent by intramuscular injection 24 and 10 days before insemination, and on Days 6, 12, and 27 of gestation (a single human dose is 0.5 mL). 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. 2) Single-dose vial, 0.5 mL, for persons 6 months of age and older. 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. 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. Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed / Inactivated Poliovirus / Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, Preservative Free. Unsolicited non-serious adverse events were reported in 417 (44%) participants in Group 1 and 394 (40%) participants in Group 2. 4Centers for Disease Control and Prevention. 2019 Nov 20:1932296819883340, Kubale J, et al. 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. Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for the usual change of one or more new strains in each year's influenza vaccine. Sanofi Pasteur Inc. 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 new facility building at Swiftwater has had an investment of $150m. However, ACIP recommends that persons with a history of egg allergy may receive any licensed, recommended influenza vaccine that is otherwise appropriate for their age and health status. Sanofi Pasteur Inc. is collecting information on pregnancy outcomes and the health of newborns following vaccination with Fluzone Quadrivalent during pregnancy. Abbreviations: ACIP = Advisory Committee on Immunization Practices; FDA = Food and Drug Administration; HA = hemagglutinin; IIV3 = inactivated influenza vaccine, trivalent; IIV4 = inactivated influenza vaccine, quadrivalent; IM = intramuscular; LAIV4 = live attenuated influenza vaccine, quadrivalent; MDV = multidose vial; NAS = intranasal; PFS = prefilled syringe; RIV4 = recombinant influenza vaccine, quadrivalent; SDV = single-dose vial. Vaccine efficacy against all influenza viral types and subtypes was a secondary endpoint and is presented in Table 8. 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. Accessed June 2022.10DiazGranados CA, et al. COVID-19 Vaccine Lot Number and Expiration Date Tool. History of severe allergic reaction (e.g., anaphylaxis) to egg is a labeled contraindication to the use of most IIVs and LAIV4. J Infect Dis. Fluzone Quadrivalent should not be combined through reconstitution or mixed with any other vaccine. Global surveillance of influenza identifies yearly antigenic variants. 9Centers for Disease Control and Prevention. Registered users can now access COVID-19 vaccine lot numbers and expiration dates provided to CDC by the vaccine manufacturer. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. Vaccination of female rabbits with Fluzone Quadrivalent revealed no evidence of impaired female fertility [see Animal Data (8.1)]. Samson et al. The safety analysis set included 675 recipients. CDC twenty four seven. BRIDGEWATER, N.J., July 1, 2022 /PRNewswire/ -- Today the US Food and Drug Administration (FDA) approved Sanofi's licensure request for vaccine approval for the upcoming 2022-2023 flu season, including: Fluzone High-Dose Quadrivalent (Influenza Vaccine), Flublok Quadrivalent (Influenza Vaccine) and Fluzone Quadrivalent (Influenza Vaccine).5 This approval comes on the heels of the CDC's Advisory Committee on Immunization Practices (ACIP) preferential recommendation for adults 65+ including Fluzone High-Dose Quadrivalent and Flublok Quadrivalent.6 Following this licensure, Sanofi will begin to ship their vaccines helping to ensure more people, including some of our most vulnerable population of 65 years and older, will be immunized with the vaccine best suited for their needs as recommended by the ACIP. You can review and change the way we collect information below. Cookies used to make website functionality more relevant to you. Among participants in the three vaccine groups combined, 55.7% were female (Fluzone Quadrivalent, 57.3%; TIV-1, 56.0%; TIV-2, 53.8%), 89.5% Caucasian (Fluzone Quadrivalent, 87.6%; TIV-1, 89.8%; TIV-2, 91.1%), 2.2% Black (Fluzone Quadrivalent, 4.0%; TIV-1, 1.8%; TIV-2, 0.9%), 7.4% Hispanic (Fluzone Quadrivalent, 8.4%; TIV-1, 7.6%; TIV-2, 6.2%) and 0.9% were of other racial/ethnic groups (Fluzone Quadrivalent, 0.0%; TIV-1, 0.9%; TIV-2, 1.8%). For participants recommended to receive two doses of influenza vaccine as per Advisory Committee on Immunization Practices guidance, the same dose was administered 4 weeks after the first. Storage Requirements. Influenza Surveillance Report (FluView), Previous Forecasts for the 2021-2022 Season, Tools to Prepare Your Practice for Flu Season, Information for Clinicians on Influenza Virus Testing, Multiplex Assays Authorized for Simultaneous Detection of Influenza Viruses and SARS-CoV-2, Information on Collection of Respiratory Specimens for Influenza Virus Testing, Information for Clinicians on Rapid Diagnostic Testing for Influenza, Information on Rapid Molecular Assays, RT-PCR, and other Molecular Assays for Diagnosis of Influenza Virus Infection, Algorithm: Interpreting Influenza Testing Results When Influenza is Circulating, Algorithm: Interpreting Influenza Testing Results When Influenza is NOT Circulating, Guide: Influenza Diagnostic Testing in Closed Setting Outbreaks, Guidance: Standard-Based Electronic Laboratory Reporting, Guidance: Antiviral and Obstetric Health Care, Guidance: Outbreak Management in Long-Term Care Facilities, Guidance: Use of Mask to Control Influenza Transmission, Guidance: Prevention & Control in Peri- and Postpartum Settings, U.S. Department of Health & Human Services, Standard dose, cell culture based (ccIIV4), Standard dose, egg based with MF59 adjuvant (aIIV4), Standard dose, egg based with MF59 adjuvant (aIIV3), 0.2-mL prefilled single-use intranasal sprayer. In adults 18 years and older, the most common side effects were pain where you got the shot; muscle aches, headache, and general discomfort. 1 This was the impetus for the 1994 federal. Antibodies against one influenza virus type or subtype confer limited or no protection against another. You can review and change the way we collect information below. Safety and effectiveness of Fluzone Quadrivalent in children below the age of 6 months have not been established. problems with your immune system as the immune response may be diminished. Call Us. Seroconversion rate (SCR) differences (SCR0.5-mL dose minus SCR0.25-mL dose) for the A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage strains were 4.6% (95% CI: -0.4%; 9.6%), 5.1% (95% CI: 0.4%; 9.8%), 1.3% (95% CI: -2.9%; 5.6%), and 2.6% (95% CI: -1.4%; 6.5%). 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. an A/Wisconsin/588/2019 (H1N1) pdm09-like virus. 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 vaccine with 10 years of data demonstrating protection from flu and its related complications.2,3,a,b In a meta-analysis of 15 published reports, including approximately 34 million people, those who received Fluzone High-Dose experienced an 18% reduction in cardiorespiratory hospitalizations and 28% decrease in pneumonia hospitalizations, both of which are reductions above what the standard dose vaccines provided.3, Fluzone High-Dose Quadrivalent builds on the legacy of the trivalent formulation, which was clinically proven to be 24.2% more effective at preventing flu than standard-dose Fluzone (Influenza Vaccine) in adults 65+.10 Based on data from Fluzone High-Dose (Influenza Vaccine), side effects were slightly more frequent after vaccination with Fluzone High-Dose compared to a standard-dose vaccine.11, The efficacy of trivalent formulation is relevant to Fluzone High-Dose Quadrivalent since both products are manufactured according to the same process and have overlapping compositions.2, In a clinical study, Flublok Quadrivalent is the first and only recombinant influenza vaccine for adults 18+ that was proven to be 30% more effective than a standard dose vaccine at preventing flu infection in over 9,000 adults 50+.1 In adults 50+, the most common side effects were tenderness, and/or pain at the injection site; headache, and tiredness.1, aProven superiority in a clinical trial between Fluzone High-Dose (Influenza Vaccine) (trivalent formulation) and a standard-dose influenza vaccine2bIncludes 10 years of evidence (2009-2019) with Fluzone High-Dose (trivalent formulation)3, Important Safety Information for Fluzone Quadrivalent (Influenza Vaccine), Flublok Quadrivalent (Influenza Vaccine) and Fluzone High-Dose Quadrivalent (Influenza Vaccine).