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. Fluzone Quadrivalent is given to people 6 months of age and older. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov. For information on flu vaccine distribution schedules, please contact the manufacturers directly. 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. 49281-0418-50. Chang LJ, et al. This summary is not intended to take the place of talking with your healthcare provider. All information these cookies collect is aggregated and therefore anonymous. pain, redness, and swelling where you got the shot. Sanofi Pasteur Inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes and newborn health status following vaccination with Fluzone Quadrivalent during pregnancy. Fluzone High Dose Quadrivalent (Influenza Vaccine) Prescribing Information Patient Information www.sanofiflu.com Fluzone Quadrivalent (Influenza Vaccine) Prescribing Information Patient Information www.sanofiflu.com Imovax Rabies (Rabies Vaccine) Prescribing Information Imogam Rabies - HT (Rabies Immune Globulin (Human) USP, Heat Treated) Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed / Inactivated Poliovirus / Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, Preservative Free. The latest UKHSA data on the maternal whooping cough vaccine programme shows that uptake has dropped to its lowest level in 7 years. 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. * 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. That means not only using mRNA or protein-based technologies, but alsonovel methodsof antigen selection in order to inducebroader protection. Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. 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. Package insert / product label Available at: https://www.cdc.gov/flu/highrisk/65over.htm. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Accessed June 2022.10DiazGranados CA, et al. In addition, HI antibody GMTs and 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 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 and 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). Data are not available to assess the effects of Fluzone Quadrivalent on the breastfed infant or on milk production/excretion. You can ask your healthcare provider for a list of other side effects that is available to healthcare professionals. 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. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. ** Fluzone Quadrivalent is currently licensed for ages 6 through 35 months at either 0.25 mL or 0.5 mL per dose; however, 0.25-mL prefilled syringes are not expected to be available for the 202021 influenza season. Forward-looking statements are statements that are not historical facts. A world leader. Available at: Izikson R. et al. Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color. It is provided for information only. 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. Selecting Viruses for the Seasonal Influenza Vaccine. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. Sanofi Pasteur #49281040010 Adacel Tdap Vaccine Indicated for People 10 to 64 Years of Age Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed, Preservative Free Injection Single-Dose Vial 0.5 mL ADACEL TDAP ADLT VACCINE, SDV 2-2.5-5M.5ML (10/BX) Compare Features 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. Single-dose vial, 0.5 mL (NDC 49281-422-58) (not made with natural rubber latex). Additional guidance regarding site selection and needle length for intramuscular administration is available in the ACIP General Best Practice Guidelines for Immunization.pdf icon. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. Furthermore, antibodies to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury. Requires Refrigeration. Protection from influenza virus infection has not been correlated with a specific level of hemagglutination inhibition (HI) antibody titer post-vaccination. 3). 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. 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. The dose and schedule for Fluzone Quadrivalent are presented in Table 1. 9Centers for Disease Control and Prevention. Available data with Fluzone Quadrivalent use in pregnant women are insufficient to inform vaccine-associated risk of adverse developmental outcomes. The .gov means its official.Federal government websites often end in .gov or .mil. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. You can review and change the way we collect information below. The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. 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. Cookies used to make website functionality more relevant to you. CDC twenty four seven. Product Dating. 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%). 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. Influenza-like illness was defined as an illness with at least 1 respiratory symptom (cough or nasal congestion) and at least 1 constitutional symptom (fever or feverishness, chills, or body aches). These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Fluzone High-Dose Quadrivalent is given to people 65 years of age and older. Flublok Quadrivalent STN: 125285 Proper Name: Influenza Vaccine Tradename: Flublok Quadrivalent Manufacturer: Protein Sciences Corporation Indication: For active immunization against. A maximum of ten doses can be withdrawn from the multi-dose vial. 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. Pregnant women who contract influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery. If you have questions or would like more information, please talk with your healthcare provider. For participants who received two doses, the doses were administered approximately 4 weeks apart. Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Adults 65 Years of Age: A Phase 3 Randomized Clinical Trial. The difference in fever rate (Group 2 minus Group 1) was 0.84% (95% CI: -2.13%; 3.80%), meeting the prespecified non-inferiority criterion (upper limit of the 2-sided 95% CI of the difference in fever rates <5%). Vaccine efficacy against all influenza viral types and subtypes was a secondary endpoint and is presented in Table 8. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Table 6 summarizes solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards. If you wish to continue to this external website, click Proceed. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Seroconversion rates 21 days following Fluzone Quadrivalent were non-inferior to those following TIV for H3N2, B/Brisbane, and B/Florida, but not for H1N1 (see Table 14). Annual vaccination with the influenza vaccine is recommended because immunity during the year after vaccination declines and because circulating strains of influenza virus change from year to year. 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.
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