Selecting Viruses for the Seasonal Influenza Vaccine. Vaccine Administration: Making the Process More Efficient in Your The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. Fluzone Quadrivalent is given to people 6 months of age and older. Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. Table 2 and Table 3 summarize solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards. Furthermore, antibodies to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. In children 6 months through 35 months of age receiving a 0.25 mL dose of Fluzone Quadrivalent in Study 1 (NCT01240746, see http://clinicaltrials.gov), the most common (10%) injection-site reactions were pain (57%)1 or tenderness (54%)2, erythema (37%), and swelling (22%); the most common solicited systemic adverse reactions were irritability (54%)2, abnormal crying (41%)2, malaise (38%)1, drowsiness (38%)2, appetite loss (32%)2, myalgia (27%)1, vomiting (15%)2, and fever (14%). 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. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. Discard if vaccine has been frozen. Adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Fluzone (trivalent) or Fluzone Quadrivalent. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 0.5-mL Dose of Fluzone Quadrivalent in Children 6 Months through 35 Months of Age. Single-dose vial, 0.5 mL (NDC 49281-422-58) (not made with natural rubber latex). Contact the Sanofi Pasteur Reimbursement Support Service (RSS). Do not administer this product intravenously, intradermally, or subcutaneously. Investigator Sponsored Studies and Externally Sponsored Collaboration, Access to Quality Healthcare Sanofi Global Health, Contributing to the eradication, elimination and control of some infectious diseases, Serving the needs of patients with non-communicable diseases, Development opportunity: how Sanofi empowers you, Influenza vaccination can reduce the risk of heart attacks by up to 45% [15-45%], Vaccination is especially important for people most at risk, Flu and Covid-19 vaccines can be administered at the same time, That means not only using mRNA or protein-based technologies, but also, We are currently innovating in our existing different technologies including egg-based flu vaccines, recombinant proteins, mRNA to develop and deliver vaccines that can. What are the ingredients in Fluzone Quadrivalent? Fluzone Quadrivalent contains 4 killed flu virus strains. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. 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. Fluzone Quadrivalent has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Product Dating. PDF Complete List of Vaccine Names and CPT/CVX Codes Safety and immunogenicity of Fluzone Quadrivalent were evaluated in adults 65 years of age and older. Swiftwater, PA: Sanofi2Fluzone High-Dose Quadrivalent [Prescribing Information]. Fluzone Quadrivalent stimulates the immune system to protect against influenza, but does not prevent other respiratory infections. 3). Supplied as package of 10 (NDC 49281-422-50). Dosage form: suspension for intramuscular injection Andrew MK et al. Forward-looking statements are statements that are not historical facts. 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. Table 4 summarizes solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards for the 0.25 mL and 0.5 mL volumes of Fluzone Quadrivalent in children 6 months through 35 months of age. 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 safety analysis set included 570 recipients, half aged 18-60 years and half aged 61 years or older. Available at: WHO - Coadministration of seasonal inactivated influenza and COVID-19 vaccines. Need help with SupplyManager? 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. With the increased risk of H5N1 bird flu being passed by . Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. For preventive vaccines, the underlying maternal condition is susceptibility to the disease prevented by the vaccine. 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 . Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of Fluzone Quadrivalent. Vaccine. Fluzone Quadrivalent is approved for use in persons 6 months of age and older. 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. The percentage of subjects 75 years of age or older was 35.4% in the Fluzone High-Dose Quadrivalent group and 35.8% in the Fluzone High-Dose group. Participants received two 0.25 mL doses of either Fluzone (N = 525) or a placebo (N = 261). A maximum of ten doses can be withdrawn from the multi-dose vial. Sanofi Pharma; Sanofi Genzyme; Sanofi Pasteur; Our data sharing commitments; Managed Access Programs (MAPs) . 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. https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal), https://heart.bmj.com/content/heartjnl/102/24/1953.full.pdf, https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE_recommendation-coadministration-influenza-vaccines, https://doi.org/10.1016/S2213-2600(21)00557-9. For Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent, other side effects may occur. 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). 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). Before administering a dose of vaccine, shake the prefilled syringe or vial. ", 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). Thank you, Bill. Package insert / product label J Am Geriatr Soc. Swiftwater, PA 18370 USA. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Available at https://www.cdc.gov/flu/spotlights/2021-2022/specific-vaccines-seniors.htm. Unsolicited non-serious adverse events were reported in 417 (44%) participants in Group 1 and 394 (40%) participants in Group 2. 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. 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) Participants were monitored for unsolicited adverse events and SAEs during the 21 days following vaccination. PDF Influenza Vaccine Products for the 2022-2023 Influenza Season The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. We take your privacy seriously. Participants received one dose of either Fluzone vaccine (N = 813), an active comparator (N = 814), or placebo (N = 325). Anyone can catch and spread flu. Package inserts for U.S.-licensed vaccinesexternal icon. ACIP Flu Meeting Update: Flu Vaccines Worked Better than Reported & ACIP Recommends Specific Vaccines for Seniors. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. IM-administered influenza vaccines should be given by needle and syringe only, with the exception of the MDV presentation of Afluria Quadrivalent, which may alternatively be given by the PharmaJet Stratis jet injector for persons aged 18 through 64 years only. 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. Vaccines - Sanofi Product Dating. WHO. Unsolicited non-serious adverse events were reported in 28 (12.4%) recipients in the Fluzone Quadrivalent group, 22 (9.8%) recipients in the TIV-1 group, and 22 (9.8%) recipients in the TIV-2 group. ever had a severe allergic reaction after getting any flu vaccine. The new facility building at Swiftwater has had an investment of $150m. The safety analysis set included 1941 participants who received at least 1 dose of study vaccine. 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.
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