Products: Comirnaty (COVID-19 vaccine) Sanofi U.S. 55 Corporate Drive Bridgewater, NJ 08807 Vaccines and biologics (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. ** 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. Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. * 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. Antibodies against one influenza virus type or subtype confer limited or no protection against another. 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. A randomized, double-blind, placebo-controlled study was conducted in a single US center during the 2007-2008 influenza season. The preferred site for infants and young children is the anterolateral aspect of the thigh. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. 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. Therefore, influenza vaccines are standardized to contain the hemagglutinins of influenza virus strains representing the influenza viruses likely to be circulating in the US during the influenza season. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. The information provided in this resource is for informational purposes only. They help us to know which pages are the most and least popular and see how visitors move around the site. 49281051105. 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. Each of the trivalent formulations contained an influenza type B virus that corresponded to one of the two type B viruses in Fluzone Quadrivalent (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). Participants were monitored for unsolicited adverse events and SAEs during the 21 days following vaccination. For information on flu vaccine distribution schedules, please contact the manufacturers directly. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov. The safety analysis set included 1941 participants who received at least 1 dose of study vaccine. Discard unused portion. If any of these defects or conditions exist, Fluzone Quadrivalent should not be administered. Influenza-like illness was defined as fever with signs or symptoms of an upper respiratory infection. 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. Drug class: Viral vaccines. Medically reviewed by Drugs.com. Heart 2016;102:19531956. Before administering a dose of vaccine, shake the prefilled syringe or vial. We take your privacy seriously. Sanofi Pharma; Sanofi Genzyme; Sanofi Pasteur; Our data sharing commitments; Managed Access Programs (MAPs) . Study 2 (NCT02915302 see http://clinicaltrials.gov) was a randomized, observer-blinded, 2-arm, multi-center safety and immunogenicity study conducted in the US. 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. 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). 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. 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). Medical professionals, medical facility employees 855.571.2100. Ten SAEs were reported during the 28-day follow-up period: 5 (0.5%) in Group 1 and 5 (0.5%) in Group 2. The latest UKHSA data on the maternal whooping cough vaccine programme shows that uptake has dropped to its lowest level in 7 years. The most commonly reported adverse events were oropharyngeal pain, rhinorrhea, injection-site induration, and headache. It's an infectious disease that does more damage than most people realize. Fluzone Quadrivalent contains 4 killed flu virus strains. Fluzone Quadrivalent/NDC 49281-422-88 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. For adults and older children, the recommended site for intramuscular influenza vaccination is the deltoid muscle. Guillain Barr syndrome (severe muscle weakness) after getting a flu vaccine. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton X-100), producing a "split virus". If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 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 . Forward-looking statements are statements that are not historical facts. 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. Accessed June 2022.10DiazGranados CA, et al. N Engl J Med. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. 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. Available at: Izikson R. et al. 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 Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. McKesson Acceptable Dating: we will ship >= 180 days. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. The most commonly reported unsolicited non-serious adverse events were cough, vomiting, and pyrexia. Study 4 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). Cookies used to make website functionality more relevant to you. Vaccine efficacy of Fluzone against all influenza viral types and subtypes is presented in Table 9. 2) (See ref. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. 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 has led the way with the first human vaccine in the US against the H5N1 virus. 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. All information these cookies collect is aggregated and therefore anonymous. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Product Dating. The safety analysis set included 1841 children 6 months through 35 months of age and 2506 children 3 years through 8 years of age. Supplied as package of 10 (NDC 49281-422-10). These cookies may also be used for advertising purposes by these third parties. 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. 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. Thank you for taking the time to confirm your preferences. Prefilled Syringes We comply with the HONcode standard for trustworthy health information. 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. Each of the trivalent formulations contained an influenza type B virus that corresponded to one of the two type B viruses in Fluzone Quadrivalent (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. 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. They help us to know which pages are the most and least popular and see how visitors move around the site. Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. (*) Please note that the CPT codes shown for each vaccine crosswalk are not mapped to the NDC codes, but are mapped to the CVX codes shown. (2019). Swiftwater, PA: Sanofi3Lee JKH, Lam GKL, Shin T, et al. 2005-2022 sanofi-aventis U.S. LLC - All rights reserved. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation. It is not known whether Fluzone Quadrivalent is excreted in human milk. Registered users can now access COVID-19 vaccine lot numbers and expiration dates provided to CDC by the vaccine manufacturer. 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. You will be subject to the destination website's privacy policy when you follow the link. Since 1977, antigenic variants of influenza A (H1N1 and H3N2) viruses and influenza B viruses have been in global circulation. Product Dating. Product: Influenza (FluMist Quadrivalent) Bavarian Nordic A/S Hejreskovvej 10A DK-3490 Kvistgaard Phone: 1-800-675-9596 Email: info@bavarian-nordic.com Product: . WHO. 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. You will be subject to the destination website's privacy policy when you follow the link. Tell your health care provider if you have ever had Guillain-Barr syndrome (severe muscle weakness) after a previous influenza vaccination. (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. 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. 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. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. A maximum of ten doses can be withdrawn from the multi-dose vial. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Pregnant women who contract influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery. 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. Sanofi Pasteur - PMC (AKA: Aventis) NDC: 49281-0400-10 Sanofi Pasteur - PMC 90700 20 90700 106 90700 20 MercK - MSD 90714 09 90633 83 90634 84 90632 52 GlaxoSmithKline - SKB NDC: 58160-0825-11 Merck- MSD NDC: 00006-4831-41 GlaxoSmithKline - SKB Merck- MSD GlaxoSmithKline - SKB Flublok Quadrivalent is given to people 18 years of age and older. However, in some human studies, antibody titers 1:40 have been associated with protection from influenza illness in up to 50% of subjects. Unsolicited non-serious adverse events were reported in 417 (44%) participants in Group 1 and 394 (40%) participants in Group 2. Influenza illness and its complications follow infection with influenza viruses. 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. 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Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases (NCIRD), Reconstruction of the 1918 Influenza Pandemic Virus, 2022-2023 Preliminary In-Season Burden Estimate, Who is at Higher Risk of Flu Complications, Flu and COVID-19 Vaccine Coadministration, Who Should & Who Should NOT Get Vaccinated, Live Attenuated Influenza Vaccine (LAIV)/Nasal Spray Vaccine, Selecting Viruses for the Seasonal Influenza Vaccine, Flu Vaccine and People with Egg Allergies, Frequently Asked Questions on Vaccine Supply, Historical Reference of Vaccine Doses Distributed, Investigating Respiratory Viruses in the Acutely Ill (IVY), Respiratory Virus Transmission Network (RVTN), Randomized Assessment of Influenza Vaccine Efficacy Network (RAIVEN), Hospitalized Adult Influenza Vaccine Effectiveness Network (HAIVEN), How Vaccine Effectiveness and Efficacy are Measured, What People with a Staph Infection Should Know about Flu, Resources for Hosting a Vaccination Clinic, Overview of Influenza Surveillance in the United States, Influenza Hospitalization Surveillance Network (FluSurv-NET), Weekly U.S. A world leader. Andrew MK et al. Td (sanofi pasteur) Age indications for use of products in the VFC program may differ from age indications on this guide or in the package inserts. 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. 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. Sanofi Pasteur Inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes following vaccination with Fluzone Quadrivalent during pregnancy. Thank you for taking the time to confirm your preferences. You can review and change the way we collect information below. Anyone can catch and spread flu. 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. 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. Influenza virus strains were selected based on the influenza vaccine production method; egg-based and cell- or recombinant based. The 1976 swine influenza vaccine was associated with an elevated risk of Guillain Barr syndrome (GBS). 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. Product Specifications Professionals Also Viewed Product Specifications Features Protect from light:Tuberculin PPD solutions can be adversely affected by exposure to light Store at 2 to 8 degrees Celsius (35 to 46 degrees Fahrenheit) Do not freeze Enough antigen for 10 tests per vial More Information SDS Professionals Also Viewed Annual influenza vaccination is recommended. 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).
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