sanofi pasteur flu vaccine lot numbers

Drug class: Viral vaccines. Vaccines are the best public health tool available to prevent flu and its serious complications. Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Sanofi flu vaccines licensed and approved for 2022-2023 influenza season, including CDC preferred higher-dose vaccines for adults 65+ * Fluzone High-Dose Quadrivalent (Influenza. If any of these defects or conditions exist, Fluzone Quadrivalent should not be administered. The most commonly reported unsolicited non-serious adverse events were cough, vomiting, and pyrexia. 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%). The Lancet Respiratory Medicine. Influenza disproportionately impacts people over 65, underrepresented communities, and people with co-morbidities such as diabetes, asthma, chronic obstructive pulmonary disease, and heart disease.7 Since 2010, it's estimated by the CDC that between 70% and 85% of seasonal flu-related deaths have occurred in people 65+, and between 50% and 70% of seasonal flu-related hospitalizations have occurred among people in this age group.4 ACIP's June 22nd recommendation will undoubtedly help reduce the risk of influenza cases and severe flu-related complications in this population at highest risk. In Study 3 (NCT00988143, see http://clinicaltrials.gov), a multi-centered randomized, open-label trial conducted in the US, adults 18 years of age and older received one dose of either Fluzone Quadrivalent or one of two formulations of comparator trivalent influenza vaccine (TIV-1 or TIV-2). Need help with SupplyManager? Accessed June 2022. For intramuscular injection only, Afluria, Afluria Quadrivalent, Flucelvax Quadrivalent, Fluad, +7 more, Tamiflu, oseltamivir, Fluzone, Xofluza, Afluria, influenza virus vaccine, inactivated. Thank you for taking the time to confirm your preferences. Cumulative 2021/2022 Season Lot Release Status (Updated 11/3/2021). Sanofi Pasteur, the vaccines business of Sanofi-Aventis, is one of the largest seasonal influenza vaccine producers in the world. Not all formulations are available from the VFC Program. 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. Fluzone Quadrivalent has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. History of severe allergic reaction (e.g., anaphylaxis) to egg is a labeled contraindication to the use of most IIVs and LAIV4. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. E, 10 Single-Dose Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. The most common side effects of Fluzone Quadrivalent are: These are not all of the possible side effects of Fluzone Quadrivalent. 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. Vaccine. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Influenza (seasonal) Fact Sheet. We take your privacy seriously. Do not use after the expiration date shown on the label. N Engl J Med. 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. Available at: Izikson R. et al. As a leader in flu vaccination, we remain committed to ensure adults 65 years and older have access to flu vaccines, proven to protect them from what really matters, such as flu-related hospitalizations due to cardiovascular events and pneumonia. For information on flu vaccine distribution schedules, please contact the manufacturers directly. 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. Inform the vaccine recipient or guardian: Vaccine Information Statements must be provided to vaccine recipients or their guardians, as required by the National Childhood Vaccine Injury Act of 1986 prior to immunization. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. 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. Study 2 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) (2) (see Clinical Studies ). Accounts Receivable 800.453.5180 Please read this information sheet before getting Fluzone Quadrivalent. 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. 2019 Sep 16;37(39):5825-5834. 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). 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. 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. 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. Annual influenza vaccination is recommended. Flu & People 65 Years and Older. The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. ", 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). Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Supplied as package of 1 (NDC 49281-637-15). Three SAEs were reported during the follow-up period, 2 (0.9%) in the TIV-1 group and 1 (0.4%) in the TIV-2 group. A maximum of ten doses can be withdrawn from the multi-dose vial. It can lead to severe complications, increasing the risk of heart attack and pneumonia. MacIntyre CR, et al. For preventive vaccines, the underlying maternal condition is susceptibility to the disease prevented by the vaccine. Data are not available to assess the effects of Fluzone Quadrivalent on the breastfed infant or on milk production/excretion. Sanofi has led the way with the first human vaccine in the US against the H5N1 virus. Available data with Fluzone Quadrivalent use in pregnant women are insufficient to inform vaccine-associated risk of adverse developmental outcomes. The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. 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. The preservative thimerosal is only in the multi-dose vial of Fluzone Quadrivalent. 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. Products: Comirnaty (COVID-19 vaccine) Sanofi U.S. 55 Corporate Drive Bridgewater, NJ 08807 Vaccines and biologics 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. NDC Number. 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. 8Grohskoph L. Influenza Vaccines for Persons Aged 65 Years: Evidence to Recommendations (EtR) Framework. Dosage form: suspension for intramuscular injection The safety analysis set included 1841 children 6 months through 35 months of age and 2506 children 3 years through 8 years of age. * 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. 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. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. For participants who received two doses, the doses were administered approximately 4 weeks apart. 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. The site is secure. Store all Fluzone Quadrivalent presentations refrigerated at 2 to 8C (35 to 46F). Pregnant women are at increased risk of complications associated with influenza infection compared to non-pregnant women. Chang LJ, et al. The dose and schedule for Fluzone Quadrivalent are presented in Table 1. Throughout the study period, a total of 41 (1.4%) recipients in the Fluzone Quadrivalent group, 7 (1.0%) recipients in the TIV-1 group, and 14 (1.9%) recipients in the TIV-2 group, experienced at least one SAE. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Sanofi Pasteur will continue to deliver and offer the trivalent formulation of Fluzone High-Dose through . 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. Eur respir J. Among participants in the three vaccine groups combined, 67.2% were female (Fluzone Quadrivalent, 68.4%; TIV-1, 67.9%; TIV-2, 65.3%), 88.4% Caucasian (Fluzone Quadrivalent, 91.1%; TIV-1, 86.8%; TIV-2, 87.4%), 9.6% Black (Fluzone Quadrivalent, 6.8%; TIV-1, 12.1%; TIV-2, 10.0%), 0.4% Hispanic (Fluzone Quadrivalent, 0.0%; TIV-1, 0.5%; TIV-2, 0.5%), and 1.7% were of other racial/ethnic groups (Fluzone Quadrivalent, 2.1%; TIV-1, 0.5%; TIV-2, 2.2%). Flu vaccine lots that have been released by FDA and are available for distribution by the manufacturers. Heart 2016;102:19531956. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Participants were monitored for unsolicited adverse events and SAEs during the 21 days following vaccination. 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. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov. 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. The intent-to-treat analysis set included 1138 healthy adults who received Fluzone or placebo. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton X-100), producing a "split virus". 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. Selecting Viruses for the Seasonal Influenza Vaccine. 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. 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).

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