Among children 6 months through 8 years of age, unsolicited non-serious adverse events were reported in 1360 (47.0%) recipients in the Fluzone Quadrivalent group, 352 (48.0%) recipients in the TIV-1 group, and 346 (48.0%) recipients in the TIV-2 group. 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). 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 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 an A/Wisconsin/588/2019 (H1N1) pdm09-like virus. Influenza illness and its complications follow infection with influenza viruses. What better way to launch Our Stories than to learn about us through the words of our people. 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. pain, redness, and swelling where you got the shot. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. The preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in persons 12 months through 35 months of age, or the deltoid muscle in persons 36 months of age. Dosage form: suspension for intramuscular injection 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). Cookies used to make website functionality more relevant to you. 49281051105. Non-inferiority of the 0.5 mL dose(s) relative to the 0.25 mL dose(s) of Fluzone Quadrivalent was demonstrated for all four strains based on pre-specified criteria (lower limit of the 2-sided 95% CI of the ratio of GMTs between groups > 0.667; lower limit of the 2-sided 95% CI of the difference in seroconversion rates >-10%). Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Influenza Virus Vaccine, Quadrivalent Inactivated, Preservative Free. 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. 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. 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 These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Need help with SupplyManager? Influenza virus strains were selected based on the influenza vaccine production method; egg-based and cell- or recombinant based. Cumulative 2021/2022 Season Lot Release Status (Updated 11/3/2021). McKesson Acceptable Dating: we will ship >= 30 days. Antibody responses to Fluzone Quadrivalent are lower in persons 65 years of age than in younger adults. 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. Antibiotics are not used in the manufacture of Fluzone Quadrivalent. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. The preferred site for infants and young children is the anterolateral aspect of the thigh. 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. Additional guidance regarding site selection and needle length for intramuscular administration is available in the ACIP General Best Practice Guidelines for Immunization.pdf icon. If you wish to continue to this external website, click Proceed. HI antibody GMTs 21 days following vaccination with Fluzone Quadrivalent were non-inferior to those following TIV for all four strains, based on pre-specified criteria (see Table 13). Anyone can catch and spread flu. The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. * 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. Swiftwater, PA: Sanofi3Lee JKH, Lam GKL, Shin T, et al. What are the ingredients in Fluzone Quadrivalent? 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. Fluzone Quadrivalent has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. Available at: Warren-Gash C, et al. Package inserts for U.S.-licensed vaccinesexternal icon. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. Before sharing sensitive information, make sure you're on a federal government site. Participants were monitored for unsolicited adverse events and SAEs during the 21 days following vaccination. E, 10 Single-Dose 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. The most commonly reported unsolicited non-serious adverse events were headache, cough, and oropharyngeal pain. Do not administer Fluzone Quadrivalent to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see Description (11)], including egg protein, or to a previous dose of any influenza vaccine. Sanofi flu vaccines licensed and approved for 2022-2023 influenza Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Pregnant women are at increased risk of complications associated with influenza infection compared to non-pregnant women. 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. 2021 Mar;69(3):696-703. Flublok Quadrivalent | FDA Michael Greenberg, MD, MPHNorth America Medial Head of Vaccines at Sanofi"ACIP's recommendation is a first step to help improve protection against flu and its complications for this 65 years and older high-risk population. We comply with the HONcode standard for trustworthy health information. It is not known whether Fluzone Quadrivalent is excreted in human milk. Disease-associated Maternal and/or Embryo/Fetal Risk. ", 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). Study 2 (NCT02915302 see http://clinicaltrials.gov) was a randomized, observer-blinded, 2-arm, multi-center safety and immunogenicity study conducted in the US. Participants received one dose of either Fluzone vaccine (N = 813), an active comparator (N = 814), or placebo (N = 325). Products: Comirnaty (COVID-19 vaccine) Sanofi U.S. 55 Corporate Drive Bridgewater, NJ 08807 Vaccines and biologics Flublok: Package Insert - Drugs.com For Fluzone Quadrivalent, in children 6 months through 35 months of age, the most common side effects were pain, tenderness, redness, and/or swelling where you got the shot; irritability, abnormal crying, general discomfort, drowsiness, loss of appetite, muscle aches, vomiting, and fever. 47823. Discard unused portion. Vaccine efficacy against all influenza viral types and subtypes was a secondary endpoint and is presented in Table 8. 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. 800.422.0280. Forward-looking statements are statements that are not historical facts. Generic name: influenza vaccine For Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent, other side effects may occur. The most commonly reported adverse events were oropharyngeal pain, rhinorrhea, injection-site induration, and headache. 1) If GBS has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone Quadrivalent should be based on careful consideration of the potential benefits and risks. Product: Influenza (FluMist Quadrivalent) Bavarian Nordic A/S Hejreskovvej 10A DK-3490 Kvistgaard Phone: 1-800-675-9596 Email: info@bavarian-nordic.com Product: . The Lancet Respiratory Medicine. Please refer to the full Prescribing Information forFluzone High-Dose Quadrivalent, Flublok Quadrivalent, orFluzone Quadrivalent. 2019 Sep 16;37(39):5825-5834. It can lead to severe complications, increasing the risk of heart attack and pneumonia. 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. Participants 6 months through 35 months of age received one or two 0.25 mL doses and participants 3 years through 8 years of age received one or two 0.5 mL doses of Fluzone Quadrivalent, TIV-1, or TIV-2. Syncope (fainting) has been reported following vaccination with Fluzone Quadrivalent. 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. 60 mcg / 0.5 mL. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Questions: Toll-free: 877-2Get-VFC (877-243-8832) 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. Furthermore, antibodies to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype. [See Clinical Studies (14.6).] 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. You are about to visit another Sanofi website. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. Antibodies against one influenza virus type or subtype confer limited or no protection against another. They help us to know which pages are the most and least popular and see how visitors move around the site. CDC twenty four seven. 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. We take your privacy seriously. (See ref. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. The most commonly reported unsolicited non-serious adverse events in both groups were cough and rhinorrhea. 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. The 1976 swine influenza vaccine was associated with an elevated risk of Guillain Barr syndrome (GBS). Single-dose, prefilled syringe (clear plunger rod), without needle, 0.5 mL (NDC 49281-422-88) (not made with natural rubber latex). In addition, Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction after previous dose of any influenza vaccine. Contact the Sanofi Pasteur Reimbursement Support Service (RSS). Sanofi Pasteur Inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes following vaccination with Fluzone Quadrivalent during pregnancy. In adults 18 years and older, the most common (10%) injection-site reaction was pain (47%); the most common solicited systemic adverse reactions were myalgia (24%), headache (16%), and malaise (11%). COVID-19 Vaccine Lot Number and Expiration Date Tool Seasonal Influenza Codes and Crosswalk This new format includes all seasonal influenza vaccines for the 2022/2023 season in a single Excel crosswalk table that provides the CVX, MVX, NDC Unit of Sale, NDC Unit of Use, and CPT (*) codes for each vaccine. Since 1977, antigenic variants of influenza A (H1N1 and H3N2) viruses and influenza B viruses have been in global circulation. Fluzone Quadrivalent Prescribing Information, Respiratory, Thoracic and Mediastinal Disorder, General Disorders and Administration Site Conditions, Active Substance: Split influenza virus, inactivated strains, influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/darwin/9/2021 san-010 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) injection, suspension, influenza a virus a/guangdong-maonan/swl1536/2019 cnic-1909 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/hong kong/2671/2019 ivr-208 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), influenza b virus b/washington/02/2019 antigen (formaldehyde inactivated) injection, suspension, 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/phuket/3073/2013 hemagglutinin antigen (formaldehyde inactivated), influenza b virus b/maryland/15/2016 bx-69a antigen (formaldehyde inactivated) injection, suspension, influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/kansas/14/2017 x-327 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), influenza b virus b/maryland/15/2016 bx-69a antigen (formaldehyde inactivated) injection, suspension, influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/tasmania/503/2020 ivr-221 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), influenza b virus b/washington/02/2019 antigen (formaldehyde inactivated) injection, suspension.