Selecting Viruses for the Seasonal Influenza Vaccine. 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, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction to any component of the vaccine (including eggs or egg products for Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent) or after previous dose of the vaccine. Sanofi : FDA approves Fluzone High-Dose Quadrivalent (Influenza 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. Since 1977, antigenic variants of influenza A (H1N1 and H3N2) viruses and influenza B viruses have been in global circulation. Available at: https://www.cdc.gov/flu/highrisk/65over.htm. Product Dating. Fluzone Quadrivalent should not be combined through reconstitution or mixed with any other vaccine. Its an infectious disease that does more damage than most people realize. The most commonly reported unsolicited non-serious adverse events were cough, vomiting, and pyrexia. Sanofi Pasteur Vaccine Production Plant, Swiftwater, Pennsylvania Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. Centers for Disease Control and Prevention. Fluzone Quadrivalent is supplied in 3 presentations: 1) Prefilled single-dose syringe (clear syringe plunger rod), 0.5 mL, for persons 6 months of age and older. 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. Storage Requirements. 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 Accounts Receivable 800.453.5180 Influenza Vaccine for the 2021-2022 Season Cumulative 2021/2022 Season Lot Release Status (Updated 11/3/2021) Flu vaccine lots that have been released by FDA and are available for. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of Fluzone Quadrivalent. Unsolicited non-serious adverse events were reported in 33 (17.4%) recipients in the Fluzone Quadrivalent group, 45 (23.7%) recipients in the TIV-1 group, and 45 (23.7%) recipients in the TIV-2 group. Prior to vaccination, always refer to the current Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza vaccines. CDC twenty four seven. Influenza (seasonal) Fact Sheet. 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. Safety and immunogenicity of Fluzone Quadrivalent were evaluated in adults 65 years of age and older. What are the possible side effects of Fluzone Quadrivalent? Furthermore, antibodies to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype. Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration, whenever solution and container permit. With the increased risk of H5N1 bird flu being passed by . In adults 18 years and older, the most common side effects were pain where you got the shot; muscle aches, headache, and general discomfort. That means not only using mRNA or protein-based technologies, but alsonovel methodsof antigen selection in order to inducebroader protection. 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. In this study, children 6 months through 35 months of age received one or two doses of either 0.25 mL or 0.5 mL of Fluzone Quadrivalent. Call your healthcare provider for advice about any side effects that concern you. Flu impacts peoples lives and puts a considerable strain on already stretched health systems during the winter season. 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. 2018 Mar 29;51(3):1701794. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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). Participants were monitored for unsolicited adverse events and SAEs during the 21 days following vaccination. For infants, Fluzone Quadrivalent is a shot given into the muscle of the thigh. 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%). The most common side effects of Fluzone Quadrivalent are: These are not all of the possible side effects of Fluzone Quadrivalent. Drug class: Viral vaccines. Fluzone Quadrivalent is given to people 6 months of age and older. Most participants were White (91.2% and 89.7%), followed by Black (6.8% and 8.0%), and Hispanic (2.8% and 2.6%) in the Fluzone High-Dose Quadrivalent and Fluzone High-Dose groups, respectively. For preventive vaccines, the underlying maternal condition is susceptibility to the disease prevented by the vaccine. 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). Single-dose, prefilled syringe (clear plunger rod), without needle, 0.5 mL (NDC 49281-422-88) (not made with natural rubber latex). Sanofi has led the way with the first human vaccine in the US against the H5N1 virus. WHO. 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). 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. They help us to know which pages are the most and least popular and see how visitors move around the site. Influenza Vaccine for the 2020-2021 Season | FDA 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. 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%). CDC twenty four seven. an A/Wisconsin/588/2019 (H1N1) pdm09-like virus. Influenza Virus Vaccine, Quadrivalent Inactivated, Preservative Free. ever had a severe allergic reaction after getting any flu vaccine. The safety analysis set included 1941 participants who received at least 1 dose of study vaccine. Influenza illness and its complications follow infection with influenza viruses. 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). It is not known whether Fluzone Quadrivalent is excreted in human milk. 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. 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. 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. Cookies used to make website functionality more relevant to you. 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. 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. Accessed on June 22, 2022. Package insert / product label 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.