Report adverse reactions to their healthcare provider and/or to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. 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. (2019). 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. In Study 3 (NCT00988143) [see Adverse Reactions (6.1)], 565 adults 18 years of age and older who had received one dose of Fluzone Quadrivalent, TIV-1, or TIV-2 were included in the per-protocol immunogenicity analysis. Available at: Warren-Gash C, et al. Pregnant women are at increased risk of complications associated with influenza infection compared to non-pregnant women. Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial. What are the possible side effects of Fluzone Quadrivalent? Vaccination of female rabbits with Fluzone Quadrivalent revealed no evidence of impaired female fertility [see Animal Data (8.1)]. 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. Fluzone Quadrivalent contains 4 killed flu virus strains. The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. If any of these defects or conditions exist, Fluzone Quadrivalent should not be administered. About 16,000. employees globally, 65% of them dedicated to manufacturing and quality operations. L The intent-to-treat analysis set included a total of 786 children 6 through 24 months of age. 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. Thomas Triomphe-- Executive Vice President, Sanofi Pasteur. Available at https://www.cdc.gov/flu/spotlights/2021-2022/specific-vaccines-seniors.htm. Accessed June 2022.5FDA Approval of Sanofi Licensure Request for Vaccine Approval for 2022-2023 Influenza Season [Data on File]6Centers for Disease Control and Prevention. 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. It can lead to severe complications, increasing the risk of heart attack and pneumonia. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Among participants in the three vaccine groups combined, 55.7% were female (Fluzone Quadrivalent, 57.3%; TIV-1, 56.0%; TIV-2, 53.8%), 89.5% Caucasian (Fluzone Quadrivalent, 87.6%; TIV-1, 89.8%; TIV-2, 91.1%), 2.2% Black (Fluzone Quadrivalent, 4.0%; TIV-1, 1.8%; TIV-2, 0.9%), 7.4% Hispanic (Fluzone Quadrivalent, 8.4%; TIV-1, 7.6%; TIV-2, 6.2%) and 0.9% were of other racial/ethnic groups (Fluzone Quadrivalent, 0.0%; TIV-1, 0.9%; TIV-2, 1.8%). Since 2001, two distinct lineages of influenza B (Victoria and Yamagata lineages) have co-circulated worldwide. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. 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. Sanofi Pasteur Inc. Accessed June 2022. The table shows the patterns for the different lot numbers for the six VFC vaccines this difference impacts. A randomized, double-blind, placebo-controlled study was conducted in a single US center during the 2007-2008 influenza season. 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. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. Tell your health care provider if you have ever had Guillain-Barr syndrome (severe muscle weakness) after a previous influenza vaccination. This study revealed no adverse effects to the fetus or pre-weaning development due to Fluzone Quadrivalent [see Animal Data (8.1)]. Samson et al. For infants, Fluzone Quadrivalent is a shot given into the muscle of the thigh. Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. Fluzone High Dose Quadrivalent (Influenza Vaccine) Prescribing Information Patient Information www.sanofiflu.com Fluzone Quadrivalent (Influenza Vaccine) Prescribing Information Patient Information www.sanofiflu.com Imovax Rabies (Rabies Vaccine) Prescribing Information Imogam Rabies - HT (Rabies Immune Globulin (Human) USP, Heat Treated) The new facility building at Swiftwater has had an investment of $150m. McKesson Acceptable Dating: we will ship >= 30 days. Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for the usual change of one or more new strains in each year's influenza vaccine. Participants received two 0.25 mL doses of either Fluzone (N = 525) or a placebo (N = 261). 2014;371(7):635-645 https://www.nejm.org/doi/full/10.1056/nejmoa131572711Falsey AR, Treanor JJ, Tornieporth N, Capellan J, Gorse GJ. 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%). Product Dating. MacIntyre CR, et al. Vaccination with Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent may not protect all people who receive the vaccine. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Cases of influenza were identified through active and passive surveillance and confirmed by cell culture and/or real-time polymerase chain reaction (PCR). Fluzone Quadrivalent is a vaccine that helps protect against influenza illness (flu). These are reference CPT codes for vaccine categorization and are not intended to represent billable codes. 2) (See ref. 2) Single-dose vial, 0.5 mL, for persons 6 months 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) 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. It can lead to severe complications, increasing the risk of heart attack and pneumonia. What are the ingredients in Fluzone Quadrivalent? 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. Prior to vaccination, always refer to the current Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza vaccines. ever had a severe allergic reaction after getting any flu vaccine. The Fluzone Quadrivalent prefilled syringe and vial presentations are not made with natural rubber latex. Global surveillance of influenza identifies yearly antigenic variants. Questions: Toll-free: 877-2Get-VFC (877-243-8832) 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%). Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury. Last updated on Nov 1, 2022. Additional guidance regarding site selection and needle length for intramuscular administration is available in the ACIP General Best Practice Guidelines for Immunization.pdf icon. 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). 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 The safety analysis set included 570 recipients, half aged 18-60 years and half aged 61 years or older. 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. You can review and change the way we collect information below. Participants received one dose of either Fluzone vaccine (N = 813), an active comparator (N = 814), or placebo (N = 325). Available at: https://www.cdc.gov/flu/highrisk/65over.htm. Discard if vaccine has been frozen. You should not get Fluzone Quadrivalent if you: Tell your healthcare provider if you or your child have or have had: Fluzone Quadrivalent is a shot given into the muscle of the arm. 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. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton X-100), producing a "split virus". You can review and change the way we collect information below. The following events have been spontaneously reported during the post-approval use of Fluzone (trivalent) or Fluzone Quadrivalent. 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. Abbreviations: ACIP = Advisory Committee on Immunization Practices; FDA = Food and Drug Administration; HA = hemagglutinin; IIV3 = inactivated influenza vaccine, trivalent; IIV4 = inactivated influenza vaccine, quadrivalent; IM = intramuscular; LAIV4 = live attenuated influenza vaccine, quadrivalent; MDV = multidose vial; NAS = intranasal; PFS = prefilled syringe; RIV4 = recombinant influenza vaccine, quadrivalent; SDV = single-dose vial. 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 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. 2021 Mar;69(3):696-703. 3). 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. 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. 2022- 2023 Influenza Season Vaccine Labels 6 Ages: 65 years or older Dosage: 0.7 mL Route: Intramuscular (IM) injection Fluzone Quadrivalent (IIV4) (Quadrivalent Inactivated Influenza Vaccine) 5 mL Multi-dose Vial 6 months or older Ages: Dosage: 0.25 mL or 0.5 mL for age 6 through 35 months 0.5 mL for age 3 years or older Route: people vaccinated annually with Sanofi's vaccines worldwide. 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). 60 mcg / 0.5 mL. A world leader. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. The effectiveness of Fluzone Quadrivalent was demonstrated based on clinical endpoint efficacy data for Fluzone (trivalent influenza vaccine) and on an evaluation of serum HI antibody responses to Fluzone Quadrivalent. Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Adults 65 Years of Age: A Phase 3 Randomized Clinical Trial. Fluzone Quadrivalent is for people who are 6 months of age and older. Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. 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 site is secure. 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. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. ACIP Flu Meeting Update: Flu Vaccines Worked Better than Reported & ACIP Recommends Specific Vaccines for Seniors. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. 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. It is provided for information only. Package insert / product label 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. 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 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 distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. 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%). All information these cookies collect is aggregated and therefore anonymous. 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. You can ask your healthcare provider for a list of other side effects that is available to healthcare professionals. Centers for Disease Control and Prevention. 2005-2022 sanofi-aventis U.S. LLC - All rights reserved. The most common side effects of Fluzone Quadrivalent are: These are not all of the possible side effects of Fluzone Quadrivalent. Influenza Virus Vaccine, Quadrivalent Inactivated, Preservative Free. 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%). We take your privacy seriously. Table 5 summarizes solicited injection-site and systemic adverse reactions reported within 3 days post-vaccination via diary cards. But not all flu vaccines are the same. You are about to visit another Sanofi website. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines). Accessed on June 22, 2022. During the 28 days following vaccination, a total of 16 (0.6%) recipients in the Fluzone Quadrivalent group, 4 (0.5%) recipients in the TIV-1 group, and 4 (0.6%) recipients in the TIV-2 group, experienced at least one SAE. Please refer to the full Prescribing Information forFluzone High-Dose Quadrivalent, Flublok Quadrivalent, orFluzone Quadrivalent. 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. Fluzone is a registered trademark of Sanofi Pasteur Inc. 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).
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