Thomas Triomphe-- Executive Vice President, Sanofi Pasteur. Andrew MK et al. The preservative thimerosal is only in the multi-dose vial of Fluzone Quadrivalent. 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. Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Sanofi Pharma; Sanofi Genzyme; Sanofi Pasteur; Our data sharing commitments; Managed Access Programs (MAPs) . Vaccine Administration: Making the Process More Efficient in Your People at Higher Risk for Flu Complications. Store all Fluzone Quadrivalent presentations refrigerated at 2 to 8C (35 to 46F). 8Grohskoph L. Influenza Vaccines for Persons Aged 65 Years: Evidence to Recommendations (EtR) Framework. PDF Complete List of Vaccine Names and CPT/CVX Codes The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. 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 Products: Comirnaty (COVID-19 vaccine) Sanofi U.S. 55 Corporate Drive Bridgewater, NJ 08807 Vaccines and biologics 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. Please refer to the full Prescribing Information forFluzone High-Dose Quadrivalent, Flublok Quadrivalent, orFluzone 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. 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). Call 1-800-VACCINE (1-800-822-2463) and choose the prompt for the RSS. Questions: Toll-free: 877-2Get-VFC (877-243-8832) (See ref. The Fluzone Quadrivalent prefilled syringe and vial presentations are not made with natural rubber latex. Antibodies against one influenza virus type or subtype confer limited or no protection against another. ", 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). 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. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Supplied as package of 1 (NDC 49281-637-15). Study 2 (NCT02915302 see http://clinicaltrials.gov) was a randomized, observer-blinded, 2-arm, multi-center safety and immunogenicity study conducted in the US. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. You can review and change the way we collect information below. 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: Fluzone Quadrivalent should not be combined through reconstitution or mixed with any other vaccine. 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. Discard unused portion. 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. Antibody responses to Fluzone Quadrivalent are lower in persons 65 years of age than in younger adults. PDF 2022-2023 Influenza Season Vaccine Label Examples-August 29, 2022 - CDC Pregnant women are at increased risk of complications associated with influenza infection compared to non-pregnant women. Fluzone High-Dose Quadrivalent is given to people 65 years of age and older. Three SAEs were considered to be possibly related to vaccination: croup in a Fluzone Quadrivalent recipient and 2 episodes of febrile seizure, 1 each in a TIV-1 recipient and a TIV-2 recipient. A developmental and reproductive toxicity study was performed in female rabbits given a 0.5 mL/dose of Fluzone Quadrivalent prior to mating and during gestation (a single human dose is 0.5 mL). For Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent, other side effects may occur. ** 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. 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. The most common side effects of Fluzone Quadrivalent are: These are not all of the possible side effects of Fluzone Quadrivalent. This summary is not intended to take the place of talking with your healthcare provider. 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. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. In adults 65 years of age and older, the most common (10%) injection-site reaction was pain (33%); the most common solicited systemic adverse reactions were myalgia (18%), headache (13%), and malaise (11%). Protection from influenza virus infection has not been correlated with a specific level of hemagglutination inhibition (HI) antibody titer post-vaccination. Anyone can catch and spread flu. The dose and schedule for Fluzone Quadrivalent are presented in Table 1. Fluzone Quadrivalent stimulates the immune system to protect against influenza, but does not prevent other respiratory infections. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. Fluzone Quadrivalent is given to people 6 months of age and older. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury. 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. Annual influenza vaccination is recommended. Participants received two 0.25 mL doses of either Fluzone (N = 525) or a placebo (N = 261). What better way to launch Our Stories than to learn about us through the words of our people. Fluzone Quadrivalent is for people who are 6 months of age and older. Ten SAEs were reported during the 28-day follow-up period: 5 (0.5%) in Group 1 and 5 (0.5%) in Group 2. If you wish to continue to this external website, click Proceed. It can lead to severe complications, increasing the risk of heart attack and pneumonia. 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 ). 2021 Mar;69(3):696-703. 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. https://doi.org/10.1016/j.vaccine.2020.09.004. ever had a severe allergic reaction after getting any flu vaccine. (2019). With the increased risk of H5N1 bird flu being passed by . The single-dose, pre-filled syringe (0.5 mL) and the single-dose vial (0.5 mL) are manufactured and formulated without thimerosal or any other preservative. Sanofi flu vaccines licensed and approved for 2022-2023 influenza Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. CDC twenty four seven. McKesson Acceptable Dating: we will ship >= 30 days. 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. 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. Fluzone Quadrivalent is a suspension for injection. We comply with the HONcode standard for trustworthy health information. ACIP General Best Practice Guidelines for Immunization. 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. In addition, HI antibody GMTs and seroconversion rates following Fluzone Quadrivalent were higher than those following TIV for the B strain not contained in each respective TIV based on pre-specified criteria (the lower limit of the 2-sided 95% CI of the ratio of the GMTs [Fluzone Quadrivalent divided by TIV] >1.5 for each B strain in Fluzone Quadrivalent compared with the corresponding B strain not contained in each TIV and the lower limit of the two 2-sided 95% CI of the difference of the seroconversion rates [Fluzone Quadrivalent minus TIV] >10% for each B strain in Fluzone Quadrivalent compared with the corresponding B strain not contained in each TIV). The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk. 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. Flublok Quadrivalent | FDA Selecting Viruses for the Seasonal Influenza Vaccine. Its an infectious disease that does more damage than most people realize. About 16,000. employees globally, 65% of them dedicated to manufacturing and quality operations. Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Product: Influenza (FluMist Quadrivalent) Bavarian Nordic A/S Hejreskovvej 10A DK-3490 Kvistgaard Phone: 1-800-675-9596 Email: info@bavarian-nordic.com Product: . Data for 2022 shows an average uptake across England of 61.5% . The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Sanofi has led the way with the first human vaccine in the US against the H5N1 virus. 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). Report adverse reactions to their healthcare provider and/or to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. The most commonly reported unsolicited non-serious adverse events were cough, vomiting, and pyrexia. Swiftwater, PA 18370 USA. 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). The 1976 swine influenza vaccine was associated with an elevated risk of Guillain Barr syndrome (GBS). You will be subject to the destination website's privacy policy when you follow the link.
Nsw Police Force Dress Policy,
Understanding Culture, Society And Politics Answer Key Module 2,
Articles S
