Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury. 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. Study 2 (NCT02915302 see http://clinicaltrials.gov) was a randomized, observer-blinded, 2-arm, multi-center safety and immunogenicity study conducted in the US. 2) (See ref. The most commonly reported unsolicited non-serious adverse events in both groups were cough and rhinorrhea. They help us to know which pages are the most and least popular and see how visitors move around the site. 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. Fluzone Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2022-2023 influenza season: A/Victoria/2570/2019 IVR-215 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). Vaccine. Vaccination of female rabbits with Fluzone Quadrivalent revealed no evidence of impaired female fertility [see Animal Data (8.1)]. Fluzone High-Dose Quadrivalent is given to people 65 years of age and older. For preventive vaccines, the underlying maternal condition is susceptibility to the disease prevented by the vaccine. (2021) Efficacy and effectiveness of high-dose influenza vaccine in older adults by circulating strain and antigenic match: An updated systematic review and meta-analysis. Accessed on June 22, 2022. Products: Comirnaty (COVID-19 vaccine) Sanofi U.S. 55 Corporate Drive Bridgewater, NJ 08807 Vaccines and biologics Sanofi Pasteur 49281040010 - McKesson Medical-Surgical These cookies may also be used for advertising purposes by these third parties. 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. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 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. Fluzone Quadrivalent contains 4 killed flu virus strains. The preferred site for infants and young children is the anterolateral aspect of the thigh. Available at: Warren-Gash C, et al. 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%). Vaccine Administration: Making the Process More Efficient in Your PDF 2019-2020 PROPER CODING of Sanofi Pasteur Products 1 This was the impetus for the 1994 federal. Based on that information and on the recommendations of the FDAs Vaccines and Related Biological Products Advisory Committee, the FDA selects the different influenza strains each year that. Antibiotics are not used in the manufacture of Fluzone Quadrivalent. Procedures should be in place to avoid injury from fainting. In adults 18 years and older, the most common side effects were pain where you got the shot; muscle aches, headache, and general discomfort. 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. 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. 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. 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. See FDA-approved patient labeling (Patient Information). The preservative thimerosal is only in the multi-dose vial of Fluzone Quadrivalent. McKesson Acceptable Dating: we will ship >= 30 days. The Lancet Respiratory Medicine. The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. Since 2001, two distinct lineages of influenza B (Victoria and Yamagata lineages) have co-circulated worldwide. (2019). Table 6 summarizes solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards. PDF Fluzone High Dose - Sanofi For participants recommended to receive two doses of influenza vaccine as per Advisory Committee on Immunization Practices guidance, the same dose was administered 4 weeks after the first. Requires Refrigeration. 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. Data for 2022 shows an average uptake across England of 61.5% . Available at: WHO - Coadministration of seasonal inactivated influenza and COVID-19 vaccines. Selecting Viruses for the Seasonal Influenza Vaccine. All information these cookies collect is aggregated and therefore anonymous. MacIntyre CR, et al. The safety analysis set included 675 recipients. Vaccination with Fluzone Quadrivalent may not protect all people who receive the vaccine. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Thank you for taking the time to confirm your preferences. Vaccination with Fluzone Quadrivalent may not protect all recipients. Participants were monitored for unsolicited adverse events and SAEs during the 28 days following vaccination. Single-dose vial, 0.5 mL (NDC 49281-422-58) (not made with natural rubber latex). For adults and older children, the recommended site for intramuscular influenza vaccination is the deltoid muscle. Available at https://www.cdc.gov/flu/spotlights/2021-2022/specific-vaccines-seniors.htm. Sanofi : FDA approves Fluzone High-Dose Quadrivalent (Influenza 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. Cookies used to make website functionality more relevant to you. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Fluzone Quadrivalent and any potential adverse effects on the breastfed child from Fluzone Quadrivalent or from the underlying maternal condition. 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. 2) Single-dose vial, 0.5 mL, for persons 6 months of age and older. Thank you for taking the time to confirm your preferences. Fluzone High-Dose Quadrivalent: Package Insert - Drugs.com The most commonly reported unsolicited non-serious adverse events were cough, vomiting, and pyrexia. Available at: https://www.cdc.gov/flu/highrisk/65over.htm. 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. It is not known whether Fluzone Quadrivalent is excreted in human milk. 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%). PDF Check Your Vials: Tdap - immunize.org The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The most common side effects of Fluzone Quadrivalent are: These are not all of the possible side effects of Fluzone Quadrivalent. Download the Seasonal Influenza Crosswalk table. 0.5-mL Dose of Fluzone Quadrivalent in Children 6 Months through 35 Months of Age. Tell your health care provider if you have ever had Guillain-Barr syndrome (severe muscle weakness) after a previous influenza vaccination. Heart 2016;102:19531956. Its an infectious disease that does more damage than most people realize. 2014;371(7):635-645 https://www.nejm.org/doi/full/10.1056/nejmoa131572711Falsey AR, Treanor JJ, Tornieporth N, Capellan J, Gorse GJ. 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 . 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. PDF Influenza Vaccine Products for the 2022-2023 Influenza Season 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. In Study 4 (NCT01218646) [see Adverse Reactions (6.1)], 660 adults 65 years of age and older were included in the per-protocol immunogenicity analysis. References1Flublok Quadrivalent [Prescribing Information]. 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%). Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. [See Clinical Studies (14.6).] The .gov means its official.Federal government websites often end in .gov or .mil. 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. 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. Strength. Participants were monitored for unsolicited adverse events and SAEs during the 21 days following vaccination. Vaccine Product Information - Order Vaccines and Contact Manufacturers The information provided in this resource is for informational purposes only. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Vaccines - Sanofi The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Medically reviewed by Drugs.com. Please refer to the full Prescribing Information forFluzone High-Dose Quadrivalent, Flublok Quadrivalent, orFluzone Quadrivalent. 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. 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 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.
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