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. FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Silver Spring, Maryland, on March 5, 2021, to select the influenza viruses for the composition of the influenza vaccine for the 2021-2022 U.S. influenza season. Procedures should be in place to avoid injury from fainting. Accessed on June 22, 2022. (2019). [See Clinical Studies (14.6).] Available at https://www.cdc.gov/flu/prevent/vaccine-selection.htm. Influenza Vaccine for the 2021-2022 Season | FDA 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). 3). 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Seasonal Influenza Vaccine, Flu Vaccine and People with Egg Allergies, Frequently Asked Questions on Vaccine Supply, Historical Reference of Vaccine Doses Distributed, Investigating Respiratory Viruses in the Acutely Ill (IVY), Respiratory Virus Transmission Network (RVTN), Randomized Assessment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. Inform the vaccine recipient or guardian: Vaccine Information Statements must be provided to vaccine recipients or their guardians, as required by the National Childhood Vaccine Injury Act of 1986 prior to immunization. You can ask your healthcare provider for a list of other side effects that is available to healthcare professionals. References1Flublok Quadrivalent [Prescribing Information]. 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. 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. The most commonly reported unsolicited non-serious adverse events were headache, cough, and oropharyngeal pain. Study 2 (NCT02915302 see http://clinicaltrials.gov) was a randomized, observer-blinded, 2-arm, multi-center safety and immunogenicity study conducted in the US. Fluzone Quadrivalent: Package Insert - Drugs.com Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. What better way to launch Our Stories than to learn about us through the words of our people. Sanofi Pasteur Inc. 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. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Flublok Quadrivalent is given to people 18 years of age and older. Generic Drug Name. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. 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. ** Fluzone Quadrivalent is currently licensed for ages 6 through 35 months at either 0.25 mL or 0.5 mL per dose; however, .25-mL prefilled syringes are not expected to be available for the 2020-21 influenza season. Sanofi has led the way with the first human vaccine in the US against the H5N1 virus. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. PDF Check Your Vials: Tdap - immunize.org HI antibody GMTs 21 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 12). Before sharing sensitive information, make sure you're on a federal government site. Available at: WHO - Coadministration of seasonal inactivated influenza and COVID-19 vaccines. J Infect Dis. 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. MacIntyre CR, et al. Availability and characteristics of specific products and presentations might change and/or differ from what is described in this table and in the text of the full report. Influenza Vaccine for the 2020-2021 Season Cumulative 2020/2021 Season Lot Release Status (Updated 2/24/2021) Flu vaccine lots that have been released by FDA and are available for. 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. In adults 50 years of age and older the most common side effects were tenderness, and/or pain where you got the shot; headache and tiredness. J Diabetes Sci Technol. PDF Lot Number Variations between Unit of Sale and Unit of Use You can review and change the way we collect information below. Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration, whenever solution and container permit. 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. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY, Media RelationsEvan Berland| + 1 215 432 0234 | evan.berland@sanofi.comSally Bain| + 1 781 264 1091 | sally.bain@sanofi.comKate Conway| + 1 617 981 2738 | kate.conway@sanofi.com, Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delpine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+1 617 764 6418| priya.nanduri@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com. 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. 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%). https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal), https://heart.bmj.com/content/heartjnl/102/24/1953.full.pdf, https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE_recommendation-coadministration-influenza-vaccines, https://doi.org/10.1016/S2213-2600(21)00557-9. 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%). It can lead to severe complications, increasing the risk of heart attack and pneumonia. The safety analysis set included 1941 participants who received at least 1 dose of study vaccine. 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. 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. 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. 2018 Mar 29;51(3):1701794. Supplied as package of 10 (NDC 49281-422-10). Product Dating. Cookies used to make website functionality more relevant to you. Thank you for taking the time to confirm your preferences. 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. DO NOT FREEZE. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. Study 1 (NCT01240746, see http://clinicaltrials.gov) was a single-blind, randomized, active-controlled multi-center safety and immunogenicity study conducted in the US. The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. 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. 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. You can review and change the way we collect information below. Dosage form: suspension for intramuscular injection However, in some human studies, antibody titers 1:40 have been associated with protection from influenza illness in up to 50% of subjects. Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Seasonal Information for Influenza Virus Vaccine, Guidance, Compliance & Regulatory Information (Biologics), Influenza Vaccine for the 2021-2022 Season. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. 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. That means not only using mRNA or protein-based technologies, but alsonovel methodsof antigen selection in order to inducebroader protection. 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. Women who receive Fluzone Quadrivalent during pregnancy are encouraged to contact Sanofi Pasteur Inc. directly or have their healthcare provider contact Sanofi Pasteur Inc. at 1-800-822-2463. COVID-19 Vaccine Lot Number and Expiration Date Tool. These are reference CPT codes for vaccine categorization and are not intended to represent billable codes. 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. 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. Forward-looking statements are statements that are not historical facts. Sanofi Pasteur Vaccine Production Plant, Swiftwater, Pennsylvania Vaccine 2021; 39: A24-A35. ** 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. 2019 Sep 16;37(39):5825-5834. 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. The most commonly reported unsolicited non-serious adverse events in both groups were cough and rhinorrhea. Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. Unsolicited non-serious adverse events were reported in 28 (12.4%) recipients in the Fluzone Quadrivalent group, 22 (9.8%) recipients in the TIV-1 group, and 22 (9.8%) recipients in the TIV-2 group. Centers for Disease Control and Prevention. 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. 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. Generic name: influenza vaccine Flublok Quadrivalent: Package Insert - Drugs.com Single-dose, prefilled syringe (clear plunger rod), without needle, 0.5 mL (NDC 49281-422-88) (not made with natural rubber latex). 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. people vaccinated annually with Sanofi's vaccines worldwide. McKesson Acceptable Dating: we will ship >= 180 days.