PDF Influenza Vaccine Products for the 2022-2023 Influenza Season Fluzone Quadrivalent/NDC 49281-422-88 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. 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. It can lead to severe complications, increasing the risk of heart attack and pneumonia. Participants received one dose of either Fluzone vaccine (N = 813), an active comparator (N = 814), or placebo (N = 325). Do not use after the expiration date shown on the label. Its an infectious disease that does more damage than most people realize. Accessed June 2022.10DiazGranados CA, et al. NDC Number. 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). 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. While patients can receive vaccinations from a variety of sources, offering them within the "medical home" leads to increased immunization rates. You will be subject to the destination website's privacy policy when you follow the link. 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). The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Available at https://www.cdc.gov/flu/prevent/vaccine-selection.htm. Storage Requirements. Cookies used to make website functionality more relevant to you. (*) Please note that the CPT codes shown for each vaccine crosswalk are not mapped to the NDC codes, but are mapped to the CVX codes shown. 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). Fluzone Quadrivalent: Package Insert - Drugs.com Flu & People 65 Years and Older. A world leader. For Fluzone Quadrivalent, in children 6 months through 35 months of age, the most common side effects were pain, tenderness, redness, and/or swelling where you got the shot; irritability, abnormal crying, general discomfort, drowsiness, loss of appetite, muscle aches, vomiting, and fever. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. Package inserts for U.S.-licensed vaccinesexternal icon. If you wish to continue to this external website, click Proceed. It is provided for information only. Product Dating. Vaccination with Fluzone Quadrivalent may not protect all recipients. GMT ratios (GMT0.5-mL dose divided by GMT0.25-mL dose) for the A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage strains were 1.42 (95% CI: 1.16; 1.74), 1.48 (95% CI: 1.21; 1.82), 1.33 (95% CI: 1.09; 1.62), and 1.41 (95% CI: 1.17; 1.70), respectively. We aim to ensure these vaccines, supported by a high level of evidence, are available to protect as many people as possible each flu season., Sandrine Samson, PhD 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. DO NOT FREEZE. DailyMed - FLUZONE HIGH-DOSE QUADRIVALENT NORTHERN HEMISPHERE 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). The .gov means its official.Federal government websites often end in .gov or .mil. Sanofi Pasteur 49281041850 - McKesson Medical-Surgical Flu vaccine lots that have been released by FDA and are available for distribution by the manufacturers. Accessed June 2022. 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. J Infect Dis. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. 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. Available data with Fluzone Quadrivalent use in pregnant women are insufficient to inform vaccine-associated risk of adverse developmental outcomes. Inactive ingredients include formaldehyde and octylphenol ethoxylate. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. Before administering a dose of vaccine, shake the prefilled syringe or vial. McKesson Acceptable Dating: we will ship >= 30 days. 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). Supplied as package of 10 (NDC 49281-422-50). Swiftwater, PA: Sanofi2Fluzone High-Dose Quadrivalent [Prescribing Information]. 9Centers for Disease Control and Prevention. 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. 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 Influenza-like illness was defined as fever with signs or symptoms of an upper respiratory infection. Forward-looking statements are statements that are not historical facts. 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. Centers for Disease Control and Prevention. The latest UKHSA data on the maternal whooping cough vaccine programme shows that uptake has dropped to its lowest level in 7 years. Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. 49281-0418-50. 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. 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. Eur respir J. Single-dose vial, 0.5 mL (NDC 49281-422-58) (not made with natural rubber latex). Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury. 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. Influenza (seasonal) Fact Sheet. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Study 2 (NCT02915302 see http://clinicaltrials.gov) was a randomized, observer-blinded, 2-arm, multi-center safety and immunogenicity study conducted in the US. IIS Data Code Sets | CDC Fluzone Quadrivalent stimulates the immune system to protect against influenza, but does not prevent other respiratory infections. problems with your immune system as the immune response may be diminished. Sanofi : FDA approves Fluzone High-Dose Quadrivalent (Influenza If you have questions or would like more information, please talk with your healthcare provider. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. Thank you for taking the time to confirm your preferences. It can lead to severe complications, increasing the risk of heart attack and pneumonia. 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. Vaccines manufactured by MedImmune (AstraZeneca), Pfizer, Merck and Bio CSL have the same lot number on their UoS and UoU so this issue does not have an impact on any of their vaccines. - McKesson Medical-Surgical However, in some human studies, antibody titers 1:40 have been associated with protection from influenza illness in up to 50% of subjects. Withdraw one dose of vaccine from the single-dose vial using a sterile needle and syringe. Fluzone High-Dose Quadrivalent: Package Insert - Drugs.com The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. 2021 Dec 6;73(11):e4288-e4295. Before sharing sensitive information, make sure you're on a federal government site. The percentage of subjects 75 years of age or older was 35.4% in the Fluzone High-Dose Quadrivalent group and 35.8% in the Fluzone High-Dose group. Dosing for infants and children age 6 through 35 months: Afluria 0.25 mL Fluarix 0.5 mL Flucelvax 0.5 mL FluLaval 0.5 mL Fluzone 0.25 mL or 0.5 mL 4. TABLE 1. Influenza vaccines United States, 2020-21 influenza season* Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of Fluzone Quadrivalent. Annual influenza vaccination is recommended. 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. Td (sanofi pasteur) Age indications for use of products in the VFC program may differ from age indications on this guide or in the package inserts. 3). 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. 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. This summary is not intended to take the place of talking with your healthcare provider. FDA-approved patient labeling (Patient Information), "-" Indicates information is not applicable, Not previously vaccinated with influenza vaccine or unknown vaccination history, Previously vaccinated with influenza vaccine, If two doses, administer at least 4 weeks apart, Sodium phosphate-buffered isotonic sodium chloride solution, INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/WASHINGTON/02/2019 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), 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/MARYLAND/15/2016 BX-69A HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED).

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