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. Before administering a dose of vaccine, shake the prefilled syringe or vial. If you wish to continue to this external website, click Proceed. Unsolicited non-serious adverse events were reported in 33 (17.4%) recipients in the Fluzone Quadrivalent group, 45 (23.7%) recipients in the TIV-1 group, and 45 (23.7%) recipients in the TIV-2 group. Flublok Quadrivalent STN: 125285 Proper Name: Influenza Vaccine Tradename: Flublok Quadrivalent Manufacturer: Protein Sciences Corporation Indication: For active immunization against. Manufactured by: In addition, Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction after previous dose of any influenza vaccine. The preferred site for infants and young children is the anterolateral aspect of the thigh. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. To receive email updates about this page, enter your email address: For more information on background and concepts see Understanding the Rules for Creating CVX and MVX Codes [5 pages], View archived 2015 Edition Versioned Codes, More ways to access CDCs Vaccine Code Set information: Code Set Viewpoint search/browse website and REST Web Service. Antibody responses to Fluzone Quadrivalent are lower in persons 65 years of age than in younger adults. 8Grohskoph L. Influenza Vaccines for Persons Aged 65 Years: Evidence to Recommendations (EtR) Framework. Swiftwater, PA 18370 USA. We believe we must protect beyond the influenza infection to help reduce the risks of its severe complications, which too often bring people to hospital. 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. It can lead to severe complications, increasing the risk of heart attack and pneumonia. Discard unused portion. 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. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Fluzone Quadrivalent should not be combined through reconstitution or mixed with any other vaccine. Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration, whenever solution and container permit. Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. 49281051105. Tuberculin Purified Protein Derivative (Mantoux) - Food and Drug 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. 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. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Tell your health care provider if you have ever had Guillain-Barr syndrome (severe muscle weakness) after a previous influenza vaccination. Vaccine efficacy of Fluzone against all influenza viral types and subtypes is presented in Table 9. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. This summary is not intended to take the place of talking with your healthcare provider. 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. 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) It is not known whether Fluzone Quadrivalent is excreted in human milk. 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). Sanofi Pasteur will continue to deliver and offer the trivalent formulation of Fluzone High-Dose through . 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Influenza (seasonal) Fact Sheet. 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. Cookies used to make website functionality more relevant to you. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Accessed, https://www.cdc.gov/flu/spotlights/2021-2022/specific-vaccines-seniors.htm, https://www.cdc.gov/flu/highrisk/index.htm, https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-22-23/03-influenza-grohskopf-508.pdf, https://www.cdc.gov/flu/prevent/vaccine-selection.htm, https://www.nejm.org/doi/full/10.1056/nejmoa1315727. (2019). Influenza-like illness was defined as an illness with at least 1 respiratory symptom (cough or nasal congestion) and at least 1 constitutional symptom (fever or feverishness, chills, or body aches). ** 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. Swiftwater, PA: Sanofi2Fluzone High-Dose Quadrivalent [Prescribing Information]. Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Adults 65 Years of Age: A Phase 3 Randomized Clinical Trial. In this study, children 6 months through 35 months of age received one or two doses of either 0.25 mL or 0.5 mL of Fluzone Quadrivalent. Since 2001, two distinct lineages of influenza B (Victoria and Yamagata lineages) have co-circulated worldwide. The new facility building at Swiftwater has had an investment of $150m. The most common side effects of Fluzone Quadrivalent are: These are not all of the possible side effects of Fluzone Quadrivalent. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton X-100), producing a "split virus". 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 High-Dose Quadrivalent (Influenza Vaccine) and Flublok Quadrivalent (Influenza Vaccine) are the only two flu vaccines proven to help prevent more cases of flu in older adults, compared to their standard-dose flu vaccine comparators as assessed in randomized controlled trials, the gold standardin evaluating clinical evidence for vaccine licensure1,2* FluzoneHigh-Dose (Influenza Vaccine) is the first and only influenza vaccine with superior flu protection and 10 years of evidence in preventing flu-related hospitalizations in adults aged 65+2,3,a,b* As the leaders in flu, Sanofi is committed to protecting patients most at-risk for the flu and its related complications, including hospitalizations due to pneumonia & cardiovascular events4. You can ask your healthcare provider for a list of other side effects that is available to healthcare professionals. The Lancet Respiratory Medicine. Global Medical Affairs Influenza, Sanofi. 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.
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