problems with your immune system as the immune response may be diminished. Flu impacts people's lives and puts a considerable strain on already stretched health systems during the winter season. 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. We are currently innovating in our existing different technologies including egg-based flu vaccines, recombinant proteins, mRNA to develop and deliver vaccines that canprotect as many people as possible against flu and its complications. This approval is the final step toward the company's complete transition to quadrivalent influenza vaccines in the U.S. Fluzone High-Dose Quadrivalent will be made available for immunization efforts during the 2020-2021 influenza season. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. All information these cookies collect is aggregated and therefore anonymous. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Influenza - Sanofi 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 distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. 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. Sanofi : FDA approves Fluzone High-Dose Quadrivalent (Influenza Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. 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. 60 mcg / 0.5 mL. There were no adverse effects on pre-weaning development or vaccine-related fetal malformations noted in this study. (See ref. 0.5 mL each, For 6 months of age and older Single-dose, prefilled syringe (clear plunger rod), without needle, 0.5 mL (NDC 49281-422-88) (not made with natural rubber latex). an A/Wisconsin/588/2019 (H1N1) pdm09-like virus. These cookies may also be used for advertising purposes by these third parties. Please refer to the full Prescribing Information forFluzone High-Dose Quadrivalent, Flublok Quadrivalent, orFluzone Quadrivalent. Medical professionals, medical facility employees 855.571.2100. E, 10 Single-Dose Among participants 6 months through 8 years of age in the three vaccine groups combined, 49.3% were female (Fluzone Quadrivalent, 49.2%; TIV-1, 49.8%; TIV-2, 49.4%), 58.4% Caucasian (Fluzone Quadrivalent, 58.4%; TIV-1, 58.9%; TIV-2, 57.8%), 20.2% Black (Fluzone Quadrivalent, 20.5%; TIV-1, 19.9%; TIV-2, 19.1%), 14.1% Hispanic (Fluzone Quadrivalent, 14.3%; TIV-1, 13.2%; TIV-2, 14.7%), and 7.3% were of other racial/ethnic groups (Fluzone Quadrivalent, 6.8%; TIV-1, 8.0%; TIV-2, 8.5%). The committee recommended that the quadrivalent formulation of egg-based influenza vaccines for the U.S. 2021-2022 influenza season contain the following: The committee recommended that the quadrivalent formulation of cell- or recombinant based influenza vaccines for the U.S. 2021-2022 influenza season contain the following: For trivalent influenza vaccines for use in the U.S. for the 2021-2022 influenza season, depending on the manufacturing method of the vaccine, the committee recommended that the A(H1N1) pdm09, A(H3N2) and B/Washington/02/2019-like virus (B/Victoria lineage) viruses recommended above for the quadrivalent vaccines be used. 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. Influenza Virus Vaccine, Quadrivalent Inactivated, Preservative Free. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines). Vaccination with Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent may not protect all people who receive the vaccine. If Fluzone Quadrivalent is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained. 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. It is provided for information only. 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. 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. in influenza and pediatrics vaccines, first worldwide . The latest UKHSA data on the maternal whooping cough vaccine programme shows that uptake has dropped to its lowest level in 7 years. Forward-looking statements are statements that are not historical facts. Prior to vaccination, always refer to the current Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza vaccines. Products: Comirnaty (COVID-19 vaccine) Sanofi U.S. 55 Corporate Drive Bridgewater, NJ 08807 Vaccines and biologics 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. 9Centers for Disease Control and Prevention. 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. Flublok Quadrivalent STN: 125285 Proper Name: Influenza Vaccine Tradename: Flublok Quadrivalent Manufacturer: Protein Sciences Corporation Indication: For active immunization against. In children 3 years through 8 years of age, the most common side effects were pain, redness, and/or swelling where you got the shot; muscle aches, general discomfort, and headache. 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. 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. Influenza (seasonal) Fact Sheet. Also please see complete Patient Information for Fluzone Quadrivalent andFluzone High-Dose Quadrivalent. 2018 Mar 29;51(3):1701794. 7Centers for Disease Control and Prevention. Cookies used to make website functionality more relevant to you. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. It can lead to severe complications, increasing the risk of heart attack and pneumonia. 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. ** 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. The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. 49281051105. 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. 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. 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). PDF Lot Number Variations between Unit of Sale and Unit of Use (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. 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. CDC twenty four seven. It's an infectious disease that does more damage than most people realize. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. Accessed June 2022. Generic Drug Name. Fluzone Quadrivalent is supplied in 3 presentations: 1) Prefilled single-dose syringe (clear syringe plunger rod), 0.5 mL, for persons 6 months of age and older. Sanofi Pasteur #49281040010 Adacel Tdap Vaccine Indicated for People 10 to 64 Years of Age Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed, Preservative Free Injection Single-Dose Vial 0.5 mL ADACEL TDAP ADLT VACCINE, SDV 2-2.5-5M.5ML (10/BX) Compare Features 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). Study 1 (NCT01240746, see http://clinicaltrials.gov) was a single-blind, randomized, active-controlled multi-center safety and immunogenicity study conducted in the US. Download the Seasonal Influenza Crosswalk table. 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. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. To receive weekly email updates about Seasonal Flu, enter your email address: We take your privacy seriously. Cases of influenza were identified through active and passive surveillance for influenza-like illness or acute otitis media and confirmed by culture. Requires Refrigeration. PDF Influenza Vaccine Products for the 2022-2023 Influenza Season Manufactured by: Discard unused portion. Product: Influenza (FluMist Quadrivalent) Bavarian Nordic A/S Hejreskovvej 10A DK-3490 Kvistgaard Phone: 1-800-675-9596 Email: info@bavarian-nordic.com Product: . Sanofi Pasteur 49281040010 - McKesson Medical-Surgical Vaccine Product Information - Order Vaccines and Contact Manufacturers Participants 6 months through 35 months of age received one or two 0.25 mL doses and participants 3 years through 8 years of age received one or two 0.5 mL doses of Fluzone Quadrivalent, TIV-1, or TIV-2. TABLE 1. Influenza vaccines United States, 2020-21 influenza season* Sanofi Pasteur will continue to deliver and offer the trivalent formulation of Fluzone High-Dose through . 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). McKesson Acceptable Dating: we will ship >= 30 days. Flu impacts peoples lives and puts a considerable strain on already stretched health systems during the winter season. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. 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. CDC twenty four seven. Antibody responses to Fluzone Quadrivalent are lower in persons 65 years of age than in younger adults. Not all formulations are available from the VFC Program. BRIDGEWATER, N.J., July 1, 2022 /PRNewswire/ -- Today the US Food and Drug Administration (FDA) approved Sanofi's licensure request for vaccine approval for the upcoming 2022-2023 flu season, including: Fluzone High-Dose Quadrivalent (Influenza Vaccine), Flublok Quadrivalent (Influenza Vaccine) and Fluzone Quadrivalent (Influenza Vaccine).5 This approval comes on the heels of the CDC's Advisory Committee on Immunization Practices (ACIP) preferential recommendation for adults 65+ including Fluzone High-Dose Quadrivalent and Flublok Quadrivalent.6 Following this licensure, Sanofi will begin to ship their vaccines helping to ensure more people, including some of our most vulnerable population of 65 years and older, will be immunized with the vaccine best suited for their needs as recommended by the ACIP.
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