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). 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. In this study, children 6 months through 35 months of age received one or two 0.25 mL doses of either Fluzone Quadrivalent or one of two formulations of a comparator trivalent influenza vaccine (TIV-1 or TIV-2), and children 3 years through 8 years of age received one or two 0.5 mL doses of either Fluzone Quadrivalent, TIV-1, or TIV-2. 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. L Manufactured by: HI antibody geometric mean titers (GMTs) and seroconversion rates 28 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 10 and Table 11). 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%). Since 1977, antigenic variants of influenza A (H1N1 and H3N2) viruses and influenza B viruses have been in global circulation. Vaccine. Global Medical Affairs Influenza, Sanofi. 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. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Sanofi Pasteur 752-21 - McKesson Medical-Surgical The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The most commonly reported unsolicited non-serious adverse events were cough, vomiting, and pyrexia. 47823. However, in some human studies, antibody titers 1:40 have been associated with protection from influenza illness in up to 50% of subjects. Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Adults 65 Years of Age: A Phase 3 Randomized Clinical Trial. Package inserts for U.S.-licensed vaccinesexternal icon. Available at: WHO - Coadministration of seasonal inactivated influenza and COVID-19 vaccines. 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. These are reference CPT codes for vaccine categorization and are not intended to represent billable codes. Influenza - Sanofi Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration, whenever solution and container permit. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. With the increased risk of H5N1 bird flu being passed by . ACIP General Best Practice Guidelines for Immunization. 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). Antibiotics are not used in the manufacture of Fluzone Quadrivalent. 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). Forward-looking statements are statements that are not historical facts. Thank you for taking the time to confirm your preferences. Procedures should be in place to avoid injury from fainting. Last updated on Nov 1, 2022. The most commonly reported unsolicited non-serious adverse events in both groups were cough and rhinorrhea. Data for 2022 shows an average uptake across England of 61.5% . 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. In Study 3 (NCT00988143, see http://clinicaltrials.gov), a multi-centered randomized, open-label trial conducted in the US, adults 18 years of age and older received one dose of either Fluzone Quadrivalent or one of two formulations of comparator trivalent influenza vaccine (TIV-1 or TIV-2). 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. Fluzone High-Dose Quadrivalent: Package Insert - Drugs.com an A/Wisconsin/588/2019 (H1N1) pdm09-like virus. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Anyone can catch and spread flu. 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. 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. Fluzone Quadrivalent is for people who are 6 months of age and older. All information these cookies collect is aggregated and therefore anonymous. You will be subject to the destination website's privacy policy when you follow the link. 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. Flublok: Package Insert - Drugs.com 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. 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%). Influenza Vaccine for the 2020-2021 Season | FDA Need help with SupplyManager? Sanofi Pasteur, the vaccines business of Sanofi-Aventis, is one of the largest seasonal influenza vaccine producers in the world. 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). Medical professionals, medical facility employees 855.571.2100. 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. 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. Generic name: influenza vaccine Non-inferiority immunogenicity criteria based on HI antibody GMTs and seroconversion rates were also met when age subgroups (6 months to <36 months and 3 years to <9 years) were examined. Participants were monitored for unsolicited adverse events and SAEs during the 28 days following vaccination. Download the Seasonal Influenza Crosswalk table. Study 2 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) (2) (see Clinical Studies ). The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. 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. 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. To report SUSPECTED ADVERSE REACTIONS, contact the Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463 (1-800- VACCINE) or Food and. 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).
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