Table 5 summarizes solicited injection-site and systemic adverse reactions reported within 3 days post-vaccination via diary cards. In adults 18 years and older, the most common (10%) injection-site reaction was pain (47%); the most common solicited systemic adverse reactions were myalgia (24%), headache (16%), and malaise (11%). If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Fluzone High-Dose Quadrivalent: Package Insert - Drugs.com Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. 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%). COVID-19 Vaccine Lot Number and Expiration Date Tool. Three SAEs were considered to be possibly related to vaccination: croup in a Fluzone Quadrivalent recipient and 2 episodes of febrile seizure, 1 each in a TIV-1 recipient and a TIV-2 recipient. 0.5 mL each, For 6 months of age and older It can lead to severe complications, increasing the risk of heart attack and pneumonia. References1Flublok Quadrivalent [Prescribing Information]. Report adverse reactions to their healthcare provider and/or to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. Swiftwater, PA 18370 USA. L Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 2021 Dec 6;73(11):e4288-e4295. Evidence for a causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated. This new format includes all seasonal influenza vaccines for the 2022/2023 season in a single Excel crosswalk table that provides the CVX, MVX, NDC Unit of Sale, NDC Unit of Use, and CPT (*) codes for each vaccine. Vaccination of female rabbits with Fluzone Quadrivalent revealed no evidence of impaired female fertility [see Animal Data (8.1)]. Vaccine Administration: Making the Process More Efficient in Your 2019 Nov 20:1932296819883340, Kubale J, et al. Fluzone Quadrivalent contains 4 killed flu virus strains. Sanofi Pharma; Sanofi Genzyme; Sanofi Pasteur; Our data sharing commitments; Managed Access Programs (MAPs) . Storage Requirements. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. 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. 2022- 2023 Influenza Season Vaccine Labels 6 Ages: 65 years or older Dosage: 0.7 mL Route: Intramuscular (IM) injection Fluzone Quadrivalent (IIV4) (Quadrivalent Inactivated Influenza Vaccine) 5 mL Multi-dose Vial 6 months or older Ages: Dosage: 0.25 mL or 0.5 mL for age 6 through 35 months 0.5 mL for age 3 years or older Route: Pregnant women who contract influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery. 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). Contact the Sanofi Pasteur Reimbursement Support Service (RSS). 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. 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. The latest UKHSA data on the maternal whooping cough vaccine programme shows that uptake has dropped to its lowest level in 7 years. The Lancet Respiratory Medicine. Influenza Virus Vaccine, Quadrivalent Inactivated, Preservative Free. in influenza and pediatrics vaccines, first worldwide . PDF Check Your Vials: Tdap - immunize.org 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. We are pursuingnext generationinfluenza vaccines with multiple vaccine technologies to develop and bring forward tomorrows vaccines to people around the world as fast as possible. Sanofi flu vaccines licensed and approved for 2022-2023 influenza season, including CDC preferred higher-dose vaccines for adults 65+ * Fluzone High-Dose Quadrivalent (Influenza. Influenza virus strains were selected based on the influenza vaccine production method; egg-based and cell- or recombinant based. 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) * Vaccination providers should consult FDA-approved prescribing information for 202021 influenza vaccines for the most complete and updated information, including (but not limited to) indications, contraindications, warnings, and precautions. In adults 65 years of age and older, the most common (10%) injection-site reaction was pain (33%); the most common solicited systemic adverse reactions were myalgia (18%), headache (13%), and malaise (11%). PDF Fluzone High Dose - Sanofi Generic name: influenza vaccine It can lead to severe complications, increasing the risk of heart attack and pneumonia. 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. Data are not available to assess the effects of Fluzone Quadrivalent on the breastfed infant or on milk production/excretion. 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). About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. The safety analysis set included 675 recipients. 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. Vaccines - Sanofi U.S. 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. PDF Complete List of Vaccine Names and CPT/CVX Codes Flublok: Package Insert - Drugs.com Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration, whenever solution and container permit. problems with your immune system as the immune response may be diminished. Non-inferiority of the 0.5 mL dose(s) relative to the 0.25 mL dose(s) of Fluzone Quadrivalent was demonstrated for all four strains based on pre-specified criteria (lower limit of the 2-sided 95% CI of the ratio of GMTs between groups > 0.667; lower limit of the 2-sided 95% CI of the difference in seroconversion rates >-10%). In Study 4 (NCT01218646) [see Adverse Reactions (6.1)], 660 adults 65 years of age and older were included in the per-protocol immunogenicity analysis. 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. ever had a severe allergic reaction to eggs or egg products. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Animal Data: In a developmental and reproductive toxicity study female rabbits were administered a 0.5 mL/dose of Fluzone Quadrivalent by intramuscular injection 24 and 10 days before insemination, and on Days 6, 12, and 27 of gestation (a single human dose is 0.5 mL). These are reference CPT codes for vaccine categorization and are not intended to represent billable codes. Sanofi Pasteur will continue to deliver and offer the trivalent formulation of Fluzone High-Dose through . 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. 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. Sanofi Pasteur 49281041850 - McKesson Medical-Surgical FLUZONEHigh-Dose is indicated for active immunization against influenza caused by the specific strains of influenza virus contained in the vaccine in adults 65 years of age and older. IM-administered influenza vaccines should be given by needle and syringe only, with the exception of the MDV presentation of Afluria Quadrivalent, which may alternatively be given by the PharmaJet Stratis jet injector for persons aged 18 through 64 years only. 2021 Mar;69(3):696-703. 49281051105. Available at: Warren-Gash C, et al. 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). These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. 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. 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. an A/Wisconsin/588/2019 (H1N1) pdm09-like virus. Available at: Izikson R. et al. Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Adults 65 Years of Age: A Phase 3 Randomized Clinical Trial. 9Centers for Disease Control and Prevention. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. Please read this information sheet before getting Fluzone Quadrivalent. Fluzone Quadrivalent contains killed viruses and cannot cause influenza. For participants recommended to receive two doses of influenza vaccine as per Advisory Committee on Immunization Practices guidance, the same dose was administered 4 weeks after the first. PDF 2019-2020 PROPER CODING of Sanofi Pasteur Products The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. The single-dose, pre-filled syringe (0.5 mL) and the single-dose vial (0.5 mL) are manufactured and formulated without thimerosal or any other preservative. Vaccine 2021; 39: A24-A35. During the 28 days following vaccination, a total of 16 (0.6%) recipients in the Fluzone Quadrivalent group, 4 (0.5%) recipients in the TIV-1 group, and 4 (0.6%) recipients in the TIV-2 group, experienced at least one SAE. Multi-dose vial, 5 mL (NDC 49281-637-78) (not made with natural rubber latex). Questions: Toll-free: 877-2Get-VFC (877-243-8832) 60 mcg / 0.5 mL. Flublok Quadrivalent: Package Insert - Drugs.com Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Thank you, Bill. Vaccines - Sanofi Flublok Quadrivalent | FDA In Study 2 (NCT02915302) [see Adverse Reactions (6.1)], 1027 children, 6 months through 35 months of age, were included in the per-protocol immunogenicity analysis. The intent-to-treat analysis set included 1138 healthy adults who received Fluzone or placebo. Study 1 (NCT01240746, see http://clinicaltrials.gov) was a single-blind, randomized, active-controlled multi-center safety and immunogenicity study conducted in the US. 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. Thank you for taking the time to confirm your preferences. Fluzone Quadrivalent has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. 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. The most commonly reported unsolicited non-serious adverse events were headache, cough, and oropharyngeal pain. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. Study 2 (NCT02915302 see http://clinicaltrials.gov) was a randomized, observer-blinded, 2-arm, multi-center safety and immunogenicity study conducted in the US. 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 ).
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