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. Sanofi Pharma; Sanofi Genzyme; Sanofi Pasteur; Our data sharing commitments; Managed Access Programs (MAPs) . Among participants in the three vaccine groups combined, 67.2% were female (Fluzone Quadrivalent, 68.4%; TIV-1, 67.9%; TIV-2, 65.3%), 88.4% Caucasian (Fluzone Quadrivalent, 91.1%; TIV-1, 86.8%; TIV-2, 87.4%), 9.6% Black (Fluzone Quadrivalent, 6.8%; TIV-1, 12.1%; TIV-2, 10.0%), 0.4% Hispanic (Fluzone Quadrivalent, 0.0%; TIV-1, 0.5%; TIV-2, 0.5%), and 1.7% were of other racial/ethnic groups (Fluzone Quadrivalent, 2.1%; TIV-1, 0.5%; TIV-2, 2.2%). Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. For intramuscular injection only, Afluria, Afluria Quadrivalent, Flucelvax Quadrivalent, Fluad, +7 more, Tamiflu, oseltamivir, Fluzone, Xofluza, Afluria, influenza virus vaccine, inactivated. 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. Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Adults 65 Years of Age: A Phase 3 Randomized Clinical Trial. 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. 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). Participants were monitored for unsolicited adverse events and SAEs during the 21 days following vaccination. It's an infectious disease that does more damage than most people realize. Thank you for taking the time to confirm your preferences. 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%). For Flublok Quadrivalent, in adults 18 through 49 years of age, the most common side effects were tenderness, and/or pain where you got the shot; headache, tiredness, muscle aches, and joint pain. Andrew MK et al. Study 1 (NCT01240746, see http://clinicaltrials.gov) was a single-blind, randomized, active-controlled multi-center safety and immunogenicity study conducted in the US. Available at: WHO - Coadministration of seasonal inactivated influenza and COVID-19 vaccines. 60 mcg / 0.5 mL. Prefilled Syringes 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. 3) Multi-dose vial, 5 mL, for persons 6 months of age and older. 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. Sanofi Pasteur Inc. is collecting information on pregnancy outcomes and the health of newborns following vaccination with Fluzone Quadrivalent during pregnancy. Available at https://www.cdc.gov/flu/spotlights/2021-2022/specific-vaccines-seniors.htm. Accessed June 2022.5FDA Approval of Sanofi Licensure Request for Vaccine Approval for 2022-2023 Influenza Season [Data on File]6Centers for Disease Control and Prevention. 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. The intent-to-treat analysis set included a total of 786 children 6 through 24 months of age. If you wish to continue to this external website, click Proceed. For adults and older children, the recommended site for intramuscular influenza vaccination is the deltoid muscle. Sanofi Pasteur Inc. 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. Fluzone is a registered trademark of Sanofi Pasteur Inc. Call Us. The new facility building at Swiftwater has had an investment of $150m. Drug class: Viral vaccines. 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 ). 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. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Fluzone Quadrivalent is a suspension for injection. 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). There were no adverse effects on pre-weaning development or vaccine-related fetal malformations noted in this study. Product Dating. Table 4 summarizes solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards for the 0.25 mL and 0.5 mL volumes of Fluzone Quadrivalent in children 6 months through 35 months of age. 4Centers for Disease Control and Prevention. 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. Pregnant women who contract influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery. That means not only using mRNA or protein-based technologies, but alsonovel methodsof antigen selection in order to inducebroader protection. To receive weekly email updates about Seasonal Flu, enter your email address: We take your privacy seriously. The Fluzone Quadrivalent prefilled syringe and vial presentations are not made with natural rubber latex. However, ACIP recommends that persons with a history of egg allergy may receive any licensed, recommended influenza vaccine that is otherwise appropriate for their age and health status. Fluzone Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Generic name: influenza vaccine Cookies used to make website functionality more relevant to you. Flu & People 65 Years and Older. Download the Seasonal Influenza Crosswalk table. Seroconversion rates 21 days following Fluzone Quadrivalent were non-inferior to those following TIV for H3N2, B/Brisbane, and B/Florida, but not for H1N1 (see Table 14). The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Influenza-like illness was defined as fever with signs or symptoms of an upper respiratory infection. 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. The site is secure. The most commonly reported unsolicited non-serious adverse events were headache, cough, and oropharyngeal pain. Flublok Quadrivalent is given to people 18 years of age and older. The Lancet Respiratory Medicine. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov. ** 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. Swiftwater, PA: Sanofi3Lee JKH, Lam GKL, Shin T, et al. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Influenza (seasonal) Fact Sheet. Also please see complete Patient Information for Fluzone Quadrivalent andFluzone High-Dose Quadrivalent. Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. 2019 Sep 16;37(39):5825-5834. All information these cookies collect is aggregated and therefore anonymous. Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for the usual change of one or more new strains in each year's influenza vaccine. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Flu vaccine lots that have been released by FDA and are available for distribution by the manufacturers. J Am Geriatr Soc. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. Participants were monitored for unsolicited adverse events for 28 days after each dose and serious adverse events (SAEs) during the 6 months following the last dose. If any of these defects or conditions exist, Fluzone Quadrivalent should not be administered. A world leader. 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. Contact the Sanofi Pasteur Reimbursement Support Service (RSS). 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. 49281051105. Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. Safety and immunogenicity of Fluzone Quadrivalent were evaluated in adults 65 years of age and older. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of Fluzone Quadrivalent. 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. However, in some human studies, antibody titers 1:40 have been associated with protection from influenza illness in up to 50% of subjects. Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. With the increased risk of H5N1 bird flu being passed by . Influenza virus strains were selected based on the influenza vaccine production method; egg-based and cell- or recombinant based. McKesson Acceptable Dating: we will ship >= 30 days. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. References1Flublok Quadrivalent [Prescribing Information]. 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. What better way to launch Our Stories than to learn about us through the words of our people. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. 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. If Fluzone Quadrivalent is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained. J Diabetes Sci Technol. It is not known whether Fluzone Quadrivalent is excreted in human milk. 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. 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. Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial. The safety analysis set included 570 recipients, half aged 18-60 years and half aged 61 years or older. Antibody responses to Fluzone Quadrivalent are lower in persons 65 years of age than in younger adults. ", About the Composition of Sanofi's 2022-2023 Licensed and Approved Influenza Vaccines, Each year, the FDA, World Health Organization (WHO), Centers for Disease Control and Prevention, and other partners collaborate by collecting and reviewing data on the circulating strains of influenza from around the world to identify those likely to cause the most illness in the upcoming flu season.9 Once strains are selected, flu vaccine manufacturers include the newly selected flu strains in their FDA-approved vaccines, and then submit applications to the FDA to include the new flu strains in their FDA-approved vaccines, including for Fluzone High-Dose Quadrivalent, Flublok Quadrivalent and Fluzone Quadrivalent.9 Today those requests for licensure were approved for the upcoming 2022-2023 flu season.5, About Fluzone Quadrivalent (Influenza Vaccine), Flublok Quadrivalent (Influenza Vaccine) and Fluzone High-Dose Quadrivalent (Influenza Vaccine). Anyone can catch and spread flu. Sanofi Pasteur Inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes following vaccination with Fluzone Quadrivalent during pregnancy. The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. 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). Vaccines are the best public health tool available to prevent flu and its serious complications. Discard if vaccine has been frozen. Procedures should be in place to avoid injury from fainting. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. The most commonly reported adverse events were oropharyngeal pain, rhinorrhea, injection-site induration, and headache. The most common side effects of Fluzone Quadrivalent are: These are not all of the possible side effects of Fluzone Quadrivalent. In Study 4 (NCT01218646, see http://clinicaltrials.gov), a multi-center, randomized, double-blind trial conducted in the US, adults 65 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). 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. 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. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Table 5 summarizes solicited injection-site and systemic adverse reactions reported within 3 days post-vaccination via diary cards. 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. Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration, whenever solution and container permit. Please read this information sheet before getting Fluzone Quadrivalent. 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. The HI antibody GMT following Fluzone Quadrivalent was higher than that following TIV-1 for B/Florida but not higher than that following TIV-2 for B/Brisbane, based on pre-specified criteria (the lower limit of the 2-sided 95% CI of the ratio of the GMTs [Fluzone Quadrivalent divided by TIV] >1.5 for each B strain in Fluzone Quadrivalent compared with the corresponding B strain not contained in each TIV). CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. 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) Fluzone Quadrivalent/NDC 49281-422-88 Discard unused portion. 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. Selecting Viruses for the Seasonal Influenza Vaccine. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. * 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. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. 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. 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. Vaccination of female rabbits with Fluzone Quadrivalent revealed no evidence of impaired female fertility [see Animal Data (8.1)]. About 16,000. employees globally, 65% of them dedicated to manufacturing and quality operations. Syncope (fainting) has been reported following vaccination with Fluzone Quadrivalent. In addition, HI antibody GMTs and seroconversion rates following Fluzone Quadrivalent were higher than those following TIV for the B strain not contained in each respective TIV based on pre-specified criteria (the lower limit of the 2-sided 95% CI of the ratio of the GMTs [Fluzone Quadrivalent divided by TIV] >1.5 for each B strain in Fluzone Quadrivalent compared with the corresponding B strain not contained in each TIV and the lower limit of the two 2-sided 95% CI of the difference of the seroconversion rates [Fluzone Quadrivalent minus TIV] >10% for each B strain in Fluzone Quadrivalent compared with the corresponding B strain not contained in each TIV). 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. Fluzone Quadrivalent is approved for use in persons 6 months of age and older. 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. For participants who received two doses, the doses were administered approximately 4 weeks apart. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. Do not administer this product intravenously, intradermally, or subcutaneously. https://doi.org/10.1016/j.vaccine.2020.09.004. People at Higher Risk for Flu Complications. Study 2 (NCT02915302 see http://clinicaltrials.gov) was a randomized, observer-blinded, 2-arm, multi-center safety and immunogenicity study conducted in the US. Guillain Barr syndrome (severe muscle weakness) after getting a flu vaccine. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Report adverse reactions to their healthcare provider and/or to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. [See Clinical Studies (14.6).] Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color. Products: Comirnaty (COVID-19 vaccine) Sanofi U.S. 55 Corporate Drive Bridgewater, NJ 08807 Vaccines and biologics Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. Call your healthcare provider for advice about any side effects that concern you. 9Centers for Disease Control and Prevention. 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 History of severe allergic reaction (e.g., anaphylaxis) to egg is a labeled contraindication to the use of most IIVs and LAIV4. 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). 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 They help us to know which pages are the most and least popular and see how visitors move around the site. Data are not available to assess the effects of Fluzone Quadrivalent on the breastfed infant or on milk production/excretion. Package insert / product label 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 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. Strength. Accessed June 2022. Fluzone Quadrivalent stimulates the immune system to protect against influenza, but does not prevent other respiratory infections. Cumulative 2021/2022 Season Lot Release Status (Updated 11/3/2021). Single-dose vial, 0.5 mL (NDC 49281-422-58) (not made with natural rubber latex). The .gov means its official.Federal government websites often end in .gov or .mil. Available at https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-22-23/03-influenza-grohskopf-508.pdf. 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: Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. 2019 Nov 20:1932296819883340, Kubale J, et al. N Engl J Med. The table shows the patterns for the different lot numbers for the six VFC vaccines this difference impacts. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. The safety analysis set included 675 recipients. Do not use after the expiration date shown on the label. If Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent are given to people with a compromised immune system, including those receiving therapies that suppress the immune system, the immune response may be lower than expected. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. 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. But not all flu vaccines are the same. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines). The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Fluzone Quadrivalent and any potential adverse effects on the breastfed child from Fluzone Quadrivalent or from the underlying maternal condition. Accounts Receivable 800.453.5180 WHO. Fluzone High-Dose Quadrivalent is given to people 65 years of age and older. 2021 Mar;69(3):696-703. 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. The information provided in this resource is for informational purposes only. 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. 800.422.0280. 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. Store all Fluzone Quadrivalent presentations refrigerated at 2 to 8C (35 to 46F). Available at: Warren-Gash C, et al. Since 2001, two distinct lineages of influenza B (Victoria and Yamagata lineages) have co-circulated worldwide. In children 6 months through 35 months of age receiving a 0.25 mL dose of Fluzone Quadrivalent in Study 1 (NCT01240746, see http://clinicaltrials.gov), the most common (10%) injection-site reactions were pain (57%)1 or tenderness (54%)2, erythema (37%), and swelling (22%); the most common solicited systemic adverse reactions were irritability (54%)2, abnormal crying (41%)2, malaise (38%)1, drowsiness (38%)2, appetite loss (32%)2, myalgia (27%)1, vomiting (15%)2, and fever (14%).
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