Fluzone Quadrivalent is for people who are 6 months of age and older. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Sanofi assumes no responsibility for the information presented on this website. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. A randomized, double-blind, placebo-controlled study was conducted in a single US center during the 2007-2008 influenza season. 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. Before sharing sensitive information, make sure you're on a federal government site. 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. The safety analysis set included 1841 children 6 months through 35 months of age and 2506 children 3 years through 8 years of age. Cookies used to make website functionality more relevant to you. Chang LJ, et al. Cases of influenza were identified through active and passive surveillance for influenza-like illness or acute otitis media and confirmed by culture. Cumulative 2021/2022 Season Lot Release Status (Updated 11/3/2021). If a prefilled syringe of Fluzone Quadrivalent is used for a child in this age group, the dose volume will be 0.5mL per dose. 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. Sanofi Pasteur 752-21 - McKesson Medical-Surgical In Study 1 (NCT01240746) [see Adverse Reactions (6.1)], 1419 children 6 months through 35 months of age and 2101 children 3 years through 8 years of age were included in the per-protocol immunogenicity analysis. 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). But not all flu vaccines are the same. Medically reviewed by Drugs.com. 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%). Fluzone is a registered trademark of Sanofi Pasteur Inc. History of severe allergic reaction (e.g., anaphylaxis) to egg is a labeled contraindication to the use of most IIVs and LAIV4. Thank you, Bill. 2) Single-dose vial, 0.5 mL, for persons 6 months of age and older. Inactive ingredients include formaldehyde and octylphenol ethoxylate. Unsolicited non-serious adverse events were reported in 417 (44%) participants in Group 1 and 394 (40%) participants in Group 2. 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). Among all randomized participants in both years, the mean age was 13.8 months; 52.5% were male, 50.8% were Caucasian, 42.0% were Black, and 7.2% were of other racial groups. 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. Single-dose, prefilled syringe (clear plunger rod), without needle, 0.5 mL (NDC 49281-422-88) (not made with natural rubber latex). The preferred site for infants and young children is the anterolateral aspect of the thigh. 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. an A/Victoria/2570/2019 (H1N1) pdm09-like virus; an A/Cambodia/e0826360/2020 (H3N2)-like virus; a B/Washington/02/2019- like virus (B/Victoria lineage); a B/Phuket/3073/2013-like virus (B/Yamagata lineage). A world leader. Discard if vaccine has been frozen. Thomas Triomphe-- Executive Vice President, Sanofi Pasteur. Flu impacts peoples lives and puts a considerable strain on already stretched health systems during the winter season. Influenza Vaccine for the 2021-2022 Season | FDA 4Centers for Disease Control and Prevention. 1 This was the impetus for the 1994 federal. Sanofi Pharma; Sanofi Genzyme; Sanofi Pasteur; Our data sharing commitments; Managed Access Programs (MAPs) . Participants were monitored for unsolicited adverse events and SAEs during the 28 days following vaccination. 3) Multi-dose vial, 5 mL, for persons 6 months of age and older. The most commonly reported unsolicited non-serious adverse events were headache, cough, and oropharyngeal pain. Fluzone Quadrivalent is approved for use in persons 6 months of age and older. Requires Refrigeration. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. ** 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. Available at: WHO - Coadministration of seasonal inactivated influenza and COVID-19 vaccines. 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. If a prefilled syringe of Fluzone Quadrivalent is used for a child in this age group, the dose volume will be 0.5mL per dose. 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. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. 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. Accessed June 2022. Vaccine efficacy of Fluzone against all influenza viral types and subtypes is presented in Table 9. Available at https://www.cdc.gov/flu/prevent/vaccine-selection.htm. IIS Data Code Sets | CDC For infants, Fluzone Quadrivalent is a shot given into the muscle of the thigh. Also please see complete Patient Information for Fluzone Quadrivalent andFluzone High-Dose Quadrivalent. 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 ). Discard unused portion. Vaccine sales in Q1 were up 15% due to strong travel and dynamic vaccine sales as they continue to recover and have now . In the follow-up period, there were two SAEs, 1 (0.5%) in the Fluzone Quadrivalent group and 1 (0.5%) in the TIV-2 group. Product Dating. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Table 2 and Table 3 summarize solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards. Annual influenza vaccination is recommended. Swiftwater, PA: Sanofi3Lee JKH, Lam GKL, Shin T, et al. Based on that information and on the recommendations of the FDAs Vaccines and Related Biological Products Advisory Committee, the FDA selects the different influenza strains each year that. CDC twenty four seven. There were no adverse effects on pre-weaning development or vaccine-related fetal malformations noted in this study. 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. Vaccine. Sanofi Pasteur Inc. is collecting information on pregnancy outcomes and the health of newborns following vaccination with Fluzone Quadrivalent during pregnancy. Tell your health care provider if you have ever had Guillain-Barr syndrome (severe muscle weakness) after a previous influenza vaccination. PDF Complete List of Vaccine Names and CPT/CVX Codes Safety and effectiveness of Fluzone Quadrivalent in children below the age of 6 months have not been established. 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. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of Fluzone Quadrivalent. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Fluzone Quadrivalent should not be combined through reconstitution or mixed with any other vaccine. You can ask your healthcare provider for a list of other side effects that is available to healthcare professionals. 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 The new facility building at Swiftwater has had an investment of $150m. Fluzone Quadrivalent contains killed viruses and cannot cause influenza. 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 All information these cookies collect is aggregated and therefore anonymous. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Silver Spring, Maryland, on March 5, 2021, to select the influenza viruses for the composition of the influenza vaccine for the 2021-2022 U.S. influenza season. Cases of influenza were identified through active and passive surveillance and confirmed by cell culture and/or real-time polymerase chain reaction (PCR). 2) (See ref. 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. Investigator Sponsored Studies and Externally Sponsored Collaboration, Access to Quality Healthcare Sanofi Global Health, Contributing to the eradication, elimination and control of some infectious diseases, Serving the needs of patients with non-communicable diseases, Development opportunity: how Sanofi empowers you, Influenza vaccination can reduce the risk of heart attacks by up to 45% [15-45%], Vaccination is especially important for people most at risk, Flu and Covid-19 vaccines can be administered at the same time, That means not only using mRNA or protein-based technologies, but also, We are currently innovating in our existing different technologies including egg-based flu vaccines, recombinant proteins, mRNA to develop and deliver vaccines that can. Table 6 summarizes solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards. You can review and change the way we collect information below. Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trial(s) of a vaccine cannot be directly compared to rates in the clinical trial(s) of another vaccine and may not reflect the rates observed in practice. 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. Sanofi (SNY) Q1 2023 Earnings Call Transcript | Nasdaq Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation. Please read this information sheet before getting Fluzone Quadrivalent. Vaccines - Sanofi The dose and schedule for Fluzone Quadrivalent are presented in Table 1. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY, Media RelationsEvan Berland| + 1 215 432 0234 | evan.berland@sanofi.comSally Bain| + 1 781 264 1091 | sally.bain@sanofi.comKate Conway| + 1 617 981 2738 | kate.conway@sanofi.com, Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delpine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+1 617 764 6418| priya.nanduri@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com. 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). (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. All information these cookies collect is aggregated and therefore anonymous. Call 1-800-VACCINE (1-800-822-2463) and choose the prompt for the RSS. They help us to know which pages are the most and least popular and see how visitors move around the site. A randomized, double-blind, placebo-controlled study was conducted at a single US center during the 1999-2000 (Year 1) and 2000-2001 (Year 2) influenza seasons. What are the possible side effects of Fluzone Quadrivalent? Antibiotics are not used in the manufacture of Fluzone Quadrivalent. 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%). 2019 Nov 20:1932296819883340, Kubale J, et al. Fluzone Quadrivalent, an inactivated influenza vaccine that contains the hemagglutinins of two influenza A subtype viruses and two influenza type B viruses, is manufactured according to the same process as Fluzone. You are about to visit another Sanofi website. Table 5 summarizes solicited injection-site and systemic adverse reactions reported within 3 days post-vaccination via diary cards. The latest UKHSA data on the maternal whooping cough vaccine programme shows that uptake has dropped to its lowest level in 7 years. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Selecting Viruses for the Seasonal Influenza Vaccine. People at Higher Risk for Flu Complications. Swiftwater, PA 18370 USA. 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. If you have questions or would like more information, please talk with your healthcare provider. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. (*) Please note that the CPT codes shown for each vaccine crosswalk are not mapped to the NDC codes, but are mapped to the CVX codes shown. Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. 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). However, in some human studies, antibody titers 1:40 have been associated with protection from influenza illness in up to 50% of subjects. PDF Influenza Vaccine Products for the 2022-2023 Influenza Season Global Medical Affairs Influenza, Sanofi. pain, redness, and swelling where you got the shot. Pregnant women are at increased risk of complications associated with influenza infection compared to non-pregnant women. 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 a vaccine that helps protect against influenza illness (flu). Sanofi Pasteur Inc. 800.422.0280. You will be subject to the destination website's privacy policy when you follow the link. 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. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. Not all formulations are available from the VFC Program. Before administering a dose of vaccine, shake the prefilled syringe or vial. Vaccine Product Information - Order Vaccines and Contact Manufacturers 7Centers for Disease Control and Prevention. an A/Wisconsin/588/2019 (H1N1) pdm09-like virus. 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. 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. This study revealed no adverse effects to the fetus or pre-weaning development due to Fluzone Quadrivalent [see Animal Data (8.1)]. Accessed June 2022.10DiazGranados CA, et al. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. 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. Influenza Virus Vaccine, Quadrivalent Inactivated, Preservative Free. 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. Sanofi Pasteur - PMC (AKA: Aventis) NDC: 49281-0400-10 Sanofi Pasteur - PMC 90700 20 90700 106 90700 20 MercK - MSD 90714 09 90633 83 90634 84 90632 52 GlaxoSmithKline - SKB NDC: 58160-0825-11 Merck- MSD NDC: 00006-4831-41 GlaxoSmithKline - SKB Merck- MSD GlaxoSmithKline - SKB Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The preservative thimerosal is only in the multi-dose vial of Fluzone Quadrivalent. The Lancet Respiratory Medicine. 49281-0418-50. 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. 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%). Sanofi flu vaccines licensed and approved for 2022-2023 influenza Influenza Vaccine for the 2020-2021 Season | FDA Storage Requirements. 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. Please refer to the full Prescribing Information forFluzone High-Dose Quadrivalent, Flublok Quadrivalent, orFluzone Quadrivalent. 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. Vaccines are the best public health tool available to prevent flu and its serious complications. Thank you for taking the time to confirm your preferences. 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. Sanofi Pasteur 49281051105 - McKesson Medical-Surgical 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).