Vaccination with Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent may not protect all people who receive the vaccine. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. 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. NDC Number. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. The safety analysis set included 570 recipients, half aged 18-60 years and half aged 61 years or older. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 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. Antibodies against one influenza virus type or subtype confer limited or no protection against another. Call your healthcare provider for advice about any side effects that concern you. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines). 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. N Engl J Med. With the increased risk of H5N1 bird flu being passed by . We comply with the HONcode standard for trustworthy health information. These cookies may also be used for advertising purposes by these third parties. The safety analysis set included 1941 participants who received at least 1 dose of study vaccine. See FDA-approved patient labeling (Patient Information). Accessed June 2022. 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. 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 has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. Influenza Surveillance Report (FluView), Previous Forecasts for the 2021-2022 Season, Tools to Prepare Your Practice for Flu Season, Information for Clinicians on Influenza Virus Testing, Multiplex Assays Authorized for Simultaneous Detection of Influenza Viruses and SARS-CoV-2, Information on Collection of Respiratory Specimens for Influenza Virus Testing, Information for Clinicians on Rapid Diagnostic Testing for Influenza, Information on Rapid Molecular Assays, RT-PCR, and other Molecular Assays for Diagnosis of Influenza Virus Infection, Algorithm: Interpreting Influenza Testing Results When Influenza is Circulating, Algorithm: Interpreting Influenza Testing Results When Influenza is NOT Circulating, Guide: Influenza Diagnostic Testing in Closed Setting Outbreaks, Guidance: Standard-Based Electronic Laboratory Reporting, Guidance: Antiviral and Obstetric Health Care, Guidance: Outbreak Management in Long-Term Care Facilities, Guidance: Use of Mask to Control Influenza Transmission, Guidance: Prevention & Control in Peri- and Postpartum Settings, U.S. Department of Health & Human Services, Standard dose, cell culture based (ccIIV4), Standard dose, egg based with MF59 adjuvant (aIIV4), Standard dose, egg based with MF59 adjuvant (aIIV3), 0.2-mL prefilled single-use intranasal sprayer. 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. For adults and older children, the recommended site for intramuscular influenza vaccination is the deltoid muscle. 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. We take your privacy seriously. 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. While patients can receive vaccinations from a variety of sources, offering them within the "medical home" leads to increased immunization rates. J Am Geriatr Soc. pain, redness, and swelling where you got the shot. 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). What better way to launch Our Stories than to learn about us through the words of our people. Influenza-like illness was defined as fever with signs or symptoms of an upper respiratory infection. Safety and immunogenicity of Fluzone Quadrivalent were evaluated in adults 65 years of age and older. Generic Drug Name. ACIP General Best Practice Guidelines for Immunization. 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. The table shows the patterns for the different lot numbers for the six VFC vaccines this difference impacts. Antibody responses to Fluzone Quadrivalent are lower in persons 65 years of age than in younger adults. 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%). Available at: Warren-Gash C, et al. For Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent, other side effects may occur. 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. in influenza and pediatrics vaccines, first worldwide . 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. https://doi.org/10.1016/j.vaccine.2020.09.004. That means not only using mRNA or protein-based technologies, but alsonovel methodsof antigen selection in order to inducebroader protection. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton X-100), producing a "split virus". It can lead to severe complications, increasing the risk of heart attack and pneumonia. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. 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. Thank you for taking the time to confirm your preferences. 49281-0418-50. But not all flu vaccines are the same. Strength. Do not administer this product intravenously, intradermally, or subcutaneously. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The information provided in this resource is for informational purposes only. Storage Requirements. Withdraw one dose of vaccine from the single-dose vial using a sterile needle and syringe. Discard if vaccine has been frozen. Storage Requirements. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. 2) Single-dose vial, 0.5 mL, for persons 6 months of age and older. 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. You can ask your healthcare provider for a list of other side effects that is available to healthcare professionals. For Fluzone High-Dose Quadrivalent, in adults 65 years of age and older, the most common side effects were pain, redness, and/or swelling where you got the shot; muscle aches, headache, and general discomfort. 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. 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. 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). Saving Lives, Protecting People, Immunogenicity, Efficacy, and Effectiveness of Influenza Vaccines, Package inserts for U.S.-licensed vaccines. COVID-19 Vaccine Lot Number and Expiration Date Tool Seasonal Influenza Codes and Crosswalk 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. 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. Fluzone Quadrivalent is a vaccine that helps protect against influenza illness (flu). 60 mcg / 0.5 mL. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private 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. 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. 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. A world leader. Vaccine efficacy of Fluzone against all influenza viral types and subtypes is presented in Table 9. ACIP Flu Meeting Update: Flu Vaccines Worked Better than Reported & ACIP Recommends Specific Vaccines for Seniors. You can review and change the way we collect information below. 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. Adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Fluzone (trivalent) or Fluzone Quadrivalent. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. 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. 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. Generic name: influenza vaccine Cookies used to make website functionality more relevant to you. During this meeting, the advisory committee reviewed and evaluated the surveillance data related to epidemiology and antigenic characteristics of recent influenza isolates, serological responses to 2020-2021 vaccines, and the availability of candidate strains and reagents. Sanofi Pasteur Inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes following vaccination with Fluzone Quadrivalent during pregnancy. To receive weekly email updates about Seasonal Flu, enter your email address: We take your privacy seriously. 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. The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. 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. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. 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. Available for Android and iOS devices. 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%). Its an infectious disease that does more damage than most people realize. 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%). 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. Fluzone Quadrivalent is for people who are 6 months of age and older. 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. 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.
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