sanofi pasteur flu vaccine lot numbers

The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. For Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent, other side effects may occur. Cases of influenza were identified through active and passive surveillance and confirmed by cell culture and/or real-time polymerase chain reaction (PCR). ACIP Flu Meeting Update: Flu Vaccines Worked Better than Reported & ACIP Recommends Specific Vaccines for Seniors. A maximum of ten doses can be withdrawn from the multi-dose vial. Seroconversion rate (SCR) differences (SCR0.5-mL dose minus SCR0.25-mL dose) for the A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage strains were 4.6% (95% CI: -0.4%; 9.6%), 5.1% (95% CI: 0.4%; 9.8%), 1.3% (95% CI: -2.9%; 5.6%), and 2.6% (95% CI: -1.4%; 6.5%). 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. 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. 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. Additional guidance regarding site selection and needle length for intramuscular administration is available in the ACIP General Best Practice Guidelines for Immunization.pdf icon. For adults and older children, the recommended site for intramuscular influenza vaccination is the deltoid muscle. Influenza Vaccine for the 2020-2021 Season | FDA (2019). Cases of influenza were identified through active and passive surveillance for influenza-like illness or acute otitis media and confirmed by culture. Call Us. Accessed on June 22, 2022. These cookies may also be used for advertising purposes by these third parties. The new facility building at Swiftwater has had an investment of $150m. Do not use after the expiration date shown on the label. Product Dating. 3). Supplied as package of 1 (NDC 49281-637-15). The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. The dose and schedule for Fluzone Quadrivalent are presented in Table 1. 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%). For preventive vaccines, the underlying maternal condition is susceptibility to the disease prevented by the vaccine. A randomized, double-blind, placebo-controlled study was conducted in a single US center during the 2007-2008 influenza season. Vaccine efficacy of Fluzone against all influenza viral types and subtypes is presented in Table 9. That means not only using mRNA or protein-based technologies, but alsonovel methodsof antigen selection in order to inducebroader protection. Before sharing sensitive information, make sure you're on a federal government site. We comply with the HONcode standard for trustworthy health information. Fluzone Quadrivalent/NDC 49281-422-88 Influenza virus strains were selected based on the influenza vaccine production method; egg-based and cell- or recombinant based. Eur respir J. ", 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). 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. FDA-approved patient labeling (Patient Information), "-" Indicates information is not applicable, Not previously vaccinated with influenza vaccine or unknown vaccination history, Previously vaccinated with influenza vaccine, If two doses, administer at least 4 weeks apart, Sodium phosphate-buffered isotonic sodium chloride solution, INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/WASHINGTON/02/2019 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED). 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%). Vaccine efficacy against all influenza viral types and subtypes was a secondary endpoint and is presented in Table 8. It's an infectious disease that does more damage than most people realize. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury. Product Dating. Fluzone Quadrivalent contains killed viruses and cannot cause influenza. Drug class: Viral vaccines. 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. 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. Fluzone is a registered trademark of Sanofi Pasteur Inc. For participants who received two doses, the doses were administered approximately 4 weeks apart. Prior to vaccination, always refer to the current Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza vaccines. Pregnant women are at increased risk of complications associated with influenza infection compared to non-pregnant women. 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). Td (sanofi pasteur) Age indications for use of products in the VFC program may differ from age indications on this guide or in the package inserts. 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). CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Unsolicited non-serious adverse events were reported in 28 (12.4%) recipients in the Fluzone Quadrivalent group, 22 (9.8%) recipients in the TIV-1 group, and 22 (9.8%) recipients in the TIV-2 group. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Cookies used to make website functionality more relevant to you. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk. DO NOT FREEZE. Fluzone Quadrivalent contains 4 killed flu virus strains. Vaccination of female rabbits with Fluzone Quadrivalent revealed no evidence of impaired female fertility [see Animal Data (8.1)]. Fluzone Quadrivalent is for people who are 6 months of age and older. You will be subject to the destination website's privacy policy when you follow the link. Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. 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. 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. Saving Lives, Protecting People, Immunogenicity, Efficacy, and Effectiveness of Influenza Vaccines, Package inserts for U.S.-licensed vaccines. Andrew MK et al. E, 10 Single-Dose For intramuscular injection only, Afluria, Afluria Quadrivalent, Flucelvax Quadrivalent, Fluad, +7 more, Tamiflu, oseltamivir, Fluzone, Xofluza, Afluria, influenza virus vaccine, inactivated. Vaccine Product Information - Order Vaccines and Contact Manufacturers If any of these defects or conditions exist, Fluzone Quadrivalent should not be administered. Vaccination with Fluzone Quadrivalent may not protect all recipients. 60 mcg / 0.5 mL. Heart 2016;102:19531956. (*) 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. Global surveillance of influenza identifies yearly antigenic variants. Participants received two 0.25 mL doses of either Fluzone (N = 525) or a placebo (N = 261). Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color. 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). 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. Tuberculin Purified Protein Derivative (Mantoux) - Food and Drug Study 2 (NCT02915302 see http://clinicaltrials.gov) was a randomized, observer-blinded, 2-arm, multi-center safety and immunogenicity study conducted in the US. Cookies used to make website functionality more relevant to you. Available at: https://www.cdc.gov/flu/highrisk/65over.htm. Table 5 summarizes solicited injection-site and systemic adverse reactions reported within 3 days post-vaccination via diary cards. Available at https://www.cdc.gov/flu/prevent/vaccine-selection.htm. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. What are the possible side effects of Fluzone Quadrivalent? 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. Single-dose vial, 0.5 mL (NDC 49281-422-58) (not made with natural rubber latex). L The safety analysis set included 1941 participants who received at least 1 dose of study vaccine. The site is secure. 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. CDC twenty four seven. TABLE 1. Influenza vaccines United States, 2020-21 influenza season* 2) (See ref. 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. Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases (NCIRD), Reconstruction of the 1918 Influenza Pandemic Virus, 2022-2023 Preliminary In-Season Burden Estimate, Who is at Higher Risk of Flu Complications, Flu and COVID-19 Vaccine Coadministration, Who Should & Who Should NOT Get Vaccinated, Live Attenuated Influenza Vaccine (LAIV)/Nasal Spray Vaccine, Selecting Viruses for the Seasonal Influenza Vaccine, Flu Vaccine and People with Egg Allergies, Frequently Asked Questions on Vaccine Supply, Historical Reference of Vaccine Doses Distributed, Investigating Respiratory Viruses in the Acutely Ill (IVY), Respiratory Virus Transmission Network (RVTN), Randomized Assessment of Influenza Vaccine Efficacy Network (RAIVEN), Hospitalized Adult Influenza Vaccine Effectiveness Network (HAIVEN), How Vaccine Effectiveness and Efficacy are Measured, What People with a Staph Infection Should Know about Flu, Resources for Hosting a Vaccination Clinic, Overview of Influenza Surveillance in the United States, Influenza Hospitalization Surveillance Network (FluSurv-NET), Weekly U.S. Unsolicited non-serious adverse events were reported in 417 (44%) participants in Group 1 and 394 (40%) participants in Group 2. The preferred site for infants and young children is the anterolateral aspect of the thigh. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton X-100), producing a "split virus". The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Selecting Viruses for the Seasonal Influenza Vaccine. Sanofi Pasteur 752-21 - McKesson Medical-Surgical Table 6 summarizes solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards. an A/Wisconsin/588/2019 (H1N1) pdm09-like virus. Fluzone Quadrivalent: Package Insert - Drugs.com 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. ** 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. Since 1977, antigenic variants of influenza A (H1N1 and H3N2) viruses and influenza B viruses have been in global circulation. 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. For participants who received two doses, the doses were administered approximately 4 weeks apart. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Registered users can now access COVID-19 vaccine lot numbers and expiration dates provided to CDC by the vaccine manufacturer. Sanofi Pasteur Vaccine Production Plant, Swiftwater, Pennsylvania Dosage form: suspension for intramuscular injection Participants received one dose of either Fluzone vaccine (N = 813), an active comparator (N = 814), or placebo (N = 325). Medically reviewed by Drugs.com. Vaccine 2021; 39: A24-A35. 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%). Also please see complete Patient Information for Fluzone Quadrivalent andFluzone High-Dose Quadrivalent. 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. 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. It can lead to severe complications, increasing the risk of heart attack and pneumonia. Discard unused portion. Requires Refrigeration. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. 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. Accessed June 2022.10DiazGranados CA, et al. There were no adverse effects on pre-weaning development or vaccine-related fetal malformations noted in this study. 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. Single-dose, prefilled syringe (clear plunger rod), without needle, 0.5 mL (NDC 49281-422-88) (not made with natural rubber latex). Vaccine. 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. J Diabetes Sci Technol. * Fluzone High-Dose Quadrivalent (Influenza Vaccine) and Flublok Quadrivalent (Influenza Vaccine) are the only two flu vaccines proven to help prevent more cases of flu in older adults, compared to their standard-dose flu vaccine comparators as assessed in randomized controlled trials, the gold standardin evaluating clinical evidence for vaccine licensure1,2* FluzoneHigh-Dose (Influenza Vaccine) is the first and only influenza vaccine with superior flu protection and 10 years of evidence in preventing flu-related hospitalizations in adults aged 65+2,3,a,b* As the leaders in flu, Sanofi is committed to protecting patients most at-risk for the flu and its related complications, including hospitalizations due to pneumonia & cardiovascular events4.
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