sanofi pasteur flu vaccine lot numbers

Furthermore, antibodies to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype. Report adverse reactions to their healthcare provider and/or to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In adults 18 years and older, the most common (10%) injection-site reaction was pain (47%); the most common solicited systemic adverse reactions were myalgia (24%), headache (16%), and malaise (11%). Prefilled Syringes Participants received two 0.25 mL doses of either Fluzone (N = 525) or a placebo (N = 261). 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 - 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 This study revealed no adverse effects to the fetus or pre-weaning development due to Fluzone Quadrivalent [see Animal Data (8.1)]. The new facility building at Swiftwater has had an investment of $150m. 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. J Diabetes Sci Technol. 2018 Mar 29;51(3):1701794. 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. Swiftwater, PA: Sanofi2Fluzone High-Dose Quadrivalent [Prescribing Information]. It is provided for information only. 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. Guillain Barr syndrome (severe muscle weakness) after getting a flu vaccine. 0.5-mL Dose of Fluzone Quadrivalent in Children 6 Months through 35 Months of Age. Annual vaccination with the influenza vaccine is recommended because immunity during the year after vaccination declines and because circulating strains of influenza virus change from year to year. They help us to know which pages are the most and least popular and see how visitors move around the site. 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. Manufactured by: Dosage form: suspension for intramuscular injection If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Table 2 and Table 3 summarize solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards. Available at https://www.cdc.gov/flu/prevent/vaccine-selection.htm. 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. Download the Seasonal Influenza Crosswalk table. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. Call your healthcare provider for advice about any side effects that concern you. Fluzone Quadrivalent is a vaccine that helps protect against influenza illness (flu). What are the possible side effects of Fluzone Quadrivalent? We take your privacy seriously. Sanofi Pasteur Inc. Sanofi assumes no responsibility for the information presented on this website. 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. 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%). WHO. J Am Geriatr Soc. Influenza virus strains were selected based on the influenza vaccine production method; egg-based and cell- or recombinant based. 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. ACIP General Best Practice Guidelines for Immunization. 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. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Its an infectious disease that does more damage than most people realize. Package insert / product label Cookies used to make website functionality more relevant to you. 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. Swiftwater, PA 18370 USA. 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. Cases of influenza were identified through active and passive surveillance for influenza-like illness or acute otitis media and confirmed by culture. 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. * 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. 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. If any of these defects or conditions exist, Fluzone Quadrivalent should not be administered. Fluzone Quadrivalent is for people who are 6 months of age and older. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation. Influenza-like illness was defined as fever with signs or symptoms of an upper respiratory infection. 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. 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. Procedures should be in place to avoid injury from fainting. We comply with the HONcode standard for trustworthy health information. Accessed on June 22, 2022. There were no adverse effects on pre-weaning development or vaccine-related fetal malformations noted in this study. 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. 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. Products: Comirnaty (COVID-19 vaccine) Sanofi U.S. 55 Corporate Drive Bridgewater, NJ 08807 Vaccines and biologics Medical professionals, medical facility employees 855.571.2100. You can review and change the way we collect information below. Available at: Warren-Gash C, et al. 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. Participants were monitored for unsolicited adverse events and SAEs during the 21 days following vaccination. Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. Study 4 included 602 subjects 50 through 64 years of age for safety analysis, randomized to receive Flublok (n=300) or another U.S.-licensed trivalent influenza vaccine (Fluzone, manufactured by Sanofi Pasteur, Inc.) as an active control (n=302). Supplied as package of 1 (NDC 49281-637-15). (*) 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. 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. NDC Number. 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). The site is secure. Contact the Sanofi Pasteur Reimbursement Support Service (RSS). Sanofi Pasteur, the vaccines business of Sanofi-Aventis, is one of the largest seasonal influenza vaccine producers in the world. 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 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) Discard unused portion. The Lancet Respiratory Medicine. 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. 2021 Dec 6;73(11):e4288-e4295. NDC Number. 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 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). Data are not available to assess the effects of Fluzone Quadrivalent on the breastfed infant or on milk production/excretion. The .gov means its official.Federal government websites often end in .gov or .mil. Annual influenza vaccination is recommended. References1Flublok Quadrivalent [Prescribing Information]. 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. 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. The Fluzone Quadrivalent prefilled syringe and vial presentations are not made with natural rubber latex. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. 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). You are about to visit another Sanofi website. Vaccines are the best public health tool available to prevent flu and its serious complications. 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. 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.

How Many Times Did Jesus Go To Gerasenes, Chase Bank Red Envelopes 2021, Articles S