WHO. 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. Fluzone is a registered trademark of Sanofi Pasteur Inc. 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. Andrew MK et al. Accessed June 2022. 3) Multi-dose vial, 5 mL, for persons 6 months of age and older. Selecting Viruses for the Seasonal Influenza Vaccine. 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. 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. ", 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). Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial. 7Centers for Disease Control and Prevention. CDC twenty four seven. Global Medical Affairs Influenza, Sanofi. You will be subject to the destination website's privacy policy when you follow the link. Supplied as package of 10 (NDC 49281-422-10). Cases of influenza were identified through active and passive surveillance and confirmed by cell culture and/or real-time polymerase chain reaction (PCR). 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%). 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. Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. 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. Sanofi Pasteur 49281051105 - McKesson Medical-Surgical 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. Sanofi Pasteur Inc. is collecting information on pregnancy outcomes and the health of newborns following vaccination with Fluzone Quadrivalent during pregnancy. Available data with Fluzone Quadrivalent use in pregnant women are insufficient to inform vaccine-associated risk of adverse developmental outcomes. Sanofi Pasteur 49281041850 - McKesson Medical-Surgical 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. Fluzone Quadrivalent is a suspension for injection. Seasonal Information for Influenza Virus Vaccine | FDA Its an infectious disease that does more damage than most people realize. Sanofi has led the way with the first human vaccine in the US against the H5N1 virus. Please refer to the full Prescribing Information forFluzone High-Dose Quadrivalent, Flublok Quadrivalent, orFluzone Quadrivalent. It is provided for information only. Influenza Vaccine for the 2021-2022 Season Cumulative 2021/2022 Season Lot Release Status (Updated 11/3/2021) Flu vaccine lots that have been released by FDA and are available for. Inform the vaccine recipient or guardian: Vaccine Information Statements must be provided to vaccine recipients or their guardians, as required by the National Childhood Vaccine Injury Act of 1986 prior to immunization. Vaccine update: issue 337, April 2023 - GOV.UK Strength. 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. Procedures should be in place to avoid injury from fainting. (See ref. We comply with the HONcode standard for trustworthy health information. Flublok Quadrivalent is given to people 18 years of age and older. In adults 50 years of age and older the most common side effects were tenderness, and/or pain where you got the shot; headache and tiredness. 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. In addition, Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction after previous dose of any influenza vaccine. 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. For adults and older children, the recommended site for intramuscular influenza vaccination is the deltoid muscle. Global surveillance of influenza identifies yearly antigenic variants. The preservative thimerosal is only in the multi-dose vial of Fluzone Quadrivalent. The new facility building at Swiftwater has had an investment of $150m. Tuberculin Purified Protein Derivative (Mantoux) - Food and Drug 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). The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed / Inactivated Poliovirus / Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, Preservative Free. 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. Chang LJ, et al. 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. Do not use after the expiration date shown on the label. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury. Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. However, in some human studies, antibody titers 1:40 have been associated with protection from influenza illness in up to 50% of subjects. Study 1 (NCT01240746, see http://clinicaltrials.gov) was a single-blind, randomized, active-controlled multi-center safety and immunogenicity study conducted in the US. Thomas Triomphe-- Executive Vice President, Sanofi Pasteur. Single-dose vial, 0.5 mL (NDC 49281-422-58) (not made with natural rubber latex). Among participants in the three vaccine groups combined, 55.7% were female (Fluzone Quadrivalent, 57.3%; TIV-1, 56.0%; TIV-2, 53.8%), 89.5% Caucasian (Fluzone Quadrivalent, 87.6%; TIV-1, 89.8%; TIV-2, 91.1%), 2.2% Black (Fluzone Quadrivalent, 4.0%; TIV-1, 1.8%; TIV-2, 0.9%), 7.4% Hispanic (Fluzone Quadrivalent, 8.4%; TIV-1, 7.6%; TIV-2, 6.2%) and 0.9% were of other racial/ethnic groups (Fluzone Quadrivalent, 0.0%; TIV-1, 0.9%; TIV-2, 1.8%). Participants were monitored for unsolicited adverse events and SAEs during the 21 days following vaccination. 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. 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. You can review and change the way we collect information below. Generic Drug Name. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. The most commonly reported unsolicited non-serious adverse events in both groups were cough and rhinorrhea. Products: Comirnaty (COVID-19 vaccine) Sanofi U.S. 55 Corporate Drive Bridgewater, NJ 08807 Vaccines and biologics 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. Vaccine efficacy of Fluzone against all influenza viral types and subtypes is presented in Table 9. What are the ingredients in Fluzone Quadrivalent? 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: It is not known whether Fluzone Quadrivalent is excreted in human milk. If Fluzone Quadrivalent is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained. 60 mcg / 0.5 mL. See FDA-approved patient labeling (Patient Information). Last updated on Nov 1, 2022. 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. 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Sanofi Pasteur will continue to deliver and offer the trivalent formulation of Fluzone High-Dose through . Influenza Vaccine for the 2020-2021 Season | FDA To receive weekly email updates about Seasonal Flu, enter your email address: We take your privacy seriously. 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. 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. ever had a severe allergic reaction after getting any flu vaccine. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Single-dose, prefilled syringe (clear plunger rod), without needle, 0.5 mL (NDC 49281-422-88) (not made with natural rubber latex). Influenza Virus Vaccine, Quadrivalent Inactivated, Preservative Free. Product Specifications Professionals Also Viewed Product Specifications Features Protect from light:Tuberculin PPD solutions can be adversely affected by exposure to light Store at 2 to 8 degrees Celsius (35 to 46 degrees Fahrenheit) Do not freeze Enough antigen for 10 tests per vial More Information SDS Professionals Also Viewed 2021 Mar;69(3):696-703. The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. 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. All information these cookies collect is aggregated and therefore anonymous. 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. 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. Unsolicited non-serious adverse events were reported in 417 (44%) participants in Group 1 and 394 (40%) participants in Group 2. 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. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Fluzone Quadrivalent is a vaccine that helps protect against influenza illness (flu). CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines). 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. 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. You can review and change the way we collect information below. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Influenza - Sanofi For preventive vaccines, the underlying maternal condition is susceptibility to the disease prevented by the vaccine. The following events have been spontaneously reported during the post-approval use of Fluzone (trivalent) or Fluzone Quadrivalent. About 16,000. employees globally, 65% of them dedicated to manufacturing and quality operations. The safety analysis set included 570 recipients, half aged 18-60 years and half aged 61 years or older. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. 1 This was the impetus for the 1994 federal. 49281-0418-50. 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. Influenza vaccination can reduce the risk of heart attacks by up to 45% [15-45%]7, Vaccination is especially important for people most at risk1, People over 65, children under 5, pregnant women and people with chronic medical conditions, Flu and Covid-19 vaccines can be administered at the same time8per a recent Sanofi study9, With our influenza vaccines, we seek to not only prevent influenza but also protect against its severe complications like heart attack and pneumonia. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Fluzone Quadrivalent contains 4 killed flu virus strains. 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. In adults 18 years and older, the most common side effects were pain where you got the shot; muscle aches, headache, and general discomfort. Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. 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. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. 2005-2022 sanofi-aventis U.S. LLC - All rights reserved. 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 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).