sanofi pasteur flu vaccine lot numbers

In Study 3 (NCT00988143, see http://clinicaltrials.gov), a multi-centered randomized, open-label trial conducted in the US, adults 18 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). Fluzone Quadrivalent is supplied in 3 presentations: 1) Prefilled single-dose syringe (clear syringe plunger rod), 0.5 mL, for persons 6 months of age and older. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk. Participants were monitored for unsolicited adverse events and SAEs during the 21 days following vaccination. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. * 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. 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. 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. Fluzone Quadrivalent Prescribing Information, Respiratory, Thoracic and Mediastinal Disorder, General Disorders and Administration Site Conditions, Active Substance: Split influenza virus, inactivated strains, influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/darwin/9/2021 san-010 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) injection, suspension, influenza a virus a/guangdong-maonan/swl1536/2019 cnic-1909 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/hong kong/2671/2019 ivr-208 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), influenza b virus b/washington/02/2019 antigen (formaldehyde inactivated) injection, suspension, 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/phuket/3073/2013 hemagglutinin antigen (formaldehyde inactivated), influenza b virus b/maryland/15/2016 bx-69a antigen (formaldehyde inactivated) injection, suspension, influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/kansas/14/2017 x-327 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), influenza b virus b/maryland/15/2016 bx-69a antigen (formaldehyde inactivated) injection, suspension, influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/tasmania/503/2020 ivr-221 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), influenza b virus b/washington/02/2019 antigen (formaldehyde inactivated) injection, suspension. The safety analysis set included 1941 participants who received at least 1 dose of study vaccine. 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. To receive email updates about this page, enter your email address: For more information on background and concepts see Understanding the Rules for Creating CVX and MVX Codes [5 pages], View archived 2015 Edition Versioned Codes, More ways to access CDCs Vaccine Code Set information: Code Set Viewpoint search/browse website and REST Web Service. The effectiveness of Fluzone Quadrivalent was demonstrated based on clinical endpoint efficacy data for Fluzone (trivalent influenza vaccine) and on an evaluation of serum HI antibody responses to Fluzone Quadrivalent. That means not only using mRNA or protein-based technologies, but alsonovel methodsof antigen selection in order to inducebroader protection. 800.422.0280. 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. DO NOT FREEZE. Study 2 (NCT02915302 see http://clinicaltrials.gov) was a randomized, observer-blinded, 2-arm, multi-center safety and immunogenicity study conducted in the US. 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. Fluzone Quadrivalent is a vaccine that helps protect against influenza illness (flu). pain, redness, and swelling where you got the shot. Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent are vaccines indicated for immunization against disease caused by influenza A and B strains contained in the vaccine. This study revealed no adverse effects to the fetus or pre-weaning development due to Fluzone Quadrivalent [see Animal Data (8.1)]. (*) 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. Do not administer this product intravenously, intradermally, or subcutaneously. Available at https://www.cdc.gov/flu/spotlights/2021-2022/specific-vaccines-seniors.htm. Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration, whenever solution and container permit. 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). Package inserts for U.S.-licensed vaccinesexternal icon. 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%). ** 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. The table shows the patterns for the different lot numbers for the six VFC vaccines this difference impacts. 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%). This summary is not intended to take the place of talking with your healthcare provider. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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%). 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. Manufactured by: 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. Contact the Sanofi Pasteur Reimbursement Support Service (RSS). 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. PDF Influenza Vaccine Products for the 2022-2023 Influenza Season The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. These cookies may also be used for advertising purposes by these third parties. This approval is the final step toward the company's complete transition to quadrivalent influenza vaccines in the U.S. Fluzone High-Dose Quadrivalent will be made available for immunization efforts during the 2020-2021 influenza season. 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%). Table 2 and Table 3 summarize solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards. 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%). ACIP General Best Practice Guidelines for Immunization. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Available at: Warren-Gash C, et al. The dose volume for Afluria Quadrivalent is 0.25 mL for children aged 6 through 35 months and 0.5 mL for persons aged 3 years. Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial. There were no adverse effects on pre-weaning development or vaccine-related fetal malformations noted in this study. The site is secure. 49281051105. A maximum of ten doses can be withdrawn from the multi-dose vial. With protection against four flu strains, Fluzone High-Dose is the only influenza vaccine licensed for use in adults 65 years of age and older to have demonstrated superior efficacy in a randomized controlled trial versus a standard dose influenza vaccine for the prevention of laboratory-confirmed influenza illness and the only influenza . Sanofi flu vaccines licensed and approved for 2022-2023 influenza https://doi.org/10.1016/j.vaccine.2020.09.004. It is not known whether Fluzone Quadrivalent is excreted in human milk. Fluzone Quadrivalent is for people who are 6 months of age and older. 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. They help us to know which pages are the most and least popular and see how visitors move around the site. Prior to vaccination, always refer to the current Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza vaccines. Fluzone Quadrivalent should not be combined through reconstitution or mixed with any other vaccine. The latest UKHSA data on the maternal whooping cough vaccine programme shows that uptake has dropped to its lowest level in 7 years. - McKesson Medical-Surgical Antibodies against one influenza virus type or subtype confer limited or no protection against another. HI antibody GMTs 21 days following vaccination with Fluzone Quadrivalent were non-inferior to those following each TIV for all four strains, based on pre-specified criteria (see Table 12). MacIntyre CR, et al. Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for the usual change of one or more new strains in each year's influenza vaccine. The Lancet Respiratory Medicine. 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). L Single-dose vial, 0.5 mL (NDC 49281-422-58) (not made with natural rubber latex). NDC Number. Of these participants, 49.7% were female, 74.3% were Caucasian, 19.2% were Black, 6.5% were of other racial groups, and 22.0% were Hispanic/Latino. Eur respir J. Cases of influenza were identified through active and passive surveillance for influenza-like illness or acute otitis media and confirmed by culture. 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. Sanofi Pasteur Inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes following vaccination with Fluzone Quadrivalent during pregnancy. Before sharing sensitive information, make sure you're on a federal government site. 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. Product Dating. 9Centers for Disease Control and Prevention. ** Fluzone Quadrivalent is currently licensed for ages 6 through 35 months at either 0.25 mL or 0.5 mL per dose; however, .25-mL prefilled syringes are not expected to be available for the 2020-21 influenza season. 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. The following events have been spontaneously reported during the post-approval use of Fluzone (trivalent) or Fluzone Quadrivalent. Cookies used to make website functionality more relevant to you. For intramuscular injection only, Afluria, Afluria Quadrivalent, Flucelvax Quadrivalent, Fluad, +7 more, Tamiflu, oseltamivir, Fluzone, Xofluza, Afluria, influenza virus vaccine, inactivated. DailyMed - FLUZONE HIGH-DOSE QUADRIVALENT NORTHERN HEMISPHERE 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. Single-dose, prefilled syringe (clear plunger rod), without needle, 0.5 mL (NDC 49281-422-88) (not made with natural rubber latex). Data for 2022 shows an average uptake across England of 61.5% . Discard unused portion. (2019). Animal Data: In a developmental and reproductive toxicity study female rabbits were administered a 0.5 mL/dose of Fluzone Quadrivalent by intramuscular injection 24 and 10 days before insemination, and on Days 6, 12, and 27 of gestation (a single human dose is 0.5 mL). Fluzone Quadrivalent is a suspension for injection. Sanofi has led the way with the first human vaccine in the US against the H5N1 virus. Vaccine Product Information - Order Vaccines and Contact Manufacturers Participants were monitored for unsolicited adverse events and SAEs during the 28 days following vaccination. The most commonly reported unsolicited non-serious adverse events in both groups were cough and rhinorrhea. Sanofi Pasteur will continue to deliver and offer the trivalent formulation of Fluzone High-Dose through . Medical professionals, medical facility employees 855.571.2100. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Accessed June 2022. Influenza (seasonal) Fact Sheet. 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. Also please see complete Patient Information for Fluzone Quadrivalent andFluzone High-Dose Quadrivalent. We are pursuingnext generationinfluenza vaccines with multiple vaccine technologies to develop and bring forward tomorrows vaccines to people around the world as fast as possible. Participants received two 0.25 mL doses of either Fluzone (N = 525) or a placebo (N = 261). 0.5-mL Dose of Fluzone Quadrivalent in Children 6 Months through 35 Months of Age. Abbreviations: ACIP = Advisory Committee on Immunization Practices; FDA = Food and Drug Administration; HA = hemagglutinin; IIV3 = inactivated influenza vaccine, trivalent; IIV4 = inactivated influenza vaccine, quadrivalent; IM = intramuscular; LAIV4 = live attenuated influenza vaccine, quadrivalent; MDV = multidose vial; NAS = intranasal; PFS = prefilled syringe; RIV4 = recombinant influenza vaccine, quadrivalent; SDV = single-dose vial. 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). Multi-dose vial, 5 mL (NDC 49281-637-78) (not made with natural rubber latex). For participants recommended to receive two doses of influenza vaccine as per Advisory Committee on Immunization Practices guidance, the same dose was administered 4 weeks after the first. 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. PDF 2022-2023 Influenza Season Vaccine Label Examples-August 29, 2022 - CDC Vaccine Administration: Making the Process More Efficient in Your Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. Vaccine. The information provided in this resource is for informational purposes only. Guillain Barr syndrome (severe muscle weakness) after getting a flu vaccine. Drug class: Viral vaccines. 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. Fluzone Quadrivalent is given to people 6 months of age and older. Please read this information sheet before getting Fluzone Quadrivalent. 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. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton X-100), producing a "split virus". You can review and change the way we collect information below. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov. For information on flu vaccine distribution schedules, please contact the manufacturers directly. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Availability and characteristics of specific products and presentations might change and/or differ from what is described in this table and in the text of the full report. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. Strength. Available at https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-22-23/03-influenza-grohskopf-508.pdf. The most commonly reported unsolicited non-serious adverse events were cough, vomiting, and pyrexia. 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. Heart 2016;102:19531956. 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. Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color. Dosage form: suspension for intramuscular injection

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