Syncope (fainting) has been reported following vaccination with Fluzone Quadrivalent. 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). For participants who received two doses, the doses were administered approximately 4 weeks apart. 7Centers for Disease Control and Prevention. Participants were monitored for unsolicited adverse events and SAEs during the 28 days following vaccination. in influenza and pediatrics vaccines, first worldwide . Prior to vaccination, always refer to the current Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza vaccines. 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. Vaccination with Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent may not protect all people who receive the vaccine. During the 28 days following vaccination, a total of 16 (0.6%) recipients in the Fluzone Quadrivalent group, 4 (0.5%) recipients in the TIV-1 group, and 4 (0.6%) recipients in the TIV-2 group, experienced at least one SAE. 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. For adults and older children, the recommended site for intramuscular influenza vaccination is the deltoid muscle. Fluzone Quadrivalent has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. 2018 Mar 29;51(3):1701794. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. Fluzone High-Dose Quadrivalent: Package Insert - Drugs.com 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. Participants were monitored for unsolicited adverse events and SAEs during the 21 days following vaccination. If any of these defects or conditions exist, Fluzone Quadrivalent should not be administered. You are about to visit another Sanofi website. J Infect Dis. People at Higher Risk for Flu Complications. Thank you for taking the time to confirm your preferences. 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. Strength. 2021 Mar;69(3):696-703. 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). Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Sanofi has led the way with the first human vaccine in the US against the H5N1 virus. For infants, Fluzone Quadrivalent is a shot given into the muscle of the thigh. 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. 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. Requires Refrigeration. 1 This was the impetus for the 1994 federal. Vaccine Product Information - Order Vaccines and Contact Manufacturers Do not administer this product intravenously, intradermally, or subcutaneously. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Tell your health care provider if you have ever had Guillain-Barr syndrome (severe muscle weakness) after a previous influenza vaccination. Before sharing sensitive information, make sure you're on a federal government site. Participants received two 0.25 mL doses of either Fluzone (N = 525) or a placebo (N = 261). Antibody responses to Fluzone Quadrivalent are lower in persons 65 years of age than in younger adults. Vaccines - Sanofi Please read this information sheet before getting Fluzone Quadrivalent. 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. Supplied as package of 10 (NDC 49281-422-50). The most common side effects of Fluzone Quadrivalent are: These are not all of the possible side effects of Fluzone Quadrivalent. Influenza virus strains were selected based on the influenza vaccine production method; egg-based and cell- or recombinant based. Accessed June 2022. Antibodies against one influenza virus type or subtype confer limited or no protection against another. Flu vaccine lots that have been released by FDA and are available for distribution by the manufacturers. The table shows the patterns for the different lot numbers for the six VFC vaccines this difference impacts. Data for 2022 shows an average uptake across England of 61.5% . Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. The most commonly reported unsolicited non-serious adverse events in both groups were cough and rhinorrhea. They help us to know which pages are the most and least popular and see how visitors move around the site. 47823. Fluzone Quadrivalent is a suspension for injection. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury. Pregnant women are at increased risk of complications associated with influenza infection compared to non-pregnant women. Available at: Izikson R. et al. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. 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. Call your healthcare provider for advice about any side effects that concern you. Fluzone is a registered trademark of Sanofi Pasteur Inc. Vaccine Administration: Making the Process More Efficient in Your A world leader. 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. 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. Fluzone Quadrivalent is a vaccine that helps protect against influenza illness (flu). 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). McKesson Acceptable Dating: we will ship >= 30 days. Flu & People 65 Years 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. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. You can review and change the way we collect information below. J Diabetes Sci Technol. ** 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. 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. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. IIS Data Code Sets | CDC Flu impacts people's lives and puts a considerable strain on already stretched health systems during the winter season. ", 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). 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. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. WHO. 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 Sanofi assumes no responsibility for the information presented on this website. Vaccine 2021; 39: A24-A35. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Participants received one dose of either Fluzone vaccine (N = 813), an active comparator (N = 814), or placebo (N = 325). Inactive ingredients include formaldehyde and octylphenol ethoxylate. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk. 2019 Sep 16;37(39):5825-5834. Samson et al. The 1976 swine influenza vaccine was associated with an elevated risk of Guillain Barr syndrome (GBS). Fluzone Quadrivalent contains killed viruses and cannot cause influenza.