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A Cell-Based Option for Seasonal Influenza Prevention in Persons 6 Months & Older

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Explore the data that led to the expansion of a licensed cell-based influenza vaccine to include patients as young as 6 months of age. 

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  • Overview

    Influenza causes considerable morbidity and mortality in children. In fact, the CDC estimates that from the 2010-2011 season to the 2019-2020 season, seasonal flu-related hospitalizations among children younger than 5 years old have ranged from 7,000 to as high as 26,000 every year.1 This is a sobering reminder of the pivotal role vaccination plays in preventing influenza disease, and now, recent safety and immunogenicity data has led to the expanded age indication for the cell-based vaccine FLUCELVAX QUADRIVALENT. Explore that data and what this approval means for patients 6 months of age and older with Drs. Charles Turck and Donald Middleton.

    1. Centers for Disease Control and Prevention. Flu and young children. https://www.cdc.gov/flu/highrisk/children.htm. Accessed December 22, 2021

    USA-QIVc-21-0169 December 2021

  • IMPORTANT SAFETY INFORMATION

    INDICATION AND USAGE
    FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 6 months of age and older.

    CONTRAINDICATIONS
    Do not administer FLUCELVAX QUADRIVALENT to anyone with a history of severe allergic reactions (e.g. anaphylaxis) to any component of the vaccine.

    WARNINGS AND PRECAUTIONS
    If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUCELVAX QUADRIVALENT should be based on careful consideration of the potential benefits and risks.

    Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

    Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUCELVAX QUADRIVALENT. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope by maintaining a supine or Trendelenburg position.

    After vaccination with FLUCELVAX QUADRIVALENT, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response.

    Vaccination with FLUCELVAX QUADRIVALENT may not protect all vaccine recipients against influenza disease.

    ADVERSE REACTIONS
    In children 6 months through 3 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (27.9%), erythema (25.8%), induration (17.3%) and ecchymosis (10.7%). The most common systemic adverse reactions were irritability (27.9%), sleepiness (26.9%), diarrhea (17.9%) and change of eating habits (17.4%).

    In children 2 through 8 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (28.7%), pain (27.9%) and erythema (21.3%), induration (14.9%) and ecchymosis (10.0%). The most common systemic adverse reactions were sleepiness (14.9%), headache (13.8%), fatigue (13.8%), irritability (13.8%) and loss of appetite (10.6%).

    In children and adolescents 9 through 17 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were injection site pain (21.7%), erythema (17.2%) and induration (10.5%).  The most common systemic adverse reactions were headache (18.1%) and fatigue (17.0%).

    In adults 18 through 64 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (45.4%), erythema (13.4%) and induration (11.6%). The most common systemic adverse reactions were headache (18.7%), fatigue (17.8%) and myalgia (15.4%).

    In adults ≥65 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (21.6%) and erythema (11.9%).

    To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

    Before administration, please see the full US Prescribing Information for FLUCELVAX QUADRIVALENT.

    FLUCELVAX® QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates.

Schedule28 May 2022
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