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Sanofi: Protection Beyond Flu

Sanofi higher-dose flu shots offer better protection vs standard dose in older adults, even for your patients who feel unstoppable1-4*†‡§

Fluzone® (Influenza Vaccine), Flublok, and Fluzone High-Dose are vaccines indicated for active immunization for the prevention of disease caused by influenza A virus subtypes and type B virus contained in (or in the case of Flublok, represented by antigens contained in) the vaccine. Fluzone is approved for use in persons 6 months of age and older. Flublok is approved for use in persons 9 years of age and older. Fluzone High-Dose is approved for use in persons 65 years of age and older.

The only 2 higher-dose flu vaccines proven to help protect against flu and its complications1-6

Fluzone High-Dose
Flublok
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*Fluzone High-Dose and Flublok contain 4x and 3x the antigen content of a standard-dose influenza vaccine, respectively.1-4

†Fluzone High-Dose and Flublok are the only higher-dose flu vaccines proven to prevent more flu in older adults than a standard-dose influenza vaccine in randomized controlled trials.3,4,7

‡In a randomized controlled trial, Fluzone High-Dose trivalent formulation provided 24% (95% CI: 10-37) better protection against influenza due to any lab-confirmed circulating strains vs a standard-dose influenza vaccine in adults 65 years of age and older.2,3 Solicited injection-site reactions and systemic adverse reactions were more frequent after vaccination with Fluzone High-Dose compared to Fluzone.2

Click here for additional efficacy and safety data for Fluzone High-Dose.

§In a randomized controlled trial, Flublok (quadrivalent) provided 30% (95% CI: 10-47) better protection against influenza due to any PCR-confirmed circulating strains vs a standard-dose quadrivalent inactivated influenza vaccine in adults 50 years of age and older.1,4

The efficacy of the quadrivalent formulation is relevant to Flublok since both vaccines are manufactured according to the same process and have overlapping compositions.1

For Flublok, in children and adolescents 9 through 17 years of age who received Flublok Quadrivalent, the most common (≥10%) solicited injection-site adverse reaction was pain (34.4%). The most common (≥10%) solicited systemic adverse reactions were myalgia (19.3%), headache (18.5%), and malaise (16.1%). In adults 18 through 49 years of age who received Flublok, the most common (≥10%) injection-site adverse reaction was pain (37%); the most common (≥10%) solicited systemic adverse reactions were headache (15%), fatigue (15%), and muscle pain (11%). In adults 50 through 64 years of age who received Flublok, the most common (≥10%) injection site adverse reaction was pain (32%); the most common (≥10%) solicited systemic adverse reactions were headache (17%), fatigue (13%), and muscle pain (11%). In adults 65 years of age and older who received Flublok, the most common (≥10%) injection site adverse reaction was pain (19%); the most common (≥10%) solicited systemic adverse reactions were fatigue (13%) and headache (10%).1

Click here for additional efficacy and safety data for Flublok.

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These vaccines and their administration are covered by Medicare and most commercial insurers.

The information above is available at CMS.gov. The information is provided for informational purposes only and is not a guarantee of coverage. The information is gathered from various resources and is subject to change.

Frequently asked questions

Important Safety Information

Do not administer Fluzone, Flublok, or Fluzone High-Dose to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine (including egg protein for Fluzone and Fluzone High-Dose). Fluzone and Fluzone High-Dose should not be administered to anyone who has had a severe allergic reaction after previous dose of any influenza vaccine.

Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of the vaccine.

If Guillain-Barré syndrome has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone, Flublok, or Fluzone High-Dose should be based on careful consideration of the potential benefits and risks.

Syncope (fainting) has been reported following vaccination with Fluzone, Flublok and Fluzone High-Dose. Procedures should be in place to avoid injury from fainting.

In two separate postmarketing observational studies, an increased risk of febrile seizures was observed during the first day following vaccination with standard dose trivalent (2024-2025) and quadrivalent (2023-2024) influenza vaccines in children 6 months through 4 years of age.

If Fluzone, Flublok, or Fluzone High-Dose are administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be attained.

Vaccination with Fluzone, Flublok, or Fluzone High-Dose may not protect all recipients.

For Fluzone, in children 6 months through 8 years of age, the most common injection-site adverse reactions were pain or tenderness and redness; the most common solicited systemic adverse reactions were irritability, drowsiness (6 months through 35 months), and myalgia (3 years through 8 years). In adults 18 through 64 years of age, the most common injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were headache and myalgia. In adults over 65 years of age, the most common injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were headache, myalgia, and malaise.

For Flublok, in children 9 through 17 years of age who received Flublok Quadrivalent, the most common solicited injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were myalgia, headache, and malaise. In adults 18 through 64 years of age who received Flublok, the most common injection site adverse reaction was pain; the most common solicited systemic adverse reactions were headache, fatigue, and myalgia. In adults 65 years of age and older who received Flublok, the most common injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were fatigue and headache.

For Fluzone High-Dose, in adults 65 years of age and older, the most common injection-site reaction was pain; the most common solicited systemic adverse reactions were myalgia, malaise, and headache.

For Fluzone, Flublok, and Fluzone High-Dose, other adverse reactions may occur.

Indications

Fluzone, Flublok, and Fluzone High-Dose are vaccines indicated for active immunization for the prevention of disease caused by influenza A virus subtypes and type B virus contained in (or in the case of Flublok, represented by antigens contained in) the vaccine. Fluzone is approved for use in persons 6 months of age and older. Flublok is approved for use in individuals 9 years of age and older. Fluzone High-Dose is approved for use in persons 65 years of age and older.

Before administration, please see the full Prescribing Information for Fluzone, Flublok, or Fluzone High-Dose. Also, please see complete Patient Information for Fluzone or Fluzone High-Dose.

Click here to learn more about Sanofi's commitment to fighting counterfeit drugs.

Important Safety Information
Indications

References: 1. Flublok. Prescribing Information. Protein Sciences Corporation. 2. Fluzone High-Dose. Prescribing Information. Sanofi Pasteur Inc. 3. DiazGranados CA, et al. N Engl J Med. 2014;371(7):635-645. doi:10.1056/NEJMoa1315727 4. Dunkle LM, Izikson R, Patriarca P, et al; PSC12 Study Team. N Engl J Med. 2017;376(25):2427-2436. doi:10.1056/NEJMoa1608862 5. Zimmerman RK, Nowalk MP, Dauer K, et al. Vaccine. 2023;41:5134-5140. 6. Lee JKH, et al. Vaccine X. 2023;14:100327. doi:10.1016/j.jvacx.2023.100327 7. Grohskopf LA, et al. MMWR Recomm Rep. 2024;73(5):1-25. doi:10.15585/mmwr.rr7305a1 8. Fluzone. Prescribing Information. Sanofi Pasteur Inc. 9. Centers for Disease Control and Prevention. Recombinant influenza (flu) vaccines. Published June 16, 2026. Accessed July 27, 2026. https://www.cdc.gov/flu/vaccine-types/flublok-vaccine.html

MAT-US-2508006-v6.0-08/2026 Last updated: August 2026

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