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FLUZONE® HIGH-DOSE QUADRIVALENT (INFLUENZA VACCINE)

For adults 65+

FLUZONE® HIGH-DOSE is the only flu vaccine approved by the Food and Drug Administration (FDA) to provide superior flu protection compared to a standard-dose flu shot in adults 65 and older. But at Sanofi, we don’t just stop there. In addition to a clinical trial, the effectiveness of FLUZONE® HIGH-DOSE was also judged by data from general day-to-day medical practice amongst 34 million 65+ adults spanning 10 years. FLUZONE® HIGH-DOSE is the only 65+ approved flu vaccine that has been proven to provide better protection against flu and flu-related complications compared with a standard-dose flu shot.

The efficacy of the trivalent and quadrivalent formulations of Fluzone High-Dose (Influenza Vaccine) are related because both are made using the same process and have overlapping compositions.

Superior protection compared to standard-dose Fluzone® (Influenza Vaccine)

24%
more effective at preventing flu

Study Design: Based on a clinical trial of ~32,000 adults 65+ conducted during 2 flu seasons, 2011-2012 and 2012-2013 where an influenza case was laboratory tested.

Compared with Fluzone®, the most common side effects were slightly more frequent and included pain and redness where you got the shot, muscle ache, tiredness, and headache.

The immune response and side effects of FLUZONE® HIGH-DOSE QUADRIVALENT were similar to the trivalent formulation in a 2017-2018 clinical study in 2,679 adults 65+. FLUZONE® HIGH-DOSE QUADRIVALENT is expected to provide better protection against the flu compared with standard-dose quadrivalent flu vaccines.

Fewer flu-related hospitalizations and deaths compared to standard-dose flu shots

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13%
fewer hospitalizations due to flu or flu-related pneumonia

40%
fewer deaths due to flu or flu-related pneumonia

27%
fewer hospitalizations due to pneumonia

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18%
fewer hospitalizations due to flu-related heart attack or stroke

28%
fewer deaths due to heart attack or stroke

Flu Drug Chemical Compound Icon Flu Drug Chemical Compound Icon

12%
fewer hospitalizations due to flu

22%
fewer deaths
due to flu

Select endpoints are presented here. Influenza-like illness, all-cause hospitalizations, and all-cause mortality were also evaluated.

Study Design: Association of these clinical events with Fluzone® High-Dose was based on a group analysis of 15 published studies in ~34 million adults 65+ conducted during 10 flu seasons from 2009-2010 through 2018-2019.

Study funding was provided by Sanofi Pasteur and the authors were employees of Sanofi Pasteur.

Study Limitations: Percentages are approximate and results may have been influenced by other variables. Results shown are pooled analysis from multiple studies; individual study results may vary.

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FLU SHOT LOCATOR

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Internal calculations by Sanofi based on IQVIA database of total flu vaccines from 8/21-3/22 in people 65+. Study details and information maintained by Sanofi.

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FLUBLOK® QUADRIVALENT (INFLUENZA VACCINE)

For adults 18+

In a clinical trial in adults 50 years and older, vaccination with FLUBLOK® QUADRIVALENT was compared to Fluarix® Quadrivalent. The effectiveness of FLUBLOK® QUADRIVALENT was also judged by data from general day-to-day medical practice amongst more than 12 million adults 65 years and older, vaccination with FLUBLOK® QUADRIVALENT was compared to standard-dose vaccines. The results were:

Better protection against the flu compared to Fluarix® Quadrivalent

30%
more effective at preventing flu

Study Design: Randomized, controlled clinical trial of ~9,000 adults 50+ conducted during 2014-2015 flu (or influenza) season.

In adults 50 years of age and older, the most common side effects were pain and/or tenderness at the injection site, headache, and tiredness.

Fewer flu-related hospitalizations and emergency room visits compared to standard-dose flu shots

Bar Graph showing FLUBLOK® Quadrivalent vaccine Excels other standard-dose flu shots

The data shown is 1 of 3 primary analyses. Two additional primary analyses were conducted: 2 vaccine analyses comparing Flucelvax Quadrivalent with Fluad (influenza vaccine) and Flublok Quadrivalent with Fluad (influenza vaccine).

Study Design: Analysis of data captured during day-to-day medical practice of Medicare fee-for-service claims collected from 12.7 million adults aged 65+ during the 2019-2020 influenza season. Specific characteristics of 2019-2020 season, such as varied strain circulation, may have impacted results.

Study conducted by the FDA and Centers for Medicare and Medicaid Services.

Study Limitations: Lack of access to information to confirm specific viral cases may have reduced the impact of comparisons made in the study.

Distortion caused by unlimited variables could have affected results.

The study period was cut off at the end of February 2020 to avoid potential bias from the overlap between influenza season and the escalation of the COVID-19 pandemic in the US.

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What are FLUBLOK® QUADRIVALENT (INFLUENZA VACCINE) and FLUZONE® HIGH-DOSE QUADRIVALENT (INFLUENZA VACCINE)?

Flublok Quadrivalent and Fluzone High-Dose Quadrivalent are indicated for immunization against disease caused by influenza A and B strains contained in the vaccine. Flublok Quadrivalent is given to people 18 years of age and older. Fluzone High-Dose Quadrivalent is given to people 65 years of age and older.

IMPORTANT SAFETY INFORMATION

Flublok Quadrivalent and Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction to any component of the vaccine (including eggs or egg products for Fluzone High-Dose Quadrivalent). In addition, Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction after previous dose of any influenza vaccine.

Tell your health care provider if you have ever had Guillain-Barré syndrome (severe muscle weakness) after a previous influenza vaccination.

If Flublok Quadrivalent and Fluzone High-Dose Quadrivalent are given to people with a compromised immune system, including those receiving therapies that suppress the immune system, the immune response may be lower than expected.

Vaccination with Flublok Quadrivalent and Fluzone High-Dose Quadrivalent may not protect all people who receive the vaccine.

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. 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 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.

For Flublok Quadrivalent and Fluzone High-Dose Quadrivalent, other side effects may occur.

For more information, talk to your health care professional and refer to the full Prescribing Information for Flublok Quadrivalent or Fluzone High-Dose Quadrivalent. Also, please see complete Patient Information for Fluzone High-Dose Quadrivalent.