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For adults 65+

FLUZONE® HIGH-DOSE (INFLUENZA VACCINE)

FLUZONE® HIGH-DOSE (INFLUENZA VACCINE) is a flu vaccine approved by the Food and Drug Administration (FDA) and has been proven to provide superior flu protection compared to a standard-dose flu shot in adults 65+.

But at Sanofi, we don’t just stop there. Studied for more than a decade, FLUZONE® HIGH-DOSE has shown to provide better protection against serious flu-related complications in adults 65+ compared with a regular flu shot.

Higher dose provides higher protection: With 4x the dose, FLUZONE® HIGH-DOSE has been shown to provide 24% better protection compared to a regular flu shot.

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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®, in adults 65 years of age and older, the most common side effects were pain where you got the shot, muscle pain, tiredness, and headache. Other side effects may occur.

In an analysis of published studies, people vaccinated with Fluzone® High-Dose experienced fewer flu-related hospitalizations compared with those vaccinated with standard-dose flu shots.

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14.3 %
fewer influenza-like illnesses*

12.8 %
fewer hospitalizations due to cardiovascular events

14.7 %
fewer hospitalizations due to respiratory events

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8.2 %
fewer hospitalizations

11.2 %
fewer hospitalizations due to flu

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16.7 %
fewer hospitalizations due to cardiorespiratory events

10.4 %
fewer hospitalizations/ER visits due to flu

Select endpoints are presented here; relative vaccine effectiveness against pneumonia was also studied.

Study Design: Association of these clinical events with FLUZONE® HIGH-DOSE was based on a systematic review of studies in more than 45 million adults aged 65+, conducted during 12 influenza seasons (2009-2010 to 2019-2020, and 2021-2022.)

Study was funded and performed by Sanofi.

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

*

Defined as visits with a rapid influenza diagnostic test followed by prescription of antiviral medication.

*Defined as visits with a rapid influenza diagnostic test followed by prescription of antiviral medication.
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For adults 18+

FLUBLOK® (INFLUENZA VACCINE)

In a clinical trial in adults 50 years and older, vaccination with FLUBLOK® (Quadrivalent) was compared to FLUARIX® QUADRIVALENT. The effectiveness of FLUBLOK® was studied in a real-world setting using data from general day-to-day medical practice amongst more than 12 million adults 65 years and older.

Better flu protection when compared to FLUARIX® QUADRIVALENT in adults 50+

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

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

The efficacy of the trivalent and quadrivalent formulations are related because both are made using the same process and have overlapping compositions.

In a review of 5 flu vaccines, FLUBLOK® (Quadrivalent) demonstrated ~13% fewer flu-related hospitalizations and emergency room visits compared with standard-dose flu shots in adults 65+

Bar graph showing flublok® vaccine excels other standard-dose flu shots Bar graph showing flublok® 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 standard-dose quadrivalent and FLUBLOK® (Quadrivalent) with standard-dose quadrivalent.

Study Design: Retrospective cohort 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 lab-confirmed influenza cases may have underestimated the differences.

Results may be affected by residual bias due to unmeasured confounders.

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.


Flucelvax® Quadrivalent was not statistically significant.

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INDICATION

IMPORTANT SAFETY INFORMATION