Sanofi ships U.S. influenza vaccines for the 2024/25 season – Company Announcement

• Customers will start receiving shipments from July 10 with additional shipments through October to healthcare provider offices, pharmacies and other immunizers to support fall immunization campaigns.
• 
  Sanofi annual higher-dose influenza (flu) vaccinations have been proven to help protect from flu and shown to better protect from serious complications of flu such as pneumonia and cardiac events when compared to standard dose vaccines in older adults.

BRIDGEWATER, N.J.
, July 10, 2024 /PRNewswire/ — Sanofi today started shipping its first influenza (flu) vaccines across the U.S. in preparation for the 2024/25 flu season. Following this first shipment, additional shipments of the full Sanofi flu vaccine portfolio will continue through October to healthcare provider offices, pharmacies and other immunizers to support fall immunization campaigns. With over 125 years of heritage in helping protect global public health, Sanofi is a world leader in vaccines, helping to vaccinate more than 500 million people annually.

Thomas Grenier

Head of Vaccines, North America, Sanofi
“Today, we began shipping flu vaccines for the upcoming season, a moment that underscores our long-standing commitment to providing global protection against disease. Getting a flu shot is imperative to not only help protect against flu infection, but also to help reduce the risks of its potentially severe complications, which can lead to hospitalizations, especially in those most vulnerable. Sanofi understands what these populations need out of their flu shots and works tirelessly from start to finish to provide proven and specific solutions.”

All flu vaccines provided by Sanofi to the US market are trivalent, meaning they offer protection against the current three strains of influenza (two influenza A strains and one influenza B strain). These strains were selected based on a collaborative review of influenza surveillance by the U.S. Food and Drug Administration (FDA), World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), among other public health experts, as the strains most likely to cause illness in the upcoming flu season.

Annual flu vaccination is one of the best ways to help protect against flu and its complications. Public health authorities worldwide reiterate their recommendations for eligible people to be vaccinated every year.

As one of the largest providers of influenza vaccines to the United States with a range of options, Sanofi meets immunization needs across the lifespan, from children as young as six months of age through adults 65 years of age and older. This year’s 2024/25 U.S. influenza season portfolio includes Fluzone High-Dose (Influenza Vaccine), Flublok (Influenza Vaccine) and Fluzone (Influenza Vaccine).

Indication and Important Safety Information for Fluzone^® High-Dose (Influenza Vaccine), Flublok^® (Influenza Vaccine) and Fluzone ^® (Influenza Vaccine)

What are Fluzone^® (Influenza Vaccine), Flublok^® (Influenza Vaccine), and Fluzone^® High-Dose (Influenza Vaccine)?

Fluzone, Flublok, and Fluzone High-Dose are vaccines indicated for the prevention of disease caused by influenza A and B strains contained in the vaccine. Fluzone is given to people 6 months of age and older. Flublok is given to people 18 years of age and older. Fluzone High-Dose is given to people 65 years of age and older.

IMPORTANT SAFETY INFORMATION FOR FLUZONE^® (INFLUENZA VACCINE), FLUBLOK^® (INFLUENZA VACCINE), AND FLUZONE^® HIGH-DOSE (INFLUENZA VACCINE)

Fluzone, Flublok, or Fluzone High-Dose 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 and Fluzone High-Dose). In addition, Fluzone and Fluzone High-Dose should not be given to anyone who has had a severe allergic reaction after a 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 Fluzone, Flublok, or Fluzone High-Dose 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 Fluzone, Flublok, or Fluzone High-Dose may not protect all people who receive the vaccine.

Fainting has occurred following vaccination with Fluzone, Flublok, and Fluzone High-Dose. Procedures should be in place to avoid injury from fainting.

For Fluzone, in children 6 months through 8 years of age, the most common side effects were pain or tenderness and redness where you got the shot, irritability, drowsiness (6 month through 35 months), and muscle pain (3 years through 8 years). In adults 18 years through 64 years of age, the most common side effects were pain where you got the shot, headache, and muscle pain. In adults over 65 years of age, the most common side effects were pain where you got the shot, headache, muscle pain, and general discomfort.

For Flublok, in adults 18 through 64 years of age, the most common side effects were pain where you got the shot, headache, tiredness, and muscle pain. In adults 65 years of age and older, the most common side effects were pain where you got the shot, tiredness and headache.

For Fluzone High-Dose, 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.

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

For more information, talk to your healthcare professional and refer to the full Prescribing and Patient information for Flublok, Fluzone or Fluzone High-Dose.

About Sanofi

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

Contacts

Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Timothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com

Investor Relations

Thomas Kudsk Larsen | +44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Arnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com
Felix Lauscher | + 1  908  612 7239 | felix.lauscher@sanofi.com
Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
Tarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.com
Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com

Sanofi Forward-Looking Statements 
This media update contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. 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. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

MAT-US-2406730-v1.0-07/2024

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SOURCE Sanofi