Tetravalent influenza vaccine(Split, inactivated)(Sanofi)

BRIDGEWATER, N.J., March 14, 2025 /PRNewswire/ -- Sanofi announced today the immediate adoption of influenza strains selected by the US Food and Drug Administration (FDA) to advance the manufacturing and delivery of its vaccine portfolio for the 2025-26 flu season in the US. As the world leader in flu vaccines, Sanofi had already begun its annual production of vaccines to ensure that robust supply is ready for the coming season. Strains selected by the FDA match those already used in production by the company to help protect eligible patients against flu and its potentially severe complications. Sanofi plans to begin shipping flu vaccines this summer so that health systems, hospitals, pharmacies, physician practices, nursing homes and other facilities can begin administering vaccines at the onset of the next flu season. Thomas Grenier Head of Vaccines, North America "The US is weathering one of its most severe flu seasons in decades, underscoring the need to protect people against seasonal influenza infection. As the world leader in flu vaccines, Sanofi works relentlessly to ensure we are prepared, which is why our manufacturing does not miss a beat as we provide eligible Americans with a portfolio of immunizations to help protect against flu infection and the potentially serious complications it can cause." In addition to declining vaccination rates, the US is currently experiencing one of the worst flu seasons in decades and rates of flu-related hospitalizations are at a 15-year high. According to estimates by the US Centers for Disease Control and Prevention, there have been 40 million illnesses, 520,000 hospitalizations and 22,000 deaths from flu through the week ending March 1. Public health authorities nationwide recommend eligible people six months of age and older be vaccinated every year to help protect against flu and its complications. Sanofi offers a range of vaccine options supported by extensive data to help protect eligible patients from flu and its complications, providing protection beyond flu by meeting immunization needs across the lifespan, from children as young as six months of age through adults 65 years of age and older. The 2025-26 US influenza season portfolio will include 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 (or in the case of FLUBLOK, represented by antigens 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 andNASDAQ: SNY Media Relations Evan Berland | +1 215 432 0234 | [email protected] Timothy Gilbert | + 1 516 521 2929 | [email protected] Investor Relations Thomas Kudsk Larsen |+44 7545 513 693 | [email protected] Alizé Kaisserian | +33 6 47 04 12 11 | [email protected] Felix Lauscher | +1 908 612 7239 | [email protected] Keita Browne | +1 781 249 1766 | [email protected] Nathalie Pham | +33 7 85 93 30 17 | [email protected] Tarik Elgoutni | +1 617 710 3587 | [email protected] Thibaud Châtelet | +33 6 80 80 89 90 | [email protected] Yun Li | +33 6 84 00 90 72 | [email protected] Sanofi forward-looking statements This press release 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 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, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. SOURCE Sanofi WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Sanofi has announced that its two combination vaccine candidates for COVID-19 and influenza (flu) have been granted fast track designation by the US Food and Drug Administration (FDA) for use in individuals aged 50 years and older. The regulator’s decision comes seven months after Sanofi gained a sole licence to Novavax’s adjuvanted COVID-19 vaccine for use in combination with its own licensed flu vaccines. It is hoped that the combined vaccine approach will alleviate the impact of both respiratory illnesses while simplifying immunisation practices for healthcare providers and patients, potentially leading to higher vaccine uptake. Sanofi’s first vaccine candidate combines its protein-based trivalent flu vaccine Fluzone High-Dose with Novavax’s adjuvanted recombinant COVID-19 vaccine, while the second consists of Sanofi’s recombinant protein-based trivalent flu vaccine Flublok and the Novavax vaccine. The combination vaccines will now benefit from the FDA’s fast-track process, which is designed to support the development and accelerate the review of products that address serious conditions. Clinical trials have shown that Fluzone and Flublok can prevent more flu infections in older adults than standard-dose flu vaccines, Sanofi said, adding that both vaccines have demonstrated significant and consistent reductions in flu-related hospitalisations in real-world evidence studies. Novavax’s COVID-19 vaccine has also been associated with a better tolerability profile than currently available mRNA COVID-19 vaccines when given as a booster dose, and has demonstrated high efficacy against COVID-19 as a primary vaccination in two late-stage studies, the company said. Sanofi has already initiated two separate phase 1/2 studies to evaluate the safety and immune response generated by the combination vaccines. Thomas Triomphe, executive vice president, vaccines at Sanofi, said: “Our goal is to develop a combined flu and COVID-19 vaccine that offers simpler scheduling and fewer injections without compromising on the… levels of efficacy, safety and tolerability of the standalone vaccines included in our combination vaccine.” Sanofi and Novavax’s licensing agreement announced in May, worth over $1.2bn, also gave Sanofi a co-exclusive licence to co-commercialise Novavax’s adjuvanted COVID-19 vaccine globally, except in countries that Novavax has existing partnership agreements with, as well as a non-exclusive licence to use the company’s Matrix-M adjuvant in vaccine products and a less than 5% stake in Novavax.