Sanofi adopts FDA-selected flu strains to ensure readiness for the 2025-26 flu season
Sanofi (SNY) has announced the immediate adoption of FDA-selected influenza strains for manufacturing its vaccine portfolio for the 2025-26 flu season in the US. The selected strains match those already in production by the company. Sanofi plans to begin shipping vaccines this summer to healthcare facilities for early season administration.
The announcement comes amid one of the worst flu seasons in decades, with CDC estimates showing 40 million illnesses, 520,000 hospitalizations, and 22,000 deaths through March 1. The company's 2025-26 US portfolio will include FLUZONE® High-Dose, FLUBLOK®, and FLUZONE® vaccines, covering patients from 6 months through 65+ years of age.
Sanofi (SNY) ha annunciato l'adozione immediata dei ceppi influenzali selezionati dalla FDA per la produzione del suo portafoglio vaccinale per la stagione influenzale 2025-26 negli Stati Uniti. I ceppi selezionati corrispondono a quelli già in produzione dall'azienda. Sanofi prevede di iniziare a spedire i vaccini quest'estate alle strutture sanitarie per la somministrazione anticipata nella stagione.
L'annuncio arriva in un periodo che sta vivendo una delle peggiori stagioni influenzali degli ultimi decenni, con le stime dei CDC che mostrano 40 milioni di malattie, 520.000 ospedalizzazioni e 22.000 decessi fino al 1° marzo. Il portafoglio statunitense 2025-26 dell'azienda includerà i vaccini FLUZONE® High-Dose, FLUBLOK® e FLUZONE®, coprendo pazienti dai 6 mesi fino ai 65+ anni di età.
Sanofi (SNY) ha anunciado la adopción inmediata de cepas de influenza seleccionadas por la FDA para la fabricación de su cartera de vacunas para la temporada de gripe 2025-26 en los EE. UU. Las cepas seleccionadas coinciden con las que ya están en producción por la compañía. Sanofi planea comenzar a enviar vacunas este verano a las instalaciones de salud para la administración anticipada de la temporada.
El anuncio llega en medio de una de las peores temporadas de gripe en décadas, con estimaciones de los CDC que muestran 40 millones de enfermedades, 520,000 hospitalizaciones y 22,000 muertes hasta el 1 de marzo. La cartera de EE. UU. 2025-26 de la compañía incluirá las vacunas FLUZONE® High-Dose, FLUBLOK® y FLUZONE®, cubriendo a pacientes desde los 6 meses hasta los 65+ años de edad.
Sanofi (SNY)는 2025-26년 미국 독감 시즌을 위한 백신 포트폴리오 제조를 위해 FDA에서 선정한 독감 균주를 즉시 채택한다고 발표했습니다. 선택된 균주는 이미 회사에서 생산 중인 것과 일치합니다. Sanofi는 이번 여름에 백신을 배송할 계획입니다 의료 시설에 조기 시즌 투여를 위해.
이번 발표는 수십 년 만에 최악의 독감 시즌 중 하나를 맞이하면서 이루어졌으며, CDC의 추정에 따르면 4천만 건의 질병, 52만 건의 입원, 2만 2천 건의 사망이 3월 1일까지 발생했습니다. 회사의 2025-26년 미국 포트폴리오는 FLUZONE® High-Dose, FLUBLOK® 및 FLUZONE® 백신을 포함하여 6개월부터 65세 이상의 환자를 포함합니다.
Sanofi (SNY) a annoncé l'adoption immédiate de souches de grippe sélectionnées par la FDA pour la fabrication de son portefeuille de vaccins pour la saison grippale 2025-26 aux États-Unis. Les souches sélectionnées correspondent à celles déjà en production par l'entreprise. Sanofi prévoit de commencer à expédier des vaccins cet été aux établissements de santé pour une administration anticipée en début de saison.
L'annonce intervient au milieu de l'une des pires saisons de grippe depuis des décennies, avec des estimations des CDC montrant 40 millions de maladies, 520 000 hospitalisations et 22 000 décès jusqu'au 1er mars. Le portefeuille américain 2025-26 de l'entreprise comprendra les vaccins FLUZONE® High-Dose, FLUBLOK® et FLUZONE®, couvrant les patients de 6 mois à 65 ans et plus.
Sanofi (SNY) hat die sofortige Annahme von von der FDA ausgewählten Influenza-Stämmen für die Herstellung seines Impfstoffportfolios für die Grippesaison 2025-26 in den USA angekündigt. Die ausgewählten Stämme stimmen mit denen überein, die bereits vom Unternehmen produziert werden. Sanofi plant, diesen Sommer Impfstoffe zu versenden an Gesundheitseinrichtungen für eine frühzeitige Verabreichung in der Saison.
Die Ankündigung erfolgt inmitten einer der schlimmsten Grippesaisons seit Jahrzehnten, wobei die Schätzungen der CDC 40 Millionen Erkrankungen, 520.000 Krankenhausaufenthalte und 22.000 Todesfälle bis zum 1. März zeigen. Das Portfolio des Unternehmens für die USA 2025-26 wird die Impfstoffe FLUZONE® High-Dose, FLUBLOK® und FLUZONE® umfassen, die Patienten im Alter von 6 Monaten bis 65+ Jahren abdecken.
- Early production alignment with FDA-selected strains ensures timely vaccine availability
- Comprehensive vaccine portfolio covering all age groups from 6 months to 65+
- Strong market position as world leader in flu vaccines
- Current declining vaccination rates could impact vaccine uptake
- Multiple competing products in the market requiring differentiation
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,
"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 and NASDAQ: SNY
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FAQ
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