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Last update 20 Mar 2025

Tetravalent influenza vaccine(Split, inactivated)(Sanofi)

Last update 20 Mar 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine, Multivalent vaccine

Synonyms

Fluzone Hd Quadrivalent, Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent, H1N1/H3N2/Victoria Lineage/Yamagata Lineage Influenza Vaccine(Split)(Sanofi)

+ [3]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Influenza, HumanInfluenza A virus infectionInfluenza B virus infection

Inactive Indication

DiphtheriaPoliomyelitisTetanus+ [1]

Originator Organization

Sanofi

Active Organization

Sanofi Pasteur, Inc.

Shenzhen Sanofi Pasteur Biological Products Co. Ltd.

Inactive Organization

Sanofi Pasteur

Drug Highest PhaseApproved

First Approval Date

United States (09 Dec 1999),

Influenza A virus infectionInfluenza B virus infection

Regulation-

118

Clinical Trials associated with Tetravalent influenza vaccine(Split, inactivated)(Sanofi)

NCT06291857

/ Not yet recruitingPhase 3

A Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety and Immunogenicity of a COVID-19 Influenza Combination Nanoparticle Vaccine and a Standalone Trivalent Nanoparticle Influenza Hemagglutinin Vaccine in Participants ≥ 65 Years of Age.

The goal of this Phase 3 study is to compare the effectiveness, safety, and side effects of the CIC vaccine with approved flu vaccines and the Novavax COVID-19 Vaccine with adjuvant.

Start Date09 Dec 2024

Sponsor / Collaborator

Novavax, Inc.

NCT05947071

/ RecruitingPhase 2IIT

Comparison of High vs Standard Dose Influenza Vaccines in Pediatric Solid Organ Transplant Recipients

Influenza virus is a significant pathogen in pediatric solid organ transplant (SOT) recipients. However, these individuals respond poorly to standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. One study compared HD-IIV vs. SD-IIV in adult SOT recipients and noted that HD-IIV was safe and more immunogenic; however, the median post-transplant period was 38 months. A phase I pediatric study comparing a single dose of HD-IIV vs. SD-IIV was safe with higher immunogenicity, but the study was limited by small sample size and median post-transplant vaccine administration was 26 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV one month apart compared to one-dose of SD-IIV revealed modestly increased immunogenicity when given at a median of 18 months post-transplant. Therefore, these studies lack both evaluation in the early post-transplant period and substantive pediatric populations. Additionally, the administration of two-doses of HD-IIV in the same influenza season has not been evaluated in pediatric SOT recipients. Thus, the optimal immunization strategy for pediatric SOT recipients less than 24 months post-transplant is unknown. In addition, immunologic predictors and correlates of influenza vaccine immunogenicity in pediatric SOT recipients have not been well-defined.
The central hypothesis of our proposal is that pediatric SOT recipients 1-23 months post-transplant who receive two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have similar safety but higher Hemagglutination Inhibition (HAI) geometric mean titers (GMTs) to influenza antigens compared to pediatric SOT recipients receiving two doses of SD-QIV.

Start Date26 Sep 2024

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT06229392

/ RecruitingPhase 1

A Phase I Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer

This Phase 1 study will assess the safety and efficacy (usefulness) of administering 2 doses of seasonal flu vaccine directly into breast cancer tissue (primary tumor), and will study the tumor and whole body response to the vaccine. If the tumor is palpable (able to fee by touch), the vaccine will be administered by a Surgeon/oncologist in the outpatient floor - both experienced and trained. If not palpable, the procedure will be done via guided Ultrasound by our Breast Radiologist -- both experienced and trained. Women with triple-negative (TNBC) and HER2+ types of breast cancer will be eligible for enrollment. Up to 18 subjects may be enrolled at Rush. Successive groups of 3 subjects per breast cancer type will be given increasing doses of vaccine. There are 3 potential dosing groups (half-dose, full dose, and high dose). Blood, stool (optional), and tumor tissue samples will be collected and tested. The active participation period is from one week prior to starting chemotherapy through three months post surgery.

Start Date28 Feb 2024

Sponsor / Collaborator

Rush University Medical Center

100 Clinical Results associated with Tetravalent influenza vaccine(Split, inactivated)(Sanofi)

100 Translational Medicine associated with Tetravalent influenza vaccine(Split, inactivated)(Sanofi)

100 Patents (Medical) associated with Tetravalent influenza vaccine(Split, inactivated)(Sanofi)

171

Literatures (Medical) associated with Tetravalent influenza vaccine(Split, inactivated)(Sanofi)

04 Feb 2025·The Journal of Infectious Diseases

Immunogenicity and Reactogenicity of High- or Standard-Dose Influenza Vaccine in a Second Consecutive Influenza Season

Article

Author: Goyal, Rakesh ; Coffin, Susan E ; McHenry, Rendie ; Maron, Gabriela ; Bahakel, Hannah ; Shoemaker, Lauren ; Spieker, Andrew J ; Smith, Hannah ; Ardura, Monica I ; Stewart, Laura S ; Grimley, Michael ; Carpenter, Paul A ; Munoz, Flor M ; Schuster, Jennifer E ; Stahl, Anna ; Bender, Margaret ; Naik, Swati ; Amarin, Justin ; Kitko, Carrie L ; Hayek, Haya ; Freedman, Jason ; Potter, Molly ; Hamdan, Lubna ; Stopczynski, Tess ; Kalams, Spyros A ; Rahman, Herdi ; Moulton, Elizabeth A ; Paulsen, Grant ; Dvorak, Christopher ; Haddadin, Zaid ; Harrison, Christopher J ; Williams, Christopher ; Barto, Shari ; Danziger-Isakov, Lara ; Batarseh, Einas ; Allison, Kim J ; Russo, Michael ; Wattier, Rachel L ; Dulek, Daniel E ; Lacombe, Kirsten ; Halasa, Natasha ; Blum, Samantha ; Truong, Kenny ; Englund, Janet A ; Bocchini, Claire E

AbstractBackgroundPediatric hematopoietic cell transplant (HCT) recipients are at high risk for morbidity from influenza virus infection. We demonstrated in a primary phase 2 randomized controlled trial that 2 post-HCT doses of high-dose trivalent influenza vaccine (HD-TIV) given 4 weeks apart were more immunogenic than 2 doses of standard-dose quadrivalent influenza vaccine (SD-QIV). Herein, we present the immunogenicity and safety of influenza vaccination in a consecutive season post-HCT using the same dosing regimen.MethodsA subcohort of study participants reenrolled and had hemagglutinin inhibition titers measured at baseline and 4 weeks after each vaccine dose in year 2. We estimated geometric mean fold rise in hemagglutinin inhibition titer from baseline for each group and used linear mixed effects models to estimate adjusted geometric mean ratios (comparing HD-TIV vs SD-QIV) for each antigen at each time point. We described systemic and injection site reactions.ResultsA total of 65 subcohort patients participated (33 SD-QIV, 32 HD-TIV). Postvaccine geometric mean fold rise and adjusted geometric mean ratio estimates were higher for both groups following a single influenza vaccine dose in year 2 as compared with 2 doses of the same formulation in year 1. Both groups had similar frequencies of injection site and systemic reactions.ConclusionsA single dose of HD-TIV or SD-QIV was more immunogenic in year 2 than 2 doses of the same formulation in year 1. Reactogenicity was comparable between groups. One dose of influenza vaccine may be sufficient after a 2-dose schedule in the prior year post-HCT.Clinical Trials RegistrationNCT02860039 (ClinicalTrials.gov).

01 Jan 2025·eClinicalMedicine

Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trial

Article

Author: Buntinx, Erik ; Ylisastigui, Pedro ; Ruiz-Guiñazú, Javier ; Le Gars, Mathieu ; Aguilar, Gloria ; Struyf, Frank ; Tapia-Calle, Gabriela ; Truyers, Carla ; Douoguih, Macaya ; Vaissiere, Nathalie ; Scheper, Gert

BackgroundVaccine co-administration can increase vaccination coverage. We assessed the safety, reactogenicity, and immunogenicity of concomitant administration of Ad26.COV2.S COVID-19 vaccine with seasonal influenza vaccines.MethodsThis non-inferiority, Phase 3, randomised, double-blind study enrolled 859 healthy adults and was conducted between 02 November 2021 and 28 November 2022. Participants aged ≥18-64 years were randomised to receive a seasonal quadrivalent standard dose (SD) influenza vaccine (Afluria Quadrivalent, Seqirus) concomitantly with Ad26.COV2.S (Coad_SD) or placebo (0.9% NaCl; Control_SD) on Day 1 and placebo or Ad26.COV2.S on Day 29. Participants aged ≥65-years were randomised to the Coad_SD or Control_SD groups, or to Coad_HD or Control_HD groups that received a seasonal quadrivalent HD (high-dose) influenza vaccine (Fluzone High-Dose Quadrivalent, Sanofi Pasteur Inc) in the same schedules. The primary outcomes were haemagglutinin inhibition titres against the four influenza vaccine strains at Day 29, and SARS-CoV-2 Spike-specific antibodies at Day 29 in the Coad_SD group and Day 57 in the Control-SD group, with a non-inferiority margin (Control-SD group/Coad_SD group) of 1.5. Reactogenicity and safety were assessed in all participants (NCT05091307).FindingsNon-inferiority criteria for concomitant administration in the SD groups were met for SARS-CoV-2 Spike-specific antibodies (ratio 1.11, 95% CI 0.97-1.26) and haemagglutinin inhibition titres for all influenza strains (A/H3N2 1.23, 95% CI 1.05-1.45; B/Victoria 0.99, 95% CI 0.84-1.19; B/Yamagata, 1.03, 95% CI 0.88-1.21) except A/H1N1 (1.28, 95% CI 1.09-1.53) for which the upper limit of the 95% CI was >1.5. Concomitant administration of Ad26.COV2.S and SD influenza vaccine induced robust immune responses in terms of SARS-CoV-2 Spike-specific antibodies and haemagglutinin inhibition to all four influenza strains. Seroconversion and seroprotection rates against all influenza vaccine strains were comparable in the Coad and Control groups. Anti-Spike antibodies 28 days after receiving Ad26.COV2.S were similar whether administered with influenza vaccine or alone. Antibody responses persisted at least 6 months post-vaccination in all groups. The reactogenicity and safety profile following co-administration was consistent with the known safety profiles of the study vaccines. No safety concerns were identified. Coadministration was immunogenic and well tolerated in adults aged ≥65 years who received HD influenza vaccine.InterpretationCo-administration of seasonal influenza vaccine with Ad26.COV2.S was immunogenic with an acceptable safety profile, supporting co-administration of these vaccines.FundingJanssen Vaccines & Prevention BV and Biomedical Advanced Research and Development Authority.

01 Oct 2024·The Lancet Infectious Diseases

Safety and immunogenicity of the intranasal H3N2 M2-deficient single-replication influenza vaccine alone or coadministered with an inactivated influenza vaccine (Fluzone High-Dose Quadrivalent) in adults aged 65–85 years in the USA: a multicentre, randomised, double-blind, double-dummy, phase 1b trial

Article

Author: Murray, Bryan ; Neumann, Gabriele ; Fierro, Carlos ; Herber, Renee ; Kawaoka, Yoshihiro ; Moser, Michael J ; Davis, Matthew ; Bilsel, Pamuk ; Aitchison, Roger ; Coelingh, Kathleen ; Rhee, Margaret ; Marshall, David ; White, Alexander ; Eiden, Joseph ; Greenberg, Harry ; Belshe, Robert ; Turner, Mark

BACKGROUNDOlder adults (aged ≥65 years) show increased susceptibility to severe disease with influenza virus infection, accounting for 70-85% of annual influenza-related fatalities in the USA. Stimulating mucosal antibodies and T cells might enhance the low vaccine effectiveness seen in older adults for currently licensed inactivated influenza vaccines, which induce mainly serum antibodies. We aimed to evaluate the safety and immunogenicity of the intranasal H3N2 M2-deficient single-replication (M2SR) vaccine, alone or coadministered with a licensed inactivated influenza vaccine (Fluzone High-Dose Quadrivalent; hereafter referred to as Fluzone HD), in older adults.METHODSIn this multicentre, randomised, double-blind, double-dummy, phase 1b trial, individuals aged 65-85 years who were considered healthy or with stable chronic conditions with no recent (<6 months) influenza vaccinations were recruited from five clinical trial sites in the USA and randomly assigned (3:3:3:1) using a permuted block design to receive the H3N2 M2SR vaccine and Fluzone HD, the H3N2 M2SR vaccine and placebo, Fluzone HD and placebo, or placebo alone. All participants received a single intranasal spray and a single intramuscular injection, whether active or placebo, to maintain masking. The primary outcome was to assess the safety of H3N2 M2SR, administered alone or with Fluzone HD, in the safety analysis set, which included all participants who were randomly assigned and received treatment. Serum and mucosal antibodies were assessed as a secondary endpoint, and cell-mediated immunity as an exploratory endpoint, in participants in the per-protocol population, which included individuals in the safety analysis set without major protocol deviations. This trial is registered with ClinicalTrials.gov, NCT05163847.FINDINGSBetween June 14 and Sept 15, 2022, 305 participants were enrolled and randomly assigned to receive the H3N2 M2SR vaccine plus placebo (n=89), H3N2 M2SR vaccine plus Fluzone HD (n=94), Fluzone HD plus placebo (n=92), or placebo alone (n=30). All randomly assigned participants were included in the safety analysis set. The most frequently reported local symptoms up to day 8 in groups that received M2SR were rhinorrhoea (43% [38 of 89] in the H3N2 M2SR plus placebo group and 38% [36 of 94] in the H3N2 M2SR plus Fluzone HD group), nasal congestion (51% [45 of 89] and 35% [33 of 94]), and injection-site pain (8% [seven of 89] and 49% [46 of 94]), and the most frequently reported solicited systemic symptoms were sore throat (28% [25 of 89]) for M2SR and decreased activity (26% [24 of 94]) for the M2SR plus Fluzone HD group. In the Fluzone HD plus placebo group, the most frequently reported local symptom was injection-site pain (48% [44 of 92]) and systemic symptom was muscle aches (22% [20 of 92]). The frequency of participants with any treatment-emergent adverse event related to vaccination was low across all groups (2-5%). One serious adverse event was reported, in a participant in the Fluzone HD plus placebo group. M2SR with Fluzone HD induced seroconversion (≥four-fold increase in haemagglutination inhibition antibodies from baseline to day 29) in 44 (48%) of 91 participants, compared with 28 (31%) of 90 participants who seroconverted in the Fluzone HD plus placebo group (p=0·023). M2SR with Fluzone HD also induced mucosal and cellular immune responses.INTERPRETATIONThe H3N2 M2SR vaccine coadministered with Fluzone HD in older adults was well tolerated and provided enhanced immunogenicity compared with Fluzone HD administered alone, suggesting potential for improved efficacy of influenza vaccination in this age group. Additional studies are planned to assess efficacy.FUNDINGUS Department of Defense.

News (Medical) associated with Tetravalent influenza vaccine(Split, inactivated)(Sanofi)

14 Mar 2025

·www.prnewswire.com

Sanofi adopts FDA-selected flu strains to ensure readiness for the 2025-26 flu season

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

VaccineDrug Approval

12 Dec 2024

·www.pharmaceutical-technology.com

Sanofi’s combo vaccines gain FDA fast track designation

The two candidates protect against influenza subtypes A and B and coronavirus (SARS-CoV-2) infections. Credit: fizkes/Shutterstock. Sanofi has announced that its two combination vaccine candidates, designed to prevent both influenza and Covid-19 infections in people aged 50 years and above, have received fast track designation from the US Food and Drug Administration (FDA). The candidates merge two existing vaccines that have demonstrated efficacy and favourable tolerability through randomised controlled studies. The first candidate combines the Fluzone high-dose influenza vaccine and the adjuvanted Novavax Covid-19 vaccine. The second merges Flublok, an influenza recombinant protein-based vaccine, with the Novavax vaccine. These influenza vaccines have significantly reduced flu-related hospitalisations in real-world evidence studies. The Novavax COVID-19 vaccine, when used as a booster dose, has a better tolerability profile than currently available mRNA vaccines and has shown high efficacy in two pivotal Phase III trials. Sanofi Vaccines executive vice-president Thomas Triomphe stated: “Building on our immunology expertise and on 12 years of robust clinical and real-world data, we aim to continue leading the way in protection against flu and its severe outcomes. “Our goal is to develop a combined flu and Covid-19 vaccine that offers simpler scheduling and fewer injections without compromising on the industry-leading levels of efficacy, safety and tolerability of the standalone vaccines included in our combination vaccine.” Two separate Phase I/II trials (NCT06695117 and NCT06695130) to assess the immune response and safety of the combo candidates have been commenced by the company. These randomised, parallel, multi-arm, modified double-blind studies are set to provide further insights into the vaccines’ performance. The two candidates aim to protect against influenza subtypes A and B and coronavirus (SARS-CoV-2) infections. The use of combination vaccines could simplify immunisation programmes, offering quicker administration, fewer injections, reduced errors and decreased syringe and vial disposal needs. This announcement follows the European Medicines Agency’s approval in November 2024 of Sanofi/Regeneron’s Dupixent for treating eosinophilic esophagitis.

Phase 3VaccineFast TrackClinical ResultDrug Approval

12 Dec 2024

·pmlive.com

Sanofi receives FDA fast track designation for COVID-19/flu combination vaccines

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.

VaccineLicense out/inFast TrackClinical StudyEmergency Use Authorization

100 Deals associated with Tetravalent influenza vaccine(Split, inactivated)(Sanofi)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Influenza, Human	China	Shenzhen Sanofi Pasteur Biological Products Co. Ltd.	21 Feb 2023
Influenza A virus infection	United States	Sanofi Pasteur, Inc.	09 Dec 1999
Influenza B virus infection	United States	Sanofi Pasteur, Inc.	09 Dec 1999

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diphtheria	Phase 3	Germany	Sanofi Pasteur	01 Oct 2010
Diphtheria	Phase 3	France	Sanofi Pasteur	01 Oct 2010
Poliomyelitis	Phase 3	France	Sanofi Pasteur	01 Oct 2010
Poliomyelitis	Phase 3	Germany	Sanofi Pasteur	01 Oct 2010
Tetanus	Phase 3	Germany	Sanofi Pasteur	01 Oct 2010
Tetanus	Phase 3	France	Sanofi Pasteur	01 Oct 2010
Whooping Cough	Phase 3	Germany	Sanofi Pasteur	01 Oct 2010
Whooping Cough	Phase 3	France	Sanofi Pasteur	01 Oct 2010
Influenza, Human	Phase 3	Puerto Rico	Sanofi Pasteur	01 Oct 2008
Influenza, Human	Phase 3	United States	Sanofi Pasteur	01 Oct 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02936180 (IV-RA, CTgov)	Phase 4	Rheumatoid Arthritis \| Influenza, Human	279	SD-QIV (Standard Dose Influenza Vaccine)	ooogdsjcvr(leirewftzl) = eaddueumuo jencssdtcs (earcbzhzoq, ovysjgstxp - tzajozwiks) View more	-	13 Aug 2024
				HD-TIV (High Dose Influenza Vaccine)	ooogdsjcvr(leirewftzl) = hefgdrvqky jencssdtcs (earcbzhzoq, czitvokkkf - tzztjcszpr) View more
NCT03722589 (CTgov)	Phase 4	Influenza, Human	944	Flublok (Flublok (Recombinant))	kjgpxypfrl(vjxpzzzvml) = kcwclhypen tzohmsgzdr (vpjaaagdbv, pcfqilxggj - mhwdvulggj) View more	-	22 Jul 2024
				Flucelvax (Flucelvax (Cell-based))	kjgpxypfrl(vjxpzzzvml) = lwoxfudvzw tzohmsgzdr (vpjaaagdbv, gttswrdszq - uvxegwpniz) View more
NCT03694808 (CTgov)	Phase 4	Influenza, Human	478	Fluad Vaccine (Fluad Vaccine)	fdozdketfb(abrrexjjmz) = tydxgpakgn vbqbvwanfh (zdwsdpinbg, jqldxkecwj - ljfpckletk) View more	-	30 Apr 2024
				Fluzone HD Vaccine (Fluzone Vaccine)	fdozdketfb(abrrexjjmz) = dtsmqaqrcx vbqbvwanfh (zdwsdpinbg, wtksdznkhd - yyyizzmzga) View more
NCT04176133 (CTgov)	Phase 2	Influenza, Human	61	Influenza vaccine+Entolimod (Entolimod 1 mcg)	ofnedgwczm(wbhiigfrph) = kpkaubggpf eyhsutdmmp (uzlkiebtiu, acwaunwdyy - sdebrrpkkz) View more	-	22 Jun 2023
				Influenza vaccine+Entolimod (Entolimod 3 mcg)	ofnedgwczm(wbhiigfrph) = brnfppgqiz eyhsutdmmp (uzlkiebtiu, pmwdpobdrj - odcotcxvoy) View more
NCT03603509 (CTgov)	Phase 4	Influenza, Human	241	Fluad Vaccine (Fluad Vaccine)	qpexwafexa(dqwycnojor) = kakdiqtyfy xjnaotfacp (lxjkuunzxr, crbfvjbdcu - dtoyudspnl) View more	-	16 May 2023
				Fluzone High-Dose (Fluzone Vaccine)	qpexwafexa(dqwycnojor) = ccvadhtldp xjnaotfacp (lxjkuunzxr, gtskefkgbb - hmvqoxkgfq) View more
NCT03293498 (CTgov)	Phase 1/2	Influenza, Human	330	Fluzone+Tri-NIV Vaccine (Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21)	cpmrqtwhwk(tzibyujptb) = dgumvjhukg rrcdxlwtnr (yymrpvjpar, bbpubstzsi - zmidnveazh) View more	-	21 Dec 2022
				Fluzone+Tri-NIV Vaccine (Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21)	cpmrqtwhwk(tzibyujptb) = pserggfepw rrcdxlwtnr (yymrpvjpar, lyelazesgu - ysrhjljgur) View more
NCT03658629 (CTgov)	Phase 2	Influenza, Human	1,375	Placebo+NanoFlu (Quad-NIV) (Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A)	mauysynhty(rjcpmbqfpu) = espscdgsjc domzzfvufe (ujwouqwnaq, ptiftzgxar - tlvsvubqxk) View more	-	04 Nov 2022
				Quad-NIV (Quad-NIV Preformulated With Adjuvant Dose A)	mauysynhty(rjcpmbqfpu) = kymieeqgla domzzfvufe (ujwouqwnaq, zmkasuqutm - rdytzwajol) View more
NCT04077424 (single cell, CTgov)	Phase 4	Influenza, Human	10	Fluzone-High Dose Quadrivalent (Fluzone-High Dose)	ifyjwqzctj(xowonfonbe) = tghsixrafw iktaiabusr (emiwgaejac, puymfuomgx - wwzrjgecnf) View more	-	12 Jul 2022
				Fluad (Fluad)	ifyjwqzctj(xowonfonbe) = musbpoqnys iktaiabusr (emiwgaejac, turuezccoj - zwyqyyjxno) View more
NCT03068949 (CTgov)	Phase 4	Influenza, Human	413	FluBlok (FluBlok)	cgstqwbnyf(epxzeyzhcm) = mpmaxtsseg svuinkhcpu (najurpskep, oweulbewee - geynkgzmkp) View more	-	30 Nov 2021
				Fluzone (Fluzone)	cgstqwbnyf(epxzeyzhcm) = gcgopthmde svuinkhcpu (najurpskep, gbxllkrpxh - wyvonzjpcg) View more
NCT03183908 (CTgov)	Phase 4	Pain \| Injection Site Reaction \| Drug-Related Side Effects and Adverse Reactions \| Influenza, Human	757	FLUAD® (Adjuvanted Influenza Vaccine (FLUAD®))	gwnfwavymi(itbqsrepni): Difference in proportions = -2.7 (95% CI, -5.8 to 0.4) View more	-	30 Mar 2021
				Fluzone® High-Dose (High-dose Influenza Vaccine (Fluzone® HD))

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Tetravalent influenza vaccine(Split, inactivated)(Sanofi)

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