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 Date01 Jun 2026

Sponsor / Collaborator

Rush University Medical Center

NCT07192458

/ RecruitingPhase 2IIT

Immunogenicity and Safety of Consecutive High-Dose vs. Standard-Dose Influenza Vaccines Administered Over Successive Seasons in Lung Transplant Recipients

This will be a follow-up study to the "Comparison of High Dose vs. Standard Dose Influenza Vaccine in Lung Allograft Recipient" study (DMID Protocol Number 22-0014) at Vanderbilt University Medical Center.
Lung transplantation is a life-saving therapy for patients with advanced lung disease, and is also associated with an improvement in quality of life. However, due to the need for life-long immunosuppression to prevent acute cellular rejection and chronic lung allograft dysfunction ("chronic rejection"), lung transplant recipients are at risk for developing major infections. In fact, one-year survival is 85%, with infection being the leading cause of death within the first year post-transplant. We will conduct a follow-up phase II, randomized, double-blind trial to assess the impact of subsequent administration of two doses of HD-IIV compared to two doses of SD-IIV among lung recipients during the early post-transplant period. Demonstration of improved immunogenicity from two doses of HD-IIV over consecutive influenza seasons would provide potential broad benefit in reducing influenza disease and its associated complications in lung transplant recipients. Moreover, studying vaccine immunogenicity and safety in the same participants over consecutive years can provide insight into the influence of immunosuppression levels and allograft aging on vaccine-mediated immune modulation. This proposed study design will contribute significantly to influenza vaccination guidance and policy for the highly vulnerable lung transplant population. This proposed study is designed to address several key knowledge gaps in vaccine-mediated protection of lung transplant recipients against influenza:
* Is there increased immunogenicity with administration of one or two doses of HD-IIV or SD-IIV in the subsequent season compared to two doses of HD-IIV or SD-IIV in the first season?
* What is the durability of the humoral and cellular immune response between influenza seasons and does two doses of HD-IIV or SD-IIV sustain higher HAI titers compared to two doses of HD-IIV or SD-IIV in the first season?
* What is the impact of maintenance immunosuppression levels on influenza vaccine immunogenicity within the same participant?
* Will the optimal immunogenic vaccination strategy be associated with an acceptable long-term safety profile over successive influenza seasons, including injection-site and systemic reactions, allosensitization, and organ rejection?

Start Date17 Sep 2025

Sponsor / Collaborator

Vanderbilt University Medical Center

NCT06291857

/ Active, not 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.

This is a medical study where participants will be randomly assigned to receive either a new combination vaccine that protects against both COVID-19 and the flu, or a standard flu vaccine. The researchers conducting the study won't know which vaccine each participant receives, ensuring their observations are unbiased. This study compares the new combination vaccine to an already available flu vaccine to see how well it works. It's a large-scale, final-stage study designed to thoroughly check how well the vaccines trigger an immune response (immunogenicity) and how safe they are.

Start Date09 Dec 2024

Sponsor / Collaborator

Novavax, Inc.

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)

144

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

01 Oct 2025·Therapeutic Advances in Infectious Disease

Real-world Effectiveness of Live Attenuated and Inactivated Influenza Vaccines in Children and Adolescents from 2003 to 2023: a Plain Language Summary of Publication

Review

Author: Gutiérrez, Aura V. ; Gray, Christen M. ; El Azzi, Georges ; Stuurman, Anke L. ; Bandell, Allyn ; Sepúlveda-Pachón, Ingrid T. ; Ubamadu, Egbe ; Enxing, Joshua ; Taylor, Sylvia ; Meeraus, Wilhelmine

Summary:

What is this summary about? This is a plain language summary describing the results of a systematic literature review and meta-analysis originally published in Expert Review of Vaccines in July 2025. Children and adolescents are an important group for influenzavaccination because they play a major role in spreading influenza viruses to others and are often hospitalized due to influenza . Live attenuated influenza vaccines (LAIV) and inactivated influenza vaccines (IIV) are two different types of influenzavaccine that are used to protect children and adolescents from influenza illness. This review looked at how well LAIV and IIV provided protection against influenza between 2003 (when LAIV was first available) and 2023 in children and adolescents under 18 years of age. Why was this review done?Influenza viruses can change rapidly in ways that affect how well vaccines work in a particular influenza season . When this happens, influenza vaccines may not provide good protection because they take many months to produce, with development starting about 6 months before the influenza season begins. The specific versions of influenza viruses, or strains, used to make vaccines change from year to year based on recommendations from The World Health Organization . Public health bodies such as the United States’ ‘Advisory Committee on Immunization Practices’ (US ACIP) and the United Kingdom’s ‘Joint Committee on Vaccination and Immunisation’ also publish recommendations on which vaccines should be used for the upcoming influenza season on their respective websites and will update these recommendations for the next influenza season if studies show that a particular vaccine isn’t providing enough protection. For this reason, influenza vaccines can lose their recommendation for use or other vaccines may be recommended instead for use in select groups. For example, the US ACIP stopped recommending LAIV for the 2016–17 and 2017–18 influenza seasons after some US-based studies showed it didn’t protect well against the influenza A (H1N1) virus following the 2009 influenza A (H1N1) pandemic. However, an updated LAIV was developed that improved on the strain selection process and contained a replacement influenza A (H1N1) strain. This led to LAIV being recommended by the committee again for the 2018–2019 influenza season, and LAIV has continued to be recommended by the committee in its seasonal vaccine guidance each year since 2019. The researchers carried out this review to look at how well LAIV and IIV protected against influenza in children and adolescents in real-world settings (e.g. outside clinical trials) since LAIV was first approved in 2003. How was this review carried out? The researchers found studies of LAIV and IIV vaccine effectiveness (VE) published in scientific journals or by public health bodies and screened the results to only include studies meeting pre-defined criteria for study design and quality. The results were examined per influenza season and also by three time periods based on influenza A (H1N1) and LAIV history to understand how well LAIV and IIV protected against influenza during each period: • 2003–04 to 2008–09: Before the 2009 influenza A (H1N1) pandemic. • 2010–11 to 2016–17: After the 2009 pandemic and before the improved LAIV strain selection process.• 2017–18 to 2022–23: After the improved LAIV strain selection process. The researchers then used two different types of meta-analysis to combine the findings from multiple studies together to create a single result, or summary estimate, of VE for LAIV and IIV to help to understand how well both types of vaccine protected against any influenza illness and against influenza illness caused by specific influenza viruses, for example influenza A (H1N1), A (H3N2), and B: • A random effects meta-analysis was used to estimate absolute vaccine effectiveness (aVE) – this is a measure of how a vaccine protects against an illness compared with not getting a vaccine . aVE was estimated for both vaccine types (LAIV and IIV). • A network meta-analysis was used to estimate relative vaccine effectiveness (rVE) – this is a measure of how well one vaccine protects against an illness compared to another vaccine . rVE was estimated for LAIV compared to IIV. All aVE and rVE summary estimates were interpreted alongside their 95% confidence intervals , which is a range of values that shows how sure researchers are about an estimate and means the true result would fall within that range 95 times out of 100 if the study were repeated 100 times. What were the main results of this review? This review examined 109 studies from Northern Hemisphere countries with winter influenza seasons. The results showed that both LAIV and IIV were similarly effective against any influenza illness compared with not being vaccinated, with an aVE of roughly 50% in each time period. rVE estimates showed that • LAIV was less effective than IIV at protecting against influenza A (H1N1) illness between the 2010–11 and 2016–17 influenza seasons (rVE=−46%; 95% confidence interval: −57% to −33%). • Following improvements to the LAIV strain selection process introduced in the 2017–18 season, both vaccines provided similar levels of protection against influenza A (H1N1) illness between 2017–18 and 2022–23, (rVE=10%; 95% confidence interval: −35% to 87%). • During the same period, LAIV and IIV were similarly effective at protecting against illness from any influenza A virus (rVE=7%; 95% confidence interval: –15% to 33%). • LAIV was also more effective than IIV against illness from any influenza B virus after the improved strain selection process (rVE=196%; 95% confidence interval: 73% to 406%). What do these results mean? These findings show that LAIV and IIV offer similar protection against any influenza illness in children and adolescents under 18 years of age, and that getting vaccinated with any influenzavaccine will provide protection against influenza illness. Who should read this summary? This summary is intended for parents considering vaccinating their children against influenza , healthcare professionals who do not specialize in influenza but vaccinate people against influenza in their medical practice, and for individuals who wish to learn about the level of protection provided by influenzavaccination . Who sponsored this research and plain language summary?This research and this plain language summary were both sponsored by AstraZeneca.

01 Aug 2025·VACCINE

Influenza strain-specific T cell responses longitudinally post-vaccination with FluZone

Article

Author: Gjertson, David W ; Pickering, Harry ; Cappelletti, Monica ; Valli, Eduardo ; Reed, Elaine F ; Ross, Ted M ; Carlock, Michael A

Despite seasonal vaccination strategies, influenza viruses still cause significant morbidity and mortality. While vaccine efficacy is generally high, effectiveness varies from year-to-year and can be impacted by numerous host factors, including age, sex, obesity, and immune history. Therefore, understanding host immune factors that promote robust vaccine responses and protection from influenza infection and disease, is important for improving vaccine design and evaluation. This study focuses on influenza-specific T cells, an understudied component of influenza vaccination responses and long-term protection from infection. This study measured influenza strain-specific T cell responses in 40 participants longitudinally following immunization with the inactivated, quadrivalent FluZone vaccine. Influenza-specific T cells were restimulated using live virus representing the four strains included in the FluZone construct. Strain-specific T cell responses were correlated with plasma chemokine and cytokine levels, and humoral immunity, quantified by hemagglutination inhibition assay. Activated and degranulating T cells were frequently detected against all strains longitudinally post-vaccination and positively correlated with serological responses. Cytokine-producing T cells were less frequently detected, and they peaked early post-vaccination, concurrent with elevated plasma IFNγ and CCL4. Changes in strain-specific T cells post-vaccination and correlation with serological responses was stronger for influenza A subtypes than B subtypes. Dynamics of cytokine-producing T cells early post-influenza vaccination may reflect ongoing immune responses, but activated and degranulating T cells better represent longitudinal changes in serological responses. Differences between T cells specific to influenza A and B subtypes warrant further investigation to understand why they diverge and the relevance to vaccine design and evaluation.

11 Jul 2025·JOURNAL OF INFECTIOUS DISEASES

High-Dose Inactivated Influenza Vaccine Inconsistently Improves Heterologous Antibody Responses in an Older Human Cohort

Article

Author: Bahl, Justin ; Hemme, Hayley ; Cao, Wangnan ; Thomas, Paul G ; Billings, W Zane ; Skarlupka, Amanda L ; Ross, Ted M ; Knight, Jessica H ; Shen, Ye ; Hammerton, Savannah M ; Ge, Yang ; Handel, Andreas

Abstract:

Background:

Older adults often mount a weak immune response to standard inactivated influenza vaccines. To induce a stronger response and better protection, a high-dose (HD) version of the inactivated Fluzone vaccine is recommended for individuals >65 years of age. While better immunogenicity and protection against the vaccine strain have been shown, it is not known if the HD vaccine also induces a robust antibody response to heterologous strains.

Methods:

We fit bayesian multilevel regression models to hemagglutination inhibition antibody data from an influenza vaccine cohort spanning the influenza seasons of 2013–2014 to 2021–2022. We used this model to estimate the average causal effect of obtaining the HD vaccine relative to the standard-dose vaccine.

Results:

We show that while there is generally a benefit derived from the HD vaccine, the impact is small and inconsistent. For some strains, the HD vaccine might even result in less robust heterologous responses.

Conclusions:

We suggest that further increases in dose might be worth investigating to help induce a stronger broad response.

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

20 Nov 2025

·firstwordpharma.com

Pfizer's mRNA flu shot trumps inactivated vaccine in late-stage study

Findings from a Phase III study demonstrated that Pfizer's experimental mRNA-based influenza vaccine was more effective at preventing illness than Fluzone, Sanofi's inactivated flu shot. The results were published Wednesday in the NEJM.The trial, which included participants from the US, South Africa and the Philippines, randomised more than 18,000 adults between the ages of 18 and 64 to receive one of the two quadrivalent vaccines during the 2022–2023 influenza season.Pfizer's mRNA jab demonstrated not just noninferiority, but superiority over Fluzone on the study's primary endpoint of relative efficacy, as measured by the reduction in the percentage of participants with laboratory-confirmed infection associated with flu-like illness at least 14 days after vaccination.While 87 Fluzone recipients experienced flu-like illness, there were only 57 cases in the experimental arm, giving the mRNA shot a relative efficacy of 34.5%. An end-of-season analysis in the evaluable efficacy population showed a relative vaccine efficacy of 28.7%. According to Pfizer, given an estimated efficacy of 44% to 54% for FDA-approved vaccines during the 2022–2023 influenza season, the 28.7% end-of-season relative efficacy finding suggests Pfizer's vaccine had an overall efficacy between 60% to 67%.The drugmaker reported that its experimental jab and Fluzone had similar adverse event profiles, though reactogenicity events occurred more frequently with the mRNA vaccine (overall local reactions, 70.1% versus 43.1%; overall systemic events, 65.8% versus 48.7%). However, Pfizer noted that most of the events were mild or moderate and generally transient, with "no clinically meaningful differences in severe events between groups." Pfizer concluded that its mRNA vaccine "provided both similar and improved prevention of a first episode of laboratory-confirmed influenza" in the trial's patient population. Despite its clinical success, the vaccine's regulatory pathway in the US remains murky. The country's health leaders have, without evidence, repeatedly cast doubt on the safety of mRNA-based vaccines, and in August cancelled about $500 million in funding for 22 mRNA vaccine programmes.Pfizer's mRNA vaccine rival Moderna withdrew an FDA application in May for its mRNA COVID-19/flu combination jab. A Phase III study of the flu vaccine alone showed that in adults aged 50 years and older, the mRNA shot achieved a relative vaccine efficacy against influenza illness of 26.6% versus a standard-dose flu shot.

Clinical ResultPhase 3VaccinemRNAEmergency Use Authorization

20 Oct 2025

·www.globenewswire.com

Press Release: Sanofi’s high-dose influenza vaccine demonstrates superior protection for older adults against hospitalization vs standard-dose

Sanofi’s high-dose influenza vaccine demonstrates superior protection for older adults against hospitalization vs standard-dose Compared to standard-dose influenza vaccines, Efluelda/Fluzone High-Dose demonstrated a reduction in laboratory-confirmed influenza hospitalizations by an additional 31.9% (95% CI, 19.7 to 42.2; p<0.001) in adults 65 years and overResults come from FLUNITY-HD, the largest influenza vaccine effectiveness study of individually randomized older adults, involving nearly half a million participants across several seasons and two geographic areasEfluelda/Fluzone High-Dose also provided superior protection, compared to standard-dose influenza vaccines*, against hospitalizations due to pneumonia or influenza, hospitalizations caused by cardio-respiratory events, and all-cause hospitalizations in older adults Efluelda/Fluzone High-Dose is the first vaccine to demonstrate superior protection against both influenza infection and hospitalizations, compared to standard-dose influenza vaccines, in individually randomized studies in adults 65 years and over Paris, October 20, 2025. New data from the FLUNITY-HD study, published on October 17 in The Lancet, demonstrated that Sanofi's Efluelda (known as Fluzone High-Dose in North America) significantly reduced the risk of hospitalization in adults 65 years and older compared to standard-dose influenza vaccines. The largest study of its kind, conducted across multiple seasons, FLUNITY-HD provides robust evidence that the high-dose influenza vaccine offers superior protection compared to standard-dose: 8.8% (95% CI, 1.7 to 15.5; one-sided p=0.008) additional protection against pneumonia/influenza hospitalizations6.3% (95% CI, 2.5 to 10.0; p<0.001) additional reduction in hospitalizations for cardio-respiratory events31.9% (95% CI, 19.7 to 42.2; p<0.001) additional reduction in lab-confirmed influenza hospitalizations2.2% (95% CI, 0.3 to 4.1; p=0.012) additional protection against all-cause hospitalizations, meaning one additional hospitalization could be averted for every 515 (95% CI, 278 to 3,929) individuals vaccinated with Efluelda instead of standard-dose. "The FLUNITY-HD study, unparalleled in its design and scale, harnesses the power and scientific rigor of individual randomization in real-world settings,” shared Professor Tor Biering-Sørensen, Cardiologist, Chief Investigator, and sponsor of the FLUNITY-HD study. “This first-of-its-kind study assessed the benefits of the high-dose influenza vaccine against severe outcomes compared to standard-dose, including against cardio-respiratory hospitalizations, in a randomized setting, covering two geographic areas. The results provide critical evidence, potentially reshaping public health strategies and clinical guidelines." Professor Federico Martinon-Torres, Co-Principal Investigator of FLUNITY-HD study, added, “This new evidence reinforces the clinical confidence healthcare professionals have that the high-dose influenza vaccine achieves superior protection over standard-dose against severe outcomes in older adults, a group considered vulnerable due to having a weakened immune system and a higher risk of developing serious complications after flu infection." Beyond clinical evidence, these findings point to potential public health and societal benefits. “Adults 65 and older represent up to 70% of flu hospitalizations. The FLUNITY-HD data confirm that our high-dose flu vaccine provides superior protection against hospitalizations compared to standard-dose vaccines in older adults,” said Bogdana Coudsy, MD, Global Head of Medical, Sanofi, Vaccines. “For every 515 older adults who receive our high-dose flu vaccine instead of standard-dose vaccines, one all-cause hospitalization is prevented. This can mean a lot, especially for vulnerable seniors, decreasing the burden on their quality of life and helping them to maintain their autonomy for longer. Additionally, preventing influenza hospitalizations may bring societal benefits such as lower healthcare costs, less pressure on medical systems, and reduced burden on caregivers.” With the addition of these new data, comprehensive research on our high-dose influenza vaccine covers 15 years of clinical evidence spanning over 45 million older adults. About the FLUNITY-HD StudyFLUNITY-HD is a pre-specified pooled analysis of two pragmatic individually randomized trials involving 466,320 participants aged 65 and older: DANFLU-2 and GALFLU. DANFLU-2 was conducted over three influenza seasons (2022-23, 2023-24 and 2024-25) with over 332,000 participants aged 65 and above in Denmark. GALFLU was conducted over two influenza seasons (2023-24 and 2024-25) with over 134,000 participants aged 65 to 79 in the region of Galicia in Spain. The largest influenza vaccine study of its kind, this multi-season analysis is designed to evaluate the real-world effectiveness of Efluelda (high-dose influenza vaccine) compared to standard-dose influenza vaccines in preventing hospitalizations, ensuring scientific rigor through individual randomization. FLUNITY-HD achieved its primary endpoint, demonstrating 8.8% additional protection against pneumonia/influenza hospitalizations (vs standard dose). Secondary endpoints include reduction in hospitalizations for cardio-respiratory events, lab-confirmed influenza hospitalizations and all-cause hospitalizations. About Efluelda / Fluzone High-Dose Efluelda is a high-dose influenza vaccine, indicated for adults aged 60 and older in Europe. It is also licensed under the brand name Fluzone High-Dose in North America where it is indicated for adults aged 65 and older. This high-dose influenza vaccine is specifically tailored for older adults whose immune systems gradually decline and weaken with age, increasing their risk for severe influenza-related illness and hospitalization compared with younger populations. It provides 4x the antigen compared to a standard-dose vaccine to deliver a better immune response against influenza for older adults. About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com Victor Rouault | +33 6 70 93 71 40 | victor.rouault@sanofi.com Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com Investor RelationsThomas Kudsk Larsen | +44 7545 513 693 | thomas.larsen@sanofi.com Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@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 Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com Sanofi forward-looking statementsThis 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. All trademarks mentioned in this press release are the property of the Sanofi group. Attachment Press Release

VaccineDrug ApprovalClinical Result

06 Aug 2025

·www.prnewswire.com

Novavax Reports Second Quarter 2025 Financial Results and Operational Highlights

Total revenue of $239 million in the second quarter of 2025 Received FDA BLA approval for Nuvaxovid™, the only recombinant protein-based, non-mRNA COVID-19 vaccine available in the U.S.; approval triggered $175 million milestone payment from Sanofi Completed transition of Nuvaxovid™ commercial leadership in the U.S. to Sanofi for the 2025-2026 COVID-19 vaccination season COVID-19-Influenza-Combination and stand-alone influenza vaccine candidates showed robust immune responses in initial cohort of a Phase 3 trial with new T-cell response data in both Novavax vaccine candidates numerically higher than in the comparator Fluzone HD arm Updated Full Year 2025 Revenue Framework and Financial Guidance Company to host conference call today at 8:30 a.m. ET GAITHERSBURG, Md., Aug. 6, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced its financial results and operational highlights for the second quarter ended June 30, 2025. "This quarter we continued to progress our growth strategy with key achievements including BLA approval for our COVID-19 vaccine, positive data from our COVID-19-Influenza-Combination and stand-alone influenza programs, advancement of our early-stage pipeline, and progression of our partnership strategy," said John C. Jacobs, President and Chief Executive Officer, Novavax. "We look forward to continuing to build on this foundation into the second half of the year." Second Quarter 2025 and Recent Highlights Strategic Priority #1: Sanofi Partnership In May 2025, the U.S. Food and Drug Administration (FDA) approved the Nuvaxovid™ Biologics License Application (BLA) for prevention of COVID-19 in adults 65 years and older and individuals aged 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. BLA approval triggered a $175 million milestone payment from Sanofi. Completed transition of Nuvaxovid commercial leadership in the U.S. to Sanofi for the 2025-2026 COVID-19 vaccination season. Transfers of marketing authorization to Sanofi for U.S. and European Union (EU) markets are expected in the fourth quarter of 2025 which will trigger an additional $50 million in combined milestones from Sanofi. Strategic Priority #2: Enhance Existing Partnerships and Leverage our Technology Platform and Pipeline to Forge Additional Partnerships In June 2025, the company reported initial cohort data for the Phase 3 trial for its COVID-19-Influenza-Combination (CIC) and stand-alone seasonal influenza vaccine candidates, showing robust immune responses for both candidates. This descriptive data set will help inform a potential future registrational Phase 3 program. Novavax intends to partner these programs and this trial reflects the completion of material investment by Novavax. Discussions are ongoing with potential partners for these late-stage assets. New T-cell response data in both CIC and stand-alone influenza vaccine candidates were numerically higher than the Fluzone HD comparator arm indicating the potential for an increased duration of protection. In May 2025, Novavax and Takeda Pharmaceuticals announced significantly improved terms for their partnership to support ongoing commercialization of Nuvaxovid in Japan. Takeda filed for approval of the updated Nuvaxovid vaccine in June and is on track to be on the market for the fall respiratory season in Japan. R21/Matrix-M®, a malaria vaccine developed in partnership with Serum Institute of India and Oxford University, continued to make meaningful progress in addressing the urgent and unmet needs of malaria-endemic regions with 20 million doses sold since launch in mid-2024. In the first quarter of 2025, Novavax announced material transfer agreements with three pharmaceutical companies to explore the utility of Matrix-M in their portfolios. These arrangements have led to discussions with potential business partners to develop new vaccines and improve existing vaccines. Strategic Priority #3: Advance our Technology Platform and Early-stage Pipeline In July 2025, the Company announced preclinical data demonstrating that Novavax's H5N1 avian pandemic influenza vaccine candidate induced robust immune responses by either single or two-dose intranasal or intramuscular administration in primed non-human primates. The results were published in Nature Communications. Continued advancement of early-stage preclinical research for H5N1 avian pandemic influenza, respiratory syncytial virus combinations, varicella-zoster virus (shingles) and Clostridioides difficile colitis vaccine candidates. Generated preliminary positive data using Matrix-M with an oncology vaccine candidate with potential future application across several tumor types. Continued work on new potential Matrix formulations intended to improve upon and expand the utility of Matrix-M. Notes Nuvaxovid Sales reflects product sales where Novavax is the commercial market lead and records revenue related to the sales and distribution of our COVID-19 vaccine. Supply Sales includes sales of finished product, adjuvant and other supplies from Novavax to our license partners. Sanofi includes revenue recognized under our license agreement including upfront payments, milestones, royalties and transition services reimbursement. Other Partners include upfronts, royalties and milestone revenue under our licensing agreements including Serum Institute and SK bioscience. Second Quarter 2025 Financial Results Total revenue for the second quarter of 2025 was $239 million, compared to $415 million in the same period in 2024. Licensing, Royalties and Other Revenue of $229 million in the second quarter of 2025 includes a $175 million milestone earned related to the Nuvaxovid BLA approval. Cost of sales for the second quarter of 2025 was $15 million, compared to $46 million in the same period in 2024. Research and development (R&D) expenses for the second quarter of 2025 were $79 million, compared to $107 million in the same period in 2024. The decrease was primarily due to reductions in overall expenditures related to COVID-19 vaccine development and the elimination of the related commercial manufacturing network infrastructure. Selling, general and administrative (SG &A) expenses for the second quarter of 2025 were $44 million, compared to $101 million for the same period in 2024. The 57% decrease was primarily due to the transition of lead commercial activities to Sanofi and the elimination of commercial infrastructure plus ongoing general administrative cost reduction efforts. Net income for the second quarter of 2025 was $107 million, compared to net income of $162 million in the same period in 2024. Cash, cash equivalents, marketable securities and restricted cash (Cash) were $628 million as of June 30, 2025, compared to $938 million as of December 31, 2024. Receipt of the $175 million milestone earned in the second quarter of 2025 related to the Nuvaxovid BLA approval is expected in the third quarter of 2025. Financial Framework Nuvaxovid Postmarketing Commitment Study As previously announced, in May 2025, our BLA for Nuvaxovid received U.S. FDA approval and with that approval came an FDA request to complete a postmarketing commitment (PMC) study. The PMC is anticipated to occur during 2025 and 2026 and cost between $70 million to $90 million to complete. Novavax will conduct this study on behalf of Sanofi and Novavax will be reimbursed approximately $55 million (at midpoint) or 70% of total costs. The Novavax cost share of approximately $25 million (at midpoint) has been absorbed within the Company's existing combined R&D and SG&A expense targets and is capped under the agreement at the currently agreed upon costs estimates. For Full Year 2025, this is expected to result in a $20 million increase to Adjusted Licensing, Royalties and Other Revenue, where Novavax records partner cost reimbursement as revenue, and an equal $20 million increase to combined R&D and SG&A expenses. Full Year 2025 Financial Guidance Novavax provides updated Full Year 2025 Financial Guidance for combined R&D and SG&A expenses and currently expects to achieve the following results: Full Year 2025 Revenue Framework Novavax transitioned lead commercial responsibility of Nuvaxovid beginning with the 2025-2026 COVID-19 vaccination season to Sanofi for select markets. Since Novavax is reliant on Sanofi's sales forecasts for certain revenue components, these are not included in the Full Year 2025 Revenue Framework. For 2025, Novavax currently expects to achieve Adjusted Total Revenue1 of between $1,000 million and $1,050 million. Adjusted Total Revenue is a non-GAAP financial measure. Adjusted Total Revenue is total revenue excluding Sanofi Supply Sales, Sanofi Royalties and Sanofi Influenza-COVID-19 Combination and Matrix-M related Milestones. See "Non-GAAP Financial Measures" below. Nuvaxovid Product Sales of $610 million include $603 million in revenue recognized in the first quarter of 2025 from the termination of the Canada and New Zealand Advance Purchase Agreements, plus sales by Novavax in the U.S. and select markets outside the U.S. $25 million to $40 million in Adjusted Supply Sales associated with collaborations with the Serum Institute on R21/Matrix-M and collaboration partners for COVID-19 vaccine, including Serum, SK bioscience and Takeda. Beginning in 2025, Supply Sales are included in Product Sales. Adjusted Licensing, Royalties and Other Revenue is a non-GAAP financial measure, Adjusted Licensing, Royalties and Other Revenue is Licensing, Royalties and Other Revenue excluding Sanofi Royalties and Sanofi Influenza-COVID-19 Combination and Matrix-M related milestones. See "Non-GAAP Financial Measures" below. Adjusted Licensing, Royalties and Other Revenue includes $225 million in U.S. BLA & Marketing Authorizations Milestones. Novavax earned a $175 million milestone upon the approval of the COVID-19 U.S. BLA in May 2025 and is eligible to receive two separate $25 million milestone payments upon the transfer to Sanofi of the Marketing Authorizations for the U.S. and EU markets, respectively. $45 million to $70 million in R&D Reimbursement. Under the Sanofi co-exclusive licensing agreement (CLA), Novavax is eligible to receive reimbursement for costs incurred related to select R&D and technology transfer activities during the transition performance period that is expected to run through the end of 2026 and beginning in Q3 2025, the reimbursement of a share of costs associated with the Nuvaxovid PMC is expected in 2025 and 2026. $35 million to $45 million in Other Partner related revenue including royalties and milestones from the Serum Institute on R21/Matrix-M and collaboration partners for COVID-19 vaccine, including Serum, SK bioscience and Takeda. $60 million amortization related to the $500 million Upfront Payment and the $50 million Database Lock Milestone from Sanofi. Revenue recognition will occur over the performance period through 2026. During 2024, a combined amortization of $440 million was recorded, and $60 million and $50 million are expected for 2025 and 2026, respectively. All remaining milestone payments under the Sanofi CLA will be recorded to revenue in the periods when earned. Components of Revenue excluded from the Full Year 2025 Revenue Framework are described below. Sanofi Supply Sales Novavax will sell Nuvaxovid commercial supply to Sanofi for the 2025-2026 COVID-19 vaccination season and the reimbursement for this supply will be recorded as product sales. Sanofi Royalties Sanofi will initiate lead commercial responsibility for the 2025-2026 COVID-19 vaccination season in select markets, including the U.S. Novavax is eligible to receive royalties in the high teens to low twenties percent on Sanofi sales. Sanofi Influenza-COVID-19 Combination and Matrix-M Related Milestones Novavax is eligible to receive up to $350 million in Phase 3 development and commercial launch milestone payments associated with Sanofi Influenza-COVID-19 combination products. For each new vaccine using Matrix-M, Novavax is eligible to receive up to $200 million in launch and sales milestones and mid-single digit sales royalties for 20 years. Conference Call Novavax will host its quarterly conference call today at 8:30 a.m. ET. To join the call without operator assistance, you may register and enter your phone number at to receive an instant automated call back. You may also dial direct to be entered to the call by an operator. The dial-in numbers for the conference call are (888) 880-3330 (Domestic) or (+1) (646) 357-8766 (International). Participants will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 11:30 a.m. ET on August 6, 2025, until 11:59 p.m. ET on August 13, 2025. To access the replay by telephone, dial (800) 770-2030 (Domestic) or (+1) (609) 800-9909 (International) and use passcode 3041984#. A webcast of the conference call can also be accessed on the Novavax website at ir.novavax.com/events. A replay of the webcast will be available on the Novavax website until September 5, 2025. About Novavax Novavax, Inc. (Nasdaq: NVAX) tackles some of the world's most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including protein-based nanoparticles and its Matrix-M adjuvant. The Company's growth strategy seeks to optimize its existing partnerships and expand access to its proven technology platform via R&D innovation, organic portfolio expansion in infectious disease and beyond, and forging new partnerships and collaborations with other companies. Please visit novavax.com and LinkedIn for more information. Non-GAAP Financial Measures The Company presents the following non-GAAP financial measures in this press release: Adjusted Total Revenue and Adjusted Licensing, Royalties and Other Revenue. Non-GAAP financial measures refer to financial information adjusted from financial measures prepared in accordance with accounting principles generally accepted in the United States (GAAP). The Company believes that the presentation of these adjusted financial measures is useful to investors as they provide additional information on comparisons between periods by including certain items that affect overall comparability. The Company uses these non-GAAP financial measures for business planning purposes and to consider underlying trends of its business. Non-GAAP financial measures should be considered in addition to, and not as an alternative for, the Company's reported results prepared in accordance with GAAP. Our use of non-GAAP financial measures may differ from similar measures reported by other companies and may not be comparable to other similarly titled measures. The Company is unable to reconcile these forward-looking non-GAAP financial measures to the most directly comparable GAAP measures without unreasonable effort because the Company is reliant on Sanofi sales forecasts for certain revenue categories, which are not available. Forward-Looking Statements This press release contains forward-looking statements relating to the future of Novavax, its mission; its corporate strategy and operating plans, objectives and prospects; its value drivers and strategic priorities, its partnerships, including expectations with respect to potential royalties, milestones, and cost reimbursement, and plans for additional potential partnering activities; its expectations regarding manufacturing capacity, timing, production and delivery for its COVID-19 vaccine; the transition of the lead responsibility for commercialization of Novavax's COVID-19 vaccine to Sanofi beginning with the 2025-2026 vaccination season; the development of Novavax's clinical and preclinical product candidates and pipeline advancement opportunities, including with respect to new Matrix formulations; the conduct, timing and potential results from clinical trials and other preclinical and postmarketing studies; scope, expectations as to the timing and outcome of future and pending regulatory filings and actions; the conduct of our postmarketing commitment ("PMC") study requested by the U.S. FDA following the U.S. FDA's approval of the BLA for our COVID-19 Vaccine and the expected costs and timing associated with the PMC study; full year 2025 financial guidance and revenue framework; negotiations regarding Novavax's existing advance purchase agreements; and Novavax's future financial or business performance. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges or delays in obtaining regulatory authorization or approval for its COVID-19 vaccine, including for future COVID-19 variant strain changes, its CIC vaccine candidate, its stand-alone influenza vaccine candidate or other product candidates; Novavax's ability to successfully and timely manufacture, market, distribute, or deliver its COVID-19 vaccine; challenges related to Novavax's partnership with Sanofi, including collaboration on the Nuvaxovid PMC, and in pursuing additional partnership opportunities; challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification, assay validation and stability testing, necessary to satisfy applicable regulatory authorities; challenges or delays in conducting clinical trials or studies for its product candidates, including the Nuvaxovid PMC; manufacturing, distribution or export delays or challenges; Novavax's substantial dependence on SII and Serum Life Sciences Limited for co-formulation and filling Novavax's COVID-19 vaccine and the impact of any delays or disruptions in their operations; difficulty obtaining scarce raw materials and supplies including for its proprietary adjuvant; resource constraints, including human capital and manufacturing capacity; constraints on Novavax's ability to pursue planned regulatory pathways, alone or with partners; challenges in implementing its global restructuring and cost reduction plan; Novavax's ability to timely deliver doses; challenges in obtaining commercial adoption and market acceptance of its COVID-19 vaccine or any COVID-19 variant strain containing formulation, or for its CIC vaccine candidate and stand-alone influenza vaccine candidate or other product candidates; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities, including requirements to deliver doses that may require Novavax to refund portions of upfront and other payments previously received or result in reduced future payments pursuant to such agreements and challenges in negotiating, amending or terminating such agreements; challenges related to the seasonality of vaccinations against COVID-19 or influenza; challenges and uncertainty related to regulatory development; challenges related to the demand for vaccinations against COVID-19 or influenza; challenges in identifying and successfully pursuing innovation expansion opportunities, including with respect to Novavax's Matrix-M adjuvant; Novavax's expectations as to expenses and cash needs may prove not to be correct for reasons such as changes in plans or actual events being different than its assumptions; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at and , for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Contacts: Investors Luis Sanay, CFA 240-268-2022 [email protected] Media Giovanna Chandler 844-264-8571 [email protected] SOURCE Novavax, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

VaccineLicense out/inPhase 3Financial StatementClinical Result

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

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KEGG	Wiki	ATC	Drug Bank
-	-	J07BB02	-

R&D Status

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

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)	zwmajkfmzi = ixfjkzsedy bhcjcqmyua (ceidtpsvqy, seifqeyhum - bewzpjfchm) View more	-	13 Aug 2024
				HD-TIV (High Dose Influenza Vaccine)	zwmajkfmzi = brrgasvtcw bhcjcqmyua (ceidtpsvqy, shgybjzera - itzvbkhgnx) View more
NCT03722589 (CTgov)	Phase 4	Influenza, Human	944	Flublok (Flublok (Recombinant))	ahumvleqmk = yuvqdmdxzn fxfmocbrvv (lkcshbqvqz, izaakdvpdp - bgbfgcgvsm) View more	-	22 Jul 2024
				Flucelvax (Flucelvax (Cell-based))	ahumvleqmk = hnazvhlmsf fxfmocbrvv (lkcshbqvqz, glvonnopns - zicdwtyzrw) View more
NCT05007041 (CTgov)	Phase 4	Pain \| Herpes Zoster \| Injection Site Reaction ... View more	267	Zoster Vaccine Recombinant (RZV) (Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine)	nfdhtygens: Difference in proportions = -0.96 (95% CI, -8.94 to 7.10), P-Value = 0.0037 View more	-	01 May 2024
				Zoster Vaccine Recombinant (RZV) (Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine)
NCT03603509 (CTgov)	Phase 4	Influenza, Human	241	Fluad Vaccine (Fluad Vaccine)	gwxuzdpmht(vhvmpkobzb) = bdnjfkapta iqmwfxutks (tbbggtebgs, actbxjblva - rbltumwuoj) View more	-	16 May 2023
				Fluzone (Fluzone Vaccine)	gwxuzdpmht(vhvmpkobzb) = lbmiqyblrh iqmwfxutks (tbbggtebgs, zdeufepmsb - wpvlntsgdz) View more
NCT04077424 (single cell, CTgov)	Phase 4	Influenza, Human	10	Fluzone (Fluzone-High Dose)	xvsdjvvree(zetjishqyv) = eckywrdpiy lnilcrxajr (smjscoazhf, qdqfayyhyj - flbdhmebdd) View more	-	12 Jul 2022
				Fluad (Fluad)	xvsdjvvree(zetjishqyv) = vndsiykfhg lnilcrxajr (smjscoazhf, wgyajkjtat - qfesckbsgs) View more
NCT03068949 (CTgov)	Phase 4	Influenza, Human	413	FluBlok (FluBlok)	dweckwylfr(rmgmzguzqc) = mytpufoitm sptplpmhaf (ibyddccjkw, ptfgxuxlpq - prxnaihfws) View more	-	30 Nov 2021
				Fluzone (Fluzone)	dweckwylfr(rmgmzguzqc) = dtxhtgnaxy sptplpmhaf (ibyddccjkw, dvsvypljhp - dcbgtwlfch) View more
NCT03183908 (CTgov)	Phase 4	Pain \| Injection Site Reaction \| Drug-Related Side Effects and Adverse Reactions ... View more	757	FLUAD® (Adjuvanted Influenza Vaccine (FLUAD®))	caoyrzucqu: Difference in proportions = -2.7 (95% CI, -5.8 to 0.4) View more	-	30 Mar 2021
				Fluzone (High-dose Influenza Vaccine (Fluzone® HD))
NCT04109222 (GRC00097, CTgov)	Phase 4	Influenza, Human	90	Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation (Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months)	nuyvrtxbtz = uyploymhzb vnjaapfhbo (trcnzpngeq, ctjuteltce - jbnjqgbdkb) View more	-	17 Dec 2020
				Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation (Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years)	nuyvrtxbtz = gxuvzsjepc vnjaapfhbo (trcnzpngeq, oebbeleano - xwhtxrxdtl) View more
NCT02566265 (SHIVERING 2, CTgov)	Phase 2	Monoclonal Gammopathy of Undetermined Significance \| Multiple Myeloma \| Waldenstrom Macroglobulinemia ... View more	122	Fluzone High Dose Vaccine (Fluzone High Dose Vaccine Then Fluzone High Dose Booster)	mfqqwowmng = zgdlbmangy htfmouvaes (fwltsuolkf, fqppgzovvm - issfzsrnde) View more	-	30 Jan 2019
				Placebo (Standard of Care)	mfqqwowmng = eosvudlfoi htfmouvaes (fwltsuolkf, nowidlhezr - ytqljnwtmu) View more
NCT02263040 (CTgov)	Phase 1/2	Influenza, Human	170	Fluzone (High Dose Fluzone)	jqegfiswik = meuxyucfuu idgpfbzwcw (jiygshwjgg, kjmyctkhcz - vmidnviutf) View more	-	28 Jan 2019
				Fluzone (Fluzone (Standard Dose))	jqegfiswik = bgcgsrpguo idgpfbzwcw (jiygshwjgg, ophfvxgadj - jrowcakurq) View more

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