A Single-arm, Open-label, Multi-center, Phase IV Trial to Evaluate the Reactogenicity, Safety, and Immunogenicity of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India

The purpose of this study is to gather additional evidence of the safety and immunogenicity of 1 dose of Fluarix Tetra (0.5 milliliter [mL]) (Northern Hemisphere (NH)2023-2024) in individuals aged 65 years and above to fulfill a post-approval condition imposed by the Indian regulatory authorities (CDSCO) for this age group in India.

Start Date14 Dec 2023

Sponsor / Collaborator

GSK Plc

NCT05734040

/ CompletedPhase 2

Phase 2a, Randomized, Double-blind (Double-dummy), Double Placebo-controlled, Parallel-group Study to Evaluate the Immunogenicity and the Safety of the Concomitant Administration of OVX836 Influenza Vaccine and Quadrivalent Inactivated Influenza Vaccines (QIVs: Fluarix Tetra and Afluria Quad) Given Intramuscularly as 2 Separate Injections Into Opposite Arms, in Comparison to the Concomitant Administration of Quadrivalent Inactivated Influenza Vaccines and Placebo, and OVX836 and Placebo Given the Same Way in Healthy Subjects Aged 18 to 60 Years.

The present study OVX836-006 aims principally to:
Confirm feasibility of the concomitant administration of the vaccines under normal clinical conditions, i.e. as two separate concomitant injections into opposite arms;
Introduce an additional representative brand of Quadrivalent Inactivated Influenza Vaccines ;
Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the Hemagglutinin response;
Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the nucleoprotein response;
Evaluate the absolute vaccine efficacy of OVX836 compared to placebo in order to corroborate the efficacy signals previously detected in the OVX836 previous studies;
Evaluate the combined vaccine efficacy of OVX836 + Quadrivalent Inactivated Influenza Vaccines versus OVX836 + placebo, and versus double placebo.

Start Date10 May 2023

Sponsor / Collaborator

Osivax SASStartup

[+2]

NCT05170399

/ RecruitingPhase 4IIT

Vaccine Responses in Patients With B Cell Malignancies

Background:
People with B cell malignancies (blood cancers) often cannot mount a full immune response to infections or certain vaccines. Bruton tyrosine kinase inhibitors (BTKis), which are used to treat blood cancers, may also negatively affect a person s response to certain vaccines. Researchers want to learn more about vaccine responses in people with certain types of blood cancers. The findings may help develop better vaccine strategies for people with these cancers.
Objective:
To learn how well vaccines work in people who have certain types of blood cancers.
Eligibility:
Adults aged 18 years or older who have chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia, or certain non-Hodgkin lymphomas.
Design:
Participants will get one or more vaccines for illnesses such as COVID-19, hepatitis B, and shingles. They can choose which vaccines they receive. They will give a blood sample before they get each vaccine. Some vaccines require a second dose 3-6 weeks later. Participants may give an optional blood sample with the second vaccine dose. About 4 weeks after they finish each vaccine series, they will give another blood sample. They will have 2-3 study visits per vaccine.
Participants may receive a booster dose for some vaccines. The booster dose is optional. They will give another blood sample with the booster dose.
Participants will have pregnancy tests, if needed.
Participants with CLL who receive BTKis may be asked to pause treatment for up to 7 weeks.
Participants may give follow-up blood samples up to 2 times a year for 5 years. These blood samples are optional.
Participation will last for up to 5 years after each vaccine series is received.

Start Date14 Sep 2022

Sponsor / Collaborator

National Heart, Lung & Blood Institute

100 Clinical Results associated with Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc)

100 Translational Medicine associated with Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc)

100 Patents (Medical) associated with Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc)

167

Literatures (Medical) associated with Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc)

31 Dec 2025·Human Vaccines & Immunotherapeutics

Influenza vaccine effectiveness against medically-attended influenza infection in 2023/24 season in Hangzhou, China

Article

Author: Zhao, Shi ; Zhang, Ke ; Yang, Shigui ; Sun, Zhou ; Niu, Beidi ; Liu, Yan ; Wang, Yaojing ; Che, Xinren ; Zhao, Gang ; Du, Shengqiang ; Lei, Hao ; Wang, Zhe

From 2020, influenza viruses circulation was largely affected by the global coronavirus disease (COVID-19) pandemic, notably leading to the extinction of the B/Yamagata lineage and raising questions about the relevance of the quadrivalent influenza vaccine, which includes this lineage. Evaluating vaccine effectiveness (VE) against influenza infections is important to inform future vaccine programs. A test-negative case-control study was conducted in five tertiary hospitals in Hangzhou, the capital city of Zhejiang province, China, enrolling medically-attended patients aged >6 months who presented with influenza-like illness (ILI) from October 1, 2023, to March 31, 2024. The VE was estimated using multivariate logistic regression models adjusted for sex, age, influenza detection methods, and influenza testing timing. Of the 157,291 medically-attended ILI participants enrolled 56,704 (36%) tested positive for influenza. Adjusted overall VE against any medically-attended influenza infection was 48% (95% Confidence interval [CI]: 46%-51%). The overall VE of the trivalent inactivated influenza vaccine (IIV3) was 59% (95% CI: 50%-66%), followed by the trivalent live attenuated vaccine (LAIV3) (VE = 53%, 95% CI: 42%-62%) and quadrivalent inactivated influenza vaccine (IIV4) (VE = 47%, 95% CI: 45%-50%). IIV3 provided even better protection against medically-attended influenza B infection than IIV4 (VE = 87%, 95% CI: 81%-92% for IIV3 versus VE = 53%, 95% CI: 50%-57% for IIV4). In the 2023/24 season in Hangzhou, China, the influenza vaccine offered moderate protection during a major epidemic. The results supported the World Health Organization recommendation to exclude the B/Yamagata lineage antigen in quadrivalent influenza vaccines in 2023.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Immunogenicity and safety of 1 versus 2 doses of quadrivalent-inactivated influenza vaccine in children aged 3–8 years with or without previous influenza vaccination histories

Article

Author: Liu, Sheng ; Zhu, Fengcai ; Wei, Mingwei ; Wen, Feng ; Zhu, Yinbiao ; Jing, Pengfei ; Shuai, Qi ; Xu, Xinglong ; Zhou, Li ; Li, Jingxin ; Yu, Jun ; Liu, Yan ; Wang, Wenjuan

This study assessed the immunogenicity and safety of a quadrivalent influenza split-virion vaccine (IIV4) in children with and without prior influenza vaccination. An open-label, phase IV clinical trial was conducted in healthy children aged 3-8 years in Pizhou, Jiangsu Province, China. Children with ≥2 doses of prior influenza vaccination (Influenza Vaccination Group) and those with no prior vaccination (Influenza Vaccine-naïve Group) were given two doses of IIV4, 4 weeks apart. The primary immunogenicity endpoints were seroprotection rates (SPRs) of hemagglutination inhibition antibody 28 days after each dose against influenza A/H1N1, A/H3N2, B/Yamagata (BY), and B/Victoria (BV). Safety endpoints included adverse events (AEs) within 28 days and serious adverse events (SAEs) within 6 months. Between September 19-25, 2021, 278 participants were screened, and 240 were enrolled (120 per group). In the Influenza Vaccination Group, SPRs after the 2nd dose were 98.28%, 92.24%, 99.14%, and 87.93%, similar to those after the 1st dose (all p > .05). In the Influenza Vaccine-naïve Group, SPRs after the 2nd dose were 99.12%, 96.49%, 99.12%, and 92.11%, significantly higher than after the 1st dose (p < .001 for all strains except BY, p = .070). Most AEs were mild or moderate, with no serious AEs related to the vaccine. Children aged 3-8 years with prior influenza vaccination need only one dose of IIV4, while those without prior vaccination require two doses. ClinicalTrials.gov, the identifier is NCT05144464.

04 Feb 2025·JOURNAL OF INFECTIOUS DISEASES

Phase 3 Study Assessing Lot-to-Lot Consistency of Respiratory Syncytial Virus Prefusion Protein F3 Vaccine and Its Immune Response, Safety, and Reactogenicity When Co-administered With Quadrivalent Influenza Vaccine

Article

Author: Ollinger, Thierry ; Chime, Nnenna ; Anspach, Bruno ; Yaplee, Deborah ; Kim, Joon Hyung ; Laajalahti, Outi ; Jain, Vishal

Abstract:

Background:

A single-dose investigational respiratory syncytial virus (RSV) vaccine, RSV prefusion protein F3 (RSVPreF3), was co-administered with a single-dose quadrivalent influenza vaccine (FLU-D-QIV) in a phase 3, randomized, controlled, multicenter study in healthy, nonpregnant women aged 18–49 years.

Methods:

The study was observer-blind to evaluate the lot-to-lot consistency of RSVPreF3, and single-blind to evaluate the immune response, safety, and reactogenicity of RSVPreF3 co-administered with FLU-D-QIV.

Results:

A total of 1415 participants were included in the per-protocol set. There was a robust immune response at day 31 across each of the 3 RSVPreF3 vaccine lots; adjusted geometric mean concentration ratios (95% confidence interval [CI]) were 1.01 (.91–1.12), 0.93 (.84–1.03), and 0.92 (.83–1.02) for RSV1/RSV2, RSV1/RSV3, and RSV2/RSV3, respectively. For FLU-D-QIV co-administered with RSVPreF3, versus FLU-D-QIV alone at day 31, noninferiority was satisfied for 3 of 4 strains assessed, with the lower limit of the 95% CI for geometric mean ratio >0.67.

Conclusions:

Immunogenic consistency was demonstrated for 3 separate lots of RSVPreF3. Immunogenic noninferiority was demonstrated when comparing FLU-D-QIV administered alone, versus co-administered with RSVPreF3, for 3 strains of FLU-D-QIV. Co-administration was well tolerated, and both vaccines had clinically acceptable safety and reactogenicity profiles.

Clinical Trials Registration:

NCT05045144; EudraCT 2021-000357-26.

News (Medical) associated with Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc)

12 Sep 2024

·pipelinereview.com

Moderna R&D Day Highlights Progress and Strategic Priorities

Focuses on ten product approvals through 2027 Expects to submit next-generation COVID vaccine for approval in 2024 Expects to submit flu/COVID combination vaccine for approval in 2024 Announces positive Phase 3 results for its RSV vaccine for high-risk adults aged 18 to 59; expects to submit sBLA for U.S. approval in 2024 Announces positive Phase 3 results for its standalone flu vaccine for adults aged 65 and older relative to high-dose licensed comparator Announces norovirus vaccine advances into Phase 3 study, bringing the total of non-respiratory pivotal stage programs to five, across oncology, rare diseases and first-in-class vaccines Implements portfolio prioritization and cost efficiencies to reduce R&D expense by $1.1 billion, from $4.8 billion in 2024E to $3.6-3.8 billion in 2027 Updates and extends financial framework through 2028 CAMBRIDGE, MA, USA I September 12, 2024 I Moderna, Inc. (NASDAQ:MRNA) today announced program and financial updates demonstrating progress and strategic prioritization of its mRNA pipeline at its annual R&D Day event. The updates include data readouts in the Company’s respiratory vaccine portfolio and a revised financial framework. “Moderna now has five respiratory vaccines with positive Phase 3 results and expects to submit three for approval this year. In addition, we have five non-respiratory products in pivotal studies across cancer, rare diseases and latent vaccines with potential for approval by 2027. Our demonstrated probability of success in R&D has been higher than industry standards at every stage of development,” said Stéphane Bancel, CEO of Moderna. “The size of our late-stage pipeline combined with the challenge of launching products means we must now focus on delivering these 10 products to patients, slow down the pace of new R&D investment, and build our commercial business.” Research and Development Strategy Over the past three years, Moderna’s robust pipeline has achieved milestones across multiple late-stage clinical trials, and its early-stage portfolio has produced proof-of-concept data with multiple candidates ready for pivotal studies. Moderna’s rate of success in research and development has been higher than the traditional biopharmaceutical industry. The Company’s combined probability of success across its mid- and late-stage pipeline is approximately 66% compared to the industry average of approximately 19%.[1] Moderna’s broad clinical success and recent commercial challenges necessitate a more selective and paced approach to its research and development investment. Through portfolio prioritization and cost efficiencies, the Company expects to reduce annual research and development expense by approximately $1.1 billion starting in 2027. During this time, Moderna will expand its commercial portfolio into oncology, rare diseases, and first-in-class non-respiratory vaccines. The Company expects this strategy to yield 10 product approvals over the next three years. Specifically, in 2021-2023, Moderna invested proceeds from its pandemic-era vaccine sales into building a diverse pipeline and established the market for its COVID-19 vaccine, Spikevax®. In 2023-2026, the Company is establishing a portfolio of five commercial respiratory vaccines that address viruses with the greatest burden of disease. Its RSV vaccine mRESVIA® was approved this year, and its investigational next-generation COVID-19 vaccine, combination flu/COVID vaccine, and RSV vaccine for high-risk younger adults, are moving toward regulatory submissions in 2024. Looking ahead to 2026-2028, Moderna will expand its commercial portfolio with first-in-class vaccines and therapeutics to address non-respiratory diseases, including cytomegalovirus, norovirus, propionic acidemia, methylmalonic acidemia, and melanoma. Updates from Moderna’s late-stage portfolio and approved vaccines include: Respiratory Virus Vaccines COVID-19 According to the U.S. Centers for Disease Control and Prevention, COVID-19 causes three times more hospitalizations than flu in people aged 65 years and older.[2] Additionally, more than 95% of adults hospitalized in 2023-2024 due to COVID-19 had no record of receiving the latest vaccine.[3] People who are hospitalized may experience a significant impact on their quality of life, including loss of muscle mass, decline in daily activity, risk of hospital readmission and death. Additionally, Long COVID data also suggest even traditionally low-risk groups should be vaccinated.[4] More than 200 symptoms of Long COVID have been reported, such as anxiety, brain fog and extreme fatigue, and Long COVID can impact many different parts of the body, including the brain, heart and lungs. Moderna continues to address the needs of the endemic COVID-19 market by supporting public health efforts to drive vaccination coverage rates to reduce the substantial burden of COVID-19 as well as by advancing next-generation vaccines. The Company’s mRNA platform produced variant-matched vaccines on an accelerated time horizon to help ensure the availability of Spikevax targeting the two selected strains this season. The updated Spikevax formulas have been approved or authorized in multiple regions including the U.S., Taiwan, Japan, the UK, Switzerland, the United Arab Emirates, South Korea and Israel. Positive results from the NEXTCove Phase 3 trial in participants aged 12 years and older showed that Moderna’s next-generation COVID-19 vaccine, mRNA-1283 , demonstrated non-inferior relative vaccine efficacy (rVE) compared to Spikevax, with a positive point estimate of 9.3% (99.4% CI: -6.6, 22.8). rVE was highest at 13.5% (95% CI: -7.7, 30.6) in participants aged 65 years and older. mRNA-1283, which is designed to have enhanced stability in refrigerated conditions and will be packaged in pre-filled syringes, paves the way for a combination vaccine against flu and COVID-19, enhancing the Company’s overall respiratory portfolio. The Company expects to file for approval in 2024 and intends to use a Priority Review Voucher. Respiratory Syncytial Virus (RSV) In addition to acute mortality and morbidity, RSV infection is associated with long-term sequelae such as exacerbation of chronic obstructive pulmonary disease in older adults. In the U.S., each year there are up to 160,000 hospitalizations and 10,000 deaths in adults 65 years and older due to RSV.[5] Across high-income countries in 2019, RSV caused an estimated 5.2 million cases, 470,000 hospitalizations and 33,000 in-hospital deaths in adults 60 years and older.[6] In the younger adult population, potential risk factors such as chronic obstructive pulmonary disease (COPD), asthma, diabetes and obesity may cause an increased risk for RSV disease. Moderna’s RSV vaccine, mRESVIA (mRNA-1345) , has been approved for adults aged 60 years and older in the U.S. and EU. mRNA-1345 is in an ongoing Phase 3 study (P303) designed to test immunogenicity and safety in high-risk adults 18 to 59 years of age. In the trial, mRNA-1345 met all primary immunogenicity endpoints and the 50 µg dose, which is the same for the currently approved mRESVIA vaccine for adults 60 years and above, was well tolerated with no safety concerns identified. The Company intends to file a supplemental Biologics License Application (sBLA) for U.S. approval in 2024 to extend the indicated age range of mRNA-1345 to high-risk adults 18 to 59 years old, and intends to use a Priority Review Voucher. Influenza (Flu) Worldwide, there are 3-5 million severe cases of flu and 290,000-650,000 flu-related respiratory deaths annually.[7] Two main types of influenza viruses (A and B) cause seasonal flu epidemics, and the influenza A viruses lead to most flu-related hospitalization in older adults. Moderna has several seasonal influenza vaccine candidates in clinical development. The Company’s investigational seasonal flu vaccine, mRNA-1010 , demonstrated consistently acceptable safety and tolerability across three Phase 3 trials. In the most recent Phase 3 trial (P303), which was designed to test the immunogenicity and safety of an optimized vaccine composition, mRNA-1010 met all immunogenicity primary endpoints, demonstrating higher antibody titers compared to a licensed standard-dose flu vaccine (Fluarix®). In an older adult extension study of P303, mRNA-1010 met all primary immunogenicity endpoints-including superiority for all strains-compared to a licensed enhanced flu vaccine (Fluzone HD®) and showed an acceptable reactogenicity profile. Moderna is no longer pursuing an accelerated approval pathway for the regulatory submission of its standalone flu vaccine, mRNA-1010, to focus its resources on the submission of a potentially more impactful flu/COVID combination vaccine, mRNA-1083, this year. The Company plans to start a confirmatory vaccine efficacy study for mRNA-1010 in 2024, funded by previously announced project financing through Blackstone Life Sciences. Combination Respiratory Vaccines Currently, flu and COVID-19 are responsible for thousands of hospitalizations and hundreds of deaths each week in the U.S. To address the burden of these respiratory diseases, the Company’s combination vaccine candidates are designed for increased uptake, higher compliance, consumer convenience and benefits to healthcare systems. As announced in June, the Phase 3 study of the Company’s investigational combination vaccine against flu and COVID-19, mRNA-1083 , met its primary endpoints and elicited higher immune responses against influenza virus and SARS-CoV-2 than licensed flu and COVID vaccines in adults 50 years and older, including an enhanced flu vaccine in adults 65 years and older.mRNA-1083 also showed an acceptable safety and reactogenicity profile compared to co-administered flu and COVID-19 vaccines. The Company expects to file for approval in 2024 and intends to use a Priority Review Voucher. Latent and Other Virus Vaccines Cytomegalovirus (CMV) CMV, a latent virus, is the most common infectious cause of birth defects in the U.S. and is responsible for several billion dollars in annual healthcare costs. One in 200 babies in the U.S. are born with a congenital CMV infection, and of those affected, one in five will have severe, life-altering health problems. Possible short- and long-term sequelae of CMV infection include microcephaly, chorioretinitis, seizures, sensorineural hearing loss, cognitive impairment and cerebral palsy. CMVictory is a pivotal Phase 3 trial evaluating mRNA-1647 against primary CMV infection in women 16 to 40 years of age. The trial is accruing cases, and a Data Safety Monitoring Board (DSMB) will evaluate vaccine efficacy from the interim analysis when the trial has accrued 81 confirmed cases. The Company expects a vaccine efficacy readout as early as the end of 2024. Norovirus Enteric viruses, including norovirus, are a leading cause of diarrheal diseases, resulting in significant morbidity and mortality worldwide, particularly among young children and older adults. Norovirus is highly contagious and a leading cause of diarrheal disease globally, associated with 18% of all acute gastroenteritis (AGE),[8] resulting in approximately 200,000 deaths per year and substantial healthcare costs.[9] Given the wide diversity of norovirus genotypes, a broadly effective norovirus vaccine will require a multivalent vaccine design.[10] A Phase 1 trial designed to evaluate the safety, reactogenicity and immunogenicity of a trivalent norovirus vaccinecandidate, mRNA-1403 , in participants 18 to 49 years of age and 60 to 80 years of age in the U.S. is ongoing. An interim analysis showed that a single dose of mRNA-1403 elicited a robust immune response across all dose levels evaluated with a clinically acceptable reactogenicity and safety profile. Additionally, robust histo-blood group antigen (HBGA) blocking antibody titers were observed against vaccine-matched norovirus genogroup I and II selected strains across all dose levels evaluated. Similar mRNA-1403-induced HBGA-blocking antibody titers were observed in younger adult and older adult age groups. The Company plans to initiate a pivotal Phase 3 trial imminently. Oncology Therapeutics The Company’s oncology portfolio includes the individualized neoantigen therapy (INT) being developed in partnership with Merck. Earlier this year, Moderna and Merck initiated three new randomized clinical studies in additional tumor types, including a Phase 2 adjuvant treatment in patients with renal cell carcinoma, or kidney cancer; a Phase 2 adjuvant treatment in patients with high-risk muscle-invasive bladder cancer; and a Phase 2/3 neoadjuvant and adjuvant treatment in patients with cutaneous squamous cell carcinoma, the second most common form of skin cancer. Moderna’s global clinical trial footprint for INT has grown to more than 45 countries. The Phase 3 clinical trial for adjuvant melanoma, mRNA-4157 , is substantially enrolled and has closed screening to new patients in many countries. Moderna and its partner Merck have had preliminary discussions with regulators on approval based on the Phase 2 results. While discussions are ongoing, initial feedback from FDA has not been supportive of accelerated approval based on the current data. The Company and its partner Merck will continue engaging with regulators on the program, and remain focused on executing the Phase 3 trial. Rare Disease Therapeutics In the prioritized portfolio, the Company’s rare disease candidates include therapies targeting two organic acidemias caused by deficient metabolic enzymes, methylmalonic acidemia (MMA) and propionic acidemia (PA), both of which are characterized by metabolic decompensation events (MDEs) that can lead to severe and life-threatening symptoms such as vomiting, lethargy, seizures and coma. Methylmalonic acidemia (MMA) therapeutic In an ongoing Phase 1/2 study designed to evaluate safety and pharmacology in trial participants with MMA , mRNA-3705 was generally well-tolerated to date with no discontinuations due to safety and no events meeting protocol-defined dose-limiting toxicity criteria. Initial data is encouraging, withreductions in methylmalonic acid and other pathway biomarkers in participants, particularly at doses of at least 0.4 mg/kg Q2W. Early results suggest potential decreases in annualized rates of MMA-related hospitalizations and MDEs compared to pre-treatment rates. Moderna is working to identify an optimal dose and continues to engage with the U.S. FDA, via the START Program , and other global regulators. The Company is on track to begin generating pivotal study data by the end of 2024. Propionic acidemia (PA) therapeutic In an ongoing Phase 1/2 study designed to evaluate safety and pharmacology in trial participants with PA, mRNA-3927 was generally well-tolerated to date with no events meeting protocol-defined dose-limiting toxicity criteria. Early results suggest potential decreases in annualized MDE frequency compared to pre-treatment, and the majority of patients have elected to continue on the open label extension study. The Company is on track to begin generating pivotal study data by the end of 2024. Programs Discontinued Based on the Company’s strategic prioritization, five programs in its pipeline are discontinued: Financial Updates Moderna expects its commercial respiratory franchise to be profitable in 2024 and beyond. In addition, the Company is updating its projected 2024 research and development expenses to approximately $4.8 billion, primarily driven by the purchase of a Priority Review Voucher, and selling, general and administrative expenses to approximately $1.2 billion. Moderna is also reducing its expected research and development investment for 2025-2028 by approximately 20%, from $20 billion for the period to $16 billion through prioritization. The Company aims to complete the majority of its respiratory investments by 2026. It is increasing research and development investments in oncology, and pacing its investments in latent and other vaccines and in rare disease therapeutics. The Company is introducing an updated financial framework for 2025 and 2026-2028. Revenue: The Company expects 2025 revenue of $2.5 billion to $3.5 billion. For 2026-2028 the Company expects a compounded annual growth rate of more than 25% or more, driven by new product launches. Cost of Sales: Cost of sales is expected to be in the range of 35% to 45% in 2025. For 2026-2028, the Company expects cost of sales to decrease as a percentage of sales with increasing revenue. Research and Development Expenses: Full-year 2025 research and development expenses are anticipated to be $4.2 billion to $4.5 billion. In the 2026-2028 period, research and development expenses are expected to be approximately $11.5 billion on a cumulative basis. Selling, General and Administrative Expenses: Selling, general and administrative expenses for 2025 are projected to be $1.0 billion to $1.2 billion. For 2026-2028, selling expenses are expected to increase incrementally as new products are brought to market, while general and administrative expenses are expected to remain flat. Income Taxes: The Company continues to expect its full-year 2025 tax expense to be negligible. Tax will also be negligible for the 2026-2028 period. Capital Expenditures: Capital expenditures for 2025 are expected to be approximately $0.3 billion. For 2026-2028, capital expenditures are expected to be flat to down from 2025 levels. Cash and Investments: Year-end cash and investments for 2025 are projected to be approximately $6 billion. Moderna plans to break even on an operating cash cost basis (which excludes stock-based compensation, depreciation and amortization expense) with $6 billion in revenue. The Company expects to achieve this in 2028. The Company has sufficient capital to fund its plans until achieving break even on a cash cost basis without raising additional equity. About Moderna Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the Company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna’s mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. INDICATION (U.S.) SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. IMPORTANT SAFETY INFORMATION FOR SPIKEVAX INDICATION (U.S.) mRESVIA (Respiratory Syncytial Virus Vaccine) is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. IMPORTANT SAFETY INFORMATION FOR MRESVIA Spikevax® and mRESVIA® are registered trademarks of Moderna. Fluarix® is a registered trademark of GSK. Fluzone® is a registered trademark of Sanofi Pasteur. [1] Statistics for Moderna based upon internal data from 10 Phase 2 trials, and six Phase 3 trials. Data reported as of September 12, 2024. Industry statistics derived from Phase 2 and 3 study data from Wong et al., Biostatistics (2019) 20, 2, pp 273-286. [2] https://www.cdc.gov/resp-net/dashboard/index.html. Data last updated as of September 6, 2024 for 2023-2024 season. [3] https://www.cdc.gov/respiratory-viruses/risk-factors/older-adults.html [4] https://www.yalemedicine.org/news/covid-vaccines-reduce-long-covid-risk-new-study-shows [5] https://www.cdc.gov/rsv/php/surveillance/index.html [6] https://pubmed.ncbi.nlm.nih.gov/36369772/ [7] https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal) [8] Ahmed, S.M., et al., Global prevalence of norovirus in cases of gastroenteritis: a systematic review and meta-analysis. Lancet Infect Dis, 2014 [9] https://www.who.int/teams/immunization-vaccines-and-biologicals/diseases/norovirus [10] https://www.cdc.gov/norovirus/downloads/global-burden-report.pdf SOURCE: Moderna

VaccineClinical ResultPhase 3Phase 2Drug Approval

12 Sep 2024

·endpts.com

GSK’s mRNA flu shot is heading to Phase 3; Summit’s $235M offering

Plus, news about Oruka Therapeutics, Centessa, Takeda, Innate Pharma and Liquidia: GSK’s mRNA flu vaccine succeeds against both strains in Phase 2: The pharma company said the vaccine candidate elicited “positive A and B strain immune responses relative to standard of care in both younger and older adults.” This vaccine program, which it licenses from CureVac, will now head into late-stage studies, but the company did not provide a timeline on when the studies will start. CureVac announced in April that the mRNA flu shot elicited lower immune responses against influenza B strains compared to commercially available vaccines and that it would further optimize the vaccine against the B strain for additional Phase 2 testing. Influenza B strains have challenged mRNA vaccine developers, though Moderna found success against B strains last year in an interim Phase 3 analysis of its mRNA flu shot compared to GSK’s Fluarix. Moderna announced Thursday morning that it’s no longer pursuing accelerated approval of its standalone mRNA flu vaccine and will instead focus on its flu and Covid-19 combination shot this year. Moderna is planning to start a confirmatory study for its flu shot this year funded by its agreement with Blackstone . — Lei Lei Wu Summit Therapeutics’ $235M raise: After beating out Merck’s Keytruda in a landmark study in lung cancer, Summit Therapeutics got $79 million from inside investors, including co-CEOs Bob Duggan and Maky Zanganeh, and $156 million from multiple biopharma institutional investors. Earlier this summer, Summit similarly raised about $200 million after initially teasing the data ahead of ASCO’s annual meeting. — Kyle LaHucik Oruka Therapeutics’ $200M PIPE: A week after closing a reverse merger for a spot on the Nasdaq, Oruka Therapeutics has reeled in more funds from a dozen or so industry investors for its I&I biologics pipeline. — Kyle LaHucik Centessa tees up $150M offering: The proceeds are expected to help pay for further clinical development of the company’s narcolepsy drug after it showed promise in Phase 1. The orexin receptor 2 agonist did not display the same toxicity issues in the trial that have plagued other candidates. — Max Bayer Takeda terminates Innate deal: The Tokyo pharma terminated its license agreement for Innate antibodies that could be used in antibody-drug conjugates less than two years after inking the deal. The French biotech is set to regain the rights next quarter. — Kyle LaHucik Liquidia adds $100M: About two-thirds of the capital came from combining a private placement and an underwritten public offering, and $32.5 million stems from a revenue interest financing pact with HealthCare Royalty. — Max Bayer

VaccinePhase 3License out/inClinical ResultPhase 1

12 Sep 2024

·www.fiercebiotech.com

GSK's mRNA flu vaccine finally overcomes tricky B strains in phase 2 trial

A spokesperson told Fierce Biotech this morning that it is not yet able to set out a timeline for when the vaccine will enter phase 3. After an initial defeat against the biggest barrier to mRNA flu vaccines—namely, B strains of influenza—GSK has returned with a reformulated candidate that has delivered the goods in the all-important population of older adults.The British pharma already demonstrated in a previous phase 2 trial in April that its candidate was able to beat licensed flu vaccines when it came to triggering an immune response against influenza A strains. But the company had to admit that it couldn’t manage the same feat against “historically challenging” B strains of influenza.CureVac, which had been developing the vaccine with GSK, said at the time that they would work on “targeted optimizations” to improve the shot’s protection against the B strains, and it seems like that has finally done the trick. GSK has returned Wednesday morning with fresh phase 2 data that show new formulations of the vaccine “demonstrated positive A and B strain immune responses relative to standard of care in both younger and older adults.”The study enrolled 250 healthy adults aged 18 to 64 years and another 250 aged 65 to 85 years. The companies tested a range of mRNA formulations and dose levels of their own vaccine against age-appropriate, approved flu shots, showing that their candidate induced acceptable immune responses for both A and B strains.Interim data also suggest the various formulations tested had “an acceptable safety and reactogenicity profile,” GSK said.The Big Pharma bought out the full rights to CureVac’s flu and COVID mRNA candidates for $430 million in July. Today’s results “confirm the mRNA platform elicits strong overall antibody titres with an acceptable safety profile,” said GSK, which will now move its vaccine into phase 3. “This marks a significant advancement in our mRNA programme and these data support moving into late-stage development,” GSK Chief Scientific Officer Tony Wood, Ph.D., said in the Sept.12 release. “Ultimately, our goal is to develop a new best-in-class vaccine to bring greater protection to people through the influenza season.”A spokesperson told Fierce Biotech this morning that the company is not yet able to set out a timeline for when the vaccine will enter phase 3, but further updates will be provided at the next quarterly earnings.GSK’s peers in the race to get the first mRNA flu vaccine to market have all encountered the same problem when it comes to B strains. Moderna is the only competitor to have already secured full success—showing a year ago that a reformulated version of its candidate was able to induce higher antibody levels for major B strains than GSK’s approved flu vaccine Fluarix in a phase 3 trial.Meanwhile, Sanofi’s executives were so disheartened by the failure of their own candidate to neutralize B strains that they proclaimed last year that the first generation of mRNA vaccines for flu “will not win.”Pfizer and BioNTech have managed to overcome B strains with their own mRNA candidate in a phase 3 study—but so far only against under-65s. The companies revealed last month that their combo COVID-flu mRNA vaccine didn’t manage to neutralize B strains in older adults.Like Pfizer, GSK also has plans to work on its own COVID-flu combination vaccine, and today’s results should ease the path toward that development.

VaccinePhase 3Phase 2mRNAClinical Result

100 Deals associated with Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc)

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Influenza, Human	Australia	GSK Plc	28 Aug 2013
Influenza A virus infection	United States	GlaxoSmithKline LLC	31 Aug 2005
Influenza A virus infection	United States	GlaxoSmithKline Biologicals SA	31 Aug 2005
Influenza B virus infection	United States	GlaxoSmithKline Biologicals SA	31 Aug 2005
Influenza B virus infection	United States	GlaxoSmithKline LLC	31 Aug 2005

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	United States	GSK Plc	07 Oct 2021
Respiratory Syncytial Virus Infections	Phase 3	New Zealand	GSK Plc	27 Apr 2021
Respiratory Syncytial Virus Infections	Phase 3	Panama	GSK Plc	27 Apr 2021
Respiratory Syncytial Virus Infections	Phase 3	South Africa	GSK Plc	27 Apr 2021
Herpes Zoster	Phase 3	United States	GSK Plc	03 Oct 2013
Herpes Zoster	Phase 3	Canada	GSK Plc	03 Oct 2013
Herpes Zoster	Phase 3	Germany	GSK Plc	03 Oct 2013
Diphtheria	Phase 3	United States	GSK Plc	23 Oct 2006
Tetanus	Phase 3	United States	GSK Plc	23 Oct 2006
Whooping Cough	Phase 3	United States	GSK Plc	23 Oct 2006

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05648357 (CTgov)	Phase 4	Influenza, Human	250	Fluarix Tetra Vaccine	euifvnafty = lcpzdwvoov hbznvkdlyh (jhscecnnzr, yjnbdnkjxr - wvuupcdtab) View more	-	28 Mar 2025
NCT05047770 (Pubmed) Manual	Phase 3	Herpes Zoster	497	mRNA-1273quFlu D-QIVt influenza vaccine (QIV)	kvgyipuhxj(ggflasuwch) = The most frequently reported adverse events in both groups were pain at the injection site and myalgia. rroeekwlxm (wbcmkkmple ) View more	Non-inferior	31 Dec 2024
				mRNA-1273 + Flu D-QIV(CoAd )
NCT03722589 (CTgov)	Phase 4	Influenza, Human	944	Flublok (Flublok (Recombinant))	nhzjuzrkjc = twfrbeqqvl pwyxpjtxcu (kxmwuifsvs, psfgonezju - zheccccipx) View more	-	22 Jul 2024
				Flucelvax (Flucelvax (Cell-based))	nhzjuzrkjc = ndjvcuvdjz pwyxpjtxcu (kxmwuifsvs, qsripizkie - lkeuvqezzb) View more
NCT05047770 (CTgov)	Phase 3	COVID-19 \| Herpes Zoster \| Influenza, Human	2,013	mRNA-1273+HZ/su (HZ/suSeq Group)	mvuakywjgq(mpilsqdamr) = twrocwmjhg smtgoejzgl (cilqszunio, loduoogsbm - szfebtpfiw) View more	-	13 Nov 2023
				mRNA-1273+HZ/su (HZ/suCoAd Group)	mvuakywjgq(mpilsqdamr) = oxtggvjiyl smtgoejzgl (cilqszunio, nkijjjjljm - hkrtbvtwlq) View more
NCT04841577 (CTgov)	Phase 3	Respiratory Syncytial Virus Infections \| Influenza, Human	976	FLU-QIV+RSVPreF3 OA investigational vaccine (Co-Ad Group)	kqnhhchjdc(vuugqfgyto) = ztcieguxci znudpfcypz (mjzrolslct, kgpkwnvzxf - rqtycwbkvw) View more	-	18 Oct 2022
				FLU-QIV+RSVPreF3 OA investigational vaccine (Control Group)	kqnhhchjdc(vuugqfgyto) = kyswkbmjmk znudpfcypz (mjzrolslct, oyochozhtm - sfkmmhhujn) View more
NCT03686514 (FLU2, CTgov)	Phase 4	Influenza, Human	39	seasonal influenza vaccine (H3N2 Birth Cohort, Born Between 1968 and 1977)	mztsmksfcd = apvnicvnsx fyshjxlvbl (hyxtwfllur, vkzfxcmymv - fmilfmvlgo) View more	-	13 Jul 2022
				seasonal influenza vaccine (H1N1 Birth Cohort, Born Between 1948 and 1957)	mztsmksfcd = uhmkejigyu fyshjxlvbl (hyxtwfllur, elwwqbjnxk - scvzyrlwqo) View more
NCT03165981 (CTgov)	Phase 4	Seizures, Febrile \| Fever \| Vaccination	221	IIV+DTaP+PCV13 (Simultaneous Vaccination Arm)	hjovntfmxb = qdywjmfkfk tadmgudjau (oxanstzgvo, pxirbfstfn - kcczhwghpo) View more	-	08 Feb 2019
				IIV+DTaP+PCV13 (Sequential Vaccination Arm)	hjovntfmxb = bqveezznln tadmgudjau (oxanstzgvo, esbnklxlwu - cgcysfjiex) View more
NCT00385255 (CTgov)	Phase 3	Diphtheria \| Whooping Cough \| Tetanus ... View more	1,726	Fluarix®+Boostrix® (Boostrix+Fluarix Group)	gmpkakltqj(rlincwsqmo) = fzbfxcxght zdmqdrdxil (ullaptmjey, badqlsbrui - mbjaaapyji) View more	-	17 Sep 2018
				Fluarix®+Boostrix® (Fluarix Boostrix Group)	gmpkakltqj(rlincwsqmo) = zdoosvrvot zdmqdrdxil (ullaptmjey, eldauwnpoe - iqsovbrlzi) View more
NCT00318149 (CTgov)	Phase 2	Influenza, Human	425	Fluarix (Fluarix 18-40 Y Group)	xcqvivtfxp(jzzbmekkrw) = bcenilfjwp nbvcxwphpg (ixylafeyfl, 1643.2) View more	-	08 Aug 2018
				Fluarix (Fluarix ≥65 Y Group)	xcqvivtfxp(jzzbmekkrw) = ouirwxftdv nbvcxwphpg (ixylafeyfl, 1557.22) View more

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Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc)

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