mRESVIA (respiratory syncytial virus vaccine) / Moderna - LARVOL DELTA

RSV vaccine development: advances and fusion protein-focused strategies. (PubMed, Front Immunol) - "This has advanced transformative milestones, including the approval of long-acting monoclonal antibodies (Nirsevimab, Clesrovimab) and the vaccines for adults (Arexvy, Abrysvo, mRESVIA)...It then emphasizes the current landscape of RSV vaccine development, categorizing platforms such as mRNA, protein subunit, virus-like particle/nanoparticle, live-attenuated, and viral vector approaches, highlighting both licensed vaccines and leading candidates under clinical evaluation. This review overviews current RSV vaccines and antibody prophylaxis and aims to inform the development of future prevention strategies."

Journal • Review • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety and immunogenicity of heterologous RSV revaccination with mRNA-1345 after primary vaccination with protein-based vaccine (ESCMID Global 2026) - No abstract available

Clinical • Late-breaking abstract • Respiratory Syncytial Virus Infections

A comparison of the national European guidelines: RSV vaccination in older adults. (PubMed, Eur Geriatr Med) - "Fifteen official governmental European guidelines were found on RSV vaccination, most of which recommend vaccination for the general population aged ≥ 75 years and at younger ages for at-risk individuals. There remains a need for more harmonized European guidelines."

Journal • Review • Infectious Disease • Metabolic Disorders • Respiratory Diseases • Respiratory Syncytial Virus Infections

mRNA-CRID-001: A Study of Modified mRNA Vaccines in Healthy Adults (clinicaltrials.gov) - P1 | N=308 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Cytomegalovirus Infection • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Safety, Tolerability, and Immunogenicity of the mRNA-1345 RSV Vaccine in Solid Organ Transplant Recipients Aged ≥18 Years (RSVVW 2026) - P3 | "A single dose was immunogenic across all SOTR groups, and a second dose boosted responses, especially in kidney SOTRs, lung SOTRs, those <2 years post-transplant, or on mycophenolate; therefore, mRNA-1345 is likely to be effective in this vulnerable population. * This submission is an encore presentation of the data first presented at IDWeek 2025 in Atlanta, Georgia, USA"

Clinical • Respiratory Diseases • Respiratory Syncytial Virus Infections • Solid Organ Transplantation • Transplantation

RSV vaccine effectiveness against hospitalization among adults aged 60 years or older: bivalent vaccines. A systematic review. (RSVVW 2026) - "Only one of currently available vaccines (i.e. RSVpreF) has been designed to for specifically target both subgroups, while other vaccines (RSVpreF3 and mRNA-1345) and monoclonal antibodies only target protein F from RSV-A...The bivalent approach could ensure consistent vaccine effectiveness and mitigate the risk of immune escape due to subgroup-specific antigenic drift. In other words, available data suggest that bivalent RSV vaccines could maximize public health impact of adult immunization programs."

Clinical • Review • Respiratory Diseases • Respiratory Syncytial Virus Infections

Advancing RSV vaccination strategies for older adults: insights of the Adult Immunization Board meeting (RSVVW 2026) - "Several adult vaccines—including the recently introduced RSV vaccines (Arexvy, Abrysvo, mRESVIA)—show strong efficacy or effectiveness, yet recommendations and funding remain uneven...Vaccination should be treated as an investment in healthy ageing, supporting functional ability and independence. With older adults now outnumbering young children globally, it is essential to ensure consistent, accessible protection across all recommended adult vaccines, including effective and appropriately funded RSV vaccination."

Clinical • Respiratory Syncytial Virus Infections

mRNA-1345 Demonstrates Consistent Vaccine Efficacy in Older Adults Aged ≥60 Years at High Risk of RSV Disease (RSVVW 2026) - P2/3 | "J Infect Dis. 2024; 230(5):e996-e1006."

Clinical • Asthma • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Diabetes • Heart Failure • Immunology • Infectious Disease • Metabolic Disorders • Nephrology • Pulmonary Disease • Renal Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Type 1 Diabetes Mellitus

RSV Vaccination in Solid Organ Transplant Recipients: Interim Findings From a Phase 3 Trial of mRNA-1345. (PubMed, Clin Infect Dis) - P3 | "mRNA-1345 was well tolerated and immunogenic in SOT recipients. A single dose induced nAb responses across subgroups, with potential additional benefit from a second dose in specific groups. Durable antibody and cellular responses support mRNA-1345 as a preventive strategy for RSV in this vulnerable population."

Journal • P3 data • P3 data: top line • Immunology • Respiratory Diseases • Respiratory Syncytial Virus Infections • Solid Organ Transplantation • Transplant Rejection • Transplantation • CD4

Current and Emerging Strategies for the Prevention of Respiratory Syncytial Virus (RSV) Infections: A Comprehensive Review of Vaccines and Antibody Therapies. (PubMed, Cureus) - "RSV vaccines, such as Arexvy, Abrysvo, and mRESVIA, as well as monoclonal antibodies, such as nirsevimab and clesrovimab, have been developed using platforms like mRNA technology, protein subunits, and viral vectors, each with unique mechanisms of action, immunogenic properties, and safety profiles...Healthcare providers play a crucial role in advocating for RSV vaccination, and the development of universal RSV vaccines has become a research priority, aiming to deliver broad protection across various populations and strains. As technological advancements continue, the future of preventative measures, including vaccines and monoclonal antibodies, is poised to bring transformative solutions, ultimately reducing the burden of RSV and improving public health worldwide."

Journal • Review • Developmental Disorders • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Protecting the Vulnerable: Narrative Review on RSV Vaccines in Adults and Pregnancy. (PubMed, J Am Pharm Assoc (2003)) - "This review summarizes current evidence supporting licensed RSV vaccines, including early post-marketing safety findings, and underscores the role of pharmacists in addressing gaps in RSV vaccine equity. Recent RSV vaccine licensure provides a novel strategy to mitigate disease severity, with pharmacists well positioned to educate patients and support informed vaccination decisions."

Journal • Review • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers (clinicaltrials.gov) - P2 | N=360 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Feb 2026 ➔ May 2026 | Trial primary completion date: Feb 2026 ➔ May 2026

Trial completion date • Trial primary completion date • Respiratory Diseases • Respiratory Syncytial Virus Infections

Real-World Evidence Evaluation of Respiratory Syncytial Virus (RSV) Vaccines: Deep Dive into Vaccine Adverse Events Reporting System. (PubMed, Diseases) - "The VAERS database reported data on vaccine types, including Arexvy®, Abrysvo®, and mRESVIA® was analyzed for adverse events and vaccination errors... RSV vaccines demonstrate a generally acceptable safety profile based on post-marketing surveillance data. However, the observed increase in hospitalization rates, vaccination errors, and pregnancy-related outcomes warrants continued active surveillance and cautious interpretation."

Adverse events • HEOR • Journal • Real-world evidence • Dermatology • Fatigue • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study of mRNA-1345 Following a Primary Dose of a Licensed Protein Subunit Respiratory Syncytial Virus (RSV) Vaccine in Adult Participants ≥60 Years of Age (clinicaltrials.gov) - P3 | N=507 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Respiratory Diseases • Respiratory Syncytial Virus Infections

Highly Efficient and Durable Th1-Biased Protective Immunity Induced by a Novel mRNA-LNP Vaccine Against RSV via AI-Assisted Antigen Screening. (PubMed, Mol Ther) - "This candidate vaccine (RSV-mF03) produced a more stable prefusion F protein and elicited durable neutralizing antibody titers over 10 times higher than those induced by mRNA-1345 (mRESVIA®). Notably, our vaccine provided complete protection against RSV challenge, with no evidence of vaccine-associated enhanced respiratory disease. Collectively, these findings demonstrate the production of a potent RSV vaccine candidate and the feasibility of integrating AI into RSV vaccine development."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

The Ministry of Food and Drug Safety (MFDS) announced on Dec. 18 that it has approved the respiratory syncytial virus (RSV) mRNA vaccine “mresvia prefilled syringe” as the first biopharmaceutical under the “New Drug Product Licensing and Review Work Procedures” implemented in January this year. (Business Korea)

Korea approval • Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults (clinicaltrials.gov) - P2 | N=172 | Completed | Sponsor: ModernaTX, Inc. | Recruiting ➔ Completed | N=325 ➔ 172

Enrollment change • Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Expert Consensus Statement on the Disease Burden and Vaccination for Respiratory Syncytial Virus (RSV) Infection in Adults. (PubMed, Tuberc Respir Dis (Seoul)) - "As of 2025, three RSV vaccines (Arexvy, Abrysvo, mRESVIA) have FDA approval; only Arexvy is approved in Korea for older adults...In the absence of effective antivirals, vaccination is a key preventive strategy. Expanding vaccination uptake, improving awareness, and integrating RSV vaccines into national immunization programs could substantially reduce RSV-related morbidity and mortality."

Journal • Asthma • Bronchiectasis • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Have Delays in Vaccine Market Access Improved in Europe and the US Over the Last Decade? (ISPOR-EU 2025) - "Delays for RSV vaccines were compared with published delays for pneumococcal, human papillomavirus and quadrivalent influenza vaccines. Three RSV vaccines were approved for use in older adults (Abrysvo [Pfizer Inc.], Arexvy [GlaxoSmithKline Biologicals] and mResviac [Moderna Inc.]), younger adults (Abrysvo), high-risk younger adults (Arexvy and mResvia) and pregnant women (Abyrsvo)... The time between vaccine licensure and NITAG recommendation has dramatically improved in Europe and the US over the last decade. Nevertheless, a substantial discrepancy remains, with delays being four to nine times longer in Europe than in the US."

Infectious Disease • Influenza • Pneumococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections

Restricting O-Linked Glycosylation of the Mucin-like Domains Enhances Immunogenicity and Protective Efficacy of a Respiratory Syncytial Virus G Glycoprotein Vaccine Antigen. (PubMed, Vaccines (Basel)) - "Background: As of 2024, three approved respiratory syncytial virus (RSV) vaccines are licensed for use in adults in the United States: Arexvy™, Abrysvo™, and mRESVIA™... This study investigated the effects of manipulation of O-linked glycosylation on a recombinant RSV G vaccine antigen in an RSV/A2 challenge study in BALB/c mice. We found that restricting the O-linked glycosylation on a recombinant RSV G vaccine antigen enhances its immunogenicity and protective efficacy in BALB/c mice."

Journal • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

The Potential Public Health Impact of the mRNA-Based Respiratory Syncytial Virus Vaccine, mRNA-1345, Under Extended Vaccination Campaigns Among Older Adults in the United Kingdom: A Modelling Study. (PubMed, Vaccines (Basel)) - "Targeting adults aged ≥60 years is expected to be particularly efficient in achieving a sustainable reduction in RSV burden. These findings could provide valuable support for national policy discussions on optimising RSV vaccination strategies in older adults, particularly regarding target age groups, revaccination schedules, and long-term programme planning."

Journal • Geriatric Disorders • Respiratory Diseases • Respiratory Syncytial Virus Infections

Are Minority Populations Truly Vaccine Hesitant? A Provider-based Approach to RSV Vaccine Uptake Suggests Otherwise (ACR Convergence 2025) - "Three RSV vaccines (RSVPreF3, RSVPreF1, and mResvia) were approved by the FDA in May 2023 for individuals aged ≥60 with the Advisory Committee on Immunization Practices (ACIP) recommending vaccination for ≥75 and for individuals ≥60 with chronic IC, including RD and those on immunosuppressive medications... Approximately 70% of patients at the LSU-UMCNO Rheumatology Clinic identify as a minority groups. Following provider education and proactive in-clinic promotion, RSV vaccination rates increased markedly in a short timeframe. These results suggest that vaccine hesitancy in minority populations may be driven more by "Provider Hesitancy"—such as limited time, competing priorities, or lack of awareness—than by patient reluctance."

Clinical • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Rheumatology

A Review of Respiratory Syncytial Virus Vaccines in the Older Adult. (PubMed, Sr Care Pharm) - "Arexvy® (RSVPreF3), Abrysvo® (RSVpreF), and mRESVIA® (mRNA-1345) have been shown to effectively prevent LRTD caused by RSV in individuals aged 60 and older. Pharmacists play a vital role in supporting CDC recommendations, educating patients and optimizing preventive health strategies."

Clinical • Journal • Review • Fatigue • Musculoskeletal Pain • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

Respiratory syncytial virus (RSV) vaccination recommendations in older adults: An update. (PubMed, Nurse Pract) - "Recently, in Canada, three vaccines, Arexvy, Abrysvo, and mResvia, have been authorized for use in older adults to prevent RSV-related lower respiratory tract disease...Monitoring of RSV vaccine efficacy and safety is ongoing. The purpose of this article is to inform NPs about the recent development of these vaccines, summarizing the safety and efficacy information and presenting a decision tree to help NPs make vaccine recommendations for nonpregnant adults."

Journal • Geriatric Disorders • Infectious Disease • Influenza • Pneumonia • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety, Tolerability, and Immunogenicity of Revaccination with mRNA-1345, an mRNA Vaccine Against RSV, Administered 12 Months Following a Primary Dose in Adults Aged ≥50 Years. (PubMed, Clin Infect Dis) - P3 | "Revaccination of adults ≥50 years with mRNA-1345 was well-tolerated with a safety profile consistent with the primary dose. RSV nAb at Day 29 were non-inferior to those after a primary mRNA-1345 dose, with antibody response persisting for 12 months."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections