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

Construction and application of a novel respiratory syncytial virus vaccine based on Bacteroides thetaiotaomicron outer membrane vesicles. (PubMed, Front Microbiol) - "For instance, Abrysvo and Arexvy pose potential safety risks in clinical use, and the long-term protective efficacy of mRESVIA may wane over time...This strategy capitalizes on the unique advantages of Bt OMVs, including efficient mucosal delivery, low inherent toxicity, and targeted modulation of T cell homeostasis-specifically enhancing Treg and Th1 responses while suppressing excessive Th2 and Th17 activation, which serves as the core mechanism for preventing vaccine-enhanced disease (VED)-to effectively present the RSV F protein antigen. It offers a novel approach to develop next-generation RSV vaccines that combine durable protection with enhanced clinical safety."

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

Public Health and Economic Impact of mRNA-1345 Vaccination on RSV Burden in US Adults Using First-Season Real-World Effectiveness (IDWeek 2026) - No abstract available

Clinical • HEOR • Real-world • Real-world effectiveness • Real-world evidence • Infectious Disease • Respiratory Syncytial Virus Infections

Post-Authorization Active Surveillance Safety Study Using Secondary Data to Monitor Real World Safety of mRESVIA® for Respiratory Syncytial Virus in the United States: Interim Descriptive Analyses (IDWeek 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Infectious Disease

Projected Public Health Impact of mRNA-1345 Revaccination Strategies in the ACIP-Recommended US Adult Population (IDWeek 2026) - No abstract available

Clinical • Infectious Disease

Safety and immunogenicity of mRNA-1345 revaccination at least 12 months following primary vaccination with a licensed protein subunit RSV vaccine. (PubMed, Vaccine) - P3 | "These findings support revaccination with mRNA-1345 administered ≥12 months after primary vaccination with a licensed RSV protein subunit vaccine. TRIAL REGISTRATION: NCT07117487."

Journal • Respiratory Syncytial Virus Infections

Bioactive lipid-derived nanoparticles for RNA delivery. (PubMed, Mater Today (Kidlington)) - "Lipid nanoparticles (LNPs) have emerged as the most widely used and clinically validated platform for delivering RNAs, including small interfering RNA (siRNA) and messenger RNA (mRNA), as exemplified by the FDA approvals of Onpattro, Comirnaty, Spikevax, and mRESVIA. We also discuss the structure-activity relationship of these bioactive lipids and overview their corresponding LNPs for specific biomedical applications. We further provide perspectives on the challenges and opportunities in translating bioactive lipid-derived LNPs into next-generation RNA nanomedicines."

Journal • Immunology

A comprehensive look at Respiratory Syncytial Virus (RSV): from pathogenesis to prevention. (PubMed, Trop Dis Travel Med Vaccines) - "Until now, three RSV vaccines, Arexvy, Abrysvo, and mRESVIA, have received approval from the FDA. In addition, monoclonal antibodies such as Nirsevimab and Clesrovimab prevent severe RSV disease and are recommended for infants. Given the significant global impact of RSV, this narrative review addresses its multifaceted aspects, including epidemiology and global impact, clinical manifestations, therapeutic strategies, vaccine development, and its emerging potential as an oncolytic agent."

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

A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk Adults (clinicaltrials.gov) - P3 | N=1153 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults (clinicaltrials.gov) - P1 | N=375 | Recruiting | Sponsor: ModernaTX, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Respiratory Diseases • Respiratory Syncytial Virus Infections

Adult immunization. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Herpes Zoster • Infectious Disease • Inflammation • Influenza • Measles • Meningococcal Infections • Pertussis • Pneumococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tetanus • Varicella Zoster

Comparison chart: Some vaccines for adults. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Infectious Disease • Inflammation • Influenza • Measles • Meningococcal Infections • Pertussis • Pneumococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tetanus

Respiratory Syncytial Virus in Adults in India: An Under-recognized Public Health Concern Demanding Urgent Immunization Action. (PubMed, Indian J Med Microbiol) - "Three vaccines-GSK Arexvy, Pfizer Abrysvo and Moderna mRNA-1345 are currently approved for adults ≥60 years in the United States and Europe...In India, CDSCO conditionally approved Phase III trials of RSVPreF in June 2025, but no adult RSV vaccine is licensed for use. This review proposes for integration of routine RSV molecular testing and reporting with outcome especially in comorbid adults, inclusion of RSV vaccination in National Technical Advisory Group on Immunisation (NTAGI) deliberations for elder and high-risk groups, accelerated regulatory pathways leveraging global bridging data and implementation of prospective multicenter studies to generate robust evidence for health technology assessment, cost-effectiveness and policy formulation."

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

Summary of the National Advisory Committee on Immunization (NACI) Statement: Updated guidance on respiratory syncytial virus (RSV) vaccines for older adults and for adults at high risk of severe RSV disease. (PubMed, Can Commun Dis Rep) - "NACI strongly recommends RSV immunization programs for all adults aged 75 years and older; adults aged 65-74 who are at increased risk of severe RSV disease; and adults aged 18 years and older who reside in chronic care facilities, have received a lung or hematopoietic stem cell transplant, are receiving home or chronic oxygen therapy, or are receiving dialysis. For other adults, vaccination may be considered on an individual basis."

Journal • Bone Marrow Transplantation • Cardiovascular • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation

A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults (clinicaltrials.gov) - P1 | N=375 | Not yet recruiting | Sponsor: ModernaTX, Inc.

New P1 trial • Respiratory Diseases • Respiratory Syncytial Virus Infections

Vaccine effectiveness of mRNA-1345 against RSV-associated hospitalization and medically attended acute respiratory illness among US veterans, 2025-2026. (PubMed, Vaccine) - "mRNA-1345 is associated with substantial protection against RSV-positive ARI-associated hospitalization that was generally consistent across medically-attended outcomes."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety, Tolerability, and Immunogenicity of Revaccination With mRNA-1345 RSV Vaccine Administered 24 Months Following a Primary Dose in Adults ≥60 Years of Age. (PubMed, J Infect Dis) - P2/3 | "mRNA-1345 revaccination at 24 months was well-tolerated and elicited nAb responses non-inferior to primary vaccination. Based on nAb titers comparable to those after primary vaccination, mRNA-1345 revaccination has the potential to provide extended protection against RSV disease once timing for revaccination is determined. Clinical Trials Registration. NCT05127434 (https://clinicaltrials.gov/study/NCT05127434)."

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

Adverse events and vaccine administration errors following RSV vaccination: Findings from the United States VAERS database, 2023-2025. (PubMed, Vaccine) - "Most AE reports following RSV vaccination were non-serious. The potential misuse of Arexvy® during pregnancy and excess dose for both Arexvy® and Abrysvo® highlight potential gaps in healthcare provider education and vaccine record retrieval."

Adverse events • Journal • Dermatology • Fatigue • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

mRNA-1365-P101: A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months (clinicaltrials.gov) - P1 | N=186 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Sep 2026 ➔ Aug 2029 | Trial primary completion date: Aug 2026 ➔ Aug 2029

Trial completion date • Trial primary completion date • Respiratory Diseases

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 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • 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 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Respiratory Diseases • Respiratory Syncytial Virus Infections

In Brief: RSV vaccine (Arexvy) for ages 18-49. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Respiratory Syncytial Virus Infections

Coadministration of mRNA-1345 RSV vaccine with high-dose quadrivalent influenza vaccine in adults aged 65 and older: An observer-blinded, placebo-controlled, randomized, phase 3 trial. (PubMed, Hum Vaccin Immunother) - P3 | "Noninferiority against RSV-A and RSV-B based on GMR was not demonstrated; GMRs (95% CI) of neutralizing antibody were 0.625 (0.570-0.686) and 0.638 (0.584-0.697) for RSV-A and RSV-B, respectively, with the lower bound of 95% CI < 0.667 for RSV-A and B. Coadminstration is estimated to maintain the efficacy of mRNA-1345 against RSV-lower respiratory tract disease based on a correlate of protection model. These results support coadministration of mRNA-1345 with QIV-HD.Clinical trials registration: ClinicalTrials.gov: NCT06060457."

Clinical • Journal • P3 data • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

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