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

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

Safety and immunogenicity of an mRNA-based RSV vaccine in seropositive children aged 12-59 months. (PubMed, Hum Vaccin Immunother) - P1 | "Subsequent doses did not further increase antibody levels. In conclusion, mRNA-1345 was well tolerated and boosted antibody levels in seropositive children aged 12-59 months."

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

Summary of the National Advisory Committee on Immunization (NACI) statement on the prevention of respiratory syncytial virus (RSV) in older adults. (PubMed, Can Commun Dis Rep) - "The authorization of three vaccines, one for adults 50 years of age and older (Arexvy) and two for adults 60 years of age and older (Abrysvo and mRESVIA), offers the opportunity to protect older Canadians from RSV disease...NACI also recommends RSV immunization programs for adults 60 years of age and older who are residents of nursing homes and other chronic care facilities. NACI recommends that receiving an RSV vaccine may be considered as an individual decision by adults 50 to 74 years of age, in consultation with their healthcare provider."

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

Evaluating the efficacy, safety, and immunogenicity of FDA-approved RSV vaccines: a systematic review of Arexvy, Abrysvo, and mResvia. (PubMed, Front Immunol) - "Continued real-world monitoring and head-to-head comparisons are needed to inform global immunization strategies. https://www.crd.york.ac.uk/PROSPERO/view/, identifier CRD420250651132."

FDA event • Journal • Review • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

mRNA-Based Respiratory Syncytial Virus Vaccine mRNA-1345 Induces Robust, Polyfunctional, and Durable CD4+ and CD8+ T Cell Responses with Similar Features in Adults Across Age Groups (IDWeek 2025) - No abstract available

Clinical • Infectious Disease • Respiratory Syncytial Virus Infections • CD4

Durable RSV-Specific CD4⁺ T-Cell Responses Following mRNA-1345 Vaccination in Adults at Increased Risk of Lower Respiratory Tract Disease Due to RSV (IDWeek 2025) - No abstract available

Clinical • Infectious Disease • Respiratory Syncytial Virus Infections • CD4

T-Cell Responses Following Two Doses of mRNA-1345 in Adult Solid Organ Transplant Recipients (IDWeek 2025) - No abstract available

Clinical • Infectious Disease

Safety, Tolerability, and Immunogenicity of the mRNA-1345 RSV Vaccine in Solid Organ Transplant Recipients Aged ≥18 Years (IDWeek 2025) - No abstract available

Clinical • Infectious Disease • Respiratory Syncytial Virus Infections

Post-marketing safety monitoring of RSV vaccines: A real-world study based on the Vaccine Adverse Event Reporting System (VAERS). (PubMed, Hum Vaccin Immunother) - "Two protein subunit vaccines - RSVPreF3 (Arexvy, GSK) and RSVpreF (Abrysvo, Pfizer) - and one mRNA RSV vaccine, mRNA-1345 (mRESVIA, Moderna), have been approved...Descriptive analysis of time-to-onset complemented the overall safety profiling, and sensitivity analysis offered further support for the observed disproportional reporting trends in certain adverse events (AEs). Our study utilized real-world data from large-scale spontaneous reporting systems to detect AEs that were disproportionately reported following RSV vaccination, thereby generating early safety signals to inform hypothesis development and support clinical awareness."

Adverse events • Journal • P4 data • Real-world evidence • Hematological Disorders • Immune Thrombocytopenic Purpura • Respiratory Diseases • Respiratory Syncytial Virus Infections • Thrombocytopenia • Thrombocytopenic Purpura

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. | N=310 ➔ 186

Enrollment change • Respiratory Diseases

A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age (clinicaltrials.gov) - P2/3 | N=36814 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus (clinicaltrials.gov) - P2 | N=346 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • 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=500 | Recruiting | Sponsor: ModernaTX, Inc.

New P3 trial • Respiratory Diseases • Respiratory Syncytial Virus Infections

Design and preclinical assessment of mRNA-1345 prefusion F glycoprotein-encoding mRNA vaccine for respiratory syncytial virus. (PubMed, Vaccine) - "In rodent models, mRNA-1345 induced a robust neutralizing and preF-biased antibody response, a T helper 1-biased cellular response, and demonstrated dose-dependent protection against RSV challenge with no evidence of enhanced respiratory disease. These results supported initial clinical evaluation of mRNA-1345 in adults, children, and RSV-naïve infants; mRNA-1345 was recently demonstrated to be efficacious against RSV disease in older adults in a pivotal efficacy study."

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

mResvia - opinion on variation to marketing authorisation (European Medicines Agency) - "On 24 July 2025 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product mResvia. The marketing authorisation holder for this medicinal product is Moderna Biotech Spain S.L. The CHMP adopted an extension to the existing indication to extend the use of mResvia to adults from 18 through 59 years of age who are at increased risk for lower respiratory tract disease caused by RSV."

CHMP • Respiratory Syncytial Virus Infections

Immune correlates analysis of mRNA-1345 RSV vaccine efficacy clinical trial. (PubMed, Nat Commun) - P2/3 | "Day 29 point estimates (95% CIs) of the hazard ratio of each endpoint (RSV-LRTD-2 + , RSV-LRTD-3 + , RSV-ARD) per 10-fold increase in RSV-A nAb are 0.44 (0.30-0.65), 0.41 (0.20-0.84), and 0.45 (0.28-0.71), respectively, similar to RSV-B nAb and preF IgG. These results demonstrate Day 29 RSV nAb and preF IgG are CoRs and support their role as CoPs against RSV endpoints."

Clinical • Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Vaccine Development for Human Pneumoviruses. (PubMed, Vaccines (Basel)) - "While significant progress has been made in RSV vaccine development, especially with three approved candidates, the development of vaccines for HMPV remains an unmet medical need. Ongoing research in combination vaccines holds promise for broader protection against multiple respiratory viruses in the future."

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