Arexvy (respiratory syncytial virus vaccine, adjuvanted) / GSK - LARVOL DELTA

GSK plc…announced Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the indication of its RSV vaccine Arexvy to include all adults aged 18 years and older. (Investing.com) - "The European Commission’s final decision on the expanded indication is expected in February 2026."

CHMP • EMA approval • Respiratory Syncytial Virus Infections

RSV OA-004: Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above (clinicaltrials.gov) - P3 | N=1720 | Active, not recruiting | Sponsor: GlaxoSmithKline | Trial completion date: May 2026 ➔ Feb 2027

Trial completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

RSVax: RSV Vaccine in Transplant Recipients (clinicaltrials.gov) - P3 | N=100 | Recruiting | Sponsor: University Health Network, Toronto | Trial primary completion date: Oct 2025 ➔ Mar 2026

Trial primary completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation

RSV Vaccines: Targeting Prefusion F and G Proteins from Structural Design to Clinical Application. (PubMed, Vaccines (Basel)) - " Approved vaccines such as Abrysvo and Arexvy utilize structural engineering to stabilize the prefusion conformation of the F protein (PreF), thereby exposing neutralizing epitopes. Subunit vaccine candidates such as DS-Cav1 and DT-PreF enhance stability through disulfide bonds and dityrosine linkages, while ADV110 targets the conserved domain of the G protein to elicit cross-strain immunity. Virus-like particle (VLP) vaccines like IVX-A12 combine RSV and human metapneumovirus antigens to provide broad-spectrum immunity. However, challenges exist, including maintaining PreF stability, overcoming immunosenescence in the elderly, and addressing safety concerns like Guillain-Barré syndrome (GBS). Future RSV vaccine development should center on combined PreF-G protein vaccines, VLP technology, and optimizing cold-chain logistics to improve global accessibility and overcome existing challenges, thereby providing more effective prevention and control of RSV infections."

Journal • Review • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • CAV1

Korea approves GSK RSV vaccine Arexvy for high-risk adults 50–59 (Chosun Biz) - "This expansion of the target age is based on the results of a global phase 3 clinical trial that compared the immunogenicity and safety after Arexvy vaccination in adults age 50 to 59 with chronic diseases to those in adults age 60 and older."

Korea approval • Respiratory Syncytial Virus Infections

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

REVULPOP: Immune Effects of Respiratory Syncytial Virus (RSV) Vaccination in Older Adults (ANZCTR) - P4 | N=120 | Not yet recruiting | Sponsor: Tasmanian Health Service

New P4 trial • CNS Disorders • Depression • Mood Disorders • Psychiatry • Respiratory Diseases • Respiratory Syncytial Virus Infections

REVULPOP: Immune Effects of Respiratory Syncytial Virus (RSV) Vaccination in Pregnant Women (ANZCTR) - P=N/A | N=50 | Not yet recruiting | Sponsor: Tasmanian Health Service

New trial • CNS Disorders • Depression • Mood Disorders • Psychiatry • 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

Increasing respiratory syncytial virus (RSV) vaccination rates in adult CF clinic (NACFC 2025) - "Abrysvo® was recently approved for people ages 18–49 years old who have chronic lung disease and Arexvy® is also available for patients ages 50 and older... The new RSV vaccine process has made a positive impact on RSV vaccination rates in the Adult CF Clinic at UCSDH. Educating patients about vaccines helps them make informed decisions, which may result in increased vaccine rates and less illness. This project identified several future considerations: 1) there is a need for education of community pharmacy staff and primary care providers regarding recommended vaccines in PwCF, outreach to these groups may be beneficial, 2) we will try to obtain access to RSV vaccine at all clinic locations to increase access and convenience for patients, and 3) we will employ these strategies to increase vaccine rates for all recommended respiratory-related vaccines."

Clinical • Cystic Fibrosis • Genetic Disorders • Immunology • Influenza • Novel Coronavirus Disease • Pertussis • Pneumococcal Infections • Pneumonia • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Near real-time surveillance and tree-based data mining to assess the safety of respiratory syncytial virus vaccines in older adults in the vaccine safety datalink. (PubMed, Vaccine) - "These post-licensure safety assessments provide evidence supporting the safety of RSV vaccines in older adults. As more data accrue, additional monitoring is warranted for rare adverse events."

Journal • Hematological Disorders • Immune Thrombocytopenic Purpura • Respiratory Diseases • Respiratory Syncytial Virus Infections • Thrombocytopenic Purpura

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease (clinicaltrials.gov) - P3 | N=750 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older (clinicaltrials.gov) - P3 | N=2621 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

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

RSV Immunogenicity Study in the Elderly (RISE) (clinicaltrials.gov) - P3 | N=65 | Recruiting | Sponsor: Karin Karin Loré

New P3 trial

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

Effectiveness of the Arexvy RSV vaccine in lung transplant recipients: Neutralizing antibody response against reference and seasonal strains (ERS 2025) - "Conclusions Arexvy® elicited a durable immune response in LTx recipients, with sustained antibody titers over six months. Further research is needed to assess long-term durability and clinical effectiveness."

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

Vaccination Update and Specific Concerns for RA. (PubMed, Curr Rheumatol Rep) - "Following the license expansion for two respiratory syncytial virus (RSV) vaccines, GSK's Arexvy and Pfizer's Abrysvo, the Advisory Committee for Immunization Practices (ACIP) expanded the recommendation for vaccination in adults at increased risk of severe RSV disease...Vaccine recommendations for RA patients constantly evolve as new DMARDs and vaccines are developed, and our understanding of their interaction with DMARDs vis a vis immunogenicity improves. It is essential to stay current with the latest recommendations from the ACIP and rheumatologic society guidelines."

Journal • Review • Herpes Zoster • Immunology • Infectious Disease • Inflammatory Arthritis • Measles • Novel Coronavirus Disease • Pneumococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections • Rheumatoid Arthritis • Rheumatology • Varicella Zoster

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

Immunogenicity and Reactogenicity of Adjuvanted (Arexvy) and Non-Adjuvanted (Abrysvo) RSV Vaccines in Immunocompromised Individuals with Hematological Malignancies (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

Vaccine Responses in Patients With B Cell Malignancies (clinicaltrials.gov) - P4 | N=500 | Recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Aug 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Oncology • BCL2

US FDA accepts application to review expanded use of GSK’s RSV vaccine, Arexvy, for adults 18-49 at increased risk (GSK Press Release) - "GSK plc...announced that the US Food and Drug Administration (FDA) has accepted for review an application to extend the indication of Arexvy (respiratory syncytial virus (RSV) vaccine, adjuvanted) to adults aged 18-49 who are at increased risk. GSK’s RSV vaccine is approved in the US for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, and for those aged 50-59 years who are at increased risk....This regulatory submission is supported by a phase IIIb trial evaluating immune response and safety in adults aged 18-49 at increased risk compared to adults aged 60 and above. The safety and reactogenicity data were consistent with results from the phase III programme that supported the initial approval of the vaccine in the US. A regulatory decision by the FDA on this submission is expected in H1 2026."

FDA approval • FDA filing • Respiratory Syncytial Virus Infections