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

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

Autoimmune Inflammatory Demyelinating Polyneuropathy Following RSV Vaccination (AAAAI 2026) - "In 2023, Arexvy became the first FDA-approved RSV vaccine for adults ≥60. In 2025, postmarketing data prompted FDA GBS warnings, estimating 1.8 cases per million doses."

Immunology • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

From Value to Equity: A Distributional Return of Investment Approach of RSV Vaccination with adjuvanted RSVPreF3 in Spain with an Actuarial and Macroeconomic Model (RSVVW 2026) - "This study evaluates the societal return on investment (ROI) of an RSV vaccination programme with adjuvanted RSV prefusion F protein–based vaccine (RSVPreF3 OA) for older adults in Spain and examines its distributional ROI (DROI) across all Autonomous Regions...This analysis shows that RSV immunisation delivers greater social value in regions with higher baseline inequality, supporting its prioritisation as both a cost-saving and equity-relevant public health intervention. Funding: GSK (GSK study number: 300566)."

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

Reducing the Burden on the Healthcare System through the Introduction of RSV Vaccination in Germany (RSVVW 2026) - "The analysis assumed eligibility in line with RSVPreF3 OA approval: individuals aged 50–59 years at increased risk and all individuals aged ≥60 years...Achieving higher vaccination coverage would further amplify these benefits, enhance healthcare capacity and improve patient outcomes. Funding: This study was funded by GSK (VEO-002437)."

Infectious Disease • 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

An Endogenously Trimerized Prefusion F Protein Vaccine for Respiratory Syncytial Virus (RSVVW 2026) - "Preclinical studies of structure-based design preF YK001Ag399 in mice, cotton rats, and non-human primates demonstrate its superiority: enhanced immunogenicity, stronger challenge protection, and robust boosting effects, with V001A (no adjuvant) outperforming ABRYSVO and V001B (with Alum/CpG adjuvant) surpassing AREXVY. It also shows superior stability under diverse conditions. This foldon-independent antigen represents a promising next-generation RSV vaccine."

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

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

Crucial Obstacles and Strategies for Human RSV Pediatric Vaccine Development. (PubMed, Viruses) - "Despite recent approvals of prefusion F (pre-F) protein-based vaccines (Arexvy, Abrysvo) for older adults and pregnant women, pediatric vaccine development faces unique challenges including enhanced respiratory disease (ERD) risks, maternal antibody interference, and immature infant immune responses...Additionally, current animal models demonstrate notable constraints in virus replication, host susceptibility, immune responses, clinical symptoms, and ERD phenomena. This review synthesizes current obstacles and innovative strategies, highlighting that the selection of multi-antigen strategies, appropriate adjuvants, and the development of more precise preclinical animal models are critical elements that will determine the efficacy and safety of future RSV vaccines."

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

GSK’s RSV vaccine, Arexvy, receives European approval for expanded use in all adults 18 years and older (GSK Press Release) - "Today’s updated indication now enables European countries to make the vaccine available to all adults aged 18 years and older."

EMA approval • Respiratory Syncytial Virus Infections

A Novel Unadjuvanted Subunit Respiratory Syncytial Virus Prefusion F Vaccine Induces Potent and Differentiated Functional Immune Responses Compared to AS01-Adjuvanted Arexvy in Older Adults. (PubMed, Open Forum Infect Dis) - "The humoral immunogenicity SCB-1019T was similar to that of Arexvy, which contains the potent AS01E adjuvant. Therefore, this phase 1 study supports further development of SCB-1019T, notably in heterologous booster settings."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

RSVPreF3OA vaccine responses in kidney transplant recipients and dialysis patients versus healthy controls. (PubMed, Nephrol Dial Transplant) - "This study provides detailed immunophenotyping of RSVPreF3OA vaccine responses in KTR, DP, and HC over 90 days, showing that RSVPreF3OA vaccination induces protective RSV responses among KTR comparable to HC, while DP mount modestly lower cellular and humoral responses."

Journal • Infectious Disease • Nephrology • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tetanus • Transplantation

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 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study in India on the Immune Response and Safety of a Respiratory Syncytial Virus (RSV) Older Adults (OA) Vaccine When Given to Older Adults 60 Years of Age and Above and Adults 50-59 Years of Age at Increased Risk (AIR) of Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV-LRTD) (clinicaltrials.gov) - P3 | N=751 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

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

Adverse Events Reported Following RSV Prefusion F Protein Vaccines Administration Among Approved Populations: A Cross-Sectional Study. (PubMed, Kans J Med) - "The higher frequency of injection site symptoms among Arexvy™ recipients may be attributable to the adjuvant included in Arexvy™ but absent in Abrysvo™. Overall, these findings indicate that both vaccines provide safe protection against RSV for older adults, with minimal side effects, in a population that previously had no vaccination option."

Adverse events • Journal • Observational data • Infectious Disease • Musculoskeletal Diseases • Respiratory Diseases • Respiratory Syncytial Virus Infections

RSV OA=ADJ=012: An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study (clinicaltrials.gov) - P3 | N=10212 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons (clinicaltrials.gov) - P2 | N=170 | Recruiting | Sponsor: Johns Hopkins University | Not yet recruiting ➔ Recruiting

Enrollment open • Respiratory Diseases

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