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

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

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