unadjuvanted RSV maternal vaccine (GSK3888550A) / GSK - LARVOL DELTA

Adjuvanted RSVPreF3 vaccine impact over three respiratory syncytial virus seasons in older adults with comorbidities. (PubMed, ERJ Open Res) - "Among participants with COPD, 15.4% (1.9-45.4) of RSV-ARI episodes in vaccine versus 22.4% (12.5-35.3) in placebo recipients were treated with systemic corticosteroids, and 46.2% (19.2-74.9) versus 56.9% (43.2-69.8) with antibiotics. Post hoc analyses of the AReSVi-006 trial suggest that adjuvanted RSVPreF3 may help prevent RSV-ARI, RSV-LRTD and RSV-related complications in medically stable older adults with underlying medical conditions like COPD and asthma."

Journal • Asthma • Cardiovascular • Chronic Obstructive Pulmonary Disease • Diabetes • Genetic Disorders • Immunology • Infectious Disease • Metabolic Disorders • Obesity • Pneumonia • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Immunogenicity and safety of a single dose of adjuvanted RSVPreF3 vaccine in adults ≥60 years of age in China: results from a phase 3 immunobridging trial. (PubMed, Front Immunol) - P3 | "The incidence of unsolicited adverse events (reported in 11.8%-13.8% of participants across Chinese groups), serious adverse events (3.4%-6.5% across all groups), and potential immune-mediated diseases (0.2%-0.3% across all groups) was low and comparable between groups. A single dose of adjuvanted RSVPreF3 was immunogenic and well tolerated in Chinese adults aged ≥60 years, supporting the extrapolation of global efficacy and a favorable benefit-risk profile in this population."

Clinical • Journal • P3 data • Fatigue • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

Immune response and safety of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine (adjuvanted RSVPreF3) in immunocompromised (IC) adults with lung or kidney transplant compared to non-IC adults up to 12 months post-vaccination (TTS 2026) - P2 | "Adjuvanted RSVPreF3 elicited humoral and cellular immune responses post-vaccination with an acceptable reactogenicity and safety profile in IC adults with lung and kidney transplant. Geometric mean neutralising titres for RSV-A and RSV-B in IC and non-IC adults, overall (A) and by mycophenolate (MC) use (B) up to 12 months post-vaccination, per-protocol set for humoral immunogenicityReactogenicity (A) and safety (B) of 1 or 2 doses of adjuvanted RSVPreF3 in IC and non-IC adults, exposed set"

Clinical • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation • CD4

Adjuvanted RSVPreF3 vaccine effectiveness against RSV-related hospitalization among US adults aged ≥60 years: Results from the CLEAR-VE RSV study over two RSV seasons (IDWeek 2026) - No abstract available

Clinical • Infectious Disease • Respiratory Syncytial Virus Infections

Unlocking the value of RSV vaccination in Japan: a return on investment analysis using an integrated actuarial-macroeconomic model. (PubMed, Front Public Health) - "For high-risk adults aged 50-59 years, the total ROI was 3.7 without DWL and 3.8 with DWL, with corresponding reductions of JPY 17,889 M in productive output loss, JPY 10,400 M in healthcare costs, and JPY 266,116 M in monetized QALY loss. Overall, adjuvanted RSVPreF3 vaccination among older adults in Japan represents good value for money from a societal perspective, where vaccine acquisition and administration costs are expected to be outweighed by substantial health, productivity, and broader economic benefits."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Letter to the Editor Regarding "Adult RSV Vaccination: What is the Role of RSV Subgroup in Disease Prevention?". (PubMed, Infect Dis Ther) - No abstract available

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Cost-effectiveness of a single dose of the adjuvanted respiratory syncytial virus preFusion protein 3 vaccine over 5 years and its potential public health impact among older adults in Italy. (PubMed, Eur J Health Econ) - "Vaccination of OAs and AIR individuals with one dose of aRSVPreF3 has the potential to reduce RSV disease-associated burden and direct costs for the Italian National Healthcare System over a 5-year period. These results could support policymakers and clinicians in decision-making processes around the recommendation and implementation of RSV vaccination in Italy."

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

AS01E-Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine (Adjuvanted RSVPreF3): Review of the First 2 Years of Post-Marketing Safety Surveillance. (PubMed, Drug Saf) - "Review of the post-marketing surveillance data from 2 years of exposure to adjuvanted RSVPreF3 showed that the safety profile of the vaccine is consistent with that observed in clinical trials supporting an unchanged and favorable benefit-risk profile for the vaccine. Additional post-marketing surveillance is ongoing to further evaluate a potential risk of rare AEs, such as Guillain-Barré syndrome, following adjuvanted RSVPreF3 vaccination."

Journal • P4 data • Atrial Fibrillation • Cardiovascular • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant (clinicaltrials.gov) - P2 | N=168 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

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

Effectiveness of the adjuvanted RSVPreF3 vaccine in preventing major adverse cardiovascular events and severe exacerbations of chronic obstructive pulmonary disease and asthma among US adults aged ≥60 years. (PubMed, Chest) - "Adjuvanted RSVPreF3 vaccination may offer considerable protection against RSV-related MACE and severe COPD and asthma exacerbation events in individuals with underlying CVD, COPD, and asthma."

Adverse events • Journal • Asthma • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study Exploring the Effect of Adjuvanted RZV or RSVPreF3 Vaccines on Coronary Plaque Progression in Adults >=50 Years of Age at Risk for Cardiovascular Events (clinicaltrials.gov) - P2 | N=450 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P2 trial • Cardiovascular

Real-world effectiveness of adjuvanted RSVPreF3 vaccination in the prevention of RSV-related hospitalization among US adults aged ≥60 years. (PubMed, Chest) - "These findings highlight the effectiveness of adjuvanted RSVPreF3 vaccination in preventing RSV-related hospitalization among older adults, including those at increased risk, suggesting that vaccination is an effective strategy in reducing RSV disease burden."

Journal • Real-world evidence • Cardiovascular • Diabetes • Metabolic Disorders • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Public health impact and cost-effectiveness of adjuvanted RSVPreF3 vaccination among US adults aged 18-49 years at increased risk for severe RSV disease. (PubMed, Vaccine) - "Model findings suggest considerable potential public health benefits and cost-effectiveness of adjuvanted RSVPreF3 vaccination among US adults aged 18-49 years at increased risk for severe RSV disease."

HEOR • Journal • Asthma • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Coronary Artery Disease • Diabetes • Diabetic Nephropathy • Genetic Disorders • Heart Failure • Immunology • Infectious Disease • Influenza • Metabolic Disorders • Nephrology • Obesity • Pulmonary Disease • Renal Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Immunogenicity and safety of co-administration of AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine and a COVID-19 mRNA vaccine in adults aged ≥50 years: a phase 3, randomized, non-inferiority trial. (PubMed, Clin Infect Dis) - "Adjuvanted RSVPreF3 co-administered with a COVID-19 mRNA vaccine maintained an acceptable safety profile in ≥50-year-olds. The marginal miss of the non-inferiority criterion for SARS-CoV-2 does not suggest clinically relevant interference. Therefore, the results support the co-administration of these vaccines."

Head-to-Head • Journal • P3 data • Fatigue • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

Estimated efficacy of the adjuvanted RSVPreF3 vaccine against diverse and worldwide predominant RSV strains, irrespective of RSV F protein variation: results of a post-hoc analysis from the AReSVi-006 trial. (PubMed, EBioMedicine) - P3 | "Our findings support the efficacy of adjuvanted RSVPreF3 across a broad set of RSV strains, representative of globally circulating strains. VE was maintained irrespective of distance to RSVPreF3 in terms of the number of aa variations."

Journal • Retrospective data • Respiratory Diseases • Respiratory Syncytial Virus Infections

Real-world Effectiveness of Adjuvanted RSVPreF3 Vaccine in Preventing RSV-associated Lower Respiratory Tract Disease Hospitalization in Adults ≥60 Years of Age: Early Results From a Test-negative Design Analysis. (PubMed, Open Forum Infect Dis) - "In a test-negative design, we estimated within-season vaccine effectiveness (VE) of adjuvanted RSVPreF3 against laboratory-confirmed respiratory syncytial virus (RSV)-lower respiratory tract disease-associated hospitalizations in adults ≥60 years during Dec2023-Feb2025. Results showed 82.3% overall VE and 81.0%-92.1% VE across subgroups, including those at increased risk of severe RSV disease."

Journal • Real-world evidence • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant (clinicaltrials.gov) - P2 | N=184 | Recruiting | Sponsor: GlaxoSmithKline

Trial initiation date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation

Immunogenicity and Safety of the Adjuvanted Respiratory Syncytial Virus Prefusion F Protein-Based Vaccine When Co-administered With the Adjuvanted Recombinant Herpes Zoster Subunit Vaccine in Adults ≥ 50 Years of Age. (PubMed, Clin Infect Dis) - P3 | "Immunogenicity, reactogenicity, and safety data support the co-administration of adjuvanted RSVPreF3 and RZV."

Journal • Herpes Zoster • Respiratory Diseases • Respiratory Syncytial Virus Infections • Varicella Zoster

Immunogenicity and safety of co-administration of adjuvanted respiratory syncytial virus prefusion F protein vaccine with 20-valent pneumococcal conjugate vaccine in adults aged ≥60 years: a randomized, non-inferiority trial. (PubMed, Clin Infect Dis) - "Co-administration of adjuvanted RSVPreF3 vaccine and PCV20 vaccine in older adults is immunologically non-inferior to their sequential administration, with an acceptable safety profile. These findings support co-administration as a strategy to enhance vaccine uptake."

Head-to-Head • Journal • Infectious Disease • Pneumococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections

Randomized, placebo-controlled phase 3 trial evaluating safety, immunogenicity, and reactogenicity of RSVPreF3-Mat in high-risk pregnant women and their infants. (PubMed, Hum Vaccin Immunother) - P3 | "In this study of high-risk pregnant women, RSVPreF3-Mat demonstrated an acceptable safety profile, induced robust immune responses with successful placental antibody transfer, and showed balanced rates of preterm birth between the groups. Trial registration: EudraCT: 2021-000994-96; NCT: NCT04980391."

Journal • P3 data • Human Immunodeficiency Virus • Infectious Disease • Obstetrics • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Adjuvanted-RSVPreF3 vaccine uptake and effectiveness in individuals with COPD: a nationwide Danish cohort study. (PubMed, Expert Rev Vaccines) - "Adjuvanted-RSVPreF3 is highly effective in preventing RSV hospitalization in individuals aged ≥ 60 years with COPD. Disease outcomes could be improved by incorporating RSV vaccination into routine COPD management."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

224083: A study evaluating persistence of the immune response of the adjuvanted RSV vaccine and the safety and immunogenicity following revaccination in adults 18 years of age and above who received lung or kidney transplant (clinicaltrialsregister.eu) - P1/2 | N=71 | Recruiting | Sponsor: GlaxoSmithKline Biologicals

New P1/2 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation

Immunogenicity and Safety of the AS01E-adjuvanted Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine in Adults Aged 18-49 Years at Increased Risk of RSV Disease Compared with Adults Aged ≥60 Years. (PubMed, Clin Infect Dis) - P3 | "Adjuvanted RSVPreF3 was immunologically noninferior in 18-49-year-olds with underlying conditions compared with ≥60-year-olds in whom efficacy was previously demonstrated, supporting efficacy inference in this younger population. Up to 6 months postvaccination, the vaccine elicited robust immune responses, and the safety profile was acceptable. Clinical Trial Registration: NCT06389487."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections • CD4

Serious adverse events and potential immune-mediated diseases following one dose of adjuvanted RSVPreF3 in adults aged ≥18 years: pooled safety analysis from five clinical trials (RSVVW 2026) - P3 | "The reported SAEs and pIMDs were consistent with events anticipated for the studied population predominantly aged ≥60 years with underlying medical conditions. Together with the demonstrated efficacy, the pooled safety data from five phase 3 trials supports a favorable benefit/risk profile of adjuvanted RSVPreF3 in adults aged ≥18 years."

Adverse events • Clinical • Serious adverse event • Immunology • Infectious Disease • Musculoskeletal Diseases • Respiratory Diseases • Respiratory Syncytial Virus Infections

Public Health Impact of Adjuvanted RSVPreF3 Vaccination in Adults Aged 60+ Years in four major metropolitan areas of China: Beijing, Chengdu, Guangzhou and Shanghai (RSVVW 2026) - "Vaccination with adjuvanted RSVPreF3 vaccine avoided RSV-LRTD cases, as well as accompanying HCRU in the form of reduced outpatient visits, ED visits, new antibiotic prescriptions, and hospitalizations, leading to improvements in population health outcome. Funding: GSK (Study ID: 223405)"

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