Abrysvo (PF-06928316) / Pfizer - LARVOL DELTA

Assessing the risk of Guillain-Barré syndrome in older adults after bivalent RSV pre-F vaccination in England. (PubMed, Nat Commun) - "Final results were consistent, with the self-controlled case-series estimating a relative incidence of 3.34 (95% CI: 2.12-5.28) and an attributable risk of 23 (95% CI: 17-26) cases per million doses. Here, we show a small risk of GBS following RSV vaccination with the bivalent pre-F in England's older adults' programme, but this is at a level that is far exceeded by the vaccine benefits."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

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

RSV Vaccination Programme for Older Adults: A Scotland-Wide Study on RSVpreF Vaccine Safety. (PubMed, Vaccines (Basel)) - "Study results indicated a good safety profile of the RSV vaccine for older eligible adults aged 75 to 79 years, although a small increased risk of GBS was identified in both analyses. Excess risk levels of GBS from vaccination align with other studies."

Journal • Acute Coronary Syndrome • Acute Kidney Injury • Cardiovascular • Congestive Heart Failure • Heart Failure • Infectious Disease • Myocardial Infarction • Renal Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Evaluating ABRYSVO Maternal Vaccine Effectiveness Among Infants (clinicaltrials.gov) - P=N/A | N=39456 | Not yet recruiting | Sponsor: Pfizer

New trial • Real-world evidence • Respiratory Diseases • Respiratory Syncytial Virus Infections

DAN-RSV: Vaccine Effectiveness of a Bivalent RSV Prefusion F Protein-Based Vaccine for Preventing RSV Hospitalizations in Adults (clinicaltrials.gov) - P4 | N=690000 | Recruiting | Sponsor: Tor Biering-Sørensen | Active, not recruiting ➔ Recruiting | N=130000 ➔ 690000 | Trial completion date: Aug 2027 ➔ Aug 2028 | Trial primary completion date: May 2027 ➔ May 2028

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Respiratory Syncytial Virus Infections

PISSARRO: A Study to Evaluate the Safety and Immunogenicity of RSVpreF Coadministered With Herpes Zoster Vaccine in Adults (clinicaltrials.gov) - P3 | N=526 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion • Herpes Zoster • Respiratory Diseases • Respiratory Syncytial Virus Infections • Varicella Zoster

BORLAND: Evaluating the Benefits of RSV Maternal Vaccination Using a Scottish National Dataset (clinicaltrials.gov) - P=N/A | N=1 | Not yet recruiting | Sponsor: Pfizer

New trial • Infectious Disease • Respiratory Diseases • 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

PIPELINE-RSV-F: Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination (clinicaltrials.gov) - P3 | N=1000 | Not yet recruiting | Sponsor: Centre Hospitalier Annecy Genevois

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

CosTaR: Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: Canadian Immunization Research Network | Not yet recruiting ➔ Recruiting

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

Cost-Effectiveness of Bivalent Respiratory Syncytial Virus Stabilized Prefusion F Subunit Vaccine (RSVpreF) Among Older Adults in Ireland (ISPOR-EU 2025) - "ICERs were all near or below the typical €45,000/QALY willingness-to-pay threshold. While all strategies evaluated would reduce the clinical and economic burden of RSV among older adults in Ireland, findings suggest RSVpreF vaccination for all aged ≥65y would have the greatest impact on the burden of RSV."

Clinical • Cost effectiveness • HEOR • Respiratory Diseases • Respiratory Syncytial Virus Infections

Public Health Impact of Bivalent Respiratory Syncytial Virus Prefusion F Vaccine for Prevention of Respiratory Syncytial Virus Illness Among High-Risk Adults Aged 18-59 Years in Germany (ISPOR-EU 2025) - "RSVpreF uptake comparable to current influenza vaccine uptake would reduce the public health burden of RSV-LRTI in CMC+/IC adults aged 18-59 years in Germany. A public health campaign aimed at increasing RSVpreF uptake to levels closer to 75% would further reduce disease."

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

Cost-Effectiveness Evaluation of RSVpreF Vaccine for Preventing RSV Among Older Adults With High Risk Under Taiwan National Vaccination Program (ISPOR-EU 2025) - "Our findings emphasize the critical importance of implementing nationwide RSV vaccination programs targeting high-risk older adults. Such initiatives have the potential to substantially reduce the clinical and economic burden of RSV infection in this population."

Clinical • Cost effectiveness • HEOR • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Coronary Artery Disease • Heart Failure • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Economic and Clinical Impact of Older Adult Vaccination With the Bivalent Respiratory Syncytial Virus Prefusion F (RSVpreF) Vaccine in Mexico (ISPOR-EU 2025) - "Year-round RSVpreF vaccination program would substantially reduce RSV's clinical and economic burden among older adults in Mexico and likely be a highly cost-effective program."

Clinical • Infectious Disease • Influenza • 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

Public Health and Economic Impact of RSVpreF Vaccination Among Older Adults in Latin America and the Caribbean (ISPOR-EU 2025) - "RSV places a substantial health and economic burden on older adults in Latin America and the Caribbean. The introduction of RSVpreF vaccination is anticipated to reduce this burden by preventing a large number of cases and death while lowering medical expenditures."

Clinical • HEOR • Respiratory Diseases • Respiratory Syncytial Virus Infections

Cost-Effectiveness of Mixed Maternal RSVpreF/Infant Nirsevimab Immunization Approach vs. Nirsevimab Alone for the Prevention of Respiratory Syncytial Virus in Chile (ISPOR-EU 2025) - "A mixed approach involving both interventions may offer greater protection against severe RSV illness at a substantially lower cost than nirsevimab alone, especially when considering potential maternal benefits to RSVpreF."

Cost effectiveness • HEOR • Respiratory Diseases • Respiratory Syncytial Virus Infections

Cost-Effectiveness Analysis of RSVpreF Vaccine for RSV Prevention in Older Adults Under Situation of the National Vaccination Program in Taiwan: A Study on Economic and Clinical Advantages (ISPOR-EU 2025) - "This study finds the RSVpreF vaccination clinically beneficial and cost-effective for older adults under Taiwan's national immunization program. With no official RSV surveillance in Taiwan and likely underdiagnosis, real-world epidemiological data is crucial to assess disease burden and the potential impact of including RSVpreF in the NIP."

Clinical • Cost effectiveness • HEOR • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

Cost-Effectiveness of Mixed-Approach Maternal RSVpreF/Infant Nirsevimab Immunization vs. Nirsevimab Alone for Prevention of Respiratory Syncytial Virus in Spain (ISPOR-EU 2025) - "Adding RSVpreF to the recommendation would reduce the burden of RSV-LRTI among infants in Spain."

Cost effectiveness • HEOR • Respiratory Diseases • Respiratory Syncytial Virus Infections

Cost-Effectiveness of Strategies to Prevent Respiratory Syncytial Virus Infections Among Infants in Ireland (ISPOR-EU 2025) - "Findings suggest that using a combination of both preventives synergistically would be more effective in reducing RSV-LRTD among infants and a more efficient use of resources than a single intervention in Ireland."

Cost effectiveness • HEOR • Infectious Disease • 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

Acceptance and impact of Nirsevimab and the RSVpreF vaccine following implementation in Austria. (PubMed, Front Public Health) - "Our findings highlight the positive impact of both RSV immunization strategies-nirsevimab and RSVpreF vaccine-while underscoring the need to enhance public awareness and education to improve immunization rates. Future immunization programs must be strengthened to provide better protection for the pediatric population and reduce RSV-associated morbidity in early life."

Journal • Retrospective data • Infectious Disease • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

Public Health and Economic Impact of RSVpreF Maternal Vaccination Among Infants in Five Asian Countries (ISPOR-EU 2025) - "RSV places substantial health and economic burden on infants in Asia. The introduction of RSVpreF vaccination could help reduce this burden, preventing medically-attended cases, deaths, and associated costs."

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

The Public Health and Economic Effects of Various RSV Vaccination Strategies With RSVpreF Among Adults in France (ISPOR-EU 2025) - "RSVpreF vaccination could prevent between 17,786-27,020 hospitalizations over 5 years and generates between €85M and €137M medical cost savings for the French health insurance, depending on the vaccination strategy."

Clinical • Infectious Disease • Influenza • Novel Coronavirus Disease • 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