Abrysvo (PF-06928316) / Pfizer - LARVOL DELTA

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

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

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

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

Economic evaluation of a bivalent respiratory syncytial virus prefusion F vaccine for older adults in Sweden: cost-effectiveness and budget impact. (PubMed, J Med Econ) - "Introducing RSVpreF vaccination for older adults in Sweden has the potential to reduce RSV-related hospitalizations, deaths, and healthcare costs. Findings support the implementation of RSV vaccination to older adults and at-risk individuals as a cost-effective and budget-saving strategy in the short term."

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

Estimated Vaccine Effectiveness for Respiratory Syncytial Virus-Related Acute Respiratory Illness in Older Adults: Findings From the First Postlicensure Season. (PubMed, Clin Infect Dis) - "Among older adults, RSVpreF demonstrated high VE against RSV-related ARI hospitalization or ED visits, including among high-risk subgroups, and against severe outcomes. RSV vaccination programs can protect groups at the highest risk of severe disease."

Journal • Critical care • Geriatric Disorders • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Retinal Disorders

Preventing Respiratory Syncytial Virus in Infants: A Comparative Review of Nirsevimab and Maternal Respiratory Syncytial Virus Prefusion F (RSVpreF) Vaccination. (PubMed, Cureus) - "Preventive options have recently expanded beyond selective palivizumab use to two population-level strategies: infant administration of the long-acting monoclonal antibody nirsevimab and maternal immunization with an RSV prefusion F (RSVpreF) vaccine during late pregnancy...We also discuss limitations of the evidence base and propose priorities for surveillance and comparative research to guide policy decisions. The goal is to provide clinicians and policymakers with a concise, practice-oriented appraisal of how these strategies can be integrated to reduce RSV burden in the first months of life."

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

Cost-effectiveness of respiratory syncytial virus prevention strategies in Mozambique: a modelling study. (PubMed, J Glob Health Econ Policy) - "We used a static cohort model to generate preliminary estimates of the potential health impact and cost-effectiveness of a maternal vaccine (RSVPreF, Abrysvo®, Pfizer) and a long-acting infant mAb (Nirsevimab, Beyfortus®, AstraZeneca, and Sanofi) over a 10-year period (2025-2034) in Mozambique...Both interventions have the potential to be cost-effective if priced below USD 5 per dose. A seasonal strategy could further improve cost-effectiveness if feasible to implement."

HEOR • Journal • 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

Impact of Maternal RSV Vaccination (Abrysvo) and Monoclonal Antibody (Beyfortus) on Reducing the Severity of RSV-related Illness in a Multiethnic Immigrant Population (AAP-NCE 2025) - "This study showed that the infants receiving either Beyfortus or Abrysvo in our highly diverse population had significantly fewer hospitalizations, oxygen support needs, and high-flow cannula requirements compared to those who did not receive any RSV prevention. Our findings affirm the reduction of severe complications in RSV-positive infants when they received RSV prevention measures via Abrysvo or Beyfortus."

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

RSV Immunoprophylaxis in Infants and Breakthrough Infection: Clinical Impact and Viral Features (AAP-NCE 2025) - "While new immunoprophylactic strategies (maternal vaccination [Abrysvo] and infant monoclonal treatment [nirsevimab]) mitigate disease burden in young infants, viral characteristics of breakthrough RSV infection have not been described. Nasopharyngeal swabs were collected from all RSV-infected children ages < 2.0 years presenting for medical care at MGH between 9/2024-2/2025... RSV immunoprophylaxis reduces disease severity, viral burden, and need for antibiotics at time of RSV infection. Specific viral subtypes do not appear to drive breakthrough RSV infection. Analyses are underway to further characterize viral traits in breakthrough RSV infection."

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

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

Preferences of Dutch Parents and Expectant Parents for Respiratory Syncytial Virus Prevention Strategies: A Discrete Choice Experiment. (PubMed, Infect Dis Ther) - "The results suggest that most Dutch parents and expectant parents would prefer a maternal vaccine to an infant mAb injection to immunise their infants against an RSV-like virus. An NIP that incorporates both strategies may enhance uptake and protect the most infants. However, as the attributes were not exhaustively or explicitly presented in the context of RSV prevention, the results may not be completely transferable."

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

CASSATT: Effectiveness of ABRYSVO® Maternal Respiratory Syncytial Virus (RSV) Vaccine Against RSV in Infants in Western Pennsylvania (clinicaltrials.gov) - P=N/A | N=1 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: Jul 2025 ➔ Jul 2027 | Trial primary completion date: Jul 2025 ➔ Jul 2027

Trial completion date • Trial primary completion date • Respiratory Diseases • Respiratory Syncytial Virus Infections

RENOIR: Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults. (clinicaltrials.gov) - P3 | N=38861 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2026 ➔ Jan 2027 | Trial primary completion date: Jun 2026 ➔ Jan 2027

Enrollment closed • Trial completion date • Trial primary completion date • Respiratory Diseases • Respiratory Syncytial Virus Infections

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

Cost-effectiveness of strategies using preventive interventions to protect infants in Chile from respiratory syncytial virus. (PubMed, Expert Rev Vaccines) - "With costs lower by $28.4 M and increased quality-adjusted life-years, MV+N would be cost-saving versus NA. RSVpreF vaccination among pregnant women along with nirsevimab for unprotected infants in Chile would be the most efficient use of resources, yielding substantial cost savings compared to use of nirsevimab alone."

HEOR • Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Preparation time and usability assessment of commercially available freeze-dried respiratory syncytial virus vaccine presentations. (PubMed, Expert Rev Vaccines) - "Compared with the V/V, the AOV was faster, preferred by participants, and reported to have more usability benefits. Findings suggest that AOV will be well accepted by HCPs."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Cost-Effectiveness Analysis of a Maternal Vaccination Program Against Respiratory Syncytial Virus in Norway. (PubMed, Influenza Other Respir Viruses) - "Based on the RSVpreF vaccine's list price in Norway, the seasonal vaccination program is cost-effective from both the healthcare and societal perspectives, considering a willingness-to-pay threshold of 500,000 NOK."

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

SPECIAL INVESTIGATION FOR ABRYSVO IN PREGNANT WOMEN AND INFANTS (clinicaltrials.gov) - P=N/A | N=490 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: Sep 2026 ➔ Mar 2026 | Trial primary completion date: Sep 2026 ➔ Mar 2026

Trial completion date • Trial primary completion date • Infectious Disease • Respiratory Diseases

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

STudy of Real World vaccinE Effectiveness of maTernal RSVpreF vaccinatiON Against Respiratory Syncytial Virus (RSV) in Hospitalised Infants in Australia (STREETON) (clinicaltrials.gov) - P=N/A | N=1 | Active, not recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Real-world evidence • Respiratory Diseases • Respiratory Syncytial Virus Infections