Abrysvo (PF-06928316) / Pfizer - LARVOL DELTA

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

RSV Prefusion F Vaccine for Prevention of Hospitalization in Older Adults. (PubMed, N Engl J Med) - P4 | "Among adults 60 years of age or older, the RSVpreF vaccine reduced the incidence of hospitalization for RSV-related respiratory tract disease as compared with no vaccine. (Funded by Pfizer; European Union Clinical Trials number, 2024-516600-42-00; DAN-RSV ClinicalTrials.gov number, NCT06684743.)."

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

Bivalent RSV Prefusion F Protein-Based Vaccine for Preventing Cardiovascular Hospitalizations in Older Adults: A Prespecified Analysis of the DAN-RSV Trial. (PubMed, JAMA) - P4 | "The findings suggest potential downstream cardiorespiratory benefits of RSV immunization, although the effect on all-cause cardiovascular hospitalization was not statistically significant. ClinicalTrials.gov Identifier: NCT06684743."

Clinical • Journal • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure • Infectious Disease • Myocardial Infarction • Respiratory Diseases • Respiratory Syncytial Virus Infections

Immunogenicity and Reactogenicity of Adjuvanted (Arexvy) and Non-Adjuvanted (Abrysvo) RSV Vaccines in Immunocompromised Individuals with Hematological Malignancies (IDWeek 2025) - No abstract available

Clinical • Infectious Disease • Respiratory Syncytial Virus Infections

Immunogenicity and Safety of Bivalent Respiratory Syncytial Virus (RSVpreF) Vaccine in Non-Pregnant HIV Infected Older Adults (IDWeek 2025) - No abstract available

Clinical • Human Immunodeficiency Virus • Infectious Disease • Respiratory Syncytial Virus Infections

How do recent population-level RSVpreF vaccine impact results from the United Kingdom relate to previously reported vaccine effectiveness results? (IDWeek 2025) - No abstract available

Clinical • Infectious Disease

Post-marketing safety monitoring of RSV vaccines: A real-world study based on the Vaccine Adverse Event Reporting System (VAERS). (PubMed, Hum Vaccin Immunother) - "Two protein subunit vaccines - RSVPreF3 (Arexvy, GSK) and RSVpreF (Abrysvo, Pfizer) - and one mRNA RSV vaccine, mRNA-1345 (mRESVIA, Moderna), have been approved...Descriptive analysis of time-to-onset complemented the overall safety profiling, and sensitivity analysis offered further support for the observed disproportional reporting trends in certain adverse events (AEs). Our study utilized real-world data from large-scale spontaneous reporting systems to detect AEs that were disproportionately reported following RSV vaccination, thereby generating early safety signals to inform hypothesis development and support clinical awareness."

Adverse events • Journal • P4 data • Real-world evidence • Hematological Disorders • Immune Thrombocytopenic Purpura • Respiratory Diseases • Respiratory Syncytial Virus Infections • Thrombocytopenia • Thrombocytopenic Purpura

Effectiveness of bivalent respiratory syncytial virus prefusion F protein-based vaccine in individuals with or without atherosclerotic cardiovascular disease: the DAN-RSV trial. (PubMed, Eur Heart J) - "The VE of an RSVpreF vaccine vs no vaccine against respiratory and cardiovascular outcomes was similar among individuals ≥ 60 years of age with pre-existing ASCVD as compared with those without."

Journal • Atherosclerosis • Cardiovascular • Congestive Heart Failure • Heart Failure • Myocardial Infarction • Respiratory Diseases • Respiratory Syncytial Virus Infections

Effect of RSV Vaccine on Heart Failure Hospitalizations: A Prespecified Analysis of the DAN-RSV Trial. (PubMed, J Am Coll Cardiol) - No abstract available

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Respiratory Diseases • Respiratory Syncytial Virus Infections

Use of Clesrovimab for Prevention of Severe Respiratory Syncytial Virus-Associated Lower Respiratory Tract Infections in Infants: Recommendations of the Advisory Committee on Immunization Practices - United States, 2025. (PubMed, MMWR Morb Mortal Wkly Rep) - "All infants should be protected against RSV-associated LRTI through use of one of these three products (i.e., maternal RSV vaccination or administration of nirsevimab or clesrovimab to the infant). No one product is preferred; the choice should be guided by parent preference, product availability, and timing of the infant's birth relative to the RSV season."

Clinical guideline • Journal • Infectious Disease • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

Integrated Analysis of the Safety Experience in Adults with the Bivalent Respiratory Syncytial Virus Prefusion F Vaccine. (PubMed, Vaccines (Basel)) - P2, P2b, P3 | "Ongoing surveillance through real-world use and clinical trial experience continue to support the safety profile of RSVpreF. ClinicalTrials.gov: NCT03529773/NCT04071158/NCT04785612/NCT05035212/NCT05096208/NCT05842967/NCT04032093/NCT04424316."

Journal • Atrial Fibrillation • Cardiovascular • Fatigue • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

Vaccine Responses in Patients With B Cell Malignancies (clinicaltrials.gov) - P4 | N=500 | Recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Aug 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Oncology • BCL2

MORISOT: A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants (clinicaltrials.gov) - P3 | N=648 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed | N=343 ➔ 648

Enrollment change • Trial completion • Human Immunodeficiency Virus • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Side Effects Associated With Respiratory Syncytial Virus Prefusion F (RSVpreF) Maternal Vaccination: A Scoping Review. (PubMed, Cureus) - "Overall, the Pfizer RSVpreF vaccine appears to be well tolerated in pregnant women, but gaps in maternal safety data warrant further research. Future studies should prioritize high-risk patients and underrepresented populations, long-term maternal health outcomes, and potential associations with hypertensive disorders to ensure comprehensive vaccine safety and equitable access."

Adverse events • Journal • Review • Cardiovascular • Gynecology • Hypertension • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Outpatient Care of the Premature Infant. (PubMed, Am Fam Physician) - "This includes newer prevention options for respiratory syncytial virus (eg, nirsevimab [Beyfortus]) and the prenatal vaccine Abrysvo...Premature infants are also at risk for neurodevelopmental disabilities, including cerebral palsy, intellectual disability, and vision and hearing impairment. Developmental screening using corrected age is recommended at ages 9, 18, and 30 months, with screening for autism spectrum disorder at 18 and 24 months."

Journal • Review • Autism Spectrum Disorder • Bronchopulmonary Dysplasia • Cerebral Palsy • CNS Disorders • Critical care • Developmental Disorders • Gastrointestinal Disorder • Genetic Disorders • Hematological Disorders • Mental Retardation • Psychiatry • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Retinal Disorders • Retinopathy of Prematurity

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

New P4 trial • Infectious Disease • Pertussis • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tetanus

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 | Not yet recruiting | Sponsor: Pfizer

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

Who is at risk of a respiratory syncytial virus hospitalisation? A linked, population-based birth cohort analysis in children aged less than 5 years. (PubMed, Lancet Reg Health West Pac) - "Our analysis provides information for funders, vaccine policy makers, parents/carers, and immunisation providers. This work was supported by a Wesfarmers Centre for Vaccines and Infectious Diseases Seed grant and a Stan Perron Charitable Foundation grant (00046ProgPart)."

Journal • Asthma • Cardiovascular • Cerebral Palsy • CNS Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Pragmatic Individually Randomized Trial to Evaluate Bivalent RSV Prefusion F Protein-based Vaccine Effectiveness for Preventing RSV Hospitalizations in Adults Aged 60 Years or Above (DAN-RSV): Rationale & Trial Design. (PubMed, Am Heart J) - P4 | "DAN-RSV is an innovative trial combining the gold standard of individual randomization with pragmatic data collection via centralized health records and national health registries. This design offers a feasible approach to assess the impact of RSVpreF on clinically meaningful cardio-respiratory outcomes in adults ≥60 years in a real-world setting - while minimizing bias through use of randomization. The results will support cost-effectiveness analyses and inform future vaccination policies."

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

Burden of respiratory syncytial virus disease in infants and the potential value of maternal immunization in Greece. (PubMed, Front Public Health) - "Administering maternal RSVpreF vaccination year-round can provide protection to infants against RSV from birth. From a payer perspective, maternal RSVpreF vaccination has been evaluated as a cost-effective alternative compared to no intervention, underscoring its value as a preventive strategy against RSV in Greece."

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

Durability of RSV Antibodies Following RSV Vaccination in Solid Organ Transplant Recipients (WTC 2025) - "In healthy populations, antibody (Ab) response and clinical protection last for >1 year following a single vaccine dose, yet Ab durability in SOTRs is not known and may inform role for additional doses.* In a national prospective cohort, we measured Anti-RSV Pre-Fusion F IgG (PreF Ab) using an electrochemiluminescence assay (Meso Scale Discovery) in SOTRs who received RSVPreF3 (AREXVY™, RSV-AS01E) or RSVpreF (ABRYSVO™, RSV-A/B) vaccines between October 2023-October 2024 at baseline, and 4, 12, and 26-weeks post-vaccination... Longitudinal data indicate relatively stable Ab levels out to 6 months post RSV vaccination in SOTRs. However, many SOTRs never achieve conservative thresholds of Ab response, suggesting ongoing vulnerability to infection and supporting investigation of additional primary vaccinations for frailer or more immunosuppressed subgroups."

Clinical • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Solid Organ Transplantation • Transplantation