Abrysvo (PF-06928316) / Pfizer - LARVOL DELTA

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

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

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

RSV Vaccination Increases CD4 T-Cell Response, but Not CD8, in Solid Organ Transplant Recipients (WTC 2025) - "To address this gap, RSV-specific T-cell responses pre- and post-vaccination were assessed in SOTRs who received an approved RSV prefusion F protein vaccine.* In a national prospective cohort of SOTRs reporting either adjuvanted RSVPreF3 (GSK, AREXVY™) or unadjuvanted RSVpreF (Pfizer, ABRYSVO™) vaccination, RSV F-specific T-cell responses were evaluated by intracellular cytokine staining and flow cytometry following RSV peptide pool stimulation... RSV vaccination increases RSV F-specific CD4+ T-cell response but does not significantly increase CD8+ T-cell responses in SOTRs. The lack of virus-specific cytotoxic T-cell response in SOTRs may suggest ongoing vulnerability to critical disease despite vaccination, particularly if humoral response wanes. Importantly, a subset of SOTRs exhibited no significant increase in CD4+ T-cell responses following vaccination, highlighting the need for further investigation into predictors of response."

Clinical • Respiratory Diseases • Respiratory Syncytial Virus Infections • Solid Organ Transplantation • Transplantation • CD4 • CD8 • IFNG • IL2

Beyond the first breath: comprehensive respiratory syncytial virus prevention through maternal immunization and infant immunoprophylaxis. (PubMed, Asian Biomed (Res Rev News)) - "For decades, monthly palivizumab injection has provided passive immunization for high-risk infants and has demonstrated efficacy in reducing RSV-related hospitalizations, while breastfeeding has been known to protect against severe RSV-LRTI...Additionally, long-acting RSV monoclonal antibodies (Nirsevimab) provide season-long protection with a single dose for infants during the first RSV season, reducing both medically attended RSV-LRTI and hospitalizations by approximately 70%-80% in infants during their first RSV season. Consequently, in 2024, the Strategic Advisory Group of Experts (SAGE) recommended that countries introduce maternal RSVPreF vaccination and/or RSV monoclonal antibodies for infant RSV prevention. Many countries have already adopted these interventions, demonstrating cost-effectiveness of monoclonal antibodies."

Journal • Review • Cardiovascular • Heart Failure • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Long-Term Safety of Respiratory Syncytial Virus Vaccination in Solid Organ Transplant Recipients (WTC 2025) - "Outcomes were stratified by vaccine type received (adjuvanted RSVPreF3-AS01E [GSK, Arexvy] or non-adjuvanted RSVPreF-A/B [Pfizer, Abrysvo]).* Between August 2023-December 2024, 85 SOTRs reported RSV vaccination of whom 81 (95%) returned ≥1 safety survey and 68 (80%) returned reactogenicity surveys including 12/68 (18%) with vaccine coadministration... RSV vaccines are safe in SOTRs, without signals for immune-related or neurological events in long-term follow-up. Reactogenicity is generally mild and higher following adjuvanted vaccination."

Clinical • Cardiovascular • Immunology • Infectious Disease • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections • Solid Organ Transplantation • Transplant Rejection • Transplantation

Equivalent RSV Specific IgG and IgA Increases After Vaccination in Transplant Recipients (WTC 2025) - "The goal of this study was to define the antibody isotypes produced and F protein conformations targeted by SOTRs in response to RSV vaccination.* In a national prospective cohort of SOTRs reporting RSV vaccination with RSVPreF3 (GSK, AREXVY™) or RSVPreF (Pfizer, ABRYSVO™), we measured RSV preF and postF IgG and IgA binding by ELISA (area under the curve (AUC)) and neutralizing titers using a live virus neutralization assay at baseline and 4 weeks post vaccination.* 19 participants reported an RSV vaccine between October 2023 and July 2024 (Table)... The increase in IgG and IgA preF and postF binding suggests that much of the response to RSV vaccines in SOTRs is due to boosting of preexisting antibodies. The significant increase in IgA preF as compared to postF, and the strong correlation of both isotypes to serum neutralizing capacity, indicates that IgA may be an important part of the RSV vaccine response in SOTRs."

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

Complementary Strategy of Maternal Immunization with RSVpreF Vaccine and Monoclonal Antibodies for the Prevention of Respiratory Syncytial Virus Among Italian Infants: A Cost-Effectiveness Assessment. (PubMed, Infect Dis Ther) - "RSV is a leading cause of severe lower respiratory tract infections and is one of the primary causes of hospitalization in high income countries and death among children aged ≤ 1 year in lower income; bivalent Stabilized Prefusion F Subunit Vaccine (RSVpreFV) for maternal immunization proves to be effective in preventing RSV infections, avoiding severe disease. The modelling exercise shows that the complementary strategy of maternal vaccination with palivizumab or nirsevimab are both dominant (better health outcomes with lower costs) on monoclonal antibodies alone; the sensitivity analysis confirms that the complementary strategies in most of the simulation remain dominant or cost-effective adopting a low threshold for the willingness to pay; finally the complementary strategies are also sustainable, owing to a limited impact on the current national budget for vaccines."

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

More evidence needed for maternal RSVpreF protection to age 6 months - Authors' reply. (PubMed, Lancet Infect Dis) - No abstract available

Journal

Post-licensure safety of respiratory syncytial virus vaccines, Vaccine Adverse Event Reporting System, United States, May 2023-December 2024. (PubMed, Prev Med Rep) - "Preterm delivery and GBS following the administration of RSV vaccines require continuous monitoring. Additionally, inappropriate administration of Arexvy in pregnant individuals should be paid attention to."

Adverse events • Journal • Cardiovascular • Dermatology • Respiratory Diseases • Respiratory Syncytial Virus Infections

Cost-Effectiveness Analysis of a Bivalent RSVPreF Vaccine in Japanese Adults Aged 60 Years and Older. (PubMed, Infect Dis Ther) - "The RSVpreF vaccine is cost-effective compared to no vaccination for adults aged 60 years and older in Japan. It has the potential to provide significant public health benefits by reducing the burden of RSV-related diseases."

HEOR • Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Budget impact of maternal vaccination with RSVpreF to protect privately insured infants in Dubai against respiratory syncytial virus. (PubMed, Hum Vaccin Immunother) - "With vaccination costs estimated at $3.6 M, overall costs would increase by $3.1 M overall and $0.19 PMPY. Findings suggest that RSVpreF use among pregnant women would substantially reduce the clinical and economic burden of RSV-LRTI in infants, requiring an investment of just $0.19 PMPY by private health insurers."

HEOR • Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections