Abrysvo (PF-06928316) / Pfizer - LARVOL DELTA

EPIDEMIOLOGY OF ADMISSIONS DUE TO BRONCHIOLITIS IN ENGLAND 2013-2023 - A SOCIOECONOMIC ANALYSIS (ESPID 2025) - "Whilst many countries have chosen a postnatal vaccination strategy with Nirsevimab, in Autumn 2024 the UK introduced maternal vaccination against RSV using Abrysvo...Conclusions/Learning Points An effective RSV vaccine will reduce not only morbidity and mortality in children, but also costs for the health service. We will present 10 years worth of data encompassing every paediatric admission with RSV, highlighting changing patterns of admissions and treatments, along with a cost effectiveness analysis of the new RSV vaccine."

Clinical • HEOR • Omic analysis • Infectious Disease • Respiratory Syncytial Virus Infections

IMPACT OF A MIXED STRATEGY OF MONOCLONAL ANTIBODY AND MATERNAL IMMUNIZATION ON PEDIATRIC RSV HOSPITALIZATIONS IN LUXEMBOURG, 2022-2024 (ESPID 2025) - "Background After the successful rollout of nirsevimab immunization in 2023, Luxembourg was among the first countries to implement a mixed strategy offering free maternal vaccination or nirsevimab immunization starting in September 2024...We found no signal of increased hospitalizations in children immunized in the previous season 2023/24. Maternal vaccination and infant immunization had similar effectiveness in preventing RSV-hospitalizations."

Clinical • Respiratory Syncytial Virus Infections

RAPID SURVEILLANCE STUDY TO EVALUATE THE SAFETY OF RESPIRATORY SYNCYTIAL VIRUS VACCINE (ABRYSVO™) EXPOSURE DURING PREGNANCY IN THE UNITED STATES (ESPID 2025) - "Conclusions/Learning Points Further investigation is needed to explore a potential increased risk of PROM and HDP following ABRYSVO exposure. RCAs, while allowing for rapid safety monitoring, have limited confounding control and therefore cannot demonstrate causality."

Clinical • Influenza • Novel Coronavirus Disease • Respiratory Syncytial Virus Infections

Real-world effectiveness of RSVpreF vaccination during pregnancy against RSV-associated lower respiratory tract disease leading to hospitalisation in infants during the 2024 RSV season in Argentina (BERNI study): a multicentre, retrospective, test-negative, case-control study. (PubMed, Lancet Infect Dis) - "These real-world estimates for the 2024 RSV season in Argentina show high RSVpreF effectiveness against RSV-associated LRTD and severe LRTD leading to hospitalisation from birth to age 3 months and sustained to age 6 months."

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

Infant Respiratory Syncytial Virus Immunization Coverage in the Vaccine Safety Datalink: 2023-2024. (PubMed, Pediatrics) - "In this population of infants, 72% were immunized against RSV. Although overall coverage was high, disparities in immunization by race and ethnicity are a call to action."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Investigation of Maternal Outcomes Following Respiratory Syncytial Virus Vaccination in the Third Trimester: Insights from a Real-World U.S. Electronic Health Records Database. (PubMed, Am J Obstet Gynecol) - No abstract available

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

A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose (clinicaltrials.gov) - P3 | N=550 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

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

Editorial: Surveillance of Seasonal Respiratory Syncytial Virus (RSV) Infection in Children and Vulnerable Adults Drives Vaccine Development and New Immunization Programs. (PubMed, Med Sci Monit) - "There are currently three available RSV vaccines that include an AS01E-adjuvanted RSV prefusion F vaccine (Arexvy), a non-adjuvanted bivalent RSV prefusion F vaccine (Abrysvo), and an mRNA vaccine (MResvia)...The long-acting monoclonal antibody, nirsevimab (Beyfortus), targets the surface F protein of RSV and is effective in late preterm and term infants...Recent modeling and clinical studies have begun to address some of the concerns regarding the safety and efficacy of new RSV vaccines in children, pregnant women, and the elderly. This editorial aims to describe how global surveillance of increasing seasonal RSV respiratory tract infections has driven the development of new vaccines and immunization programs for infants, children, pregnant women, and vulnerable adults."

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

Nirsevimab and Maternal Respiratory Syncytial Virus Vaccine Recommendations for the Pediatric Population. (PubMed, Pediatr Ann) - "[Pediatr Ann. 2025;54(5):e160-e166.]."

Journal • Review • Infectious Disease • Oncology • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections • Solid Tumor

Cost-Effectiveness Analysis of Bivalent Respiratory Syncytial Virus Prefusion F Vaccine for Adults 60 Years of Age and Older in Japan (ISPOR 2025) - "As of December 2024, RSV vaccines are not included in the routine national immunization program... RSVpreF vaccination was a cost-effective strategy for the prevention of RSV disease in Japanese adults 60 years of age and older. The introduction of RSV vaccination has the potential to improve public health by reducing RSV cases and saving lives in Japan."

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

Cost-Effectiveness of Strategies for Prevention of Respiratory Syncytial Virus (RSV) Infections Among Infants in Canada (ISPOR 2025) - "Findings suggest that both strategies evaluated would yield similar clinical benefits; however, seasonal RSVpreF with complementary nirsevimab should be adopted by provincial decision-makers seeking a budget-conscious strategy for RSV prevention."

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

Cost-effectiveness analysis of prevention strategies for pediatric respiratory syncytial virus infection in Japan (ISPOR 2025) - "The standard of care (SoC), a monoclonal antibody (mAb), palivizumab, was licensed for the prevention of RSV infection for infants with risk and premature infants born ≤35 weeks gestational age (wGA)... A year-round RSVpreF vaccine with nirsevimab could be one of the most optimal prophylaxis strategies for pediatric RSV infection in Japan."

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

Immunogenicity and Safety of the Bivalent Respiratory Syncytial Virus Prefusion F Subunit Vaccine in Immunocompromised or Renally Impaired Adults. (PubMed, Vaccines (Basel)) - P3 | " A single dose of the RSVpreF vaccine conferred robust immune responses in immunocompromised and renally impaired adults with no safety concerns. (ClinicalTrials.gov Identifier: NCT05842967)."

Journal • Fatigue • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

Summary of the National Advisory Committee on Immunization (NACI) Statement on the Prevention of Respiratory Syncytial Virus (RSV) in Infants. (PubMed, Can Commun Dis Rep) - "Immunization programs for the prevention of respiratory syncytial virus (RSV) in infants have been available in Canada since the authorization of palivizumab in 2002...Currently, nirsevimab is preferred over RSVpreF. Program introduction could occur in stages depending on access to supply, cost effectiveness, and affordability of available options."

Journal • Critical care • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Learn About ABRYSVO Vaccine in Older Adults to Prevent Severe Respiratory Syncytial Virus (RSV) Disease (clinicaltrials.gov) - P=N/A | N=1 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: May 2025 ➔ May 2029

Trial completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Design of a peptide-based vaccine against human respiratory syncytial virus using a reverse vaccinology approach: evaluation of immunogenicity, antigenicity, allergenicity, and toxicity. (PubMed, Front Immunol) - "Attempts to develop an hRSV vaccine have faced safety and efficacy challenges, with only three FDA-approved vaccines (Moderna's Mresvia, Pfizer's Abrysvo, and GSK's Arexvy) available...We then characterized its kinetic properties, evaluated its structural integrity, and analyzed its interactions with Toll-like receptors (TLRs) using molecular docking, modeling, and refinement with AlphaFold3 and ClusPro...This study presents a promising peptide-based vaccine candidate against hRSV that can effectively engage the immune system, showing strong immunogenicity and antigenicity. Future in vitro and in vivo studies are essential to evaluate the ability of the multi-epitope vaccine candidate to stimulate both humoral and cell-mediated immune responses and to assess its efficacy and safety profile."

Journal • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • IFNG • IL2 • TLR1 • TLR4

PISSARRO: A Study to Evaluate the Safety and Immunogenicity of RSVpreF Coadministered With Herpes Zoster Vaccine in Adults (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Herpes Zoster • Respiratory Diseases • Respiratory Syncytial Virus Infections • Varicella Zoster

New developments in the prevention and management of RSV in 2025 (PubMed, Rev Med Suisse) - "Prevention has advanced with the introduction of vaccines such as Arexvy and Abrysvo, as well as nirsevimab for infants. These innovations are expected to significantly reduce the burden of RSV in the coming years."

Journal • Infectious Disease • Pediatrics • Pneumonia • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Immunogenicity of RSV Vaccination in Thoracic-Organ Transplantation (ISHLT 2025) - "This study evaluated the immunogenicity of two RSV vaccines, Arexvy and Abrysvo, in this population.Methods This was a prospective, single-center study among transplant recipients and healthy controls eligible for the RSV vaccine...Univariate analyses found age and mycophenolate mofetil negatively associated with increased Ab titers (p<0.05), while vaccine, organ type and time from transplant were not...Most thoracic transplant recipients mounted a robust response to the RSV vaccine that was durable over a 3-month period. Presuming that the humoral and cellular responses measured relate to protection, its duration may inform the need for additional vaccine doses in this population."

Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation • CD4 • CD8

IS37 - The RSV landscape in adults: disease burden, public health impact, and the latest clinical and real-world data on vaccination with RSVpreF (ESCMID Global 2025) - "Organised by Pfizer Aim of the session: - Provide an overview of the global burden of RSV disease - both RSV A and B subtypes - inclusive of circulation and seasonality - Explore the public health perspective, including implications of?long-term effects and sequelae, as well as provide an overview of the current global RSV vaccination recommendations - Demonstrate the clinical impact and risk of complications on both older adults and 18 - 59-year-olds with increased risk of RSV - inclusive of hospitalization, mortality and under - recognition - Provide an overview of?the RSVpreF vaccine bivalent design, clinical differentiation and latest clinical data for RSCpreF - Showcase RSVpreF vaccine implementation through the latest ongoing real-world evidence REFERENCES: Abrysvo (RSVpreF vaccine) Summary of Product Characteristics. https://www.ema.europa.eu/en/documents/product-information/abrysvo-epar-product-information_en.pdf."

Clinical • Real-world • Real-world evidence • Respiratory Syncytial Virus Infections

IS21 - Reducing the global burden of RSV in infants via maternal immunisation (ESCMID Global 2025) - "Organised by Pfizer Aim of the session: - Describe the high global burden of RSV disease in young infants, highlighting the importance of prevention in this population - Discuss the rationale and mechanism of maternal immunization and how it can help protect from RSV disease in the infant population during the window of highest vulnerability - Provide an overview of the latest RSVpreF vaccine clinical trial data, and examine real-world evidence - Share key learnings on the implementation of RSVpreF maternal immunization programs, including a review of current global licensures and recommendations References: Abrysvo (RSVpreF vaccine) Summary of Product Characteristics. https://www.ema.europa.eu/en/documents/product-information/abrysvo-epar-product-information_en.pdf."

Clinical • 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=500 | Not yet recruiting | Sponsor: Pfizer

New P3 trial • Herpes Zoster • Respiratory Diseases • Respiratory Syncytial Virus Infections • Varicella Zoster

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

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

A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose (clinicaltrials.gov) - P3 | N=550 | Not yet recruiting | Sponsor: Pfizer

New P3 trial • 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 | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Jul 2025 | Trial primary completion date: Dec 2025 ➔ Jul 2025

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