Abrysvo (PF-06928316) / Pfizer - LARVOL DELTA

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

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

The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products (clinicaltrials.gov) - P4 | N=181 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Active, not recruiting | N=400 ➔ 181

Enrollment change • Enrollment closed • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

PIPELINE-RSV: Pregnancy and Infant PrEparedness pLatform IN Europe, RSV-International Adaptive Platform Trial to Evaluate Two Approved Prevention Options to Prevent Respiratory Syncytial Virus in Infants: Maternal Vaccine to Women in Pregnancy and Monoclonal Antibody to the Infants, Given Alone or in Combination. (clinicaltrials.gov) - P3 | N=1500 | Not yet recruiting | Sponsor: PENTA Foundation

New P3 trial • Respiratory Diseases • Respiratory Syncytial Virus Infections

Vaccine Development for Human Pneumoviruses. (PubMed, Vaccines (Basel)) - "While significant progress has been made in RSV vaccine development, especially with three approved candidates, the development of vaccines for HMPV remains an unmet medical need. Ongoing research in combination vaccines holds promise for broader protection against multiple respiratory viruses in the future."

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

SPECIAL INVESTIGATION FOR ABRYSVO IN INDIVIDUALS AGED 60 YEARS OR OLDER (clinicaltrials.gov) - P=N/A | N=1100 | Active, not recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Active, not recruiting | Initiation date: Sep 2025 ➔ May 2025

Enrollment closed • Trial initiation date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Cost-effectiveness of immunization strategies to protect infants against respiratory syncytial virus in the Netherlands. (PubMed, Hum Vaccin Immunother) - "RSVpreF with complementary nirsevimab for infants prevented 4,723 cases, yielding 108 QALYs; total costs increased by € 35.5M and cost-effectiveness was € 329,187/QALY (vs. no intervention). Maternal RSVpreF with complementary nirsevimab was more cost-effective than nirsevimab alone."

HEOR • Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Respiratory syncytial virus (RSV) infections in adults: Current trends and recommendations for prevention - a global challenge from a local perspective. (PubMed, Hum Vaccin Immunother) - "Recently, three vaccines (RSVPreF3, RSVpreF, and mRNA-1345) have been approved for adults to date. In this article, we aimed to review the characteristics of RSV infections in adults and the evidence on the safety and efficacy of RSV vaccines, with a glimpse of the current situation in Türkiye- one of the low- and middle- income countries (LMICs)."

Journal • Review • Infectious Disease • Influenza • Preventive care • Respiratory Diseases • Respiratory Syncytial Virus Infections

Respiratory Syncytial Virus Prevention in the Adult Population: State of the Art. (PubMed, Semin Respir Crit Care Med) - "This evidence led to recent approval of two subunit vaccines (Arexvy and Abrysvo) and one nucleic acid-based vaccine (mResvia) by regulatory authorities...The coadministration of approved RSV vaccines with seasonal influenza vaccines has been proven to be non-inferior to the immune response from sequential administration. Other vaccines coadministered against different pathogens are currently under investigation."

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

DAN-RSV: Vaccine Effectiveness of a Bivalent RSV Prefusion F Protein-Based Vaccine for Preventing RSV Hospitalizations in Older Adults (clinicaltrials.gov) - P4 | N=130000 | Active, not recruiting | Sponsor: Tor Biering-Sørensen | Recruiting ➔ Active, not recruiting

Enrollment closed • 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 primary completion date: May 2025 ➔ May 2029

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

SPECIAL INVESTIGATION FOR ABRYSVO IN INDIVIDUALS AGED 60 YEARS OR OLDER (clinicaltrials.gov) - P=N/A | N=1100 | Not yet recruiting | Sponsor: Pfizer | Trial completion date: Sep 2028 ➔ Feb 2029 | Initiation date: Apr 2025 ➔ Sep 2025 | Trial primary completion date: Sep 2028 ➔ Feb 2029

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

Respiratory syncytial virus preventives for children in Australia: current landscape and future directions. (PubMed, Med J Aust) - "Previously, palivizumab, a costly, short-acting monoclonal antibody, was the primary preventive option. The recent introductions of nirsevimab (Beyfortus), a long-acting monoclonal antibody, and Abrysvo, a maternal RSV vaccine, have brought about significant advances in RSV prevention for children...Key logistical considerations include ensuring timely access and equitable distribution, particularly for First Nations populations who face increased risk from RSV infection. Coordinated efforts are essential to overcome health care disparities and deliver effective prevention strategies to these prioritised groups."

Journal • Review • Asthma • Immunology • Infectious Disease • Pediatrics • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

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

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

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 bivalent respiratory syncytial virus Prefusion F (RSVpreF) maternal vaccine among infants in the United States. (PubMed, Vaccine) - "Maternal vaccination with RSVpreF would substantially reduce the clinical and economic burden of RSV in infants, resulting in a cost-effectiveness ratio of $89,733 per QALY if administered year-round or cost savings if administered seasonally."

HEOR • Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Potential public health and economic impact of maternal vaccination with bivalent respiratory syncytial virus prefusion F (RSVpreF) vaccine for the prevention of acute respiratory infection among infants in the United States. (PubMed, Expert Rev Vaccines) - "With 54.9% uptake, RSVpreF would prevent 89,908 cases (hospital: 10308; ED: 20538; OC: 59062), corresponding with a $368 million decrease (direct: $286 M; indirect: $81 M) in total 1-year costs. Even with limited uptake and without considering benefits to pregnant persons or reductions in RSV-related sequelae, maternal vaccination with RSVpreF would substantially reduce the public health and economic burden of RSV-ARI in US infants."

HEOR • Journal • Infectious Disease • 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=525 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

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

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