Synagis (palivizumab) / AbbVie, AstraZeneca, SOBI - LARVOL DELTA

Polybodies for the treatment of respiratory syncytial virus infection. (PubMed, Drug Discov Today) - "Although current prophylactics, such as palivizumab, nirsevimab, and clesrovimab, which target the RSV F protein, have enhanced early protection, more effective options with broader impact and longer-lasting efficacy are needed. In response to ongoing research efforts to develop new treatments for RSV, nanobodies have emerged as a promising option. Therefore, in this review, we discuss available therapies and explore the potential of nanobodies in treating RSV, with particular emphasis on the importance of polybodies [polyspecific and polyvalent antibodies (PsAbs and PvAbs)] in managing RSV infections."

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

Prophylactic monoclonal antibodies against respiratory syncytial virus in early life: An in-depth review of mechanisms of action, failure factors, and future perspectives. (PubMed, Pediatr Allergy Immunol) - "For over two decades, palivizumab was the only monoclonal antibody (mAb) available for prophylaxis, restricted to high-risk groups due to cost and limited duration of protection. Recent advances in structural virology and antibody engineering have led to the emergence of long-acting mAbs, notably nirsevimab and clesrovimab, which offer single-dose seasonal protection and are now shifting RSV prevention strategies from high-risk targeting to universal infant immunization...This review explores the molecular and immunological underpinnings of RSV-targeted mAbs, evaluates current real-world evidence, and outlines future directions-including bispecific antibodies and nanobody-based therapies-that could further transform RSV prophylaxis. Sustained genomic surveillance and a deeper understanding of host immunity will be crucial to preserve the long-term efficacy of these innovations in pediatric infectious disease prevention."

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

Clesrovimab for the Prevention of Respiratory Syncytial Virus Lower Respiratory Tract Disease in Infants. (PubMed, J Pharm Technol) - " Clesrovimab offers simplified dosing, favorable safety, and potential cost savings compared with palivizumab and nirsevimab. Clesrovimab is a promising addition to RSV prevention strategies, offering effective, safe, and accessible immunization for infants. Ongoing research will clarify its role in high-risk populations and broader clinical use."

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

Comparison of the public health impact of RSV disease prevention options for infants: a static decision model of the us birth cohort. (PubMed, Expert Rev Vaccines) - "We compared the impact of these interventions on RSV-LRTD events and costs versus the previous standard-of-practice (SoP; palivizumab-only strategy). RSVpreF maternal vaccination would avert 76,915 RSV-LRTDs including 9,649 hospitalizations, equating to $345 million in total cost savings. While all three interventions are estimated to reduce RSV-LRTD burden in infants, all-infant protection with nirsevimab was estimated to avert more events and associated medical costs for all infant subgroups compared to clesrovimab or RSVpreF."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Synagis: Study of Palivizumab in Children With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease (clinicaltrials.gov) - P=N/A | N=138 | Not yet recruiting | Sponsor: AstraZeneca | Trial completion date: Jun 2026 ➔ Feb 2027 | Initiation date: Aug 2025 ➔ Nov 2025 | Trial primary completion date: Jun 2026 ➔ Feb 2027

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

Virus-like Particle Vaccines Containing RSV Fusion Protein Cleavage Mutations Are Immunogenic and Protective in Cotton Rats With a Prime Dose. (PubMed, Immune Netw) - "Palivizumab-binding antigenic site II epitope was preferentially exposed by combination mutations in the furin cleavage sites and F peptide together with a change in the TM domain...The VLP also induced the highest level of INF-γ, indicating the Th1-skewed immune response against the virus infection. A single dose of RSV F mutant exposing an antigenic site II on VLP vaccine could induce RSV-neutralizing Abs, conferring protection without causing vaccine-enhanced disease in cotton rats."

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

Epidemiology of moderate-to-severe respiratory syncytial virus infections in children in subtropical Okinawa, Japan: a 4-year retrospective study. (PubMed, Trop Med Health) - "This study provides a comprehensive region-wide assessment of moderate-to-severe pediatric RSV infections in a subtropical setting in Japan. Despite not including data on the use of palivizumab, nirsevimab, or maternal vaccination, the findings provide essential baseline data to guide the implementation of new preventive strategies tailored to local epidemiology."

Clinical • Journal • Retrospective data • Infectious Disease • Novel Coronavirus Disease • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

Cost-effectiveness of infant and maternal RSV immunization strategies, in British Columbia, Canada. (PubMed, Vaccine) - "These findings support policy recommendations to prioritize nirsevimab for high- and moderate-risk infants as the most cost-effective strategy. Maternal RSVpreF vaccination offers added health benefits and is cost-effective compared with the historical standard of care, though not when considered incrementally."

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

Immune Checkpoint Inhibitors Reverse the Mesenchymal Stromal Cell-Mediated Immunosuppression in Acute Myeloid Leukemia Microenvironment (ASH 2024) - "With the established 3D model, the effect of CPI (bispecific anti-PD-1 x anti-LAG-3 DART®molecule, MGD013/tebotelimab; anti-LAG-3 IgG4 antibody; and anti-PD-1 IgG4 antibody, nivolumab) on AML killing and T-cell activity were assessed and compared to a palivizumab-based IgG4 antibody as a control. Conclusion : MSCs play a major role in influencing CD8+ T cell-mediated killing of AML cells through the suppression of CD8+ T cell activity, potentially involving the LAG-3 immune checkpoint mechanism. LAG-3 immune checkpoint inhibitor showed effective response in reversing T-cell suppression within the AML microenvironment and warrants further investigation as an immunotherapeutic in AML."

Checkpoint inhibition • IO biomarker • Stroma • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD33 • CD34 • CD73 • CD8 • ENG • HAVCR2 • HLA-C • IFNG • PD-L1 • PTPRC • THY1 • TNFA

Impact of Nirsevimab on the Health Burden and Costs of Respiratory Syncytial Virus (RSV) in the Infant Population From the Healthcare System in Argentina (ISPOR-EU 2025) - "Maternal RSV vaccination was recently added to Argentina's national immunization schedule to protect all infants, complementing palivizumab use in high-risk groups, such as those born very preterm or with underlying conditions. Implementing Nirsevimab in Argentina could substantially reduce the health burden associated with RSV from the healthcare system."

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

Projected Public Health Benefits of Nirsevimab for RSV Prevention in Infants in Greece (ISPOR-EU 2025) - "This study evaluates the public health impact of introducing nirsevimab into the Greek national immunization program for RSV prevention in all infants, compared to the current standard of care (SoC), palivizumab in high-risk infants. A static population-level model was developed to estimate the reduction in RSV-related outcomes in the Greek birth cohort (71,249 for year 2024) during their first RSV season. Immunization with nirsevimab in Greece could offer a new effective strategy to reduce RSV-related morbidity and healthcare demand, while maintaining healthcare system sustainability. Nirsevimab uptake would not only address a critical unmet medical need but also help relieve pressure on Greece's already stretched healthcare system and strengthen its capacity for future challenges."

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

Modeling the Public Health Impact of Nirsevimab and Maternal Vaccination With RSVpreF Against Infant Respiratory Syncytial Virus Infection in Germany (ISPOR-EU 2025) - "Both interventions were compared against the pre-2024 standard of care (SoC) in Germany: (3) palivizumab for high-risk infants (<29 weeks of gestational age (wGA), bronchopulmonary dysplasia, or hemodynamically significant congenital heart disease) and no prophylaxis for otherwise healthy infants born preterm (≥29 wGA) and at term. Our study suggests a higher public health impact for an all-infants immunization strategy with nirsevimab than for year-round maternal vaccination with RSVpreF when compared with the previous SoC in Germany."

Bronchopulmonary Dysplasia • Cardiovascular • Heart Failure • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Budget Impact Analysis of Introducing Nirsevimab Into the National Immunization Program for Infants in Korea (ISPOR-EU 2025) - "The current strategy of palivizumab for high-risk children <24 months was compared to nirsevimab for all infants <12 months and high-risk children <24 months. If nirsevimab is introduced into the NIP in Korea, it could substantially reduce RSV-related medical costs. In addition to improving infant health outcomes, it would also lessen productivity losses for caregivers and reduce the burden on postpartum care centers, thereby contributing to a meaningful reduction in the broader societal impact of RSV infections."

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

Assessing Public Health and Economic Benefits of Nirsevimab or RSVpreF for Preventing RSV-Related Outcomes in Japanese Infants (ISPOR-EU 2025) - "While current standard of practice (SoP) provides monthly palivizumab only to high-risk infants during RSV season, this study evaluates the public health and economic impact of two immunoprophylaxis strategies: universal prophylaxis with nirsevimab and maternal immunisation (MI) with RSVpreF, compared to SoP. A static decision-analytic model tracked the Japanese birth cohort during their first RSV season and the second season for some high-risk infants. Universal immunisation with nirsevimab could substantially reduce both the health and economic burden of RSV in Japan. Nirsevimab's sustained efficacy throughout the RSV season, its ability to protect infants regardless of gestational age, and its flexible administration allowing optimal timing of protection contribute to its superior performance compared to MI, offering comprehensive protection across the entire infant population."

HEOR • Respiratory Diseases • Respiratory Syncytial Virus Infections

Assessment of the Cost Utility of Palivizumab for Preventing Severe Respiratory Syncytial Virus (RSV) Infection in Preterm Infants Born 29-35 Weeks' Gestational Age in the Philippines (ISPOR-EU 2025) - "Palivizumab was found to be cost-effective (vs no prophylaxis) for use in Filipino 29-35wGA infants. The IRST should be considered to target prophylaxis in 32-35wGA infants."

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

Long-term impact of nirsevimab on prevention of respiratory syncytial virus infection using a real-word global database. (PubMed, J Infect) - "This study indicated that the preventive effect of nirsevimab against RSV infection was maintained for up to 12 months following administration, whereas a preventive effect beyond 12 months was not observed. The results of this study need to be interpreted with caution owing to some important limitations."

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

Updated Swedish guidelines for the management and treatment of RSV infection. (PubMed, Infect Dis (Lond)) - "The long-acting drug nirsevimab is preferred over the shorter-acting palivizumab; (v) Universal prophylaxis in infants reduce disease burden for both families and society; (vi) If supply is limited, children at highest risk should be prioritised for prophylaxis; (vii) Maternal vaccination during pregnancy lowers the risk of severe RSV in newborns, decreasing hospital admissions. Recommendations and funding decision for maternal vaccination is under investigation during the autumn of 2025; (viii) In the elderly, vaccination is the most effective pharmacological prevention; (ix) There is no effective antiviral treatment for established RSV disease; management is symptomatic and supportive. Hospitalised children should not be subjected to measures with no proven effect, preferable minimal interventions, with treatment focused on ensuring adequate nutrition; (x) The Swedish recommendations state that during the RSV season 2025/2026, nirsevimab should be administered to..."

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

Establishment of Respiratory Syncytial Virus Microneutralization Assay in Ghana, a Lower-Middle-Income Country (ASTMH 2025) - "Fifty-one whole blood samples from the healthy donor service, are left blank or spiked with 10 or 100 µg/ml palivizumab or RSM01, mAbs against two RSV epitopes. Four researchers in Ghana have been trained on the assay. With the successful implementation of the RSV neutralization assay in dried blood in Ghana, a good foundation has been set for clinical trials and accessible correlate of protection surveillance in children in LMICs."

Respiratory Diseases • Respiratory Syncytial Virus Infections

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

Epidemiological characterization and seasonality of respiratory syncytial virus in the United Arab Emirates: A five-year study at a tertiary care hospital, 2018-2022. (PubMed, J Infect Public Health) - "The study underscores the impact of COVID-19 on RSV seasonality in the UAE and highlights the need for sustained surveillance to optimize RSV prevention strategies."

Journal • Infectious Disease • Novel Coronavirus Disease • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

Subgroup limitations and imaging variability in palivizumab studies: implications for public health assessment. (PubMed, Eur J Pediatr) - No abstract available

Journal

Respiratory syncytial virus. What's new in prevention? (PubMed, Semin Fetal Neonatal Med) - "Prevention of RSV lower respiratory tract infections (LRTI) in infants has been limited to general measures and palivizumab, a monoclonal antibody indicated for the highest risk groups...Likewise, novel extended half-life monoclonal antibodies, nirsevimab and the recently approved clesrovimab, opened the possibility of large-scale protection targeted to all infants born during the winter season and those <6 months at the beginning of it. Several RCTs and results from populations adopting nirsevimab prophylaxis demonstrated a large decrease in the incidence of RSV-LRTIs and a great impact in infant public health. Deployment of either strategies or in combination as part of immunization programs can be complement each other even as newer immunologic agents are being introduced."

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

Multicentre study on nirsevimab: Bayesian analysis reveals persisting risk for preterm infants. (PubMed, BMJ Paediatr Open) - "Nirsevimab prophylaxis was associated with reduced hospitalisation and severity. However, protection waned in preterm infants, highlighting the need to investigate modified dosing strategies for this high-risk population."

Journal • Retrospective data • Critical care • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

S5224: Our Littlest Grads: Follow-Up of NICU Preemies (AAP-NCE 2025) - "This session will cover topics critical to the follow-up of premature infants, including nutritional and feeding needs, increased risks of respiratory disease, developmental outcomes, eligibility for early intervention services, and use of palivizumab."

CNS Disorders • Respiratory Diseases

Genetic variability of respiratory syncytial virus and its impact on monoclonal antibody binding sites: a national cross-sectional study during the 2023-2024 season. (PubMed, Int Immunopharmacol) - "This study provides a critical genomic snapshot of RSV in Italy prior to the introduction of vaccines and mAbs. Continuous surveillance is essential for monitoring viral evolution and supporting the long-term effectiveness of future immunization strategies."

Clinical • Journal • Observational data • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections