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

Palivizumab in Donor Derived RSV Infection in an Adult Bilateral Lung Transplant Recipient (ISHLT 2026) - "Abstract is embargoed at this time."

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

Identifying High-Cost RSV Hospitalizations at a Secondary Hospital in Japan. (PubMed, Keio J Med) - "Eighteen admissions were identified as cost outliers and classified into three subgroups: (1) children with airway or neurologic disorders, often older than 24 months; (2) otherwise healthy infants under 12 months; and (3) children eligible for palivizumab who contracted RSV before or after the recommended prophylaxis period. Our findings emphasize the existence of high-cost RSV cases outside the currently recognized high-risk groups, including older children with chronic airway disease and healthy young infants. Clinical burden and healthcare costs may be reduced by refining prophylaxis strategies and early intervention in Japan."

Journal • CNS Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Talk 4 - Pediatric Considerations (ISHLT 2026) - "Pediatric RSV treatments (Palivizumab) 4. Tailoring immunosuppression: is monotherapy achievable?"

Clinical • Pediatrics • Respiratory Syncytial Virus Infections

Clinical and economic evaluation of risk factor guided respiratory syncytial virus prophylaxis in Colombian preterm infants. (PubMed, Cost Eff Resour Alloc) - "Palivizumab prophylaxis of 32-35 wGA infants at moderate- and high-risk of RSVH, identified using the Colombian-adapted IRST, proved to be cost-effective versus no intervention."

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

Recent developments in pediatric respiratory syncytial virus prevention: The expanding role of monoclonal antibodies. (PubMed, Am J Health Syst Pharm) - "The utility of RSV monoclonal antibodies continues to evolve, with these antibodies offering promising targeted, durable protection against a virus that remains a major cause of morbidity in infants and young children. Ongoing surveillance, real-world evidence, and continued innovation will further refine the role of these agents in clinical practice. Pharmacists play a pivotal role in evaluating appropriate candidates for therapy, navigating payor and formulary requirements, and educating caregivers and healthcare teams on administration, storage, and monitoring."

Journal • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

Sequence variability of Hungarian RSV G and F proteins between 2017 and 2023: single-center study. (PubMed, Int J Med Microbiol) - "At the same time, neither K272E/N nor any other mutation is present in the palivizumab binding region in our strains. Several mutations in the nirsevimab binding region could be detected in our strains; however, none of these mutations, which would affect nirsevimab activity, were found in our isolates."

Journal • Infectious Disease • Novel Coronavirus Disease • Pediatrics • Respiratory Diseases

Hospitalization Outcomes of Full-Term and Premature Children Aged Less Than 2 Years Hospitalized With RSV. (PubMed, Pediatrics) - "Premature children accounted for 1 in 5 hospitalizations among children aged less than 2 years hospitalized with RSV. Compared with term children, all premature children had increased risk for severe in-hospital outcomes in early infancy, and those with BPD remained at increased risk of prolonged hospitalization through age 23 months."

Journal • Bronchopulmonary Dysplasia • Critical care • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Reliability of RSV Antigen Diagnostic Tests in the Presence of Nirsevimab. (PubMed, Pediatr Infect Dis J) - "Nirsevimab did not interfere with RSV detection with any of the antigen tests evaluated, suggesting patients who receive nirsevimab are unlikely to require alternative assays for clinical RSV diagnosis."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Molecular Surveillance Reveals F-Gene Mutations and Constrained G-Gene Evolution in Human Respiratory Syncytial Virus: Implications for Vaccine Efficacy in Saudi Arabia. (PubMed, Vaccines (Basel)) - "Given the highly effective HRSV prophylactics, including the approved vaccines and monoclonal antibodies, these mutations raise critical concerns regarding vaccine efficacy against HRSV-B. These findings underscore the necessity of sustained, seasonal molecular surveillance to monitor the emergence of variants and provide a molecular basis for further clinical studies."

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

The Evolving Landscape of Respiratory Syncytial Virus (RSV) Prophylaxis in Infants. (PubMed, Cureus) - "Research turned toward developing the monoclonal antibody palivizumab, which provided the first practical means of protecting high-risk infants against RSV infection. Subsequent advances in monoclonal antibodies, especially nirsevimab, and the advent of the maternal vaccination program with the Bivalent Prefusion F Vaccination have expanded disease prevention to the population level instead of targeting high-risk infants. These advances promise to reduce hospitalizations and severe disease, improving overall community health. Future priorities include ensuring equitable access, maintaining long-term safety surveillance, and integrating RSV prevention into national immunization programs worldwide."

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

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