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

Respiratory Syncytial Virus Infection Triggering a Pulmonary Hypertensive Crisis in a Boy With Prader-Willi Syndrome-Associated Sleep-Disordered Breathing. (PubMed, Cureus) - "Early screening and ongoing surveillance for sleep-disordered breathing, cardiopulmonary complications, and careful management during intercurrent infections are essential. RSV immunoprophylaxis, such as palivizumab, may warrant individualized consideration in high-risk young children with PWS who have impaired airway clearance or considerable respiratory comorbidity."

Journal • Cardiovascular • CNS Disorders • Genetic Disorders • Hematological Disorders • Hypertension • Infectious Disease • Metabolic Disorders • Obstructive Sleep Apnea • Pediatrics • Prader–Willi syndrome • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Sleep Disorder

Nirsevimab vs Palivizumab: 3‑Season Analysis of Hospital Admission Rates and LOS for High‑Risk Infants < 20 months in a Federally Qualified Health Center NICU Follow‑Up Clinic (PAS 2026) - No abstract available

Clinical • Infectious Disease

Comparative Analysis of Reported Adverse Events with Nirsevimab and Palivizumab in the FAERS Database (PAS 2026) - No abstract available

Adverse events • Cardiovascular

Synagis: Study of Palivizumab in Children With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease (clinicaltrials.gov) - P=N/A | N=138 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Respiratory Diseases • Respiratory Syncytial Virus Infections

A New Paradigm for RSV Treatment: EV148 Leverages Pre-Existing Immunity to Achieve Strain-Independent Antiviral Efficacy in Neonatal Lambs (RSVVW 2026) - "Monoclonal antibodies such as palivizumab and nirsevimab provide prophylaxis for high-risk populations but demonstrate limited therapeutic efficacy in hospitalized patients with established infection...In therapeutic BALB/c mouse models, single-dose subcutaneous treatment 72 hours post-infection reduced nasal viral titers by >4.0 log₁₀ and viral RNA by >3.0 log₁₀—outperforming ribavirin, Presatovir, and investigational fusion inhibitors...Most critically, in blinded neonatal lamb studies—a translationally relevant large animal model that recapitulates human infant lower respiratory tract disease—single-dose EV148 administered 24 hours post-infection reduced gross lung lesions by 75%, significantly decreased viral titers in both lung tissue and bronchoalveolar lavage fluid with dose-dependent reductions in viral RNA, and prevented clinical disease progression including abnormal lung sounds and elevated resting respiratory rates. These data establish EV148 as a..."

Clinical • IO biomarker • Infectious Disease • Inflammation • Influenza • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections • IFNG • IL1B • IL6 • TNFA

A New Paradigm for RSV Treatment: EV148 Leverages Pre-Existing Immunity to Achieve Strain-Independent Antiviral Efficacy in Neonatal Lambs. (RSVVW 2026) - "Monoclonal antibodies such as palivizumab and nirsevimab provide prophylaxis for high-risk populations but demonstrate limited therapeutic efficacy in hospitalized patients with established infection...In therapeutic BALB/c mouse models, single-dose subcutaneous treatment 72 hours post-infection reduced nasal viral titers by >4.0 log₁₀ and viral RNA by >3.0 log₁₀—outperforming ribavirin, Presatovir, and investigational fusion inhibitors...Most critically, in blinded neonatal lamb studies—a translationally relevant large animal model that recapitulates human infant lower respiratory tract disease—single-dose EV148 administered 24 hours post-infection reduced gross lung lesions by 75%, significantly decreased viral titers in both lung tissue and bronchoalveolar lavage fluid with dose-dependent reductions in viral RNA, and prevented clinical disease progression including abnormal lung sounds and elevated resting respiratory rates. These data establish EV148 as a..."

Clinical • IO biomarker • Infectious Disease • Inflammation • Influenza • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections • IFNG • IL1B • IL6 • TNFA

Bivalent RSV prefusion F vaccination elicits effective neutralization of contemporary and monoclonal antibody-resistant RSV strains. (PubMed, NPJ Vaccines) - "Monoclonal Ab-resistant mutant strains (MARMs) displaying in vitro resistance to nirsevimab, clesrovimab, and palivizumab (up to 300,000-fold resistance over the parental strain) were also evaluated. RSVpreF immune sera effectively neutralized both the panel of global clinical isolates and all MARMs tested. These findings demonstrate that the bivalent RSVpreF polyclonal response maintains robust neutralizing activity against circulating RSV A and B strains, including those that escape RSV F mAbs, and provides broad protective immunity against RSV."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Palivizumab in Donor Derived RSV Infection in an Adult Bilateral Lung Transplant Recipient (ISHLT 2026) - "Usual therapeutic approaches include IVIG, ribavirin and corticosteroids with limited evidence...She received induction with basilixumab, tacrolimus, mycophenolate mofetil and methylprednisolone...The patient left ICU on day 77 and was discharged on day 87. Graft function continues to increment, with reassuring biopsies and favourable patient progress.Summary This case demonstrates safe and efficacious use of single dose palivizumab to augment conventional therapy in early and life-threatening RSV infection in the profoundly immunocompromised lung transplant recipient."

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

Clesrovimab approval for RSV: a lifesaving opportunity for global infant health equity. (PubMed, Ann Med Surg (Lond)) - "The approval marks a significant advancement for infant RSV prevention in high-income settings, but to effectively reduce the global burden, particularly in resource-limited environments, equitable access and affordability must be prioritized. This intervention offers a vital opportunity to decrease RSV-related morbidity and mortality among vulnerable infants worldwide."

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

COMPARATIVE POST-MARKETING SAFETY STUDY OF NIRSEVIMAB AND PALIVIZUMAB: A PHARMACOVIGILANCE ANALYSIS USING FAERS AND WHO VIGIACCESS (ISPOR 2026) - "This post-marketing analysis suggests a comparable safety profile for both drugs. While very few adverse events were aligned with FDA labeling based on clinical trial data, additional safety signals were identified, necessitating an ongoing pharmacovigilance study to inform clinical and regulatory decision-making."

Adverse events • Clinical • P4 data • Hematological Disorders • Infectious Disease • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Thrombocytopenia

Respiratory syncytial virus (RSV) antibody and small-molecule drugs: current status of clinical translation and challenges. (PubMed, Front Microbiol) - "We analyze the evolution of immunoprophylaxis from palivizumab to next-generation long-acting antibodies like nirsevimab, which have reshaped prevention strategies. Furthermore, we evaluate small-molecule agents, contrasting the limitations of early fusion inhibitors with the improved efficacy and resistance barriers of emerging polymerase inhibitors such as ziresovir...Moving forward, the field must prioritize multi-target combination therapies to mitigate resistance and establish global surveillance networks. Ultimately, international collaboration is essential to ensure equitable access, sustainable pricing, and the successful implementation of next-generation RSV therapeutics."

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

ECONOMIC EVALUATION OF PALIVIZUMAB FOR RESPIRATORY SYNCYTIAL VIRUS PROPHYLAXIS IN PRETERM INFANTS IN ECUADOR (ISPOR 2026) - "Palivizumab is a dominant and cost-saving strategy for preventing severe RSV disease in preterm infants in Ecuador. By reducing RSV-related hospitalisations and recurrent wheezing, palivizumab improves health outcomes while lowering healthcare costs, supporting its inclusion as a high-value intervention within the Ecuadorian public health system."

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

Maternal perspectives on the RSV vaccine (Abrysvo): a thematic analysis of survey findings from the first season of implementation in England and Scotland. (PubMed, Arch Dis Child) - "Uptake of the maternal vaccine was influenced by barriers to access, informational gaps and perceived safety concerns. Improved vaccine delivery, enhanced awareness and personalised antenatal counselling are essential to increase vaccine uptake. There is an urgent need to address structural inaccessibility and provide tailored antenatal education to address informational gaps. Ongoing qualitative research is crucial to guide targeted public health interventions ahead of future RSV seasons."

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

Estimation of Public Health Impact with Use of Nirsevimab During the 2024-2025 RSV Season in the USA: a Modeling Study. (PubMed, Pulm Ther) - "Nirsevimab has already achieved substantial reductions in RSV-associated clinical burden at current national coverage levels. Modeled increases in coverage demonstrate large, incremental public health gains with complete universal immunization yielding up to an 86% reduction in RSV MA-LRTDs. These findings highlight the importance of implementing strategies that enhance access, reduce inequities, and support higher, sustained coverage to maximize population-level benefits of RSV prophylaxis."

Journal • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

Prevention of respiratory syncytial virus in children (PubMed, Ugeskr Laeger) - "Until now, prevention relied on palivizumab for high-risk infants, limited by high costs and monthly injections. This review describes new preventive options including maternal vaccination (Abrysvo) and monoclonal antibodies (nirsevimab, clesrovimab). From October 2025, Denmark introduced a seasonal maternal vaccination, expected to substantially reduce RSV-related hospitalisations. Additionally, monoclonal antibodies are recommended for premature and high-risk infants."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Impact of RSV Immunoprophylaxis Strategies on Infant Health: A Systematic Review and Meta-Analysis (RSVVW 2026) - "Palivizumab and new long-acting mAbs (nirsevimab) each substantially lower RSV hospitalizations and critical illness. Maternal RSV vaccination also confers significant protection to infants with no major safety signals observed."

Retrospective data • Review • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Efficacy and Safety of RSV Immunoprophylaxis in Preventing Infant LRTIs: A Systematic Review and Meta-analysis (RSVVW 2026) - "Immunoprophylaxis with monoclonal antibodies, such as monthly palivizumab for high-risk infants and single-dose nirsevimab for all infants, has emerged to prevent severe RSV disease. This prophylactic strategy has a favorable safety profile. Our findings underscore the substantial benefits of RSV immunoprophylaxis and support its expanded use to prevent lower respiratory tract infections and related complications in early infancy."

Retrospective data • Review • CNS Disorders • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Clesrovimab Safety, Pharmacokinetics, and RSV-associated Disease Incidence over Two RSV Seasons among Infants at Increased Risk for Severe RSV Disease: Phase 3 SMART Trial (RSVVW 2026) - P3 | "Participants were randomized 1:1 to receive clesrovimab (105mg on day 1, placebo on day 28) or monthly palivizumab in season 1; all eligible participants received clesrovimab (210mg) open-label in season 2. The observed exposures after a 210mg dose of clesrovimab in season 2 were generally comparable to that of a 105mg dose. Season 1 efficacy was established through PK bridging from CLEVER; modeling is currently underway to examine extrapolation of efficacy to season 2."

Clinical • P3 data • PK/PD data • Bronchopulmonary Dysplasia • Cardiovascular • Heart Failure • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Prevention of RSV in Early Infancy: A Systematic Review and Meta-Analysis of Maternal Vaccination and Monoclonal Antibody Prophylaxis (RSVVW 2026) - "Infants who received a monoclonal antibody (palivizumab or nirsevimab) had a ~70% lower rate of medically attended RSV LRTI and ~75% fewer RSV hospitalizations compared to controls. These findings underscore the effectiveness of passive immunization approaches in this vulnerable age group and support their incorporation into public health programs to reduce the global RSV disease burden. Further studies are warranted to determine the optimal implementation of these interventions, including comparative effectiveness, cost-effectiveness, and long-term impact on infant health."

Retrospective data • Review • CNS Disorders • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Advancing Infant Protection Against Respiratory Syncytial Virus: Clinical Impact of Passive Immunisation Strategies (RSVVW 2026) - "Pooled analyses confirm ~80% effectiveness of nirsevimab in preventing RSV-associated hospital or ICU admissions...Merck's clesrovimab (MK-1654) recently showed an ≈84% reduction in infant RSV hospitalizations through 5 months in a Phase 2/3 trial, with no new safety signals. With these new tools, routine monthly palivizumab (used for decades in high-risk infants) is being phased out in favor of once-per-season antibodies or maternal vaccines...Current evidence demonstrates high efficacy. Ongoing surveillance is needed to monitor rare outcomes, but these interventions represent powerful new tools for infant RSV prevention."

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

Long-Acting Monoclonal Antibodies Reduce RSV Hospitalizations in Infants: Evidence from Recent Trials (RSVVW 2026) - "To evaluate the effectiveness and safety of long-acting monoclonal antibodies against RSV (such as nirsevimab and clesrovimab) in reducing medically attended RSV lower respiratory tract infections and RSV-related hospitalizations in infants following a single preventive dose, and to assess their potential impact on large-scale RSV prevention strategies...Passive immunization with monoclonal antibodies can reduce RSV disease, but the older antibody palivizumab required monthly dosing and was limited to high-risk infants...Broad implementation of these antibodies as a preventive strategy could markedly lessen infant hospitalizations and critical care utilization due to RSV. Ongoing surveillance and additional studies will further clarify their long-term impact and optimal integration into infant immunization program"

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

Characteristics of RSV-Related Hospitalizations in infants during two consecutive universal immunization campaigns with nirsevimab in Galicia (Spain): the NIRSE-GAL study (RSVVW 2026) - "The S276N substitution, identified in three breakthrough cases, affects antigenic site II (palivizumab binding site) and warrants surveillance attention. Hospitalizations occured mainly during second season in immunized infants, i.e. after nirsevimab's protective window had elapsed. No escape variants to nirsevimab were detected, as all RSV-A breakthrough cases belonged to contemporary A.D.1/A.D.3 lineages."

Clinical • Infectious Disease • Respiratory Syncytial Virus Infections

Modelling the clinical and economic impact of clesrovimab against respiratory syncytial virus among infants in Italy (RSVVW 2026) - "A previously published decision tree model was adapted to Italy and simulated the clinical and economic impact of clesrovimab in infants, compared with three alternative interventions: nirsevimab, palivizumab, and RSVpreF maternal vaccine. Full term infants also incurred the greatest share of total costs across all clinical outcomes and care settings, underscoring the importance of RSV interventions for all infants. Of the administration strategies evaluated, SP+ administration of clesrovimab led to the greatest improvement in clinical outcomes and the lowest total treatment costs versus the comparator interventions."

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

Efficacy, effectiveness, public health impact and safety of extended half-life monoclonal antibodies for preventing RSVLRTI in neonates and infants: A systematic literature review and meta-analysis (RSVVW 2026) - "The proportion of patients with anti-drug antibodies (ADAs) was numerically higher in nirsevimab compared to placebo in two RCTs (6.1% and 31.3% for nirsevimab), but similar in two trials, and similar to palivizumab in another RCT. These conclusions are limited by the scarcity of evidence for the safety and effects of clesrovimab. The review is currently being updated and findings incorporating data through October 2025 will be presented."

Retrospective data • Review • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Cost-Effectiveness Analysis of Complementary Strategy to protect infants in Romania using Maternal Vaccination with Bivalent Respiratory Syncytial Virus Prefusion F (RSVpreF) Vaccine and Palivizumab (RSVVW 2026) - "From both societal and healthcare perspectives, RSVpreF in combination with palivizumab was dominant (i.e., cost saving) compared to palivizumab alone. A complementary prophylaxis of maternal RSVpreF vaccine and palivizumab would be a cost-saving strategy compared to palivizumab alone for preventing RSV-related disease in infants in Romania."

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