Beyfortus (nirsevimab) / AstraZeneca, Sanofi, SOBI - LARVOL DELTA

The dawn of preventing respiratory syncytial virus lower respiratory tract infections in children. (PubMed, S Afr Med J) - "Recently, two new RSV prevention strategies have emerged: nirsevimab, a long-acting monoclonal antibody, and a maternal RSV vaccine. Both strategies have shown high efficacy in reducing RSV-LRTI hospitalisation in infants and are being considered for licensure in SA. Implementation of these prevention strategies, combined with public engagement and collaboration between stakeholders, could significantly reduce RSV-related morbidity and mortality in SA."

Journal • Asthma • Critical care • Immunology • Infectious Disease • Pulmonary 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

Nirsevimab Effectiveness Against RSV-Related Hospitalisations in Children Under 24 Months: A Test-Negative Case-Control Study in Portugal, 2024-2025. (PubMed, Influenza Other Respir Viruses) - "Sensitivity analyses confirmed the robustness of the results. These findings support Nirsevimab's effect in a predominantly healthy infant population and contribute to informing public health decisions for RSV immunisation."

Journal • 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

Monitoring effectiveness of nirsevimab immunization against RSV hospitalization using surveillance data: a test-negative case-control study, Spain, October 2024-March 2025. (PubMed, Epidemiol Infect) - No abstract available

Journal • Respiratory Syncytial Virus Infections

Nirsevimab Prophylaxis Reduced Bronchiolitis, Hospitalizations and Intensive Care Admissions in Children up to 2 Years of Age. (PubMed, Acta Paediatr) - No abstract available

Journal • Critical care • Pulmonary Disease • Respiratory Diseases

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

A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea (clinicaltrials.gov) - P=N/A | N=3000 | Recruiting | Sponsor: Sanofi | Trial completion date: Apr 2030 ➔ Sep 2029 | Trial primary completion date: Apr 2030 ➔ Sep 2029 | Not yet recruiting ➔ Recruiting

Enrollment open • Trial completion date • Trial primary completion date • Respiratory Diseases

Nirsevimab Effectiveness Against Intensive Care Unit Admission for Respiratory Syncytial Virus in Infants - 24 States, December 2024-April 2025. (PubMed, MMWR Morb Mortal Wkly Rep) - "Nirsevimab was 80% effective (95% CI = 70%-86%) against RSV-associated ICU admission and 83% effective (95% CI = 74%-90%) against acute respiratory failure when received a median of 52 days (IQR = 32-89 days) and 50 days (IQR = 32-86 days) before onset for each respective endpoint. These estimates support the recommendation for use of nirsevimab as a prevention strategy to protect infants against severe outcomes from RSV infection."

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

Efficacy of nirsevimab for the prevention of RSV disease in infants: A systematic review, meta-analysis of randomized controlled trials, and global perspectives on recommendations and unmet needs. (PubMed, Pediatr Neonatol) - "Nirsevimab exhibits excellent efficacy and safety in RSV prevention. Although most countries align administration with RSV seasonality, Taiwan distinctively endorses year-round prophylaxis. Customized immunization policies considering local epidemiology and seasonality may optimize protection and inform global RSV prevention strategies."

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

A Clinical Trial of SIBP-A16 Injection in Healthy Adults (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Shanghai Institute Of Biological Products | Not yet recruiting ➔ Recruiting

Enrollment open • Respiratory Diseases

Position statement of the Mexican Association of Pediatrics on the immunoprevention of respiratory syncytial virus infection during pregnancy and infancy. (PubMed, World J Pediatr) - "Both maternal respiratory syncytial virus vaccination (RSVpreF) and passive immunization with nirsevimab demonstrate robust efficacy and favorable safety, protecting newborns and infants from severe respiratory syncytial virus infections. The document provides actionable, evidence-based recommendations tailored for the Latin American healthcare context, aiming to reduce severe respiratory syncytial virus disease incidence and improve national infant health outcomes."

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

Respiratory syncytial virus bronchiolitis requiring respiratory support with a history of IVIG after nirsevimab. (PubMed, Pediatr Int) - No abstract available

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

Exploring parental awareness and willingness to use monoclonal antibodies for respiratory syncytial virus prevention. (PubMed, Hum Vaccin Immunother) - "Respiratory syncytial virus (RSV) remains a leading cause of severe illness in infancy, and the recent availability of new monoclonal antibodies such as nirsevimab presents an appealing prevention choice...The study indicated that female parents, and those who reported believing in monoclonal antibodies effectiveness were more likely to report willingness to use treatment (AOR = 5.161, p < .001). Despite low awareness in general about RSV, parents have positive feelings toward monoclonal antibody injections, and professional, clear communications are critical with particular reference to mothers to increase acceptability and utilization of RSV prevention strategies in Jordan."

Journal • Cough • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

Nirsevimab Prophylaxis and Respiratory Syncytial Virus Hospitalizations Among Infants. (PubMed, JAMA Netw Open) - "In this multicenter cohort study, nirsevimab prophylaxis was associated with substantially lower RSV hospitalization risk and reduced in-hospital RSV severity, supporting its implementation as a public health strategy. However, the persistent risk associated with prematurity and household RSV exposure suggests a need for supplemental approaches to optimize RSV prevention in high-risk infants."

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

Notes from the Field: Expanding Birthing Hospital Enrollment in the Vaccines for Children Program to Increase Infant Immunization Against Respiratory Syncytial Virus - United States, October 2023-March 2025. (PubMed, MMWR Morb Mortal Wkly Rep) - "Enrollment of birthing hospitals in VFC thus has the potential to expand infant immunization against RSV. This report describes enrollment of U.S. birthing hospitals (those with more than one birth during the previous year or at least one registered maternity bed) in the VFC program since the introduction of nirsevimab."

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

Impact of Nirsevimab in Its Second Season on Respiratory Syncytial Virus and Non-RSV Admissions in Children Under 5. (PubMed, Pediatr Infect Dis J) - "Universal nirsevimab immunization was associated with sustained reductions in RSV-related hospitalizations and critical illness, but also in hospitalizations due to other respiratory viruses."

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

PIPELINE-RSV-F: Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination (clinicaltrials.gov) - P3 | N=1000 | Not yet recruiting | Sponsor: Centre Hospitalier Annecy Genevois

New P3 trial • Infectious Disease • 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

Expert consensus on monoclonal antibody immunoprophylaxis against respiratory syncytial virus in infants and young children in tropical and subtropical regions of China (PubMed, Zhongguo Dang Dai Er Ke Za Zhi) - "In recent years, with advances in monoclonal antibody development, the long-acting RSV monoclonal antibody nirsevimab has been introduced into clinical practice worldwide, including in China, and has become a core intervention for immunoprophylaxis in infants and young children...They cover: epidemiological features of RSV; disease burden and clinical manifestations of RSV infection; dosage and administration of RSV monoclonal antibodies; efficacy and safety of RSV monoclonal antibodies; year-round immunoprophylaxis strategies for infants and young children; immunoprophylaxis strategies for infants and young children with special health conditions; coadministration of RSV monoclonal antibodies with vaccines in the national immunization program; and management measures for immunoprophylaxis with long-acting RSV monoclonal antibodies. The aim is to provide scientific and standardized guidance for frontline clinical and public health practice to reduce the incidence,..."

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

REVIVE: Understanding the uptake of respiratory syncytial virus prevention products by pregnant people and newborns in order to improve public health policy (ANZCTR) - P=N/A | N=10000 | Not yet recruiting | Sponsor: Monash University

New trial • Respiratory Diseases • Respiratory Syncytial Virus Infections

How a major discovery can become a public health failure when used subotptimally: lessons from early nirsevimab implementation. (PubMed, Ital J Pediatr) - "Our clinical insights and reflections aim to inspire deeper engagement among policymakers, health agencies, and clinicians to better adapt and integrate RSV preventive strategies-maximizing benefit not only for susceptible infants, but for society at large. In a world of finite healthcare resources, optimizing both the reach and the value of such essential interventions is imperative, given the multitude and diversity of health needs our society is facing."

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

Nirsevimab for preventing respiratory syncytial virus lower respiratory tract infections in infants: a systematic review and meta-analysis. (PubMed, Front Public Health) - "There is no clear evidence that effectiveness differs for infants born in season (at birth immunization) compared with out of season groups, or that effectiveness varies in preterm infants compared to healthy term infants. https://www.crd.york.ac.uk/PROSPERO/view/CRD42024591323."

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

Effectiveness of long-acting monoclonal antibodies against laboratory-confirmed RSV in children aged < 24 months and hospitalised for severe acute respiratory infection, European pilot study, 2024 to 2025. (PubMed, Euro Surveill) - "We measured effectiveness of nirsevimab against laboratory-confirmed respiratory syncytial virus (RSV) infection in a test-negative case-control study among children aged < 24 months hospitalised for severe acute respiratory infection in three European countries. The overall effectiveness in the 2024/25 season among 2,201 children was 79% (95% CI: 58 to 89) and 85%, 78% and 69% at < 30, 30-89 and 90-215 days since immunisation. Immunisation was effective for preventing RSV-related hospitalisation in children, but effectiveness by time since immunisation needs monitoring in future seasons."

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

Cost-effectiveness of introducing a maternal vaccine or long-acting monoclonal antibody to prevent infant respiratory syncytial virus disease in Nepal. (PubMed, J Glob Health) - "We estimated the potential health impact and cost-effectiveness of introducing a maternal vaccine (RSVpreF) or long-acting infant monoclonal antibody (mAb) (nirsevimab) over the period 2025-34 in Nepal...New passive immunisation strategies have the potential to prevent a substantial number of RSV-related hospitalisations and deaths in Nepal. Cost-effectiveness and product choice will heavily depend on the price negotiated for each product."

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