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

Palivizumab for Severe Respiratory Syncytial Virus Infection in Immunocompetent Adults: A Case Series. (PubMed, Infect Drug Resist) - "These cases suggest that Palivizumab may be a potential therapeutic option for severe RSV infection in immunocompetent adults. Further research, including randomized controlled trials, is needed to confirm these preliminary findings and establish optimal dosing and treatment protocols."

Journal • Brain Cancer • Cardiovascular • Hypertension • Infectious Disease • Meningioma • Oncology • Respiratory Diseases • Respiratory Syncytial Virus Infections • Solid Tumor

Community-acquired respiratory virus infections in patients with haematological malignancies or undergoing haematopoietic cell transplantation: updated recommendations from the 10th European Conference on Infections in Leukaemia. (PubMed, Lancet Infect Dis) - "Passive immunisation with palivizumab or nirsevimab is recommended for children younger than 2 years, but data are insufficient for pre-exposure or post-exposure prophylaxis, or treatment of older children and adults. For other CARVs, recommendations include only supportive care, improving immune functions, correcting hypogammaglobulinaemia, and judicious lowering of corticosteroids. We highlight unmet needs in immunisation and antivirals for reducing CARV-associated morbidity and mortality in patients with haematological malignancies and those undergoing HCT."

Journal • Review • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Influenza • Leukemia • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation

Analysis of the economically justifiable price of nirsevimab to prevent respiratory syncytial virus infection in Korea. (PubMed, Hum Vaccin Immunother) - "Probabilistic sensitivity analyses showed that nirsevimab was cost-effective at $527 in 55% of the simulations at the 1 GDP threshold and 54% at the 1.5 GDP threshold. Nirsevimab is estimated to be a cost-effective intervention for preventing RSV-associated lower respiratory tract infections within a universal immunization program for all infants and palivizumab-eligible children <2 years in South Korea."

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

Is Palivizumabe a Protective Factor for the Development of Asthma in Children? A Systematic Review With Metanalysis. (PubMed, Pediatr Pulmonol) - "Palivizumab prophylaxis does not reduce asthma risk in premature children without congenital heart disease. Its primary benefit lies in preventing severe RSV infections, with no direct impact on asthma developing."

Clinical • Journal • Review • Asthma • Cardiovascular • Heart Failure • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Status of advanced respiratory syncytial virus antiviral therapeutics 2025. (PubMed, Curr Opin Virol) - "Prophylactic monoclonal antibody treatments, palivizumab and nirsevimab, are recommended in some instances for newborns, but treatment cost and need for intravenous administration limit universal accessibility. The only antiviral approved for the RSV indication, ribavirin, is no longer recommended for clinical use, creating an urgent need for a novel generation of effective therapeutics. Extensive anti-RSV drug discovery efforts have long been dominated by viral entry inhibitors that emerged as pharmacodominant in automated drug discovery campaigns, yet more recently developed candidates have expanded the target range to the viral polymerase complex and nucleoprotein. Focusing on advanced therapeutic candidates and investigational drugs that have entered clinical trials, this review will discuss challenges in RSV drug development in perspective of recent breakthroughs in RSV prophylaxis, assess the current stage of RSV therapeutic candidates, and identify key..."

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

Addressing immunization gaps in children with congenital heart disease - a narrative review. (PubMed, Med Pharm Rep) - "RSV prophylaxis with palivizumab is advisable in patients with hemodynamically significant CHD during winter season...Furthermore, adjustments to the vaccination schedule might be necessary for patients who require antithrombotic prophylaxis or blood transfusions. Lastly, special attention should be given to individuals at a high risk of decompensation after immunization, who might require close parental or medical monitoring for up to 72 hours post-vaccination."

Journal • Review • Cardiovascular • Heart Failure • Infectious Disease • Inflammation • Influenza • Meningococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections • Rotavirus Infections • Varicella Zoster

Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007) (clinicaltrials.gov) - P3 | N=1003 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

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

Clesrovimab (Enflonsia) for prevention of severe RSV infection in infants. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Estimating the economically justifiable price of nirsevimab versus standard of practice for the prevention of respiratory syncytial virus infections in neonates and infants in Spain: a cost-utility modelling study. (PubMed, BMJ Public Health) - "The aim of this study was to estimate the economically justifiable price (EJP) of nirsevimab in Spain, being the price to consider nirsevimab efficient compared with the standard of practice (administration of palivizumab in eligible infants and no intervention in all other). Nirsevimab reduces RSV-related health events, leading to cost savings and avoided QALY loss associated with RSV infection in infants compared to the previous standard of practice. This study provides a range of cost-effective prices that would lead nirsevimab to be an efficient intervention, or even dominant (achieves better outcomes and produces cost savings), compared with the standard of-practice for RSV prevention, being key for decision-making in public health."

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

Cost of universal immunization with Nirsevimab vs. standard of practice for infants in their first RSV season. Foggia District, Italy, 2023-2024. (PubMed, Vaccine) - "This study assessed the direct costs of using Palivizumab for RSV prevention in the Foggia District, Italy, during the 2023/2024 season, and explored the cost savings coming from reallocating resources to Nirsevimab in a universal RSV program. Considering also hospitalization expenses, coverage reaches 46.4 % of infants, or 66.2 % if unspecified bronchiolitis is included. These results suggest notable cost savings and greater coverage, supporting a universal RSV initiative."

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

Beyond the first breath: comprehensive respiratory syncytial virus prevention through maternal immunization and infant immunoprophylaxis. (PubMed, Asian Biomed (Res Rev News)) - "For decades, monthly palivizumab injection has provided passive immunization for high-risk infants and has demonstrated efficacy in reducing RSV-related hospitalizations, while breastfeeding has been known to protect against severe RSV-LRTI...Additionally, long-acting RSV monoclonal antibodies (Nirsevimab) provide season-long protection with a single dose for infants during the first RSV season, reducing both medically attended RSV-LRTI and hospitalizations by approximately 70%-80% in infants during their first RSV season. Consequently, in 2024, the Strategic Advisory Group of Experts (SAGE) recommended that countries introduce maternal RSVPreF vaccination and/or RSV monoclonal antibodies for infant RSV prevention. Many countries have already adopted these interventions, demonstrating cost-effectiveness of monoclonal antibodies."

Journal • Review • Cardiovascular • Heart Failure • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Enhancing Respiratory Syncytial Virus Immunoprophylaxis: Addressing Challenges Beyond Palivizumab in the Gulf Region. (PubMed, Oman Med J) - No abstract available

Journal • Respiratory Diseases

The impact of nirsevimab prophylaxis on RSV hospitalizations: a real-world cost-benefit analysis in Tuscany, Italy. (PubMed, Front Public Health) - "Real-world data from the Tuscany birth cohort (N = 21,017) experiencing their first RSV season in the 2023/2024 season were used to calculate the net benefit and benefit cost ratio (BCR) of three possible nirsevimab prophylaxis strategies compared with prophylaxis practices at the time of the study, which includes the use of palivizumab in eligible infants. Universal prophylaxis strategies with nirsevimab, targeting all infants during their first RSV epidemic season, substantially reduce hospitalization burdens without increasing economic pressure on the healthcare system. Although alternative strategies are more cost-effective, they prevent fewer hospitalizations, emphasizing the public health value of broader prophylaxis approaches."

HEOR • Journal • Real-world evidence • Respiratory Diseases • Respiratory Syncytial Virus Infections

Palivizumab for preventing severe respiratory syncytial virus (RSV) infection in children. (PubMed, Cochrane Database Syst Rev) - "Based on the available evidence, prophylaxis with systemic palivizumab reduces hospitalisation due to RSV infection and probably results in little to no difference in mortality. Intranasal palivizumab may increase hospitalisation due to RSV infection. Palivizumab probably results in little to no difference in adverse events. Moreover, palivizumab probably results in a slight reduction in hospitalisation due to respiratory-related illness. Systemic palivizumab may result in a large reduction in RSV infections, whilst intranasal palivizumab may increase RSV infection. Systemic palivizumab also reduces the number of wheezing days, whilst intranasal palivizumab may result in little to no difference in the mean fraction of wheezing days. These results may be applicable to children with a high risk of severe RSV infection due to comorbidities. Further research is needed to establish the effect of palivizumab in children with other comorbidities known as risk factors for severe..."

Clinical • Journal • Review • Bronchopulmonary Dysplasia • Cardiovascular • Critical care • Heart Failure • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Dynamics of Respiratory Syncytial Virus Illness and Serology During Pregnancy and Infancy in the United States and South Africa. (PubMed, Open Forum Infect Dis) - "Naturally acquired RSV serum neutralizing titers were determined from 726 pregnant individuals and their infants at birth and assessed in relationship to serum neutralizing titers conferred by serum palivizumab protective levels...South Africa versus US comparison revealed similar, broad distributions of maternal serum RSV neutralizing titers but lower transplacental transfer rates in South Africa (0.6 [95% confidence interval {CI}, .6-.7]) than the US (1.3 [95% CI, 1.1-1.4]) and high rates of community spread of infant asymptomatic RSV infection in South Africa versus the US. These findings suggest that the effectiveness of maternal immunization against infant RSV relies on immunization shifting natural distribution of maternal RSV neutralizing titers into the protective range for infants, which is supported by efficacy demonstrated with RSV maternal immunization."

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

Complementary Strategy of Maternal Immunization with RSVpreF Vaccine and Monoclonal Antibodies for the Prevention of Respiratory Syncytial Virus Among Italian Infants: A Cost-Effectiveness Assessment. (PubMed, Infect Dis Ther) - "RSV is a leading cause of severe lower respiratory tract infections and is one of the primary causes of hospitalization in high income countries and death among children aged ≤ 1 year in lower income; bivalent Stabilized Prefusion F Subunit Vaccine (RSVpreFV) for maternal immunization proves to be effective in preventing RSV infections, avoiding severe disease. The modelling exercise shows that the complementary strategy of maternal vaccination with palivizumab or nirsevimab are both dominant (better health outcomes with lower costs) on monoclonal antibodies alone; the sensitivity analysis confirms that the complementary strategies in most of the simulation remain dominant or cost-effective adopting a low threshold for the willingness to pay; finally the complementary strategies are also sustainable, owing to a limited impact on the current national budget for vaccines."

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

Identification of crucial disulfidptosis genes and regulatory biomarkers in diabetic retinopathy based on bioinformatics analysis. (PubMed, Biochem Biophys Res Commun) - "Additionally, drug-target predictions identified Bevacizumab, Daclizumab, and Palivizumab as possible therapeutic options targeting C1QA and FCGR2B. These findings establish a theoretical foundation for leveraging disulfidptosis-related biomarkers in DR diagnosis and treatment."

Biomarker • Journal • Diabetic Retinopathy • Retinal Disorders • C1QA • FCGR2B • ITGAM • SPI1 • TYROBP

New therapies for old viruses: when everyone gets something wrong (PubMed, Epidemiol Prev) - "The respiratory syncytial virus causes numerous respiratory infections in children, with particularly severe manifestations during the first months of life, especially in premature infants or those with pre-existing clinical conditions.In Italy, the introduction of nirsevimab, a monoclonal antibody that is more practical and potentially usable in a broader population compared to the previous palivizumab, has highlighted several critical issues in the management of the prevention system. A national agreement was reached, allocating funds for an immunization campaign covering approximately 75% of newborns, corresponding to the availability guaranteed by the manufacturer. Additionally, a solidarity distribution mechanism was introduced, allowing up to 20% of doses to be shared among regions to protect the most vulnerable individuals.Despite the campaign started with the onset of the epidemic season, challenges persist in organizing procurement processes and managing..."

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

Evaluation of a monoclonal antibody against respiratory syncytial virus, Clesrovimab, in infants and children: Comprehensive rationale and study design for the late-stage clinical trials. (PubMed, Contemp Clin Trials) - P2/3, P3 | "The methodology of the accelerated late-stage development of clesrovimab, including the model-informed dose selection approach, the seamless enrollment in the phase 3 portion of CLEVER, and the extrapolation of efficacy from the population in CLEVER to the population in SMART, may be used to inform future trial designs where acceleration is needed to address an unmet medical need."

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

Expert consensus on the burden of respiratory syncytial virus disease and the utility of nirsevimab for disease prevention and protection of infants. (PubMed, World J Pediatr) - "The burden of RSV disease in young children is substantial, especially in those < 2 years old, accounting for up to 47% of bronchiolitis and pneumonia admissions in children < 6 months. The administration of a single dose of nirsevimab may be offered to infants at birth for the prevention of RSV in Singapore."

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

Development and Validation of a New Set of Primers for Identification of Circulating Lineages and Palivizumab/Nirsevimab Resistance in HRSV Isolates from Cabo Verde. (PubMed, Trop Med Infect Dis) - "No previously described mutations in the F protein that confer resistance to Palivizumab and Nirsevimab were found. However, continuous monitoring of HRSV genotypes is crucial to promptly identifying resistant viruses, considering their potential impact on public health."

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

Respiratory syncytial virus immunization in children: The old, the new and what's just around the corner. (PubMed, Hum Vaccin Immunother) - "Until recently, immunization was limited to high-risk infants and children, including those born prematurely or with significant co-morbidities, via monthly dosing with the monoclonal antibody (mAb) palivizumab. Recent approvals of long-acting mAb nirsevimab and the maternal RSV pre-fusion F vaccine combined with other anticipated options such as long-acting mAb clesrovimab, and future pediatric vaccines, signal a shift in RSV immunization...We report findings from a survey assessing the level of immunization acceptance among Canadian parents. Provision of education through healthcare professionals, printed materials, parent groups, social media, and the internet were recommended."

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

Parental Knowledge and Understanding of Respiratory Syncytial Virus and How to Decrease the Risk of Infection: The Canadian Premature Babies Foundation Survey 2023. (PubMed, Neonatal Netw) - "Moreover, 65.4% received information about palivizumab, and 97.0% were confident about its use. Although 79.4% were unaware of nirsevimab, 75.4% would accept it...Parents require accurate, reliable, and consistent information on RSV and its prevention, delivered to them in the NICU, following discharge, and via reputable online resources. Health care professionals, both in the NICU and community, should be well-informed and receive regular education throughout the year on RSV and the latest thinking on prevention."

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

Improvement in Palivizumab Administration in Severely Immunocompromised Children: A Single-institution Quality Improvement Initiative. (PubMed, Pediatr Qual Saf) - "No profoundly immunocompromised patients meeting the operational definition or receiving palivizumab experienced severe RSV. We improved adherence to palivizumab administration guidelines for profoundly immunocompromised children over 8 consecutive RSV seasons without increasing RSV infection incidence or severity."

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

Respiratory Syncytial Virus: A Narrative Review of Updates and Recent Advances in Epidemiology, Pathogenesis, Diagnosis, Management and Prevention. (PubMed, J Clin Med) - "Non-pharmaceutical interventions, maternal vaccination, and prophylaxis with monoclonal antibodies, e.g., palivizumab and nirsevimab, a newly introduced long-acting agent, are efficient protective and preventive measures. Treatment is still, for the most part, supportive in nature and focuses on oxygen supplementation, hydration, and respiratory support for patients with more severe disease courses; however, the development of immunoprophylaxis and vaccine candidates shows promise for reducing the global burden of RSV."

Journal • Review • Asthma • Immunology • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections