Latest news with #Nirsevimab


Hans India
4 days ago
- Health
- Hans India
Need for awareness and immunization against Respiratory Syncytial Virus in India
Bengaluru: Medical experts in India are calling for urgent attention to Respiratory Syncytial Virus (RSV), a highly contagious but under-discussed cause of lower respiratory tract infections in infants and children under five. RSV, often mistaken for a mild seasonal cold, accounts for ~ 3.6 million hospitalizations and ~ 100,000 deaths in children under five each year globally. India, with the largest birth cohort of ~ 25 million newborns annually, contributes significantly to this burden. The impact is particularly severe during the country's monsoon and early winter months, when neonatal ICUs experience a surge in admissions. Alarmingly, even healthy, full-term infants across all socio-economic backgrounds often require oxygen or ventilator support due to RSV-related complications. Therefore, raising awareness among parents and healthcare professionals about available preventive measures is critical to reducing the disease's toll on young lives. Dr. Vasant M. Khalatkar, Current National President, Indian Academy of Pediatrics (IAP), said 'RSV remains a significant threat to infant health, and while hygiene measures like handwashing are essential, they're often not enough—especially for babies under one year. With the recent World Health Organization (WHO) recommendation for long-acting monoclonal antibodies (mAb) and India enabling access to these solutions, we now have vital tools to protect our youngest. Palivizumab has been available for high-risk infants, offering protection through monthly dosing during the RSV season. Now, with the arrival of Nirsevimab—a single-dose, long-acting antibody that provides season-long protection—we're seeing a major advancement. Administered shortly after birth or during routine follow-ups, these preventive options can greatly reduce RSV-related hospitalizations and shield infants from serious complications like bronchiolitis and pneumonia. Prevention, timely awareness, and parental engagement are critical to reducing RSV's impact across India.' Dr. Cesar Mascarenas, Head of Medical International Region, Sanofi, commented 'We have long been working to close critical gaps in prevention by advancing science-driven solutions that align with evolving global recommendations, including those from the WHO. Addressing RSV burden in India with advanced preventive care is the need of the hour. Strengthening awareness, improving access to protective interventions, and enabling timely immunization are essential steps in reducing the impact of RSV and safeguarding the health of future generations.' Dr. Bhavesh Kotak, Head, Medical Affairs, Dr. Reddy's, added 'India bears a significant share of the global RSV burden. Unlike high-income countries with advanced prevention care and early access to preventive solution, India still faces challenges in timely diagnosis and protection. Increased awareness around the severity of RSV and enabled access to ground-breaking immunization solutions will be critical in building a more equitable and effective national response to RSV.' In April 2025, Sanofi and Dr. Reddy's announced the expansion of their partnership to bring to India a novel, single-dose preventive immunization developed to protect infants from RSV-related complications. Caregivers or parents are advised to speak with their pediatricians / neonatologist for more details.

Bangkok Post
6 days ago
- Health
- Bangkok Post
Protecting Thailand's Youngest and Oldest from RSV, Flu
Bangkok, July 7, 2025 — As Thailand transitions from the rainy to early winter seasons, respiratory infections surge dramatically, making awareness and proper prevention crucial. Recognising this urgent public health concern, Sanofi Thailand supported a vital Health Talk session at Thailand Healthcare 2025 under the topic: "Infants Catch It Easily, the Elderly are at High Risk: Understanding RSV and Influenza." The session featured distinguished medical experts Prof. Dr. Sasisopin Kiertiburanakul and Assoc. Prof. Dr. Sophida Boonsathorn Reeves, infectious disease specialists from the Faculty of Medicine, Ramathibodi Hospital, Mahidol University. They shared comprehensive knowledge and strategic prevention approaches to protect families, with particular focus on the most vulnerable groups: newborns, infants, and seniors aged 65 and above. Respiratory Syncytial Virus (RSV) represents a significant threat as a primary cause of respiratory infections in newborns and infants (0–2 years). The virus spreads through respiratory droplets from coughing and sneezing, as well as contact with contaminated surfaces. Its reach is extensive—nearly all children will contract RSV at least once by age five, with an overwhelming 90% infected by age two and 50% within their first year of life. RSV outbreaks are mostly seasonal. In Thailand, the outbreak typically begins with the rainy season around June to July, peaks between August and October, and gradually declines in November and December. A common misconception among new mothers is that babies who stay indoors are automatically safe. However, this false sense of security overlooks the reality that family members can unknowingly bring the virus home, putting even homebound infants at substantial risk. RSV manifests through symptoms including persistent coughing, characteristic wheezing, thick mucus production, and high fever. Particularly concerning is that one in three infected children may progress to severe lower respiratory tract infections like pneumonia or bronchiolitis. The absence of specific treatment for RSV—with care limited to supportive measures—underscores the critical importance of prevention, especially for infants under 12 months. Assoc. Prof. Dr. Sophida Boonsathorn Reeves emphasised this urgency: "Infants under one year—whether full-term, premature, or with underlying conditions—are all at risk of severe RSV, potentially requiring ICU care or even resulting in death." Recent medical advances have introduced RSV monoclonal antibodies that can be administered directly to provide immediate protection. Compelling clinical evidence demonstrates their effectiveness in reducing hospitalisations from lower respiratory tract infections by 79.5%, decreasing overall RSV-related hospitalisations by 83.2%, and reducing ICU admissions by 75.3%. The Royal College of Paediatricians of Thailand (RCPedT) has issued comprehensive clinical practice guidelines for the use of Nirsevimab. It is recommended that all healthy newborns and infants under eight months of age receive Nirsevimab, with consideration also given to healthy infants aged 8 to 12 months. Ideally, the antibody should be administered prior to the onset of the RSV season, which typically spans from June to October each year. For infants born during this period, Nirsevimab should be given as soon as possible after birth. The protection begins immediately upon administration and provides immunity for at least six months throughout the RSV season. Prof. Dr. Sasisopin Kiertiburanakul, an infectious disease specialist, reported alarming statistics: within just the first half of 2025, Thailand documented over 370,000 influenza cases resulting in 51 deaths, predominantly among seniors aged 65 and over due to naturally weakened immunity and existing health conditions. Annual influenza vaccination is essential, particularly during the rainy to early winter season when transmission rates peak. Seniors are strongly advised to consult their healthcare providers about timely vaccination. Prof. Dr. Sasisopin explained this vulnerability: "Older adults face heightened risks due to weakened immunity and chronic illnesses like heart, kidney, or lung disease. Influenza can significantly worsen these underlying conditions, potentially leading to serious complications or death." Two distinct vaccine formulations are available: the standard dose for individuals aged six months and older, and the high-dose formulation specifically designed for adults aged 65 and above. The high-dose vaccine contains four times more antigen to generate a stronger immune response in older recipients. Extensive research demonstrates that high-dose vaccines substantially reduce influenza infection risk by 24%, decrease hospitalisation rates by 64%, and lower mortality by 49% compared to standard-dose alternatives. High-dose influenza vaccines have maintained an excellent safety and efficacy record in the United States and Europe for over a decade, with more than 200 million doses administered globally. Both the World Health Organization and Thailand's Department of Disease Control confirm that three-strain and four-strain influenza vaccines offer comparable protection levels, noting that the B/Yamagata strain has not circulated significantly since 2020. Consequently, three-strain vaccines currently provide adequate immunological coverage. Conclusion As seasonal patterns elevate RSV and influenza prevalence, comprehensive awareness and implementation of appropriate preventive strategies are vital to protect yourself and your loved ones. Sanofi Thailand maintains its steadfast commitment to enhancing immunity among Thai people, reducing the burden of preventable illnesses, and fostering improved long-term health outcomes nationwide.


Medscape
05-06-2025
- Health
- Medscape
Nirsevimab Cuts Bronchiolitis Cases in Young Infants
Nirsevimab implementation in Catalonia, Spain, was associated with a 44% reduction in emergency department (ED) visits for bronchiolitis in infants younger than 6 months and a 48% reduction in hospital admissions compared with previous seasons. The multinational study analyzed 1,574,392 ED visits and 255,689 hospital admissions across Spain, the United Kingdom, and Italy. METHODOLOGY: Researchers conducted a multinational retrospective analysis of ED visits and admissions at 68 hospitals in Catalonia (Spain), one hospital in Rome (Italy), and four hospitals in the United Kingdom from May 1, 2018, to April 30, 2024. Analysis included data for all diagnoses, respiratory diagnoses excluding bronchiolitis, and bronchiolitis diagnoses for different age groups (< 6 months, 6-11 months, and 12-23 months). A generalized linear model in Poisson regression was utilized to obtain risk ratio and 95% CI of bronchiolitis in the 2023-2024 season compared with a mean of previous seasons, excluding 2020-2021 (as a COVID year). TAKEAWAY: In Catalonia, the risk ratio was 0.52 (95% CI, 0.48-0.55) for bronchiolitis-related hospital admissions in infants aged less than 6 months in the 2023-2024 season compared with previous years. ED visits for bronchiolitis in Catalonia showed a risk ratio of 0.56 (95% CI, 0.54-0.58) for infants younger than 6 months and 0.93 (95% CI, 0.89-0.97) for infants aged 6-11 months. No significant reduction in risk ratio for ED visits or admissions was observed in the 2023-2024 season at other study sites in the United Kingdom and Italy. According to the authors, the effect of nirsevimab was less clear in older infants aged 6-11 and 12-23 months. IN PRACTICE: 'Nirsevimab had a clear impact in reducing attendances and admissions for infants with bronchiolitis aged < 6 months in Catalonia. However, the impact on older infants was less clear, making it unrealistic to imagine a substantial change in the epidemiology of infants accessing EDs or inpatient wards, at least in the near future,' wrote the authors of the study. SOURCE: The study was led by Aida Perramon-Malavez, Computational Biology and Complex Systems Group, Department of Physics, Universitat Politécnica de Catalunya in Barcelona, Spain. It was published online in The Lancet Regional Health – Europe . LIMITATIONS: As a retrospective analysis, the study faced several limitations. The proportion of visits and admissions coded as bronchiolitis varied widely across countries, potentially due to coding differences or health system factors rather than true epidemiological differences. The researchers could not directly match all diagnoses in International Classification of Diseases, 10th Revision, to Systematized Nomenclature of Medicine Clinical Terms codes. Limited virology testing of ED visits prevented determination of the relative contribution of respiratory syncytial virus toward the disease burden in the studied seasons. DISCLOSURES: Damian Roland disclosed receiving grants from Wellcome Trust, Respiratory Syncytial Virus Consortium in Europe, Imperial College London, and National Institute for Health Research. Antoni Soriano-Arandes reported receiving consulting fees and honoraria for lectures from Sanofi, MSD, and Pfizer, along with grants from La Marató de TV3. Additional disclosures are noted in the original article.


Medscape
13-05-2025
- Health
- Medscape
RSV Vaccination Associated With Fewer Infant Hospitalizations
Respiratory syncytial virus (RSV)–associated hospitalization rates among infants in the United States were significantly lower in the first year when prevention products were widely available, based on surveillance network data from the 2024-2025 season. Both a maternal vaccine for RSV and a long-acting monoclonal antibody for infants and young children aged 0-19 months (nirsevimab) were in use during the 2024-2025 RSV season, wrote Monica Patton, MD, an epidemiologist at the Centers for Disease Control and Prevention's National Center for Immunization and Respiratory Diseases, and colleagues. In a study published in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report, the researchers reviewed data from the RSV-Associated Hospitalization Surveillance Network (RSV-NET) and New Vaccine Surveillance Network (NVSN). They compared RSV-associated hospitalizations in children aged 5 years or younger during the first year of availability of RSV prevention products in 2024-2025 with RSV-associated hospitalizations for a pooled period of 2018-2019 and 2019-2020, before the COVID-19 pandemic. The study included 11,681 RSV-associated hospitalizations from 2018 to 2020 and 6708 from 2024 to 2025. The median age of the children with RSV-associated hospitalizations was significantly older in the later time period than in the early period for both networks (14.7 months vs 6.7 months in RSV-NET and 12.7 months vs 6.3 months in NVSN). RSV-associated hospitalization rates among infants aged 0-7 months were reduced by 43% in RSV-NET and 28% in the NVSN for the 2024-2025 season vs the pre-pandemic period. RSV-associated hospitalizations for children aged 8-19 months or 20-59 months were not significantly different between the two time periods, and slightly higher in the 2024-2025 period. Notably, the largest estimated reductions in both networks were among infants aged 0-2 months (52% and 45% for RSV-NET and NVSN, respectively). The largest reduction in RSV-association hospitalizations overall occurred during the RSV peak months of December-February. 'Higher RSV-associated hospitalization rates during 2024-25 compared with 2018-20 among children in older age groups, who were largely ineligible for RSV prevention products, suggest a more severe 2024-25 season overall and indicate that observed reductions in hospitalization rates among younger infants might be underestimated,' the researchers wrote in their discussion. The findings were limited by several factors including the lack of individual-level data to assess causality, concerns that RSV-NET and NVSN data might not be nationally representative, and the use of interim data that may not reflect the entire RSV season, the researchers noted. However, the results support the current recommendations of the Advisory Committee on Immunization Practices (ACIP)'s recommendations for RSV prevention products in the form of maternal vaccination or nirsevimab for infants, they said. Early Data Support Effectiveness 'RSV prevention products such as maternal RSV vaccine and nirsevimab are relatively new tools in the protection against RSV disease,' said Shirin A. Mazumder, MD, an infectious diseases specialist in Memphis, Tennessee, in an interview. 'Collecting data from the most recent RSV season is important to gauge the effectiveness of the RSV prevention products and the impact of these products on severe RSV infection resulting in hospitalization among infants and young children,' said Mazumder, who was not involved in the study. The findings of the interim evaluation were not surprising and confirmed the effectiveness of maternal RSV vaccine and use of nirsevimab in infants shown in previous studies, Mazumder told Medscape Medical News . Barriers and Next Steps 'A single dose of the maternal RSV vaccine administered in the last trimester of pregnancy is effective in producing antibodies that are passed along to the fetus and provides protection from RSV during the first 6 months of a newborn's life; however, timing is a potential barrier,' Mazumder told Medscape Medical News . 'There is a limited window for mothers to receive the vaccine as it can only be given during weeks 32-36 of pregnancy and between the months of September through January,' she said. Issues of access related to product availability and insurance coverage are evolving barriers for some patients as well, said Mazumder. 'Prenatal counseling and education, along with continued support from ACIP can help to overcome some of the existing barriers,' she said. Research on data from more geographic areas and among different populations may help to provide a more comprehensive picture of the impact of RSV prevention products, Mazumder added.


The Hindu
04-05-2025
- Health
- The Hindu
Study finds lab-created antibody effective in preventing severe respiratory illness in infants
A monoclonal antibody -- a protein created in a lab which mimics the work of a natural antibody -- could be highly effective in preventing severe RSV-- Respiratory syncytial virus, a respiratory infection and major cause of serious illness in infants, according to a research. Study findings Findings of the study, published in The Lancet Child and Adolescent Health journal, show that injecting infants with the antibody 'nirsevimab' reduces risk of RSV-related hospitalisations by 83 per cent and intensive care admissions by 81 per cent. Infant immunisation programmes could, therefore, help address the health and economic burden due to RSV in the high-risk period following birth, a team of researchers from Canada and the US said. RSV, or respiratory syncytial virus, is one of the leading causes of serious respiratory ill-health in the early years of one's life, and is usually prevalent during early winter months. Globally, the condition is estimated to cause 36 lakh hospitalisations a year among children aged under five, according to the World Health Organization. Nirsevimab was approved in 2023 by regulatory agencies, including the US' Food and Drug Administration and European Medicines Agency, after the lab-created antibody was found to be safe and effective in clinical trials. Effectiveness of nirsevimab Through national programmes, infants in high-income countries, such as in the US and European Union, have been injected with nirsevimab. The researchers said that efficacy of nirsevimab seen in the controlled settings of a clinical trial may not fully reflect how the lab-created antibody performs in real-world settings. Real-world effectiveness studies are essential to evaluate the effectiveness of nirsevimab across diverse infant populations and clinical settings, the team added. For this study, the researchers analysed 27 previously published studies, which were conducted during the RSV seasons of 2023-2024 across five countries -- France, Italy, Luxembourg, Spain and the US. The team mainly focussed on infants aged under 12 months. "Nirsevimab is highly effective in preventing RSV-related outcomes in infants, with a pooled real-world effectiveness of 83 per cent against hospitalisation, 81 per cent against ICU admission, and 75 per cent against LRTI (lower respiratory tract infections)," the authors wrote. The lab-created antibody was also found to be more effective among infants aged over three months, compared to those aged under three months. Monoclonal is an antibody, not a vaccine The researchers noted that nirsevimab is not a vaccine, despite being delivered as an injection. A monoclonal antibody is created in a lab to mimic how an antibody works, whereas a vaccine empowers the body's immune system to produce an immune response, which involves creating antibodies, they said. The findings indicate that the benefits of nirsevimab seen in clinical trials could be translated into real-world settings, potentially reducing the burden of RSV disease among infants and use of healthcare resources, the authors said.