Latest news with #Nirsevimab
Hindustan Times
4 days ago
- Health
- Hindustan Times
Early immunisation critical in preventing RSV in infants
Respiratory illnesses in newborns are a major cause of concern, especially when they involve difficulty in breathing. Among the leading causes is Respiratory Syncytial Virus (RSV), a common and highly severe virus that affects the lungs and airways of infants and children under five. This virus often mimics symptoms of a common cold, such as a runny nose or low-grade fever. This similarity can create confusion for parents and health care providers alike, leading to delays in detection and intervention, which allows the illness to rapidly escalate. Vaccination (Getty Images/iStockphoto) For newborns and infants, whose immune systems are still developing, and airways are small, RSV can quickly become serious. Their tiny airways can get easily blocked by swelling and mucus, leading to lung infections like bronchiolitis or pneumonia. Each year, RSV leads to over 3.6 million hospitalisations and about 100 000 deaths in children under five years of age. As per WHO, most paediatric RSV deaths (97%) occur in low- and middle-income countries where there is limited access to supportive medical care. Even healthy, full-term babies can face complications, and in some cases, require intensive medical care. In India, RSV cases spike during the monsoon and early winter, but the virus can circulate throughout the year. This makes timely protection critical. Medical advancements now offer a way to shield infants through immunisation strategies. While the RSVpreF maternal vaccine is not yet available in India, two monoclonal antibodies have emerged as key preventive options in India. Palivizumab, is administered monthly to high-risk infants such as those born prematurely or with underlying heart or lung conditions. Nirsevimab, on the other hand, is a long-acting monoclonal antibody offering protection with a single-dose. It is designed for all infants regardless of risk category and can be administered soon after birth, before hospital discharge, or during early routine check-ups. Early immunization plays a vital role in protecting infants not just from immediate illness, but also from long-term respiratory complications. Severe RSV infections in the first year of life have been linked to increased risk of recurrent wheezing, asthma, ear infections, and reduced lung function well into adolescence. Infants are especially vulnerable because their immune systems are still developing, and their smaller airways are more easily blocked by inflammation caused by the virus. By providing protection before exposure, through timely use of preventive monoclonal antibodies, we are better equipped to avoid serious outcomes for babies. Parents must understand the importance of stopping the virus before it can take hold, reducing the likelihood of hospitalisation and long-term health issues. For parents and health care providers alike, early immunisation isn't just a seasonal precaution, it's a critical investment in the child's long-term respiratory health and overall well-being. This article is authored by Dr Faisal B Nahdi, paediatrician, Rainbow Children's Hospital, Hyderabad.
Medscape
25-07-2025
- Health
- Medscape
Why Are RSV Vaccine Rates so Shockingly Low?
Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infections in infants and children younger than 2 years. The most severe and life-threatening cases typically affect infants younger than 6 months. However, older toddlers, adults with chronic illnesses or multiple comorbidities, and older adults are also at an elevated risk. Immunization Progress Research on both active and passive RSV immunization has advanced significantly in recent years. Following the approval of the first prophylactic antibody in 2022 and two vaccines in 2023, the prevention of severe RSV illnesses has become increasingly effective. Current strategies include maternal vaccination to protect newborns, immunization of older adults, and passive immunization of infants using the monoclonal antibody nirsevimab. In June, the FDA approved a second monoclonal antibody: clesrovimab. Nirsevimab Nirsevimab (Beyfortus) has been available in the European Union since November 2022. It is indicated for RSV prophylaxis in all infants during their first RSV season and in children up to 2 years of age who are at increased risk during their second season. Nirsevimab is a human monoclonal immunoglobulin G1 (IgG1) kappa antibody produced using recombinant DNA technology. It binds to a highly conserved site on the RSV fusion (F) glycoprotein, which is present only in the prefusion form of the viral surface protein. Nirsevimab has a markedly longer serum half-life than earlier antibodies. The drug is administered as a single intramuscular dose adjusted according to the child's weight. Germany's Standing Committee on Vaccination recommends that infants born between April and September receive antibodies in autumn before their first RSV season. Those born between October and March should receive the vaccine as soon as possible after birth. Clesrovimab Clesrovimab (Enflonsia) is a human monoclonal IgG1 kappa antibody. Unlike nirsevimab, it binds to two sites in both the pre- and post-fusion conformations of the F protein. It is administered as a single intramuscular injection and does not require weight-based dosing. The manufacturer has applied for approval from the European Medicines Agency, and the decision is pending. RSV Vaccines Three RSV vaccines, each targeting a different group, are currently authorized for use in Germany. Arexvy: A monovalent recombinant protein vaccine that includes the RSV F protein and the AS01E adjuvant. It is approved for adults aged 60 years or older. Abrysvo: A bivalent recombinant protein vaccine containing prefusion F antigens from RSV subtypes A and B. It is authorized for use in pregnant women to protect their infants up to 6 months of age and in adults aged 60 years or older. mResvia: Approved in mid-2024, this is the only mRNA RSV vaccine currently available. It is indicated for adults aged 60 years or older and was recently approved in the US for high-risk adults aged 18-59 years. Real-World Data Although clinical trials have demonstrated the strong efficacy of RSV vaccines and antibodies in preventing severe illnesses, data from real-world immunization programs are limited. A new systematic review by UK researchers addressed this gap. Between December 2024 and February 2025, they conducted monthly searches across the Ovid, Embase, MEDLINE, and global health databases. The review included 43 studies that evaluated nirsevimab, maternal RSV vaccination, and adult RSV vaccination. The goal was to assess uptake across countries and demographic groups. Data from more than 1.38 million individuals in Spain, France, Italy, Luxembourg, and the US were analyzed. One study combined records from Catalonia and Andorra. Most data (86%) were drawn from electronic health records and medical registries, and vaccine data were solely from the US. Nirsevimab Uptake In Spain, the uptake of nirsevimab during the 2023-2024 RSV season reached 90.1% (95% CI, 86.4-92.9), the highest of any country reviewed. Infants born during the RSV season and Spanish nationals had higher immunization rates. In the US, 51.2% of eligible infants received nirsevimab in 2023-2024. Uptake was greater among preterm infants, those with at least one comorbidity, and those from Hispanic backgrounds. France recorded 76.5% coverage, with higher rates in infants younger than 3 months than in those aged 3-12 months. Luxembourg reported 83.8%, Italy 68.7%, and Catalonia-Andorra combined 60.2%. Subgroup analyses revealed that children who experienced RSV or other acute respiratory infections were less likely to receive nirsevimab. Maternal Vaccination Maternal RSV vaccine coverage during pregnancy was 30.5% (95% CI, 20.6-42.6). Uptake was significantly lower among women without health insurance or with statutory coverage than among those with private insurance. Black and Hispanic women had lower rates than non-Hispanic White women. Older Adult Vaccination Four population-based studies assessed RSV vaccine uptake in adults aged 60 years or older, showing an average rate of 18.2% (95% CI, 10.8-28.9) in 2023-2024. Uptake was higher among adults older than 75 years, those with comorbidities, and immunocompromised individuals. As with maternal vaccination, the rates were lower among the Black and Hispanic populations. The researchers highlighted the concerningly low uptake among pregnant women and older adults despite the availability of effective prevention tools. They called for coordinated national, clinical, and public health efforts to improve immunization rates in high-risk populations. World Health Organization (WHO) Guidance In May, the WHO published its first position paper on RSV immunization in infants and young children, underscoring global urgency. RSV is the leading cause of pediatric morbidity and mortality. In 2019, an estimated 100,000 children younger than 5 years died from RSV-related lower respiratory tract infections, representing about 2% of all deaths in this age group. Approximately half of these deaths occur in infants younger than 5 months, with 97% occurring in low- and middle-income countries. Globally, RSV accounts for an estimated 3.6 million hospitalizations annually in children younger than 5 years. The WHO recommends that all countries implement immunization programs to prevent severe RSV disease in vulnerable groups. The choice between maternal vaccination and the use of long-acting monoclonal antibodies, such as nirsevimab, should be based on local factors, including health system integration, cost, and overall feasibility. Germany's Robert Koch Institute provides additional guidance in its fact sheets on RSV immunization, including details on nirsevimab and adult vaccinations.
Mint
23-07-2025
- Business
- Mint
Dr Reddy's Labs Q1 Results: Net profit rises just 1.4% YoY to ₹1,409 crore; revenue surges 11%
Dr Reddy's Labs Q1 Results: Leading pharmaceutical company Dr Reddy's Laboratories announced earnings for the April to June quarter of the financial year 2025-26 on Wednesday, July 23. The company reported a consolidated net profit growth of 1.4 per cent to ₹ 1,409 crore in Q1FY26 compared to ₹ 1,392 crore posted in the year-ago period. The pharma major's revenue from operations in the June-ended quarter stood at ₹ 8,572 crore, up 11.3 per cent from ₹ 7,696 crore in the corresponding quarter of the last financial year. In terms of segment-wise performance, revenue from Global Generics, which constitutes nearly 90 per cent of the total revenue, stood at ₹ 7,562 crore compared to ₹ 6,885crore. The company posted ₹ 970 crore revenue from Pharmaceutical Services and Active Ingredients in Q1FY26, compared to ₹ 1,030 crore. The total expenses rose 15.8 per cent at ₹ 6,957 crore in the April to June quarter for the fiscal year 2025-26 from ₹ 6,006 crore in the same quarter previous year. The pharma company's EBITDA was ₹ 2,278 crore, accounting for approximately 26.7% of total revenues. Partnership with Alvotech to co-develop, manufacture and co-commercialise pembrolizumab, a biosimilar candidate to Keytruda. Collaboration with Sanofi to launch Beyfortus (Nirsevimab), a drug for preventing Respiratory Syncytial Virus (RSV) in India. • Launched Sensimune in India, an immunotherapy product for house dust mite-induced allergies in partnership with ALK-Abell6. Speaking on the results and the upcoming course of action, Co-Chairman & MD, G V Prasad said, 'the pricing pressure on Lenalidomide is expected to intensify in the U.S. generics market. We remain focused on strengthening our base business by delivery of our pipeline assets, improving overall productivity and business development.'
Yahoo
21-07-2025
- Health
- Yahoo
RSV vaccine to be offered to premature babies in NI
A vaccination programme to tackle respiratory syncytial virus (RSV) is to be extended to cover premature babies born in Northern Ireland. A long-acting injection is to be offered for eligible children from this autumn. RSV is a common, but highly infectious, respiratory virus that affects the breathing system, particularly in young children and older adults. It infects 90% of children by the age of two and is one of the leading causes of hospitalisation in the first year of life. An RSV vaccine has been available to pregnant women in Northern Ireland since last September and is offered from 28 weeks of pregnancy. The new programme will cover those infants born very prematurely and too early to benefit from the RSV vaccination given to their mothers. The single Nirsevimab injection offers about 80% protection and replaces Palivizumab, which gives 55% protection and is administered up to five times. It follows advice from the Joint Committee on Vaccination and Immunisation. Chief Medical Officer Sir Michael McBride said: "Vaccinations have been extremely effective in eradicating diseases and protecting children and other vulnerable groups from serious illness and death. "Worryingly, we are now seeing a decline in the uptake of childhood immunisations. "Vaccinations offer children the very best start in life. Quite simply, if children aren't vaccinated, they're not protected." Health Minister Mike Nesbitt said the new vaccine would strengthen winter preparedness in the health service and reduce pressures on GPs, emergency departments and hospital admissions.
Belfast Telegraph
19-07-2025
- Health
- Belfast Telegraph
RSV vaccine to be offered to premature babies in NI from autumn, health officials announce
Chief Medical Officer Sir Michael McBride said it will strengthen protection against the potentially serious respiratory syncytial virus (RSV). RSV is a common cause of coughs and colds and infections are very common. Almost all children get them at least once before they are two years old. They're not usually serious, but some babies and adults have a higher risk of getting seriously ill, including babies under six months old and young children who were born prematurely, according to the NHS. An RSV vaccine has been available to pregnant women here since last September and is offered from 28 weeks of pregnancy. Now, a long-acting injection will be offered for eligible children from this autumn, the Department of Health said. Nirsevimab will replace the current jab, Palivizumab, following advice from the Joint Committee on Vaccination and Immunisation (JCVI) in February 2023. It offers over 80% protection against the virus and is administered as a single injection that provides protection right through an RSV season – from September to February each year. Kneecap to face no further action from police after Glastonbury performance Health Minister Mike Nesbitt said: 'The risk of contracting RSV for children born very prematurely in their first winter is extremely serious and has a significant impact on our health service each year. 'My department has approved using this new vaccine in line with the approach being taken across the other UK nations. 'This innovative vaccine further strengthens our winter preparedness to prevent avoidable hospital admissions and reduce pressures on GPs and emergency departments. 'It follows on from the launch of an RSV vaccination programme for pregnant women and adults aged 75-79 years old last year. 'I would encourage parents and guardians of those eligible to avail of the vaccination to help protect their baby from illness.' Chief Medical Officer Sir Michael McBride said: 'RSV is a potentially serious virus, particularly for very young babies. 'Vaccinations have been extremely effective in eradicating diseases and protecting children and other vulnerable groups from serious illness and death. 'Worryingly, we are now seeing a decline in the uptake of childhood immunisations. Vaccinations offer children the very best start in life. Quite simply, if children aren't vaccinated, they're not protected.'
