RSV
Study in Europe: monoclonal antibodies effectively prevent respiratory syncytial virus in infants
Data from Belgium, Portugal and Spain show that immunisation of children after birth reduced the risk of hospitalization due to RSV infection by almost 80%
European Centre for Disease Prevention and Control (ECDC)
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Distribution of hospitalised RSV cases and controls, by date of symptom onset, and distribution of included immunised patients, by week of immunisation, VEBIS immunisation effectiveness multicentre hospital study, Europe, 2024/25 season (n = 2,201).
view moreCredit: Eurosurveillance
Respiratory syncytial virus (RSV) is a common respiratory virus which usually causes mild, cold-like symptoms during the respiratory virus season. However, especially among young infants under six months of age or people over 65, RSV infection might turn more severe. Health complications associated with RSV include bronchiolitis (inflammation of the small airways in the lung), pneumonia or even sepsis which can require prolonged hospital stays.
Immunisation products to prevent RSV disease in infants and older adults have been authorised in the European Union since 2022. These include long-acting monoclonal antibodies are given to newborns during the winter season as well as vaccines for pregnant people to protect newborns during their first winter season after birth. [1] The European RSV season has returned to pre-pandemic seasonality, lasting from around October to April.
Immunisation of infants effectively prevented hospitalisation related to RSV
In their rapid communication published in Eurosurveillance, Savulescu et al. looked at data from three European countries which had RSV immunisation programmes in place during the winter season 2024/25 to establish the effectiveness of the long-acting monoclonal antibody (nirsevimab) against RSV infection. [2]
For their case-control study among children below the age of two years, the authors screened data from 4,102 hospitalised children in Belgium, Portugal and Spain between September 2024 and May 2025. Of those, 791 children who had been tested positive for RSV were included in the study analysis and 1,410 children who tested negative for RSV in the control group.
In the study, children were considered immunised if they received nirsevimab between September 2024 and May 2025 before testing, regardless of the dose, or their age and weight at the time of immunisation.
Protection levels decline incrementally several months after immunisation
Based on their analysis, Savulescu et al. conclude that “immunisation of children after birth effectively prevented RSV-related hospitalisation in children during the 2024/25 European winter season”. Among 2,201 children the pooled overall immunisation effectiveness was at 79%, i.e. receiving long-acting monoclonal antibodies significantly reduced the risk of hospitalisation due to RSV infection in this age group.
However, the level of protection declined over time following immunisation: starting from 85% during the first month (<30 days) after immunisation to 78% during days 30 to 89 after immunisation and 69% after three months (90 to 215 days) from immunisation.
Among infants aged 0–6 months, i.e. the newborns at highest risk for severe RSV illness, the overall effectiveness of immunisation with long-acting monoclonal antibodies was 80%. The authors highlight that “effectiveness by time since immunisation needs monitoring in future seasons.”
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Notes to editors/reference
[1] Among the authorised RSV immunisation products are long-acting monoclonal antibody product administered directly to neonates and infants (Beyfortus/nirsevimab) and one maternal vaccine to provide protection to infants through transplacental transfer of RSV neutralising antibodies (Abrysvov).
[2] Savulescu Camelia, Ganser Iris, Nicolay Nathalie, Lajot Adrien, Campos Sandra, Martínez-Baz Iván, Rodrigues Ana Paula, Vandromme Mathil, Cara-Rodríguez Marta, Echeverría Aitziber, Gaio Vânia, Parsy Marie-Pierre, Garrido Ana Roldan, Castilla Jesús, Guiomar Raquel, Bacci Sabrina, Rose Angela MC, the VEBIS hospital network RSV IE group. 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. Euro Surveill. 2025;30(45), Available from: https://www.eurosurveillance/content/10.2807/1560-7917.ES.2025.30.45.2500816
This study was funded by European Centre for Disease Prevention and Control through Vaccine Effectiveness, Burden and Impact Studies (VEBIS) Lot 1 framework contract ECDC/2021/016.
[3] Marking the start of the 2025/26 season for respiratory diseases in Europe, ECDC issues a rapid scientific advice on effective ways to mitigate the impact of RSV disease in infants through immunisation interventions. Available from: https://www.ecdc.europa.eu/en/publications-data/rapid-scientific-advice-protecting-infants-against-respiratory-syncytial-virus
Journal
Eurosurveillance
Method of Research
Data/statistical analysis
Subject of Research
People
Article Title
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
Article Publication Date
13-Nov-2025
COI Statement
APR reported honoraria from Sanofi for a lecture on RSV, MV reported national funding from SARI surveillance from Belgian Public Services (FPS Santé Publique). Collaborators from the VEBIS hospital network RSV IE group: NDa reported grants from Sciensano and MSD, honoraria for lectures from Astra Zeneca, support for attending meetings from MSD, Gilead, ViiV healthcare, Eumedica (payments made to the institution), and participation in Advisory board of MSD in the past 36 months. CB reported an 8-month contract as project officer with European Public Health Association (EUPHA) in the past 36 months. SDa reported support for attending ESPID 2025 from Sanofi-Pasteur. CB, LDM, PM, SH, YD, YL, NB reported national funding for SARI surveillance from Belgian Public Services (FPS Santé Publique). All other authors declare no conflicts of interest related to this work.
Experts urge continued hepatitis B vaccine birth doses for newborns
Status quo policies have prevented an estimated one million hospitalizations and 90,000 deaths
In a commentary published in Gastroenterology, leading experts urge that all newborns in the United States continue to receive the first dose of hepatitis B vaccine within 24 hours of birth.
Hepatitis B vaccines are safe and effective with over one billion doses administered worldwide.
Since 1991, the Centers for Disease Control and Prevention (CDC) and the Advisory Committee on Immunization Practices (ACIP) have recommended hepatitis B vaccine for all infants, not just those born to mothers who have tested positive for hepatitis B, with the first dose given within 24 hours of birth for infants born to mothers who tested positive for hepatitis B.
Their recommendation was updated in 2005 to specify that the first dose should be administered within 12 hours of birth for infants born to mothers who tested positive for hepatitis B and before hospital discharge for other infants.
In 2018, the timing of the first dose was updated to be within 24 hours of birth for all infants, including pre-term infants and those born to mothers who tested hepatitis B negative.
The authors of this commentary have identified this universal “birth dose” as an essential safety net for preventing chronic hepatitis B infection, which can lead to premature death from cirrhosis or liver cancer.
The result of these policies has been a 95% decline in infant hepatitis B infections, which have prevented an estimated one million hospitalizations and 90,000 deaths.
In this Q&A, first author Anna S. Lok, M.D., the Alice Lohrman Andrews Research Professor of Hepatology at Michigan Medicine, discusses the importance of continued universal hepatitis B vaccination for children at birth.
Why is it important that all children receive a hepatitis B vaccine at birth, not just those children born to mothers who have tested positive?
Anna S. Lok, M.D.: We don’t know the status of every mother—the U.S. healthcare system is not perfect.
A lot of people don't have insurance, or they show up very late to the hospital. They show up when they're in labor, and you may not necessarily have the ability to check the mother's status. But if you vaccinate every newborn baby, then you don't need to worry about infants whose mother has unknown hepatitis B status.
The other issue is that we assume that the only source of infection is from the mother, but that's not true, because some babies can be infected through other people.
There is evidence that fathers can transmit the infection. In some families, it could be the grandparents taking care of the baby. Or it could be the nanny who's taking care of the baby. Or you drop off your baby at daycare. And you don't know the status of people in daycare, or the other kids in daycare.
Now, of course, the contact between the other people and the baby is different from the contact between the mother and the baby. But babies do get scratches, and the skin may break.
If babies are to get infected, they have a 90% chance of going on to chronic infection, which can lead to cirrhosis and liver cancer and early death. If your immune system is mature and you get infected when you're an adult, then your chance of getting chronic infection is only 5%.
Why is it important that people are vaccinated as children?
Lok: In addition to the 90% chance of chronic infection, if children are infected, they can further spread the infection.
The other issue is practicality. Trying to get adolescents and adults vaccinated is a very tricky issue, because we don't have a good infrastructure.
Getting babies vaccinated on day 1 when they’re in the hospital has a much higher chance of getting it done.
Are hepatitis B vaccines safe for children?
Lok: Hepatitis B vaccine was first approved in 1981. More than 1 billion doses have already been administered.
It's one of the few vaccines that were approved for use in newborns and for pregnant women. These are the most vulnerable people. There are very few things that we approve for use in newborn babies within the first 12-24 hours of birth. There are very few things that we feel comfortable in recommending for use during pregnancy.
What is your overall message to parents and policymakers on this issue?
Lok: We have safe and effective vaccines that have been around for 45 years. And if we use the vaccine appropriately and give it to every single newborn baby at the time of birth, we can prevent infections. We don't need to worry about children getting chronic infections, cirrhosis and liver cancer.
It's the most cost-effective way of preventing infection, rather than waiting for people to get infected and monitoring and treating them for the rest of their life. We have treatment for hepatitis B but they do not eliminate the virus and do not cure the disease.
If vaccine can prevent other chronic diseases, such as diabetes, I'm sure that we would. It's just that we don't have a vaccine for diabetes.
We can prevent chronic hepatitis B, and we have a lot of data to show that vaccines work and are safe.
Additional authors: John W. Ward, M.D, Mei-Hwei Chang, M.D., Chari Cohen, DrPH., M.P.H.
Journal
Gastroenterology
Method of Research
Commentary/editorial
Article Title
Hepatitis B Vaccination: A remarkable success story that must continue
Article Publication Date
12-Nov-2025
COI Statement
ASL has received research grants from Ipsen, KOWA, and TARGET to University of Michigan, and serves as consultant/advisor for Arbutus, Brii, Chroma, Grifols, Moderna, Pfizer, Pioneering, Precision, Virion, and Zenasbio for development of hepatitis B cure therapies and prevention of hepatitis B reactivation, and as member of the Data and Safety Monitoring Board for a Novo Nordisk clinical trial on metabolic dysfunction-associated steatotic liver disease. The Task Force for Global Health receives funds for the general support of the Coalition for Global Hepatitis Elimination from Abbott, AbbVie, Cepheid, Dynavax, Gilead, GlaxoSmithKline, Merck, Pharco, Roche, Siemens, Zydus Life Sciences, governmental agencies, and philanthropic organizations. MH Chang has no conflict of interest. The Hepatitis B Foundation receives program and research grants from Gilead Sciences, nChroma, Grifols, Vir Biotechnologies, Dynavax Technologies, Roche, and GlaxoSmithKline. CC serves on patient/advocate advisory committees for GlaxoSmithKline and Gilead, with renumeration going directly to the Hepatitis B Foundation.
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