For parents and decision-makers
Ways to protect infants
New options for protecting infants against RSV have been developed in recent years. Long-acting monoclonal antibodies and the RSV vaccine given in pregnancy are two immunisation approaches with different timing and delivery characteristics. This page sets out clinical trial results, real-world data and the key practical points together.
Key message Long-acting monoclonal antibodies are a newer option that can cover roughly one RSV season with a single dose. Which option is appropriate is assessed according to the baby’s age, timing of birth, risk status and current national recommendations.
What has changed in prevention?
The first systematic preventive intervention against RSV was palivizumab, approved in 1998. This monoclonal antibody binds the RSV F (fusion) protein and is given by monthly intramuscular injection. Randomised controlled trials found that it reduced RSV-related hospital admission by around 40–50% in preterm infants and those with chronic lung or congenital heart disease.12
Its critical limitation from a public health perspective is that it requires monthly repetition, is expensive, and covers only defined risk categories.20 These features formed the structural basis for decades of treating RSV prevention as a narrow subgroup issue. Palivizumab is clinically valuable, but it cannot underpin a population-level strategy.
Nirsevimab: one dose for a whole season
Nirsevimab, approved by the European Medicines Agency (EMA) in 2022 and the US Food and Drug Administration (FDA) in 2023, represents a turning point.34
It is a next-generation monoclonal antibody targeting the pre-fusion conformation of the RSV F protein, with a long half-life and given as a single dose. Thanks to its extended half-life, a single dose is intended to reduce the risk of RSV-related lower respiratory tract disease over a period of roughly five to six months.
Its fundamental difference from palivizumab is not the mechanism but the population it targets. All infants, regardless of risk category, can be protected for a season with a single dose. This is what makes it possible, for the first time, to design RSV protection as a genuine population-level infant health strategy.
What does the evidence show?
Two pivotal phase 3 trials form a complementary and robust body of evidence.
MELODY trial
Randomised, double-blind, placebo-controlled (2022)
- Population
- Healthy term and late-preterm infants
- Efficacy against lower respiratory tract infection
- 74.5%
- Reduction in hospital admission
- 62.1%
- Source
- Hammitt et al., 2022
HARMONIE trial
Open-label, large population (2023)
- Population
- Approximately 8,000 healthy term infants
- Design
- Broad coverage representing routine clinical practice
- Reduction in hospital admission
- 83.2%
- Source
- Drysdale et al., 2023
Real-world data
After nirsevimab came into widespread use in the USA and France in the 2023–2024 season, real-world data consistently supported the phase 3 findings. Early data compiled from the CDC-run RSV-NET and NVSN platforms showed a reduction of more than 90% in RSV-related hospital admissions among infants who received it. National data from France point to a field effectiveness of around 83%.78
- Spain · Galicia
NIRSE-GAL: two consecutive seasons
In this prospective study, conducted with immunisation coverage of 94.4%, hospital admissions for RSV-associated acute lower respiratory infection fell by 85.9% in the first season and 55.3% in the second. Primary care visits (including bronchitis, bronchiolitis, wheeze and asthma consultations) fell by around 30%, and reductions of up to 78.2% were reported in recurrent lower respiratory admissions.9
- Chile · national programme
NIRSE-CL: 155,000 infants
Chile’s national nirsevimab programme in the 2024 season covered approximately 155,000 eligible infants and achieved over 94% uptake. Admissions for RSV-associated lower respiratory infection fell by 76.4% and paediatric intensive care admissions by 84.9%.10
RSV vaccination in pregnancy
The other significant intervention is RSV vaccination given to the expectant mother. The bivalent pre-fusion F protein vaccine, approved by the FDA in 2023, is given between 32 and 36 weeks of gestation; the mother's immune response is transferred across the placenta so that the newborn is protected passively in the first months of life.1213
The MATISSE trial was a phase 3 study of more than 7,400 women vaccinated between 24 and 36 weeks of gestation. Efficacy against severe RSV-associated lower respiratory illness was reported as 81.8% in the first three months after birth and 69.4% over the first six months. The fact that protection is highest in the first weeks after birth is a critical advantage of maternal vaccination for the early neonatal period.11
Comparing the three options
| Nirsevimab | Maternal RSV vaccine | Palivizumab | |
|---|---|---|---|
| Administration | Single intramuscular dose | Single intramuscular dose, 32–36 weeks of gestation | Monthly intramuscular injection |
| Target group | All infants | Expectant mother (in pregnancy) | High-risk infants |
| Duration of protection | ~5–6 months (full season) | ~3–6 months (in the infant, variable) | ~1 month (repeat required) |
| Effectiveness reported in selected studies | ~62–83% (phase 3). Some real-world studies have reported estimates approaching or exceeding 90%. | ~70–82% (highest early) | ~40–50% |
| Status in Türkiye | Consult TİTCK and Ministry of Health sources for current licensing, access and reimbursement | Consult TİTCK and Ministry of Health sources for current licensing, access and reimbursement | Consult TİTCK and Ministry of Health sources for current licensing, access and reimbursement |
These figures come from different populations, endpoints, follow-up periods and study designs; they should not be read as a direct product comparison. For current licensing, indication, access and reimbursement information in Türkiye, consult TİTCK and Ministry of Health sources. This table is for general orientation.
Why coverage is decisive
However high individual effectiveness may be, the most critical variable determining population-level public health impact is coverage. Modelling shows that where coverage stays below 50%, system-level reductions in hospital admissions are very limited; as coverage rises into the 70–80% range, systemic gains multiply.
In maternal vaccination programmes, factors such as gestational week, timing of birth and access to antenatal care can affect coverage. In some nirsevimab programmes, combining delivery-unit and primary care administration has been reported to achieve coverage above 90%.910 These results may vary between countries and delivery models.
- 50–70k Hospital admissions estimated preventable in one US season at 80% coverage Modelling studies
- $1.29 bn Total savings calculated for a universal nirsevimab strategy (32,404 admissions prevented) Kieffer et al., 2025
- $345 m Savings calculated for a maternal vaccination strategy (9,649 admissions prevented) Kieffer et al., 2025
Delivery data from Spain make the cost effect of timing concrete. The number of infants needed to immunise (NNI) to prevent one RSV admission was 41 in the delivery-room group (estimated cost ~€9,000), rising to 90 in the catch-up group, where cost more than doubled.17 This gap demonstrates the budget impact of running immunisation predominantly through birth units.
For Türkiye, the national RSV economic burden study has quantified the financial load RSV infections place on the health system through hospital admissions, intensive care expenditure and parental work loss.16
How could this be delivered in Türkiye?
Türkiye's family medicine and hospital infrastructure offers significant capacity that could be assessed for a possible national delivery model. Hospital-based administration for infants born during the season, and access through primary care for those born before it, are among the models used in international examples.
International experience consistently shows that the highest and most homogeneous coverage is achieved through hybrid models combining hospital-based initiation with primary care integration.7918 Where delivery depends on a single channel, coverage is more limited and it becomes harder to include infants born late in the season or lost to follow-up.
Sources
- Johnson, S., Griego, M., & Muñoz, M. F. (2023). Monoclonal antibodies for the prevention of respiratory syncytial virus disease. Pediatric Drugs, 25(6), 637–651. doi.org/10.1007/s40272-023-00591-w
- T.C. Sağlık Bakanlığı. (t.y.). Palivizumab uygulama kılavuzu. T.C. Sağlık Bakanlığı.
- European Medicines Agency (EMA). (2022). Beyfortus (nirsevimab): European public assessment report. EMA.
- U.S. Food and Drug Administration (FDA). (2023a). Beyfortus (nirsevimab-alip) approval documentation. FDA.
- Hammitt, L. L., Dagan, R., Yuan, Y., Baca Cots, M., Bosheva, M., Madhi, S. A., Muller, W. J., Zar, H. J., Brooks, D., Garcia-Garcia, M. L., Principi, N., Xu, X., Wang, J., Zhang, B., Udata, C., & Griffin, M. P. (2022). Nirsevimab for prevention of RSV in healthy late-preterm and term infants. New England Journal of Medicine, 386(9), 837–846. doi.org/10.1056/NEJMoa2110275
- Drysdale, S. B., Cathie, K., Flamein, F., Knuf, M., Melgar, V., Robertson, P., ve ark., & HARMONIE Study Group. (2023). Nirsevimab for prevention of hospitalizations due to RSV in infants. New England Journal of Medicine, 389(26), 2425–2435. doi.org/10.1056/NEJMoa2305385
- Bardsley, M., Begier, E., Bonnett, T. S., ve ark. (2024). Effectiveness of nirsevimab against RSV hospitalisation among infants in France, 2023–24 season. New England Journal of Medicine, 391, 420–428. doi.org/10.1056/NEJMoa2401234
- Moline, H. L., Tannis, A., Toepfer, A. P., ve ark. (2024). Early estimate of nirsevimab effectiveness for prevention of RSV-associated hospitalization among infants. MMWR Morbidity and Mortality Weekly Report, 73(9), 200–206. doi.org/10.15585/mmwr.mm7309a4
- Razzini, J., Giné-Vázquez, I., Jin, J., ve ark. (2026). Impact of universal nirsevimab prophylaxis in infants on hospital and primary care outcomes across two respiratory syncytial virus seasons in Galicia, Spain (NIRSE-GAL): A population-based prospective observational study. The Lancet Infectious Diseases, 26(5), 522–534. doi.org/10.1016/S1473-3099(25)00742-X
- Torres, J., Sauré, D., Goic, M., ve ark. (2025). Effectiveness and impact of nirsevimab in Chile during the first season of a national immunisation strategy against RSV (NIRSE-CL): A retrospective observational study. The Lancet Infectious Diseases, 25(10), 1189–1198. doi.org/10.1016/S1473-3099(25)00344-2
- Kampmann, B., Madhi, S. A., Munjal, I., Simões, E. A. F., Pahud, B. A., Llapur, C., Baker, J., Pérez Marc, G., Radley, D., Shittu, E., Soni, P., & Jansen, K. U. (2023). Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. New England Journal of Medicine, 388(16), 1451–1464. doi.org/10.1056/NEJMoa2216480
- U.S. Food and Drug Administration (FDA). (2023b). Abrysvo (RSVpreF vaccine) approval report. FDA.
- European Medicines Agency (EMA). (2023). Abrysvo (RSVpreF): European public assessment report. EMA.
- Esposito, S., Fainardi, V., Capra, M. E., Aricò, M., Lanzoni, A., Campana, B. R., Niceforo, M., Neglia, C., Valletta, E., & Biasucci, G. (2025). Acceptance of nirsevimab for the prevention of respiratory syncytial virus infection in neonates: A cross-sectional survey in Emilia-Romagna, Italy. Vaccines, 13(9), 896. doi.org/10.3390/vaccines13090896
- Kieffer, A., Ghemmouri, M., Soudani, S., Shin, T., Hodges, E., Greenberg, M., ve ark., & Yarnoff, B. (2025). Comparison of the public health impact of RSV disease prevention options for infants: A static decision model of the US birth cohort. Expert Review of Vaccines, 24(1), 1086–1098. doi.org/10.1080/14760584.2025.2591816
- Malhan, B. S. (2026). Türkiye’de Respiratuar Sinsityal Virüs (RSV) Enfeksiyonu Ekonomik Yük Çalışması. Sağlık Ekonomisi ve Politikası Derneği Raporu.
- Núñez, O., ve ark. (2025). Infants needed to immunise with nirsevimab to prevent one RSV hospitalisation, Spain, 2023/24 season. Eurosurveillance, 30(6), Article 2500040. doi.org/10.2807/1560-7917.ES.2025.30.6.2500040
- Pérez Martín, J. J., Zornoza Moreno, M., ve ark. (2024). Implementation of the first respiratory syncytial virus (RSV) immunization campaign with nirsevimab in an autonomous community in Spain. Human Vaccines & Immunotherapeutics, 20(1), 2365804. doi.org/10.1080/21645515.2024.2365804
- Centers for Disease Control and Prevention (CDC). RSV in infants and young children. www.cdc.gov/rsv/infants-young-children/index.html · 2026-08-04
- Caserta, M. T., O'Leary, S. T., Munoz, F. M., & Ralston, S. L. (2023). Palivizumab prophylaxis in infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics, 152(1), e2023061803. doi.org/10.1542/peds.2023-061803
- Estrella-Porter, P., Correcher-Martínez, E., Orrico-Sánchez, A., & Carreras, J. J. (2025). Post-marketing surveillance of nirsevimab: Safety profile and adverse event analysis from Spain's 2023–2024 RSV immunisation campaign. Vaccines, 13(6), 623. doi.org/10.3390/vaccines13060623
The information on this site is for general guidance only and does not replace examination, diagnosis or treatment by a clinician.