35:I[703058,["/_next/static/immutable/chunks/355lxm8rh3fxr.js","/_next/static/immutable/chunks/0yecwcl2vsgzm.js","/_next/static/immutable/chunks/33s6yl_7t575t.js","/_next/static/immutable/chunks/2sgwc-d-l730j.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/34zte87e1oxbr.js","/_next/static/immutable/chunks/3o8_7x7kr1gqd.js","/_next/static/immutable/chunks/3gndzt6n9hhhz.js","/_next/static/immutable/chunks/368brjxhfaune.js","/_next/static/immutable/chunks/2-7hs63mi7grl.js","/_next/static/immutable/chunks/1xa6orki-joi9.js","/_next/static/immutable/chunks/316o2u2mp21uq.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/0g9dls0-elfj5.js"],"PaperListPageClient"] 36:T6c7,Although both maternal respiratory syncytial virus (RSV) prefusion F vaccination (RSVpreF) and infant nirsevimab immunization have been approved for the prevention of RSV lower respiratory tract infections, the 2 have not been evaluated in a single study, and their sequential administration has not been studied systematically. We performed a prospective, randomized, open-label, phase 4 study at 8 US sites of mother-infant pairs randomized 1:1:1:1 during pregnancy: maternal RSVpreF vaccine alone, maternal RSVpreF vaccine/infant nirsevimab at birth, maternal RSVpreF vaccine/infant nirsevimab at 3 months, or infant nirsevimab alone at birth. We are following the mother-infant pairs for 12 months to ascertain safety, infant tolerability, and the magnitude and durability of RSV-A and -B neutralizing antibodies (nAbs). We report interim data from September 19, 2024, to May 15, 2025, including 4-month infant follow-up. In total, 181 mothers were enrolled. Both products alone and in combination were safe. No related serious adverse events were observed in mothers or infants. Nirsevimab was well tolerated, and all local and systemic reactogenicity was mild to moderate in severity. RSVpreF vaccination boosted maternal RSV-A nAb titers 17.35-fold at the time of delivery, and titers were durable through 3 months postdelivery. The geometric mean transfer ratio of RSV-A nAbs was higher than 1.3 and similar across groups. RSV nAbs were highly elevated in infants at 6 weeks and 3 months, irrespective of group, with modest differences in waning. Maternal RSVpreF vaccine and infant nirsevimab administration, either alone or in combination, were safe and provided high RSV nAb titers in infants through interim follow-up.37:T96d, BACKGROUND Although both maternal respiratory syncytial virus (RSV) prefusion F vaccination (RSVpreF) and infant nirsevimab immunization have been approved for the prevention of RSV lower respiratory tract infections, the 2 have not been evaluated in a single study, and their sequential administration has not been studied systematically. METHODS We performed a prospective, randomized, open-label, phase 4 study at 8 US sites of mother-infant pairs randomized 1:1:1:1 during pregnancy: maternal RSVpreF vaccine alone, maternal RSVpreF vaccine/infant nirsevimab at birth, maternal RSVpreF vaccine/infant nirsevimab at 3 months, or infant nirsevimab alone at birth. We are following the mother-infant pairs for 12 months to ascertain safety, infant tolerability, and the magnitude and durability of RSV-A and -B neutralizing antibodies (nAbs). We report interim data from September 19, 2024, to May 15, 2025, including 4-month infant follow-up. RESULTS In total, 181 mothers were enrolled. Both products alone and in combination were safe. No related serious adverse events were observed in mothers or infants. Nirsevimab was well tolerated, and all local and systemic reactogenicity was mild to moderate in severity. RSVpreF vaccination boosted maternal RSV-A nAb titers 17.35-fold at the time of delivery, and titers were durable through 3 months postdelivery. The geometric mean transfer ratio of RSV-A nAbs was higher than 1.3 and similar across groups. RSV nAbs were highly elevated in infants at 6 weeks and 3 months, irrespective of group, with modest differences in waning. CONCLUSIONS Maternal RSVpreF vaccine and infant nirsevimab administration, either alone or in combination, were safe and provided high RSV nAb titers in infants through interim follow-up. 38:Tcd2,Real-world evidence on nirsevimab impact beyond the first season when given under universal immunisation programmes is emerging. We aimed to assess the medium-term impact of universal infant respiratory syncytial virus (RSV) prophylaxis with nirsevimab across inpatient and outpatient settings during two consecutive RSV seasons. NIRSE-GAL is an ongoing, population-based, prospective, longitudinal study in Galicia, Spain. For this study, we included all infants eligible for nirsevimab in the 2023-24 RSV campaign in Galicia, followed up from their first RSV season (2023-24) until the end of their second RSV season (2024-25). The primary endpoint was RSV-related lower respiratory tract infection (LRTI) hospitalisation. Secondary endpoints were LRTI hospitalisation, acute bronchitis or bronchiolitis hospitalisation, pneumonia admissions, all-cause hospitalisations, and primary health-care outcomes (acute bronchitis or bronchiolitis, wheezing or asthma, LRTI, respiratory infections, acute otitis media, and all otitis diagnoses). The first recurrences of these endpoints were also assessed as secondary endpoints. Impact was estimated by Poisson regression models using weekly incidence rates of historical non-pandemic seasons (2017-18 to 2022-23) as comparators, adjusted for RSV seasonality, and evaluated across three follow-up periods: the first RSV season, the second RSV season, and up to 18 months. This study is registered with ClinicalTrials.gov, NCT06180993. Of 12 492 eligible infants, 11 796 received nirsevimab (94·4% coverage). Compared with historical cohorts, RSV-related LRTI hospitalisations decreased by 85·9% (95% CI 80·2-90·0) in the first season and 55·3% (22·5-74·3) in the second, with an estimated 123 infants needing to be immunised to prevent a second-season admission. First LRTI hospitalisations decreased by 59·8% (46·5-69·8) in the first season and 48·1% (33·1-59·7) up to 18 months. Acute bronchitis or bronchiolitis admissions decreased by 59·0% (37·9-72·9) in the first season and 58·7% (40·6-71·3) up to 18 months. All-cause hospitalisation declined by 20·3% (3·1-34·4) in the first season, with no significant reduction thereafter. First recurrent admissions in the second season decreased by 78·2% (25·6-93·6) for RSV-related LRTI, 62·4% (30·9-79·6) for LRTI, and 76·9% (5·3-94·4) for acute bronchitis or bronchiolitis. First outpatient visits declined during the first season by 30·8% (17·5-41·9) for bronchitis or bronchiolitis, 33·4% (21·6-43·4) for LRTI, and 27·7% (14·9-38·5) for wheezing or asthma. First recurrent outpatient visits also declined, by 52·5% (39·7-62·6) for acute bronchitis or bronchiolitis, 28·2% (17·8-37·3) for wheezing or asthma, and 47·3% (35·3-57·2) for LRTI. Universal infant nirsevimab prophylaxis markedly reduced RSV-related hospitalisations and outpatient morbidity, with sustained reductions in RSV-related LRTI hospitalisations into the second season and no signal of adverse shift in RSV morbidity. These findings provide robust population-level evidence that could be valuable for infant immunisation policies and cost-effectiveness models. Sanofi and AstraZeneca. For the Spanish translation of the abstract see Supplementary Materials section.22:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"Beyfortus: Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on Beyfortus (brand). Clinician-written summaries and actionable practice insights. 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Sustained program implementation with ongoing surveillance appears warranted."}},{"doi":"10.1001/jama.2026.17871","pmid":"42684247","title":"RSV Immunization Effectiveness and Safety for the 2026-2027 Respiratory Season","journal_title":"JAMA","journal_issn":"0098-7484","published_at":"2026-09-02T00:00:00.000Z","url":"https://doi.org/10.1001/jama.2026.17871","source_score":632,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-09-09T06:20:57.083Z","updated_at":"2026-09-09T06:20:57.083Z","tags":[{"paper_doi":"10.1001/jama.2026.17871","tag_type":"age_group","value":"mixed","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"brand","value":"Abrysvo","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"brand","value":"Arexvy","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"brand","value":"Beyfortus","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"brand","value":"Enflonsia","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"brand","value":"mRESVIA","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"category","value":"Medicine, General & Internal","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"condition","value":"Respiratory Syncytial Virus Infection","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"generic","value":"clesrovimab","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"generic","value":"mRNA-1345","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"generic","value":"nirsevimab","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"generic","value":"RSVpreF","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"impact_flag","value":"confirms_prior","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"level_of_evidence","value":"1","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"modality","value":"Monoclonal Antibody","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"modality","value":"RSV Vaccine","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"sample_size","value":"n=75","value_numeric":75},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"study_design","value":"Systematic Review","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"warning","value":"Effectiveness estimates for clesrovimab (Enflonsia) were listed as an eligible product but no specific VE data for it were reported in the available text.","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"warning","value":"Study designs within this review are heterogeneous; level of evidence rating of 1 applies to the systematic review as a whole, though individual included studies vary widely in design and risk of bias.","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"warning","value":"The GBS signal was identified in a single self-controlled case series; causality is not established.","value_numeric":null},{"paper_doi":"10.1001/jama.2026.17871","tag_type":"warning","value":"The sample_size tag reflects the number of included studies (n=75), not a patient-level N, as total patient enrollment across all studies was not reported in the abstract or extracted text.","value_numeric":null}],"summaries":{"what_studied":"This systematic review synthesized evidence from 75 studies (12 RCTs, 33 comparative observational, 16 non-comparative observational, 14 descriptive) on the effectiveness and safety of US-licensed RSV vaccines (RSVpreF/ABRYSVO, RSVPreF3-AS01/Arexvy, mRNA-1345/mRESVIA) and monoclonal antibodies (nirsevimab/Beyfortus, clesrovimab/Enflonsia) across older adults (≥60 years), pregnant individuals, infants, children, and immunocompromised persons, covering literature through June 29, 2026.","key_result":"RSV vaccination in older adults reduced RSV-related hospitalization (VE 83.3%; 95% CI, 42.9%–96.9%), with evidence of waning after the first season. Maternal vaccination (32–36 weeks' gestation) reduced infant RSV-related hospitalization (VE 51.0%–70.0%). Nirsevimab effectiveness against infant RSV-related hospitalization ranged from 63.6% to 93.0% within 6–12 months. No GBS cases were found in 3 RCTs, though 1 self-controlled case series identified a possible GBS signal within 42 days post-vaccination in older adults. No comparative study linked RSV vaccination in pregnancy to preterm birth.","limitations":"Most observational studies carry residual confounding risk. Durability data beyond 2 seasons is sparse. Effectiveness estimates for immunocompromised persons and younger adults (18–59 years) remain limited.","practice_takeaway":"RSV vaccines and nirsevimab provide meaningful protection against severe RSV disease across key risk groups; clinicians should counsel older adults that protection may wane after the first season. The possible GBS signal in older adults warrants ongoing monitoring but does not currently outweigh benefit."}},{"doi":"10.1016/j.ijid.2026.109076","pmid":"42660409","title":"Heterogeneous Reduction in Paediatric RSV Hospitalisations Following Regional Nirsevimab Immunisation Strategies: A Multicentre Study","journal_title":"International Journal of Infectious Diseases","journal_issn":"1201-9712","published_at":"2026-08-27T00:00:00.000Z","url":"https://doi.org/10.1016/j.ijid.2026.109076","source_score":7,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-09-04T06:22:09.712Z","updated_at":"2026-09-04T06:22:09.712Z","tags":[{"paper_doi":"10.1016/j.ijid.2026.109076","tag_type":"age_group","value":"pediatric","value_numeric":null},{"paper_doi":"10.1016/j.ijid.2026.109076","tag_type":"brand","value":"Beyfortus","value_numeric":null},{"paper_doi":"10.1016/j.ijid.2026.109076","tag_type":"category","value":"Infectious Diseases","value_numeric":null},{"paper_doi":"10.1016/j.ijid.2026.109076","tag_type":"condition","value":"Respiratory Syncytial Virus Infection","value_numeric":null},{"paper_doi":"10.1016/j.ijid.2026.109076","tag_type":"generic","value":"nirsevimab","value_numeric":null},{"paper_doi":"10.1016/j.ijid.2026.109076","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1016/j.ijid.2026.109076","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1016/j.ijid.2026.109076","tag_type":"modality","value":"Monoclonal Antibody","value_numeric":null},{"paper_doi":"10.1016/j.ijid.2026.109076","tag_type":"sample_size","value":"n=10915","value_numeric":10915},{"paper_doi":"10.1016/j.ijid.2026.109076","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/j.ijid.2026.109076","tag_type":"study_design","value":"Retrospective Multicentre Cohort Study","value_numeric":null},{"paper_doi":"10.1016/j.ijid.2026.109076","tag_type":"warning","value":"Group F data come from a single centre — findings for that group should be interpreted cautiously.","value_numeric":null},{"paper_doi":"10.1016/j.ijid.2026.109076","tag_type":"warning","value":"Group G's apparently elevated ratio (1.84) is attributed to baseline instability rather than a true increase in risk, which may be misread without context.","value_numeric":null},{"paper_doi":"10.1016/j.ijid.2026.109076","tag_type":"warning","value":"Sample size (n=10,915) reflects total RSV hospitalisations across six seasons, not individual patients enrolled in a prospective study.","value_numeric":null},{"paper_doi":"10.1016/j.ijid.2026.109076","tag_type":"warning","value":"The level of evidence is rated 3 (retrospective cohort); the study explicitly cannot establish causation or compare effectiveness between regional strategies.","value_numeric":null}],"summaries":{"what_studied":"This retrospective multicentre study across 19 Italian paediatric units examined RSV-related hospitalisations in children under 18 years over six seasons (January 2019–March 2025), comparing rates before and after regional nirsevimab immunisation rollouts grouped by eligibility criteria (Groups A–G).","key_result":"10,915 RSV hospitalisations were recorded; in the 2024–2025 season, overall hospitalisations fell 43.6%. Groups with broader eligibility and earlier rollout saw the greatest reductions (Group B ratio 0.28, 95% CI 0.22–0.36; Group A ratio 0.40, 95% CI 0.22–0.74), while narrower or delayed programmes showed modest reductions (ratios 0.58–0.70). One group (G) showed no clear reduction after accounting for baseline instability (ratio 1.84, 95% CI 1.15–2.94).","limitations":"Observational design prevents causal inference or direct comparison of regional strategies. Group G results were confounded by baseline instability. Group F findings are from a single centre and are only indicative.","practice_takeaway":"Broader nirsevimab eligibility criteria and timely seasonal rollout appear to drive the largest reductions in paediatric RSV hospitalisations. Programmes with narrow eligibility or delayed start showed substantially smaller benefits."}},{"doi":"10.1001/jamapediatrics.2026.3384","pmid":"42573985","title":"First- and Second-Year Outcomes After Nirsevimab Immunization","journal_title":"JAMA Pediatrics","journal_issn":"2168-6203","published_at":"2026-08-10T00:00:00.000Z","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13458943/","source_score":70,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-08-17T13:33:04.744Z","updated_at":"2026-08-17T13:33:04.744Z","tags":[{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"age_group","value":"infant","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"brand","value":"Beyfortus","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"category","value":"Pediatrics","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"condition","value":"Asthma","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"condition","value":"Ear, Nose, and Throat Bacterial Infection","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"condition","value":"Lower Respiratory Tract Infection","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"condition","value":"Respiratory Syncytial Virus Infection","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"generic","value":"nirsevimab","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"impact_flag","value":"confirms_prior","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"impact_flag","value":"safety_signal","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"modality","value":"Monoclonal Antibody","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"sample_size","value":"n=250198","value_numeric":250198},{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"study_design","value":"Matched Cohort Study","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"warning","value":"The associations with ENT bacterial infections and asthma hospitalizations in year 2 are observational and may be confounded by differential healthcare-seeking behavior or unmeasured factors; causality cannot be established.","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"warning","value":"The full text of the article was not accessible; all extracted data are from the abstract and results section only — key subgroup analyses or sensitivity analyses may be missing.","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"warning","value":"The sample size tag (n=250,198) reflects the combined total across both cohorts (74,672 + 175,526); these are distinct cohorts, not a single pooled trial.","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.3384","tag_type":"warning","value":"Two impact flags were applied (safety_signal for ENT/asthma associations; confirms_prior for RSV effectiveness) — this is unusual but warranted given the dual nature of the findings.","value_numeric":null}],"summaries":{"what_studied":"This nationwide matched cohort study evaluated nirsevimab effectiveness against RSV-LRTI-related hospitalizations across two consecutive RSV seasons (2023–2024 and 2024–2025) in French infants, and assessed whether protection persisted into a second year and whether nirsevimab was associated with hospitalizations for non-RSV infections and asthma.","key_result":"Nirsevimab reduced RSV-LRTI-related hospitalizations by 66% (95% CI, 61%–70%) in year 1 of the 2023 cohort and 72% (95% CI, 69%–75%) in year 1 of the 2024 cohort (0.8% vs 2.4% and 0.5% vs 1.9% immunized vs unimmunized, respectively). No protection carried into the second year (wHR, 1.03; 95% CI, 0.73–1.43). Notably, nirsevimab was associated with higher rates of ENT bacterial infection hospitalizations in year 1 (wHR 1.36–1.43) and in year 2 (wHR, 1.56), and with higher asthma hospitalization rates in year 2 (wHR, 1.24; 95% CI, 1.05–1.46).","limitations":"- Observational design cannot exclude residual confounding despite 1:1 matching and weighted Cox models.\n- The ENT and asthma signals in year 2 may reflect surveillance or healthcare-seeking bias rather than a true causal effect.\n- Full text was not available; analysis is based on the abstract and reported results only.","practice_takeaway":"Nirsevimab provides strong, consistent protection against RSV hospitalization in the first season across consecutive years of use, but clinicians should be aware that protection does not extend into a second RSV season. The unexpected associations with ENT bacterial infections and asthma hospitalizations in year 2 warrant further investigation before drawing causal conclusions."}},{"doi":"10.1093/cid/ciag406","pmid":"42560328","title":"The Effectiveness of Nirsevimab on Antibiotic Use in Children Using Target Trial Emulation","journal_title":"Clinical Infectious Diseases","journal_issn":"1058-4838","published_at":"2026-08-06T00:00:00.000Z","url":"https://doi.org/10.1093/cid/ciag406","source_score":11,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-08-14T13:24:57.618Z","updated_at":"2026-08-14T13:24:57.618Z","tags":[{"paper_doi":"10.1093/cid/ciag406","tag_type":"age_group","value":"infant","value_numeric":null},{"paper_doi":"10.1093/cid/ciag406","tag_type":"brand","value":"Beyfortus","value_numeric":null},{"paper_doi":"10.1093/cid/ciag406","tag_type":"category","value":"Infectious Diseases","value_numeric":null},{"paper_doi":"10.1093/cid/ciag406","tag_type":"condition","value":"Acute Respiratory Tract Infection","value_numeric":null},{"paper_doi":"10.1093/cid/ciag406","tag_type":"condition","value":"Bronchiolitis","value_numeric":null},{"paper_doi":"10.1093/cid/ciag406","tag_type":"condition","value":"Respiratory Syncytial Virus Infection","value_numeric":null},{"paper_doi":"10.1093/cid/ciag406","tag_type":"generic","value":"nirsevimab","value_numeric":null},{"paper_doi":"10.1093/cid/ciag406","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1093/cid/ciag406","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1093/cid/ciag406","tag_type":"modality","value":"Monoclonal Antibody","value_numeric":null},{"paper_doi":"10.1093/cid/ciag406","tag_type":"sample_size","value":"n=15341","value_numeric":15341},{"paper_doi":"10.1093/cid/ciag406","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1093/cid/ciag406","tag_type":"study_design","value":"Target Trial Emulation / Retrospective Cohort Study","value_numeric":null},{"paper_doi":"10.1093/cid/ciag406","tag_type":"warning","value":"Level of evidence assigned as 3 (observational study with target trial emulation framework); some may rate this higher due to methodological rigor.","value_numeric":null},{"paper_doi":"10.1093/cid/ciag406","tag_type":"warning","value":"The brand name 'Beyfortus' is inferred from nirsevimab's known proprietary name — not explicitly stated in the paper.","value_numeric":null},{"paper_doi":"10.1093/cid/ciag406","tag_type":"warning","value":"The RSV hospitalization antibiotic outcome has a very wide confidence interval (4.8%–90.1%), indicating high uncertainty likely due to small event counts; this finding should be interpreted cautiously.","value_numeric":null},{"paper_doi":"10.1093/cid/ciag406","tag_type":"warning","value":"The study design is labeled 'Target Trial Emulation' but is based on observational EHR data from a single healthcare network; residual confounding cannot be excluded.","value_numeric":null}],"summaries":{"what_studied":"This target trial emulation used electronic health record data from 32 primary care practices to compare nirsevimab vs. no treatment in infants <8 months on antibiotic prescribing during the RSV season. Primary outcomes were time to first antibiotic prescription for outpatient ARTIs, outpatient bronchiolitis, and RSV-related hospitalizations.","key_result":"Among 15,341 eligible infants (7,413 receiving nirsevimab), nirsevimab reduced antibiotic prescribing by **14.4%** (95% CI: 7.8%–20.6%) for outpatient ARTIs, **40.3%** (95% CI: 25.1%–52.5%) for outpatient bronchiolitis, and **69.4%** (95% CI: 4.8%–90.1%) for RSV-related hospitalizations.","limitations":"- Observational design with potential for unmeasured confounding despite target trial emulation framework.\n- Wide confidence interval for the RSV hospitalization outcome (4.8%–90.1%) suggests imprecision, likely due to rare events.\n- Single healthcare network limits generalizability to other practice settings.","practice_takeaway":"Nirsevimab not only prevents RSV illness but meaningfully cuts antibiotic prescribing across outpatient and inpatient settings — adding antibiotic stewardship as a concrete benefit when counseling families on immunoprophylaxis. The largest effect is seen for RSV-related hospitalizations, where antibiotic use dropped by ~70%."}},{"doi":"10.1016/s1473-3099(26)00253-7","pmid":"42480569","title":"Effectiveness of nirsevimab immunisation on invasive pneumococcal disease in children nationwide in France: an observational cohort study","journal_title":"The Lancet Infectious Diseases","journal_issn":"1473-3099","published_at":"2026-07-21T00:00:00.000Z","url":"https://doi.org/10.1016/s1473-3099(26)00253-7","source_score":26,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-07-28T14:02:26.031Z","updated_at":"2026-07-28T14:02:26.031Z","tags":[{"paper_doi":"10.1016/s1473-3099(26)00253-7","tag_type":"age_group","value":"infant","value_numeric":null},{"paper_doi":"10.1016/s1473-3099(26)00253-7","tag_type":"brand","value":"Beyfortus","value_numeric":null},{"paper_doi":"10.1016/s1473-3099(26)00253-7","tag_type":"category","value":"Infectious Diseases","value_numeric":null},{"paper_doi":"10.1016/s1473-3099(26)00253-7","tag_type":"condition","value":"Invasive Pneumococcal Disease","value_numeric":null},{"paper_doi":"10.1016/s1473-3099(26)00253-7","tag_type":"condition","value":"Respiratory Syncytial Virus Infection","value_numeric":null},{"paper_doi":"10.1016/s1473-3099(26)00253-7","tag_type":"generic","value":"nirsevimab","value_numeric":null},{"paper_doi":"10.1016/s1473-3099(26)00253-7","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1016/s1473-3099(26)00253-7","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1016/s1473-3099(26)00253-7","tag_type":"modality","value":"Monoclonal Antibody","value_numeric":null},{"paper_doi":"10.1016/s1473-3099(26)00253-7","tag_type":"sample_size","value":"n=527971","value_numeric":527971},{"paper_doi":"10.1016/s1473-3099(26)00253-7","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/s1473-3099(26)00253-7","tag_type":"study_design","value":"Retrospective Cohort Study","value_numeric":null},{"paper_doi":"10.1016/s1473-3099(26)00253-7","tag_type":"warning","value":"IPD event counts are small (n=112 total), which may mean the confidence intervals, while statistically significant, carry meaningful uncertainty around the true effect size.","value_numeric":null},{"paper_doi":"10.1016/s1473-3099(26)00253-7","tag_type":"warning","value":"The brand name 'Beyfortus' was inferred from context — the paper does not explicitly name the brand; verify if needed.","value_numeric":null},{"paper_doi":"10.1016/s1473-3099(26)00253-7","tag_type":"warning","value":"The 'practice_changing' impact flag is assigned cautiously: the authors themselves call for confirmatory studies, and the observational design limits causal claims.","value_numeric":null}],"summaries":{"what_studied":"This retrospective cohort study used French national health data to assess whether nirsevimab immunisation (vs. no nirsevimab) reduced hospitalisation for invasive pneumococcal disease (IPD) in 527,971 liveborn children under 12 months, with 6–9 months of follow-up (birth cohort: Feb 2023–Jan 2024).","key_result":"IPD occurred in 17 immunised children (14.2 per 100,000) vs. 95 non-immunised children (23.3 per 100,000). After inverse probability of treatment weighting, nirsevimab was associated with a **36% reduction** in odds of IPD at 6 months (OR 0.64, 95% CI 0.46–0.82), sustained at 9 months (OR 0.66, 95% CI 0.51–0.85).","limitations":"- Only 22.6% of the cohort received nirsevimab, limiting statistical power for rare IPD events (112 total cases).\n- Residual confounding cannot be excluded despite propensity score weighting; immunised children may differ in unmeasured ways (e.g., healthcare-seeking behaviour, PCV uptake).\n- Retrospective, observational design prevents causal inference.","practice_takeaway":"Nirsevimab may offer a benefit beyond RSV prevention by reducing IPD risk in infants — clinicians should be aware of this potential added value when counselling families. However, findings are observational and require confirmation before changing pneumococcal vaccination strategies."}},{"doi":"10.1001/jamapediatrics.2026.1346","pmid":"42149577","title":"Dual Immunization Against RSV With RSVpreF and Nirsevimab","journal_title":"JAMA Pediatrics","journal_issn":"2168-6203","published_at":"2026-05-18T00:00:00.000Z","url":"https://doi.org/10.1001/jamapediatrics.2026.1346","source_score":15,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-05-26T13:34:49.705Z","updated_at":"2026-05-26T13:34:49.705Z","tags":[{"paper_doi":"10.1001/jamapediatrics.2026.1346","tag_type":"age_group","value":"infant","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.1346","tag_type":"brand","value":"Abrysvo","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.1346","tag_type":"brand","value":"Beyfortus","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.1346","tag_type":"category","value":"Pediatrics","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.1346","tag_type":"condition","value":"Respiratory Syncytial Virus Lower Respiratory Tract Infection","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.1346","tag_type":"generic","value":"nirsevimab","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.1346","tag_type":"generic","value":"RSVpreF vaccine","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.1346","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.1346","tag_type":"modality","value":"Maternal Vaccine","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.1346","tag_type":"modality","value":"Monoclonal Antibody","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.1346","tag_type":"study_design","value":"Cohort Study","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.1346","tag_type":"warning","value":"Brand name tags (Beyfortus, Abrysvo) are inferred from the drug names in context; the paper itself does not explicitly name brands in the available text.","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.1346","tag_type":"warning","value":"Only the data sharing statement was present in the full text — no methods, results, or discussion were extractable. Key result, sample size, and practice takeaway could not be determined. Summary reflects abstract-level information only.","value_numeric":null},{"paper_doi":"10.1001/jamapediatrics.2026.1346","tag_type":"warning","value":"Study uses French national health data (SNDS), which is not publicly available; reproducibility is limited to those with CNIL authorization.","value_numeric":null}],"summaries":{"what_studied":"This cohort study examined RSV-associated lower respiratory tract infection (LRTI) hospitalizations in French infants who received both maternal RSVpreF vaccination and nirsevimab during the 2024–2025 RSV season.","limitations":"The full text was not available for review — only the data sharing statement was extractable. No outcome data, sample size, or results could be confirmed from the provided content."}},{"doi":"10.1002/ppul.71647","pmid":"42142018","title":"Virus Detection and Hospitalization Rate in Infants With Bronchiolitis After Nirsevimab Introduction: A Retrospective Comparative Two‐Season Study","journal_title":"Pediatric Pulmonology","journal_issn":"8755-6863","published_at":"2026-05-16T00:00:00.000Z","url":"https://doi.org/10.1002/ppul.71647","source_score":2,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-05-21T13:20:55.316Z","updated_at":"2026-05-21T13:20:55.316Z","tags":[{"paper_doi":"10.1002/ppul.71647","tag_type":"age_group","value":"infant","value_numeric":null},{"paper_doi":"10.1002/ppul.71647","tag_type":"brand","value":"Beyfortus","value_numeric":null},{"paper_doi":"10.1002/ppul.71647","tag_type":"category","value":"Respiratory System","value_numeric":null},{"paper_doi":"10.1002/ppul.71647","tag_type":"condition","value":"Bronchiolitis","value_numeric":null},{"paper_doi":"10.1002/ppul.71647","tag_type":"condition","value":"Respiratory Syncytial Virus Infection","value_numeric":null},{"paper_doi":"10.1002/ppul.71647","tag_type":"generic","value":"nirsevimab","value_numeric":null},{"paper_doi":"10.1002/ppul.71647","tag_type":"impact_flag","value":"confirms_prior","value_numeric":null},{"paper_doi":"10.1002/ppul.71647","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1002/ppul.71647","tag_type":"modality","value":"Monoclonal Antibody","value_numeric":null},{"paper_doi":"10.1002/ppul.71647","tag_type":"sample_size","value":"n=168","value_numeric":168},{"paper_doi":"10.1002/ppul.71647","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1002/ppul.71647","tag_type":"study_design","value":"Retrospective Cohort Study","value_numeric":null},{"paper_doi":"10.1002/ppul.71647","tag_type":"warning","value":"Nirsevimab vaccination coverage rate in the study population is not reported, which limits causal attribution of the observed reductions.","value_numeric":null},{"paper_doi":"10.1002/ppul.71647","tag_type":"warning","value":"The 95% confidence intervals reported for reductions appear to represent relative risk or rate ratios rather than absolute risk differences — clinical interpretation of the CIs should account for this.","value_numeric":null},{"paper_doi":"10.1002/ppul.71647","tag_type":"warning","value":"The post-nirsevimab cohort is notably smaller (n=49 vs. n=119), which may partly reflect the intervention effect but could also reflect seasonal variation or other confounders not fully addressed.","value_numeric":null}],"summaries":{"what_studied":"This retrospective two-season study compared bronchiolitis hospitalizations in infants under 12 months before (2023–2024, n=119) and after (2024–2025, n=49) nirsevimab introduction in Italy, assessing changes in virus circulation and hospitalization rates (ED visits, pediatric ward, PICU admissions).","key_result":"After nirsevimab introduction, RSV-related pediatric ward admissions fell by 59% (95% CI 0.30–0.57; p<0.001), ED visits by 52% (95% CI 0.39–0.59; p<0.001), and PICU admissions by 60% (95% CI 0.17–0.99; p<0.05). Hospitalized infants were older, with the greatest reduction in those ≤3 months. Influenza increased from 4.2% to 14.6% of cases, and bocavirus emerged (0% → 8.3%) in the post-nirsevimab season.","limitations":"- Single-center retrospective design limits generalizability.\n- Small post-nirsevimab cohort (n=49) reduces statistical power, especially for PICU analysis.\n- No data on nirsevimab coverage rates in the catchment population, making attribution of reductions to the intervention indirect.","practice_takeaway":"Nirsevimab introduction was associated with large reductions in RSV-driven bronchiolitis admissions across all care levels, particularly in very young infants. Clinicians should remain alert to a relative rise in influenza and bocavirus as alternative bronchiolitis pathogens in nirsevimab-immunized populations."}},{"doi":"10.1016/s2352-4642(26)00075-1","pmid":"42107385","title":"Effectiveness of nirsevimab immunisation after birth versus RSVpreF maternal vaccination in preventing RSV-related hospitalisations in infants: a population-based retrospective cohort study","journal_title":"The Lancet Child & Adolescent Health","journal_issn":"2352-4642","published_at":"2026-05-07T00:00:00.000Z","url":"https://doi.org/10.1016/s2352-4642(26)00075-1","source_score":17,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-05-15T13:23:08.330Z","updated_at":"2026-05-15T13:23:08.330Z","tags":[{"paper_doi":"10.1016/s2352-4642(26)00075-1","tag_type":"age_group","value":"infant","value_numeric":null},{"paper_doi":"10.1016/s2352-4642(26)00075-1","tag_type":"brand","value":"Abrysvo","value_numeric":null},{"paper_doi":"10.1016/s2352-4642(26)00075-1","tag_type":"brand","value":"Beyfortus","value_numeric":null},{"paper_doi":"10.1016/s2352-4642(26)00075-1","tag_type":"category","value":"Pediatrics","value_numeric":null},{"paper_doi":"10.1016/s2352-4642(26)00075-1","tag_type":"condition","value":"Lower Respiratory Tract Infection","value_numeric":null},{"paper_doi":"10.1016/s2352-4642(26)00075-1","tag_type":"condition","value":"Respiratory Syncytial Virus Infection","value_numeric":null},{"paper_doi":"10.1016/s2352-4642(26)00075-1","tag_type":"generic","value":"nirsevimab","value_numeric":null},{"paper_doi":"10.1016/s2352-4642(26)00075-1","tag_type":"generic","value":"RSVpreF vaccine","value_numeric":null},{"paper_doi":"10.1016/s2352-4642(26)00075-1","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1016/s2352-4642(26)00075-1","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1016/s2352-4642(26)00075-1","tag_type":"modality","value":"Maternal Vaccine","value_numeric":null},{"paper_doi":"10.1016/s2352-4642(26)00075-1","tag_type":"modality","value":"Monoclonal Antibody","value_numeric":null},{"paper_doi":"10.1016/s2352-4642(26)00075-1","tag_type":"sample_size","value":"n=164140","value_numeric":164140},{"paper_doi":"10.1016/s2352-4642(26)00075-1","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/s2352-4642(26)00075-1","tag_type":"study_design","value":"Retrospective Cohort Study","value_numeric":null},{"paper_doi":"10.1016/s2352-4642(26)00075-1","tag_type":"warning","value":"Gestational age at RSVpreF vaccination in the study was 28–36 weeks, meaning the ≥8-week-before-delivery subgroup represents earlier vaccination; generalisability to programmes with different scheduling windows may be limited.","value_numeric":null},{"paper_doi":"10.1016/s2352-4642(26)00075-1","tag_type":"warning","value":"The brand name for RSVpreF vaccine is listed as 'Abrysvo' (Pfizer); the study does not specify the brand explicitly — this is inferred from context.","value_numeric":null},{"paper_doi":"10.1016/s2352-4642(26)00075-1","tag_type":"warning","value":"The 'impact_flag' of practice_changing is applied because the ≥8-week RSVpreF timing finding directly informs public health policy, though the finding is exploratory/secondary and should be interpreted cautiously.","value_numeric":null}],"summaries":{"what_studied":"This population-based retrospective cohort study compared the effectiveness of nirsevimab given at birth versus RSVpreF maternal vaccination (28–36 weeks gestation) in preventing RSV-related LRTI hospitalisations in infants up to age 6 months during the 2024–25 RSV season in metropolitan France (n=164,140 total; 42,098 matched pairs).","key_result":"Nirsevimab was associated with a 22% lower odds of RSV-related LRTI hospitalisation vs. RSVpreF vaccination (OR 0.78, 95% CI 0.70–0.86); absolute rates were 0.83% (350/42,098) vs. 0.96% (403/42,098). When RSVpreF was given ≥8 weeks before delivery, no statistically significant difference was found (OR 1.01, 95% CI 0.77–1.32).","limitations":"- Retrospective observational design with residual confounding despite propensity score adjustment.\n- RSVpreF was only introduced in 2024, so vaccine uptake and timing patterns may reflect early-adopter behaviour not generalizable to future seasons.\n- Matching on birth date, region, and sex may not fully account for clinical risk factors (e.g., prematurity, comorbidities).","practice_takeaway":"Nirsevimab at birth provides modestly better RSV-LRTI hospitalisation protection than RSVpreF maternal vaccine overall, but RSVpreF given ≥8 weeks before delivery may close that gap — clinicians counselling pregnant patients should factor in gestational timing when discussing maternal vaccination. Both strategies substantially reduce burden; the choice may hinge on vaccination timing feasibility."}},{"doi":"10.1542/peds.2025-075223","pmid":"42070784","title":"Maternal RSV Vaccination, Infant Nirsevimab, or Both: Interim Analysis of a Randomized Trial","journal_title":"Pediatrics","journal_issn":"0031-4005","published_at":"2026-05-04T00:00:00.000Z","url":"https://doi.org/10.1542/peds.2025-075223","source_score":18,"is_retracted":false,"is_open_access":false,"raw_metadata":{"ooir":{"day":"2026-05-07","doi":"10.1542/peds.2025-075223","days":"7","issn":"0031-4005","rank":"9","field":"Clinical Medicine","score":"18","category":"Pediatrics","categories":["Pediatrics"],"_categories":["Pediatrics"]},"pubmed":{"doi":"10.1542/peds.2025-075223","title":"Maternal RSV Vaccination, Infant Nirsevimab, or Both: Interim Analysis of a Randomized Trial.","journal":"Pediatrics","methods":"","results":"In total, 181 mothers were enrolled. Both products alone and in combination were safe. No related serious adverse events were observed in mothers or infants. Nirsevimab was well tolerated, and all local and systemic reactogenicity was mild to moderate in severity. RSVpreF vaccination boosted maternal RSV-A nAb titers 17.35-fold at the time of delivery, and titers were durable through 3 months postdelivery. The geometric mean transfer ratio of RSV-A nAbs was higher than 1.3 and similar across groups. RSV nAbs were highly elevated in infants at 6 weeks and 3 months, irrespective of group, with modest differences in waning.","abstract":"$36","keywords":[],"pubmed_id":"42070784","conclusions":"","publication_date":"2026-05-04T00:00:00"},"crossref":{"DOI":"10.1542/peds.2025-075223","URL":"https://doi.org/10.1542/peds.2025-075223","ISSN":["0031-4005","1098-4275"],"link":[{"URL":"https://publications.aap.org/pediatrics/article-pdf/doi/10.1542/peds.2025-075223/1930604/pediatrics.2025075223.pdf","content-type":"application/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https://publications.aap.org/pediatrics/article-pdf/doi/10.1542/peds.2025-075223/1930604/pediatrics.2025075223.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":null,"type":"journal-article","issue":null,"score":1,"title":["Maternal RSV Vaccination, Infant Nirsevimab, or Both: Interim Analysis of a Randomized Trial"],"author":[{"given":"Christina A.","family":"Rostad","sequence":"first","affiliation":[{"name":"1Children’s Healthcare of Atlanta Arthur M. 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Buddy","family":"Creech","sequence":"additional","affiliation":[{"name":"5Vanderbilt University Medical Center, Nashville, Tennessee"}]},{"given":"Judith M.","family":"Martin","sequence":"additional","affiliation":[{"name":"6University of Pittsburgh School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania"}]},{"given":"Rebecca C.","family":"Brady","sequence":"additional","affiliation":[{"name":"7University of Cincinnati College of Medicine, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio"}]},{"given":"Kimberly","family":"Jones-Beatty","sequence":"additional","affiliation":[{"name":"8University of Maryland School of Medicine, University of Maryland, Baltimore, Maryland"}]},{"given":"Martina","family":"Badell","sequence":"additional","affiliation":[{"name":"1Children’s Healthcare of Atlanta Arthur M. 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F.","family":"Pasetti","sequence":"additional","affiliation":[{"name":"12University of Maryland School of Medicine, University of Maryland, Baltimore, Maryland"}]},{"given":"Britta","family":"Flach","sequence":"additional","affiliation":[{"name":"11Fred Hutchinson Cancer Center, Seattle, Washington"}]},{"given":"Christine M.","family":"Posavad","sequence":"additional","affiliation":[{"name":"11Fred Hutchinson Cancer Center, Seattle, Washington"},{"name":"13University of Washington, Seattle, Washington"}]},{"given":"Joy","family":"Miedema","sequence":"additional","affiliation":[{"name":"14FHI 360, Washington, District of Columbia"}]},{"given":"Jeanna M.","family":"Piper","sequence":"additional","affiliation":[{"name":"15National Institutes of Health, Bethesda, Maryland"}]},{"given":"Sonnie","family":"Kim","sequence":"additional","affiliation":[{"name":"15National Institutes of Health, Bethesda, Maryland"}]},{"given":"Tatiana","family":"Beresnev","sequence":"additional","affiliation":[{"name":"15National Institutes of Health, Bethesda, Maryland"}]},{"given":"Cristina","family":"Cardemil","sequence":"additional","affiliation":[{"name":"15National Institutes of Health, Bethesda, Maryland"}]},{"given":"James D.","family":"Campbell","sequence":"additional","affiliation":[{"name":"8University of Maryland School of Medicine, University of Maryland, Baltimore, 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replicated.","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"warning","value":"The brand name of RSVpreF vaccine (Abrysvo, Pfizer) is inferred from the product description; the paper does not explicitly name the brand in the provided abstract.","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"warning","value":"The study is not powered to detect differences in RSV lower respiratory tract infection rates — only immunogenicity and safety endpoints are reported.","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"warning","value":"The total n reflects mothers enrolled; the number of infants was not explicitly stated.","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"warning","value":"This is an interim analysis; 12-month clinical efficacy and full safety data are not yet available.","value_numeric":null}],"summaries":{"what_studied":"A prospective, randomized, open-label phase 4 trial at 8 US sites assigned pregnant participants and their infants 1:1:1:1 to maternal RSVpreF alone, maternal RSVpreF plus infant nirsevimab at birth, maternal RSVpreF plus infant nirsevimab at 3 months, or infant nirsevimab alone at birth, with planned 12‑month follow-up; this interim report includes infant data to 4 months.","key_result":"Among 181 mothers, no related serious adverse events occurred in mothers or infants; nirsevimab was well tolerated with only mild to moderate local and systemic reactogenicity. Maternal RSVpreF increased maternal RSV‑A neutralizing antibody titers 17.35‑fold at delivery with durability to 3 months; infant geometric mean transfer ratio of RSV‑A nAbs was >1.3 across groups, and infant RSV nAbs were high at 6 weeks and 3 months with modest waning.","limitations":"Open-label design. Interim analysis with infant follow-up only to 4 months, and outcomes reported focus on safety and neutralizing antibody responses rather than clinical RSV disease.","practice_takeaway":"Maternal RSVpreF vaccination and infant nirsevimab, alone or in sequence, were well tolerated and yielded high infant RSV neutralizing titers through 3 months in this interim analysis. 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Impact was estimated with Poisson models versus historical non‑pandemic seasons (2017–18 to 2022–23), adjusted for RSV seasonality; the primary endpoint was RSV-related LRTI hospitalisation.","key_result":"RSV-related LRTI hospitalisations fell by 85.9% (95% CI 80.2–90.0) in the first season and 55.3% (22.5–74.3) in the second; an estimated 123 infants needed to be immunised to prevent one second‑season admission.","limitations":"Non-randomised design with historical comparators may be affected by secular trends. Industry funding (Sanofi and AstraZeneca).","practice_takeaway":"In a universal program, a single infant dose of nirsevimab markedly reduced RSV-related hospitalisations and outpatient visits, with sustained but smaller hospitalisation reductions into the second season. All-cause hospitalisations declined only in the first season."}}],"initialOffset":11,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"brand","value":"Beyfortus"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Brands","href":"/hub/tag/brand"},{"name":"Beyfortus"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"brand","hub_tag_value":"Beyfortus"}}}]] 25:null 29:[["$","title","0",{"children":"Beyfortus: Research & Clinical Takeaways | ReachRx"}],["$","meta","1",{"name":"description","content":"Explore peer-reviewed papers on Beyfortus (brand). Clinician-written summaries and actionable practice insights. 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