{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T06:08:59Z","timestamp":1789711739542,"version":"4.0.1"},"reference-count":40,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T00:00:00Z","timestamp":1789689600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Public Health"],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Respiratory syncytial virus (RSV) is the leading cause of infant lower respiratory tract infection (LRTI) and hospitalisation worldwide. Maternal RSV prefusion F (RSVpreF) vaccination protects infants through transplacental antibody transfer. We aimed to synthesise the efficacy, real-world effectiveness, and safety of maternal RSV vaccination for preventing infant LRTI, integrating randomised and observational evidence.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We searched PubMed, Embase, Scopus, and Cochrane CENTRAL (to June 2026) for randomised controlled trials (RCTs) and observational studies of maternal RSV vaccination reporting infant LRTI, hospitalisation, or maternal\u2013infant safety. A single reviewer, with large language model-assisted verification, screened records, extracted data, and assessed risk of bias (RoB 2; Newcastle\u2013Ottawa Scale). Randomised and observational evidence were pooled separately using random-effects models; overlapping populations were resolved based on study periods and named participating sites. Certainty was rated with GRADE (PROSPERO CRD420261400053).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Twenty-four studies (9 RCTs enrolling approximately 18,600 pregnant women, 15 observational) were included; all 15 observational studies evaluated the licensed Pfizer vaccine (Abrysvo). Pooled vaccine effectiveness against infant RSV-associated hospitalisation was 79.7% (95% CI 73.9\u201384.2) within 3\u202fmonths and 68.1% (57.1\u201376.3) through 6\u202fmonths. Randomised efficacy against severe RSV-LRTI was 70% for the licensed Pfizer vaccine, closely concordant with the real-world effectiveness; efficacy against medically attended RSV-LRTI was 51.5% (36.3\u201363.1). Preterm birth was modestly increased in the randomised trials (Mantel\u2013Haenszel RR 1.17, 95% CI 1.03\u20131.32), but the signal was not robust: it became non-significant after excluding the GSK trial (GRACE; 1.10, 0.95\u20131.27), and for the licensed Pfizer vaccine, the increase was small and not robustly significant (pivotal MATISSE trial 1.20, 0.98\u20131.46; three-trial Pfizer pool 1.21, 1.00\u20131.46), while observational data showed a biologically implausible protective association (0.90, 0.82\u20130.99), consistent with healthy vaccinee confounding. No other maternal or neonatal safety signal was identified. Certainty of evidence was moderate for effectiveness and efficacy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Maternal RSVpreF vaccination confers substantial, generalisable protection against infant RSV disease, with randomised and real-world evidence in close agreement. For the licensed Pfizer vaccine administered within its approved 32\u201336-week window, no robustly significant increase in preterm birth is established, supporting its continued programmatic use alongside ongoing post-marketing surveillance.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Systematic review registration<\/jats:title>\n                    <jats:p>\n                      Unique Identifier: CRD420261400053\n                      <jats:ext-link>https:\/\/www.crd.york.ac.uk\/PROSPERO\/view\/CRD420261400053<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fpubh.2026.1935421","type":"journal-article","created":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T05:38:20Z","timestamp":1789709900000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and safety of maternal RSV vaccination against infant lower respiratory tract infections: a systematic review and meta-analysis"],"prefix":"10.3389","volume":"14","author":[{"given":"Gokce Naz","family":"Kucukbas Ozonder","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology, Perinatology Division, Kocaeli City Hospital","place":["Kocaeli, T\u00fcrkiye"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arzu","family":"Yavuz","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Kocaeli City Hospital, University of Health Sciences","place":["Kocaeli, T\u00fcrkiye"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,9,18]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"2047","DOI":"10.1016\/S0140-6736(22)00478-0","article-title":"Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5\u202fyears in 2019: a systematic analysis","volume":"399","author":"Li","year":"2022","journal-title":"Lancet"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"1451","DOI":"10.1056\/NEJMoa2216480","article-title":"Bivalent prefusion F vaccine in pregnancy to prevent respiratory syncytial virus illness in infants","volume":"388","author":"Kampmann","year":"2023","journal-title":"N Engl J Med"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"1009","DOI":"10.1056\/NEJMoa2305478","article-title":"RSV prefusion F protein-based maternal vaccine - preterm birth and other outcomes","volume":"390","author":"Dieussaert","year":"2024","journal-title":"N Engl J Med"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"426","DOI":"10.1056\/NEJMoa1908380","article-title":"Respiratory syncytial virus vaccination during pregnancy and effects in infants","volume":"383","author":"Madhi","year":"2020","journal-title":"N Engl J 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pregnancy","volume":"386","author":"Sim\u00f5es","year":"2022","journal-title":"N Engl J Med"},{"key":"ref8","volume-title":"Safety Monitoring of Pfizer\u2019s RSVpreF Vaccine in Pregnancy: Preterm and Small-for-Gestational-Age Birth","year":"2025"},{"key":"ref9","doi-asserted-by":"publisher","first-page":"127","DOI":"10.1097\/AOG.0000000000006130","article-title":"Maternal respiratory syncytial virus vaccination and preterm birth: a Utah statewide retrospective cohort study","volume":"147","author":"Solsman","year":"2026","journal-title":"Obstet Gynecol"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"3465","DOI":"10.1016\/S0264-410X(03)00352-9","article-title":"Safety and immunogenicity of respiratory syncytial virus purified fusion protein-2 vaccine in pregnant 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leading to hospitalisation in infants during the 2024 RSV season in Argentina (BERNI study): a multicentre, retrospective, test-negative, case-control study","volume":"25","author":"P\u00e9rez Marc","year":"2025","journal-title":"Lancet Infect Dis"},{"key":"ref14","doi-asserted-by":"publisher","first-page":"637","DOI":"10.1016\/S2352-4642(26)00134-3","article-title":"A national programme of bivalent prefusion F vaccination in pregnancy and protection against respiratory syncytial virus hospitalisation in infants until age 6 months in the UK: a multicentre, prospective, test-negative, case-control study","volume":"10","author":"O\u2019Hagan","year":"2026","journal-title":"Lancet Child Adolesc Health"},{"key":"ref15","doi-asserted-by":"publisher","first-page":"e2616773","DOI":"10.1001\/jamanetworkopen.2026.16773","article-title":"Maternal respiratory syncytial virus prefusion F vaccination and acute respiratory illness in 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