{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T02:12:11Z","timestamp":1788401531871,"version":"build-2803163510"},"reference-count":70,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T00:00:00Z","timestamp":1754006400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Pfizer Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Background\/objectives: This was a post hoc analysis of safety data across the bivalent respiratory syncytial virus prefusion F (RSVpreF) vaccine clinical trial development program. Methods: Data from eight clinical trials in 46,913 immunocompetent adults who received RSVpreF or placebo were analyzed. Local reactions and systemic events were assessed among non-pregnant \u226518-year-olds (n = 9517); adverse events (AEs) among pregnant and non-pregnant 18\u201359-year-olds (n = 9238); and vaccine-related AEs among non-pregnant \u226518-year-olds (n = 39,314). Post-marketing data in non-pregnant adults were considered. Results: Local reactions and systemic events were reported more frequently in RSVpreF versus placebo recipients; injection site pain was the most common local reaction (RSVpreF, 18.9%; placebo, 7.4%), and fatigue (23.5%; 18.4%) and headache (19.5%; 15.0%) were the most common systemic events. Percentages of AEs within 1 month after vaccination were similar across groups (RSVpreF, 12.8%; placebo, 13.1%); severe AEs were reported in \u22641.5% of participants. Differences in percentages of individuals reporting vaccine-related AEs between the RSVpreF and placebo groups were &lt;0.2% for all related AEs. Serious AEs throughout the study were reported in \u226414.0% (RSVpreF, 12.6%; placebo, 14.0%). No atrial fibrillation, Guillain-Barr\u00e9 syndrome, or acute polyneuropathy cases were reported. The AE data from post-marketing data sources were consistent with the safety profile from the clinical trial program, with no new safety concerns. Conclusions: Integrated data demonstrated that RSVpreF was well tolerated with a favorable safety profile in non-pregnant and pregnant adults. Ongoing surveillance through real-world use and clinical trial experience continue to support the safety profile of RSVpreF. ClinicalTrials.gov: NCT03529773\/NCT04071158\/NCT04785612\/NCT05035212\/NCT05096208\/NCT05842967\/NCT04032093\/NCT04424316.<\/jats:p>","DOI":"10.3390\/vaccines13080827","type":"journal-article","created":{"date-parts":[[2025,8,6]],"date-time":"2025-08-06T15:09:53Z","timestamp":1754492993000},"page":"827","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Integrated Analysis of the Safety Experience in Adults with the Bivalent Respiratory Syncytial Virus Prefusion F Vaccine"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-0327-9265","authenticated-orcid":false,"given":"Kumar","family":"Ilangovan","sequence":"first","affiliation":[{"name":"Vaccine Research & Development, Pfizer Inc., Pearl River, NY 10965, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Radley","sequence":"additional","affiliation":[{"name":"Vaccine Research & Development, Pfizer Inc., Pearl River, NY 10965, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Patton","sequence":"additional","affiliation":[{"name":"Vaccine Research & Development, Pfizer Ltd., Marlow SL7 1YL, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emma","family":"Shittu","sequence":"additional","affiliation":[{"name":"Vaccine Research & Development, Pfizer Ltd., Marlow SL7 1YL, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Maddalena","family":"Lino","sequence":"additional","affiliation":[{"name":"Worldwide Safety, Pfizer Srl, 20152 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christos","family":"Goulas","sequence":"additional","affiliation":[{"name":"Worldwide Safety, Pfizer Hellas SA, 55535 Thessaloniki, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3389-8414","authenticated-orcid":false,"given":"Kena A.","family":"Swanson","sequence":"additional","affiliation":[{"name":"Vaccine Research & Development, Pfizer Inc., Pearl River, NY 10965, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annaliesa S.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Vaccine Research & Development, Pfizer Inc., Pearl River, NY 10965, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alejandra","family":"Gurtman","sequence":"additional","affiliation":[{"name":"Vaccine Research & Development, Pfizer Inc., Pearl River, NY 10965, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iona","family":"Munjal","sequence":"additional","affiliation":[{"name":"Vaccine Research & Development, Pfizer Inc., Pearl River, NY 10965, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,8,1]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"220105","DOI":"10.1183\/16000617.0105-2022","article-title":"Burden of respiratory syncytial virus infection in older and high-risk adults: A systematic review and meta-analysis of the evidence from developed countries","volume":"31","author":"Martin","year":"2022","journal-title":"Eur. 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