{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T11:54:43Z","timestamp":1793361283725,"version":"4.5.0"},"reference-count":13,"publisher":"American Medical Association (AMA)","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"\n Importance<\/jats:title>\n Respiratory syncytial virus (RSV) is associated with hospitalization and death among older adults. Characterizing the safety and effectiveness of recently introduced vaccines against RSV is critical.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To assess the safety and effectiveness of vaccines against RSV and the major adverse events among patients aged 60 years or older during the 2023-2024 RSV season.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n In this study using a data platform containing electronic health records for more than 270 million patients across the US, a test-negative case-control design was used to estimate vaccine effectiveness (VE), and a self-controlled case series of vaccine recipients was included to estimate vaccine-associated adverse events. Records from participants aged 60 years or older with acute respiratory infection (ARI) and testing for RSV between October 1, 2023, and April 30, 2024, were included in the VE study. For vaccine safety analysis, all participants aged 60 years or older who received the RSV vaccine from July 1, 2023, to June 30, 2024 were included. Data were analyzed from August 2024 to March 2025.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n Cases were those patients who tested positive for RSV, and controls were those who tested negative for RSV. Patients were classified as vaccinated if the vaccine was received at least 14 days before testing. VE against RSV-associated ARI diagnosis, emergency department or urgent care visits, or hospitalizations was estimated using (1\u2009\u2212\u2009odds ratio)\u2009\u00d7\u2009100%. Excess risks of immune thrombocytopenic purpura and Guillain-Barr\u00e9 syndrome diagnosis for 6 weeks after vaccine administration were calculated.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Of 787\u202f822 patients tested for RSV, 53\u202f963 were positive (733\u202f859 were controls); 1318 cases (2.4%) and 66\u202f928 controls (9.1%) were vaccinated. Overall, VE was 75.1% (95% CI, 73.6%-76.4%) against ARI and was similar for age groups of 60 to 74 years and 75 years or older and against urgent care visits or hospitalizations. Immunocompromised patients had a VE from 67.0% (95% CI, 62.6%-70.9%) for patients aged 60 to 74 years to 73.1% (95% CI, 69.9%-76.0%) for those aged 75 years or older, and the lowest VE (ie, from 29.4% [95% CI, 3.5%-48.4%] for patients aged 60-74 years to 44.4% [95% CI, 1.0%-68.8%] for those aged \u226575 years) was for a subgroup of patients who received stem cell transplants. Among 4\u202f746\u202f518 vaccine recipients, no excess risk of immune thrombocytopenic purpura diagnosis was detected. An excess of 5.2 cases (RSVPreF3+AS01) or 18.2 cases (RSVPreF) of Guillain-Barr\u00e9 syndrome were diagnosed per 1\u202f000\u202f000 doses of RSV vaccine administered.<\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n VE for the RSV protein subunit vaccine in this case-control study was similar to the VE in clinical trials. The VE for immunocompromised patients was mildly (overall) to moderately (for stem cell transplant recipients) diminished. Risk of immune thrombocytopenic purpura after vaccination was not elevated, but the risk of Guilain-Barr\u00e9 syndrome was statistically significantly elevated in patients who received the RSVPreF vaccine but not in those who received RSVPreF+AS01 vaccine, although the risk was small. These observations should inform clinicians\u2019 choices and patient instructions.<\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2025.8322","type":"journal-article","created":{"date-parts":[[2025,5,9]],"date-time":"2025-05-09T11:30:32Z","timestamp":1746790232000},"page":"e258322","source":"Crossref","is-referenced-by-count":75,"title":["Effectiveness and Safety of Respiratory Syncytial Virus Vaccine for US Adults Aged 60 Years or Older"],"prefix":"10.1001","volume":"8","author":[{"given":"Sarah E.","family":"Fry","sequence":"first","affiliation":[{"name":"Center for Artificial Intelligence in Drug Discovery, Case Western Reserve University School of Medicine, Cleveland, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pauline","family":"Terebuh","sequence":"additional","affiliation":[{"name":"Center for Artificial Intelligence in Drug Discovery, Case Western Reserve University School of Medicine, Cleveland, Ohio"},{"name":"Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David C.","family":"Kaelber","sequence":"additional","affiliation":[{"name":"The Center for Clinical Informatics Research and Education, MetroHealth System, Cleveland, Ohio"},{"name":"Department of Medicine, Case Western Reserve University, Cleveland, Ohio"},{"name":"Department of Pediatrics, Case Western Reserve University, Cleveland, Ohio"},{"name":"Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rong","family":"Xu","sequence":"additional","affiliation":[{"name":"Center for Artificial Intelligence in Drug Discovery, Case Western Reserve University School of Medicine, Cleveland, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela B.","family":"Davis","sequence":"additional","affiliation":[{"name":"Center for Community Health Integration, Case Western Reserve University, Cleveland, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","published-online":{"date-parts":[[2025,5,9]]},"reference":[{"issue":"29","key":"zoi250302r3","doi-asserted-by":"publisher","first-page":"793","DOI":"10.15585\/mmwr.mm7229a4","article-title":"Use of respiratory syncytial virus vaccines in older adults: recommendations of the Advisory Committee on Immunization Practices\u2014United States, 2023.","volume":"72","author":"Melgar","year":"2023","journal-title":"MMWR Morb Mortal Wkly Rep"},{"issue":"32","key":"zoi250302r4","doi-asserted-by":"publisher","first-page":"696","DOI":"10.15585\/mmwr.mm7332e1","article-title":"Use of respiratory syncytial virus vaccines in adults aged =60 years: updated recommendations of the Advisory Committee on Immunization Practices\u2014United States, 2024.","volume":"73","author":"Britton","year":"2024","journal-title":"MMWR Morb Mortal Wkly Rep"},{"issue":"26","key":"zoi250302r6","doi-asserted-by":"publisher","first-page":"2434","DOI":"10.1056\/NEJMoa2215201","article-title":"Vaccine effectiveness of JYNNEOS against mpox disease in the United States.","volume":"388","author":"Deputy","year":"2023","journal-title":"N Engl J Med"},{"issue":"5","key":"zoi250302r7","doi-asserted-by":"publisher","first-page":"1063","DOI":"10.1038\/s41591-022-01753-y","article-title":"Effectiveness of mRNA-1273 against SARS-CoV-2 Omicron and Delta variants.","volume":"28","author":"Tseng","year":"2022","journal-title":"Nat Med"},{"issue":"21","key":"zoi250302r9","doi-asserted-by":"publisher","first-page":"489","DOI":"10.15585\/mmwr.mm7321a3","article-title":"Early safety findings among persons aged =60 years who received a respiratory syncytial virus vaccine\u2014United States, May 3, 2023\u2013April 14, 2024.","volume":"73","author":"Hause","year":"2024","journal-title":"MMWR Morb Mortal Wkly Rep"},{"issue":"13","key":"zoi250302r11","doi-asserted-by":"publisher","first-page":"1105","DOI":"10.1001\/jama.2024.15775","article-title":"RSV vaccine effectiveness against hospitalization among US adults 60 years and older.","volume":"332","author":"Surie","year":"2024","journal-title":"JAMA"},{"issue":"6","key":"zoi250302r12","doi-asserted-by":"publisher","first-page":"602","DOI":"10.1001\/jamainternmed.2024.0212","article-title":"Acute cardiac events in hospitalized older adults with respiratory syncytial virus infection.","volume":"184","author":"Woodruff","year":"2024","journal-title":"JAMA Intern Med"},{"issue":"3","key":"zoi250302r13","doi-asserted-by":"publisher","first-page":"599","DOI":"10.1016\/j.vaccine.2010.06.003","article-title":"Guillain-Barr\u00e9 syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immunization safety data.","volume":"29","author":"Sejvar","year":"2011","journal-title":"Vaccine"},{"key":"zoi250302r1","unstructured":"Food and Drug Administration. Approval letter: AREXVY. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration. May 23, 2023. Accessed October 21, 2024. https:\/\/www.fda.gov\/media\/167806\/download"},{"key":"zoi250302r2","unstructured":"Food and Drug Administration. Approval letter: ABRYSVO. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration. May 31, 2023. Accessed October 21, 2024. https:\/\/www.fda.gov\/media\/168890\/download"},{"key":"zoi250302r5","unstructured":"Epic Systems. Epic Cosmos. Accessed March 25, 2025. https:\/\/cosmos.epic.com\/"},{"key":"zoi250302r8","unstructured":"Lloyd? P. Evaluation of Guillain-Barre syndrome (GBS) following RSV vaccination among adults 65 years and older [Presentation slides]. Presented at the Advisory Committee on Immunization Practices meeting, Atlanta, GA; June 26, 2024. Accessed March 20, 2025. https:\/\/www.cdc.gov\/acip\/downloads\/slides-2024-06-26-28\/06-RSV-Adult-Lloyd-508.pdf"},{"key":"zoi250302r10","unstructured":"Surie? D. Effectiveness of adult respiratory syncytial virus (RSV) vaccines, 2023\u20132024 [Presentation slides]. Presented at the Advisory Committee on Immunization Practices meeting, Atlanta, GA; June 26, 2024. Accessed March 20, 2025. https:\/\/www.cdc.gov\/acip\/downloads\/slides-2024-06-26-28\/07-RSV-Adult-Surie-508.pdf"}],"container-title":["JAMA Network Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/articlepdf\/2833776\/fry_2025_oi_250302_1746203859.61115.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,5,9]],"date-time":"2025-05-09T11:30:35Z","timestamp":1746790235000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/fullarticle\/2833776"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,9]]},"references-count":13,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2025,5,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamanetworkopen.2025.8322","relation":{},"ISSN":["2574-3805"],"issn-type":[{"value":"2574-3805","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,9]]}}}