{"title":"Meet the Equation: ITT Episode 2.1.","authors":"","doi":"10.1056/NEJMp2601974","DOIUrl":"https://doi.org/10.1056/NEJMp2601974","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"394 18","pages":"e34"},"PeriodicalIF":78.5,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147846160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Thuy-Lan Lite, Stephanie Goya, Margaret L Davis, Amy E Morris, Chloe Bryson-Cahn, Alexander Vengerovsky, Carlos G Corpuz, B Ethan Nunley, Janine R Maenza, Thomas R Hawn, Andrew M Luks, John B Lynch, Timothy M Uyeki, Helen Y Chu, Alexander L Greninger, Clifford C Sung
{"title":"Human Infection with Highly Pathogenic Avian Influenza A(H5N5) Virus.","authors":"Thuy-Lan Lite, Stephanie Goya, Margaret L Davis, Amy E Morris, Chloe Bryson-Cahn, Alexander Vengerovsky, Carlos G Corpuz, B Ethan Nunley, Janine R Maenza, Thomas R Hawn, Andrew M Luks, John B Lynch, Timothy M Uyeki, Helen Y Chu, Alexander L Greninger, Clifford C Sung","doi":"10.1056/NEJMc2518178","DOIUrl":"https://doi.org/10.1056/NEJMc2518178","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":78.5,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147846176","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Isabel Leroux-Roels, Grace Huang, Murdo Ferguson, Anita Kohli, Rebecca Clark, Markus Bickel, Mieke Soens, Evelyn Du, Alicia Pucci, Bryony Hicks, Colbie Eschen, Rituparna Das, Eleanor Wilson
{"title":"Efficacy and Safety of an mRNA Seasonal Influenza Vaccine in Adults.","authors":"Isabel Leroux-Roels, Grace Huang, Murdo Ferguson, Anita Kohli, Rebecca Clark, Markus Bickel, Mieke Soens, Evelyn Du, Alicia Pucci, Bryony Hicks, Colbie Eschen, Rituparna Das, Eleanor Wilson","doi":"10.1056/NEJMoa2516491","DOIUrl":"https://doi.org/10.1056/NEJMoa2516491","url":null,"abstract":"<p><strong>Background: </strong>Seasonal influenza causes substantial illness and death in adults 50 years of age or older, even with current vaccines. An investigational messenger RNA (mRNA)-based vaccine called mRNA-1010 encodes hemagglutinin glycoproteins from World Health Organization-recommended influenza strains.</p><p><strong>Methods: </strong>In this phase 3, double-blind, active-controlled trial, we randomly assigned adults 50 years of age or older to receive trivalent mRNA-1010 (37.5 μg, which includes 12.5 μg of each strain) or a licensed standard-dose comparator. The primary efficacy end point was relative vaccine efficacy against reverse-transcriptase-polymerase-chain-reaction (RT-PCR)-confirmed, protocol-defined influenza-like illness caused by influenza A or B, from at least 14 days after vaccination through the end of the influenza season. Hypothesis testing was conducted hierarchically to assess noninferiority (lower boundary of the 95% confidence interval [CI], >-10%), superiority (lower boundary of the 95% CI, >0%), and a higher level of superiority (lower boundary of the 95% CI, >9.1%).</p><p><strong>Results: </strong>A total of 40,703 participants received mRNA-1010 (20,350 participants) or the standard-dose comparator (20,353 participants); the median follow-up was 181 days (range, 1 to 227). RT-PCR-confirmed, protocol-defined influenza-like illness was observed in 411 of 20,179 recipients of mRNA-1010 (2.0%) and 557 of 20,124 recipients of the standard-dose comparator (2.8%), which corresponds to a relative vaccine efficacy of 26.6% (95% CI, 16.7 to 35.4), thereby meeting the criteria for noninferiority, superiority, and higher-level superiority. Solicited adverse reactions were more frequent with mRNA-1010 than with the standard-dose comparator (injection-site pain in 65.8% vs. 29.8%, fatigue in 45.1% vs. 20.3%, headache in 37.8% vs. 18.0%, and myalgia in 35.4% vs. 11.6%); most reactions were mild to moderate and transient. Serious adverse events were reported in 2.2% of the recipients of mRNA-1010 (with three events considered by the investigator to be vaccine-related) and in 1.9% of the recipients of the standard-dose comparator (with two events considered by the investigator to be vaccine-related).</p><p><strong>Conclusions: </strong>In this trial, mRNA-1010 was superior to standard-dose licensed vaccines for prevention of RT-PCR-confirmed, protocol-defined influenza-like illness in adults 50 years of age or older. Solicited adverse reactions were more frequent with mRNA-1010. (Funded by Blackstone Life Sciences and Moderna; Fluent ClinicalTrials.gov number, NCT06602024.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"394 18","pages":"1803-1813"},"PeriodicalIF":78.5,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147846191","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Antithrombotic Therapy after Ablation for Atrial Fibrillation.","authors":"Paweł T Matusik, Leon M Ptaszek","doi":"10.1056/NEJMc2602513","DOIUrl":"https://doi.org/10.1056/NEJMc2602513","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"394 18","pages":"1868-1869"},"PeriodicalIF":78.5,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147846231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Antithrombotic Therapy after Ablation for Atrial Fibrillation.","authors":"Simon Christie, Andrew P Sullivan","doi":"10.1056/NEJMc2602513","DOIUrl":"https://doi.org/10.1056/NEJMc2602513","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"394 18","pages":"1869"},"PeriodicalIF":78.5,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147846236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"An Evidence-Based Approach to Covid-19 Vaccination.","authors":"Eric A Meyerowitz","doi":"10.1056/NEJMc2507760","DOIUrl":"10.1056/NEJMc2507760","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":"e37"},"PeriodicalIF":78.5,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144602258","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Philipp Krisai, Michael Kühne, Christian Sticherling
{"title":"Antithrombotic Therapy after Ablation for Atrial Fibrillation.","authors":"Philipp Krisai, Michael Kühne, Christian Sticherling","doi":"10.1056/NEJMc2602513","DOIUrl":"https://doi.org/10.1056/NEJMc2602513","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"394 18","pages":"1869-1870"},"PeriodicalIF":78.5,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147846228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ann Marie Navar, Alberico L Catapano, Christie M Ballantyne
{"title":"Trial of the Oral PCSK9 Inhibitor Enlicitide. Reply.","authors":"Ann Marie Navar, Alberico L Catapano, Christie M Ballantyne","doi":"10.1056/NEJMc2602975","DOIUrl":"https://doi.org/10.1056/NEJMc2602975","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"394 18","pages":"1868"},"PeriodicalIF":78.5,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147846289","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Trial of the Oral PCSK9 Inhibitor Enlicitide.","authors":"Xuemei Xie, Guandou Yuan","doi":"10.1056/NEJMc2602975","DOIUrl":"https://doi.org/10.1056/NEJMc2602975","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"394 18","pages":"1867-1868"},"PeriodicalIF":78.5,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147846270","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}