| アブストラクト | Severe adverse events (AEs) after COVID-19 vaccination are not well studied in randomized controlled trials (RCTs) due to rarity and short follow-up. To monitor the safety of COVID-19 vaccines ("Pfizer" vaccine dose 1 and 2, "Moderna" vaccine dose 1 and 2, and "Janssen" vaccine single dose) in the U.S., especially regarding severe AEs, we compare the relative rankings of these vaccines using both RCT and the Vaccine Adverse Event Reporting System (VAERS) data. The risks of local and systemic AEs were assessed from the three pivotal COVID-19 vaccine trials and also calculated in the VAERS cohort consisting of 559,717 reports between December 14, 2020 and September 17, 2021. AE rankings of the five vaccine groups calculated separately by RCT and VAERS were consistent, especially for systemic AEs. For severe AEs reported in VAERS, the reported risks of thrombosis and GBS after Janssen vaccine were highest. The reported risk of shingles after the first dose of Moderna vaccine was highest, followed by the second dose of the Moderna vaccine. The reported risk of myocarditis was higher after the second dose of Pfizer and Moderna vaccines. The reported risk of anaphylaxis was higher after the first dose of Pfizer vaccine. Limitations of this study are the inherent biases of the spontaneous reporting system data, and only including three pivotal RCTs and no comparison with other active vaccine safety surveillance systems. |
|---|
| 投稿者 | Luo, Chongliang; Du, Jingcheng; Cuker, Adam; Lautenbach, Ebbing; Asch, David A; Poland, Gregory A; Tao, Cui; Chen, Yong |
|---|
| 組織名 | Department of Biostatistics, Epidemiology and Informatics, University of;Pennsylvania, Philadelphia, PA, 19104, USA.;Division of Public Health Sciences, Washington University School of Medicine in;St. Louis, St. Louis, MO, USA.;School of Biomedical Informatics, The University of Texas Health Science Center;at Houston, Houston, TX, USA.;Department of Medicine and Department of Pathology and Laboratory Medicine,;Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.;Division of Infectious Diseases, Department of Medicine, Perelman School of;Medicine, University of Pennsylvania, Philadelphia, PA, USA.;Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine,;University of Pennsylvania, Philadelphia, PA, USA.;Division of General Internal Medicine, University of Pennsylvania, Philadelphia,;PA, USA.;Leonard Davis Institute of Health Economics, Philadelphia, PA, USA.;Mayo Clinic Vaccine Research Group, Mayo Clinic, Rochester, MN, USA.;Pennsylvania, Philadelphia, PA, 19104, USA. ychen123@upenn.edu.;ychen123@upenn.edu. |
|---|
