PMID- 35768434 OWN - NLM STAT- MEDLINE DCOM- 20220701 LR - 20240216 IS - 2045-2322 (Electronic) IS - 2045-2322 (Linking) VI - 12 IP - 1 DP - 2022 Jun 29 TI - Comparability of clinical trials and spontaneous reporting data regarding COVID-19 vaccine safety. PG - 10946 LID - 10.1038/s41598-022-13809-7 [doi] LID - 10946 AB - 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. CI - (c) 2022. The Author(s). FAU - Luo, Chongliang AU - Luo C AD - Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, PA, 19104, USA. AD - Division of Public Health Sciences, Washington University School of Medicine in St. Louis, St. Louis, MO, USA. FAU - Du, Jingcheng AU - Du J AD - School of Biomedical Informatics, The University of Texas Health Science Center at Houston, Houston, TX, USA. FAU - Cuker, Adam AU - Cuker A AD - Department of Medicine and Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. FAU - Lautenbach, Ebbing AU - Lautenbach E AD - Division of Infectious Diseases, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. AD - Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. FAU - Asch, David A AU - Asch DA AD - Division of General Internal Medicine, University of Pennsylvania, Philadelphia, PA, USA. AD - Leonard Davis Institute of Health Economics, Philadelphia, PA, USA. FAU - Poland, Gregory A AU - Poland GA AD - Mayo Clinic Vaccine Research Group, Mayo Clinic, Rochester, MN, USA. FAU - Tao, Cui AU - Tao C AD - School of Biomedical Informatics, The University of Texas Health Science Center at Houston, Houston, TX, USA. FAU - Chen, Yong AU - Chen Y AD - Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, PA, 19104, USA. ychen123@upenn.edu. AD - Leonard Davis Institute of Health Economics, Philadelphia, PA, USA. ychen123@upenn.edu. LA - eng GR - R56 AG069880/AG/NIA NIH HHS/United States GR - R56 AG074604/AG/NIA NIH HHS/United States GR - R01 LM013519/LM/NLM NIH HHS/United States GR - 1R01AI130460/NH/NIH HHS/United States GR - R01 AG073435/AG/NIA NIH HHS/United States GR - R01 AI130460/AI/NIAID NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural DEP - 20220629 PL - England TA - Sci Rep JT - Scientific reports JID - 101563288 RN - 0 (COVID-19 Vaccines) SB - IM MH - Adverse Drug Reaction Reporting Systems MH - COVID-19/epidemiology/prevention & control MH - *COVID-19 Vaccines/adverse effects MH - Humans MH - Randomized Controlled Trials as Topic MH - United States/epidemiology MH - *Vaccination/adverse effects PMC - PMC9243073 COIS- Dr. Cuker has served as a consultant for Synergy; has received authorship royalties from UpToDate; and his institution has received research support on his behalf from Alexion, Bayer, Novartis, Novo Nordisk, Pfizer, Sanofi, Spark, and Takeda. Dr. Asch is partner and part owner of VAL Health. Dr. Poland is the chair of a Safety Evaluation Committee for novel investigational vaccine trials being conducted by Merck Research Laboratories. Dr. Poland provides consultative advice on vaccine development to Merck & Co., Medicago, GlaxoSmithKline, Sanofi Pasteur, Johnson & Johnson/Janssen Global Services LLC, Emergent Biosolutions, Dynavax, Genentech, Eli Lilly and Company, Kentucky Bioprocessing, Bavarian Nordic, AstraZeneca, Exelixis, Regeneron, Janssen, Vyriad, Moderna, and Genevant Sciences, Inc. These activities have been reviewed by the Mayo Clinic Conflict of Interest Review Board and are conducted in compliance with Mayo Clinic Conflict of Interest policies. Dr. Poland holds patents related to vaccinia, influenza, and measles peptide vaccines. Dr. Poland has received grant funding from ICW Ventures for preclinical studies on a peptide-based COVID-19 vaccine. This research has been reviewed by the Mayo Clinic Conflict of Interest Review Board and was conducted in compliance with Mayo Clinic Conflict of Interest policies. The rest of the authors report no conflicts of interest. EDAT- 2022/06/30 06:00 MHDA- 2022/07/02 06:00 PMCR- 2022/06/29 CRDT- 2022/06/29 23:15 PHST- 2022/02/08 00:00 [received] PHST- 2022/05/27 00:00 [accepted] PHST- 2022/06/29 23:15 [entrez] PHST- 2022/06/30 06:00 [pubmed] PHST- 2022/07/02 06:00 [medline] PHST- 2022/06/29 00:00 [pmc-release] AID - 10.1038/s41598-022-13809-7 [pii] AID - 13809 [pii] AID - 10.1038/s41598-022-13809-7 [doi] PST - epublish SO - Sci Rep. 2022 Jun 29;12(1):10946. doi: 10.1038/s41598-022-13809-7.