| アブストラクト | Two messenger RNA (mRNA) vaccines developed by Pfizer-BioNTech and Moderna are being rolled out. Despite the high volume of emerging evidence regarding adverse events (AEs) associated with the COVID-19 mRNA vaccines, previous studies have thus far been largely based on the comparison between vaccinated and unvaccinated control, possibly highlighting the AE risks with COVID-19 mRNA vaccination. Comparing the safety profile of mRNA vaccinated individuals with otherwise vaccinated individuals would enable a more relevant assessment for the safety of mRNA vaccination. We designed a comparative safety study between 18 755 and 27 895 individuals who reported to VigiBase for adverse events following immunization (AEFI) with mRNA COVID-19 and influenza vaccines, respectively, from January 1, 2020, to January 17, 2021. We employed disproportionality analysis to rapidly detect relevant safety signals and compared comparative risks of a diverse span of AEFIs for the vaccines. The safety profile of novel mRNA vaccines was divergent from that of influenza vaccines. The overall pattern suggested that systematic reactions like chill, myalgia, fatigue were more noticeable with the mRNA COVID-19 vaccine, while injection site reactogenicity events were more prevalent with the influenza vaccine. Compared to the influenza vaccine, mRNA COVID-19 vaccines demonstrated a significantly higher risk for a few manageable cardiovascular complications, such as hypertensive crisis (adjusted reporting odds ratio [ROR], 12.72; 95% confidence interval [CI], 2.47-65.54), and supraventricular tachycardia (adjusted ROR, 7.94; 95% CI, 2.62-24.00), but lower risk of neurological complications such as syncope, neuralgia, loss of consciousness, Guillain-Barre syndrome, gait disturbance, visual impairment, and dyskinesia. This study has not identified significant safety concerns regarding mRNA vaccination in real-world settings. The overall safety profile patterned a lower risk of serious AEFI following mRNA vaccines compared to influenza vaccines. |
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| 投稿者 | Kim, Min Seo; Jung, Se Yong; Ahn, Jong Gyun; Park, Se Jin; Shoenfeld, Yehuda; Kronbichler, Andreas; Koyanagi, Ai; Dragioti, Elena; Tizaoui, Kalthoum; Hong, Sung Hwi; Jacob, Louis; Salem, Joe-Elie; Yon, Dong Keon; Lee, Seung Won; Ogino, Shuji; Kim, Hanna; Kim, Jerome H; Excler, Jean-Louis; Marks, Florian; Clemens, John D; Eisenhut, Michael; Barnett, Yvonne; Butler, Laurie; Ilie, Cristian Petre; Shin, Eui-Cheol; Il Shin, Jae; Smith, Lee |
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| 組織名 | College of Medicine, Korea University, Seoul, Republic of Korea.;Samsung Advanced Institute for Health Sciences and Technology (SAIHST),;Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of Korea.;Department of Pediatrics, Yonsei University College of Medicine, Seoul, Republic;of Korea.;Department of Pediatrics, Severance Children's Hospital, Yonsei University;College of Medicine, South Korea.;Department of Pediatrics, Eulji University School of Medicine, Daejeon, Republic;Laboratory of the Mosaics of Autoimmunity, Saint Petersburg State University,;Saint-Petersburg, Russian Federation.;Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Affiliated to;Tel-Aviv University School of Medicine, Tel-Hashomer, Israel.;Department of Internal Medicine IV, Medical University Innsbruck, Innsbruck,;Austria.;Research and Development Unit, Parc Sanitari Sant Joan de Deu, Universitat de;Barcelona, Fundacio Sant Joan de Deu, CIBERSAM, Barcelona, Spain.;ICREA, Pg. Lluis Companys 23, Barcelona, Spain.;Instituto de Salud Carlos III, Centro de Investigacion Biomedica en Red de Salud;Mental, CIBERSAM, Madrid, Spain.;Pain and Rehabilitation Centre, and Department of Health, Medicine and Caring;Sciences, Linkoping University, Linkoping, Sweden.;Laboratory of Microorganismes and Active Biomolecules, Sciences Faculty of Tunis,;University Tunis El Manar, Tunis, Tunisia.;Yonsei University College of Medicine, Seoul, Republic of Korea.;Faculty of Medicine, University of Versailles Saint-Quentin-en-Yvelines,;Montigny-le-Bretonneux, France.;Sorbonne Universite, INSERM, CIC-1901 Paris-Est, CLIP(2) Galilee, UNICO-GRECO;Cardio-oncology Program, and Department of Pharmacology, Pitie-Salpetriere;Hospital, Assistance Publique-Hopitaux de Paris, Paris, France.;Department of Pediatrics, Seoul National University Children's Hospital, Seoul;National University College of Medicine, Seoul, Republic of Korea.;Department of Data Science, Sejong University College of Software Convergence,;Seoul, Republic of Korea.;Cancer Immunology and Cancer Epidemiology Programs, Dana-Farber Harvard Cancer;Center, Boston, Massachusetts, USA.;Department of Epidemiology, Harvard TH Chan School of Public Health, Boston,;Massachusetts, USA.;Program in MPE Molecular Pathological Epidemiology, Department of Pathology,;Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.;Broad Institute of Massachusetts Institute of Technology and Harvard, Cambridge,;College of Medicine, Ewha Womans University, Seoul, Republic of Korea.;International Vaccine Institute, Seoul, Republic of Korea.;Cambridge Institute of Therapeutic Immunology and Infectious Disease, University;of Cambridge School of Clinical Medicine, Cambridge, UK.;University of Antananarivo, Antananarivo, Madagascar.;International Centre for Diarrheal Diseases Research, Dhaka, Dhaka, Bangladesh.;UCLA Fielding School of Public Health, Los Angeles, California, USA.;Luton & Dunstable University Hospital, Luton, United Kingdom.;Centre for Health, Performance, and Wellbeing, Anglia Ruskin University,;Cambridge, UK.;Queen Elizabeth Hospital Foundation Trust, King's Lynn, Norfolk, England.;Laboratory of Immunology and Infectious Diseases, Graduate School of Medical;Science and Engineering, Korea Advanced Institute of Science and Technology,;Daejeon, Republic of Korea.;The Center for Epidemic Preparedness, Korea Advanced Institute of Science and;Technology, Daejeon, Republic of Korea. |
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