Article Dans Une Revue Journal of Medical Virology Année : 2022

Comparative safety of mRNA COVID-19 vaccines to influenza vaccines: A pharmacovigilance analysis using WHO international database

1 Korea University [Seoul]
2 Samsung Medical Center Sungkyunkwan University School of Medicine
3 Yonsei University
4 SPBU - Saint Petersburg State University
5 IMU - Innsbruck Medical University = Medizinische Universität Innsbruck
6 ICREA - Institució Catalana de Recerca i Estudis Avançats = Catalan Institution for Research and Advanced Studies
7 CIBER-SAM - Centro de Investigación Biomédica en Red Salud Mental [Madrid]
8 LIU - Linköping University
9 UTM - Tunis El Manar University [University of Tunis El Manar] [Tunisia] = Université de Tunis El Manar [Tunisie] = جامعة تونس المنار (ar)
10 UB - Universitat de Barcelona
11 UVSQ Santé - UFR Sciences de la santé Simone Veil
12 CIC Paris-Est - Centre d'investigation clinique Paris Est [CHU Pitié Salpêtrière]
13 ICAN - Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases
14 SNU - Seoul National University [Seoul]
15 Sejong University - Department of Applied Mathematics
16 Harvard T.H. Chan School of Public Health
17 BWH - Brigham & Women’s Hospital [Boston]
18 EWHA - EWHA Womans University
19 IVI - International Vaccine Institute
20 CAM - University of Cambridge [Cambridge, UK]
21 Université d'Antananarivo
22 ICDDR,B - International Centre for Diarrhoeal Disease Research, Bangladesh
23 Fielding School of Public Health
24 ARU - Anglia Ruskin University
25 KAIST - Korea Advanced Institute of Science and Technology
Se Yong Jung
Se-Jin Park
  • Fonction : Auteur
Sunghwi Hong
  • Fonction : Auteur
Michael Eisenhut
  • Fonction : Auteur
Cristian Petre Ilie
  • Fonction : Auteur
Jae Il Shin
  • Fonction : Auteur correspondant
Lee Smith

Résumé

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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Dates et versions

hal-03604072 , version 1 (10-03-2022)

Identifiants

Citer

Min-Seo Kim, Se Yong Jung, Jong-Gyun Ahn, Se-Jin Park, Yehuda Shoenfeld, et al.. Comparative safety of mRNA COVID-19 vaccines to influenza vaccines: A pharmacovigilance analysis using WHO international database. Journal of Medical Virology, 2022, 94 (3), pp.1085-1095. ⟨10.1002/jmv.27424⟩. ⟨hal-03604072⟩
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