1. Comparative safety analysis of mRNA and adenoviral vector COVID-19 vaccines: a nationwide cohort study using an emulated target trial approach.
- Author
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Choi MJ, Na Y, Hyun HJ, Nham E, Yoon JG, Seong H, Seo YB, Choi WS, Song JY, Kim DW, Kim YE, Jung J, and Cheong HJ
- Subjects
- Humans, Middle Aged, Aged, Male, Female, Adult, Young Adult, Aged, 80 and over, Adolescent, Cohort Studies, mRNA Vaccines, Incidence, Adenoviridae genetics, Vaccines, Synthetic adverse effects, Vaccines, Synthetic administration & dosage, Vaccines, Synthetic immunology, BNT162 Vaccine, COVID-19 prevention & control, COVID-19 epidemiology, 2019-nCoV Vaccine mRNA-1273, ChAdOx1 nCoV-19, COVID-19 Vaccines adverse effects, COVID-19 Vaccines administration & dosage, COVID-19 Vaccines immunology, SARS-CoV-2 genetics, SARS-CoV-2 immunology
- Abstract
Objective: This nationwide cohort study compared the incidence of adverse events of special interest (AESIs) between adenoviral vector-based (ChAdOx1) and mRNA-based (BNT162b2 or mRNA-1273) coronavirus disease 2019 (COVID-19) vaccines., Methods: A targeted trial emulation study was conducted using data from the National Health Insurance Service database. Vaccinees aged 18-85 years who had received at least one dose of ChAdOx1 or an mRNA-based vaccine were identified. The 42-day risks of AESIs were calculated., Results: A total of 1 767 539 ChAdOx1 vaccinees were matched exactly with mRNA vaccinees according to their risk factors. The 42-day risks of adverse events were low (∼0 to 176 events per 100 000 persons in both vaccine groups), and the incidence rates of AESIs were comparable between the two platforms, except for a higher occurrence of acute cardiac injury (incidence rate ratio [IRR], 1.22; 95% CI, 1.10-1.35), myocarditis or pericarditis (IRR, 2.14; 95% CI, 1.14-4.04), and arrhythmia (IRR, 1.46; 95% CI, 1.24-1.71) in mRNA vaccinees. The incidence of Guillain-Barré syndrome (IRR, 0.20; 95% CI, 0.06-0.69), vasovagal syncope (IRR, 0.77; 95% CI, 0.62-0.97), radiculopathy (IRR = 0.59, 95% CI, 0.41-0.84), and aseptic arthritis (IRR, 0.81; 95% CI, 0.70-0.93) was significantly lower in mRNA-based vaccinees compared with ChAdOx1 vaccinees., Discussion: A remarkable platform-dependent difference was observed in the safety profiles of COVID-19 vaccines, particularly for myocarditis or pericarditis and Guillain-Barré syndrome. However, the overall risk of AESIs was low for both vaccine platforms., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
- Published
- 2024
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