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Comparative safety analysis of mRNA and adenoviral vector COVID-19 vaccines: a nationwide cohort study using an emulated target trial approach.
- Source :
-
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases [Clin Microbiol Infect] 2024 May; Vol. 30 (5), pp. 646-652. Date of Electronic Publication: 2023 Dec 13. - Publication Year :
- 2024
-
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.<br />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.<br />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.<br />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.<br /> (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
- 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
Subjects
Details
- Language :
- English
- ISSN :
- 1469-0691
- Volume :
- 30
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
- Publication Type :
- Academic Journal
- Accession number :
- 38101473
- Full Text :
- https://doi.org/10.1016/j.cmi.2023.12.010