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Clin Microbiol Infect
. 2023 Dec 13:S1198-743X(23)00600-6.
doi: 10.1016/j.cmi.2023.12.010. Online ahead of print. Comparative safety analysis of mRNA and adenoviral vector COVID-19 vaccines: a nationwide cohort study using an emulated target trial approach
Min Joo Choi 1 , Yewon Na 2 , Hak Jun Hyun 3 , Eliel Nham 4 , Jin Gu Yoon 4 , Hye Seong 4 , Yu Bin Seo 5 , Won Suk Choi 4 , Joon Young Song 4 , Dong Wook Kim 6 , Young-Eun Kim 7 , Jaehun Jung 8 , Hee Jin Cheong 9
Affiliations
Objective: This nationwide cohort study compared the incidence of adverse events of special interest (AESIs) between adenoviral vector- (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 (approximately 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% confidence interval [CI] 1.10-1.35), myocarditis/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, 91% 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 to ChAdOx1 vaccinees.
Conclusions: A remarkable platform-dependent difference was observed in the safety profiles of COVID-19 vaccines, particularly for myocarditis/pericarditis and Guillain-Barré syndrome. Nevertheless, the overall risk of AESIs was low for both vaccine platforms.
. 2023 Dec 13:S1198-743X(23)00600-6.
doi: 10.1016/j.cmi.2023.12.010. Online ahead of print. Comparative safety analysis of mRNA and adenoviral vector COVID-19 vaccines: a nationwide cohort study using an emulated target trial approach
Min Joo Choi 1 , Yewon Na 2 , Hak Jun Hyun 3 , Eliel Nham 4 , Jin Gu Yoon 4 , Hye Seong 4 , Yu Bin Seo 5 , Won Suk Choi 4 , Joon Young Song 4 , Dong Wook Kim 6 , Young-Eun Kim 7 , Jaehun Jung 8 , Hee Jin Cheong 9
Affiliations
- PMID: 38101473
- DOI: 10.1016/j.cmi.2023.12.010
Objective: This nationwide cohort study compared the incidence of adverse events of special interest (AESIs) between adenoviral vector- (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 (approximately 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% confidence interval [CI] 1.10-1.35), myocarditis/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, 91% 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 to ChAdOx1 vaccinees.
Conclusions: A remarkable platform-dependent difference was observed in the safety profiles of COVID-19 vaccines, particularly for myocarditis/pericarditis and Guillain-Barré syndrome. Nevertheless, the overall risk of AESIs was low for both vaccine platforms.