tetano
Editor, Senior Moderator
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[SUP] 1 [/SUP], Yewon Na[SUP] 2 [/SUP], Hak Jun Hyun[SUP] 3 [/SUP], Eliel Nham[SUP] 4 [/SUP], Jin Gu Yoon[SUP] 4 [/SUP], Hye Seong[SUP] 4 [/SUP], Yu Bin Seo[SUP] 5 [/SUP], Won Suk Choi[SUP] 4 [/SUP], Joon Young Song[SUP] 4 [/SUP], Dong Wook Kim[SUP] 6 [/SUP], Young-Eun Kim[SUP] 7 [/SUP], Jaehun Jung[SUP] 8 [/SUP], Hee Jin Cheong[SUP] 9 [/SUP]
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[SUP] 1 [/SUP], Yewon Na[SUP] 2 [/SUP], Hak Jun Hyun[SUP] 3 [/SUP], Eliel Nham[SUP] 4 [/SUP], Jin Gu Yoon[SUP] 4 [/SUP], Hye Seong[SUP] 4 [/SUP], Yu Bin Seo[SUP] 5 [/SUP], Won Suk Choi[SUP] 4 [/SUP], Joon Young Song[SUP] 4 [/SUP], Dong Wook Kim[SUP] 6 [/SUP], Young-Eun Kim[SUP] 7 [/SUP], Jaehun Jung[SUP] 8 [/SUP], Hee Jin Cheong[SUP] 9 [/SUP]
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.