tetano
Editor, Senior Moderator
J Infect Chemother
. 2024 Aug 3:S1341-321X(24)00209-5.
doi: 10.1016/j.jiac.2024.07.025. Online ahead of print. SARS-CoV-2 mRNA vaccine-related myocarditis and pericarditis: An analysis of the Japanese Adverse Drug Event Report database
Keisuke Takada[SUP] 1 [/SUP], Kazuaki Taguchi[SUP] 2 [/SUP], Masaru Samura[SUP] 3 [/SUP], Yuki Igarashi[SUP] 4 [/SUP], Yuko Okamoto[SUP] 5 [/SUP], Yuki Enoki[SUP] 5 [/SUP], Koji Tanikawa[SUP] 4 [/SUP], Kazuaki Matsumoto[SUP] 5 [/SUP]
Affiliations
Background: The association between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccines and myocarditis/pericarditis in the Japanese population has not been systematically investigated. This study was aimed at clarifying the association between SARS-CoV-2 mRNA vaccines (BNT162b2 and mRNA-1273) and myocarditis/pericarditis as well as influencing factors by using the Japanese Adverse Drug Event Report database.
Methods: Reporting odds ratios (RORs) and 95% confidence intervals (95% CIs) for the association between the vaccines and myocarditis/pericarditis were calculated using data from the database (April 2004-December 2023). Age, sex, onset time, and outcomes in symptomatic patients were evaluated.
Results: The total number of reports was 880,999 (myocarditis: 1,846; pericarditis: 761). The adverse events associated with the vaccines included myocarditis (919 cases) and pericarditis (321 cases), with the ROR [95% CIs] being significant for both (myocarditis: 30.51 [27.82-33.45], pericarditis: 21.99 [19.03-25.40]). Furthermore, the ROR [95% CIs] of BNT162b2 and mRNA-1273 were 15.64 [14.15-17.28] and 54.23 [48.13-61.10], respectively, for myocarditis, and 15.78 [13.52-18.42] and 27.03 [21.58-33.87], respectively, for pericarditis. Furthermore, most cases were ≤30 years or male. The period from vaccination to onset was ≤8 days, corresponding to early failure type based on analysis using the Weibull distribution. Outcomes were recovery or remission for most cases; however, they were severe or caused death in some cases.
Conclusion: In the Japanese population, SARS-CoV-2 mRNA vaccination was significantly associated with the onset of myocarditis/pericarditis. The influencing factors included age of ≤30 years and male. Furthermore, although most adverse events occurred early after vaccination, overall outcomes were good.
Keywords: BNT162b2; Japanese Adverse Drug Event Report database; mRNA-1273; myocarditis; pericarditis.
. 2024 Aug 3:S1341-321X(24)00209-5.
doi: 10.1016/j.jiac.2024.07.025. Online ahead of print. SARS-CoV-2 mRNA vaccine-related myocarditis and pericarditis: An analysis of the Japanese Adverse Drug Event Report database
Keisuke Takada[SUP] 1 [/SUP], Kazuaki Taguchi[SUP] 2 [/SUP], Masaru Samura[SUP] 3 [/SUP], Yuki Igarashi[SUP] 4 [/SUP], Yuko Okamoto[SUP] 5 [/SUP], Yuki Enoki[SUP] 5 [/SUP], Koji Tanikawa[SUP] 4 [/SUP], Kazuaki Matsumoto[SUP] 5 [/SUP]
Affiliations
- PMID: 39103148
- DOI: 10.1016/j.jiac.2024.07.025
Background: The association between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccines and myocarditis/pericarditis in the Japanese population has not been systematically investigated. This study was aimed at clarifying the association between SARS-CoV-2 mRNA vaccines (BNT162b2 and mRNA-1273) and myocarditis/pericarditis as well as influencing factors by using the Japanese Adverse Drug Event Report database.
Methods: Reporting odds ratios (RORs) and 95% confidence intervals (95% CIs) for the association between the vaccines and myocarditis/pericarditis were calculated using data from the database (April 2004-December 2023). Age, sex, onset time, and outcomes in symptomatic patients were evaluated.
Results: The total number of reports was 880,999 (myocarditis: 1,846; pericarditis: 761). The adverse events associated with the vaccines included myocarditis (919 cases) and pericarditis (321 cases), with the ROR [95% CIs] being significant for both (myocarditis: 30.51 [27.82-33.45], pericarditis: 21.99 [19.03-25.40]). Furthermore, the ROR [95% CIs] of BNT162b2 and mRNA-1273 were 15.64 [14.15-17.28] and 54.23 [48.13-61.10], respectively, for myocarditis, and 15.78 [13.52-18.42] and 27.03 [21.58-33.87], respectively, for pericarditis. Furthermore, most cases were ≤30 years or male. The period from vaccination to onset was ≤8 days, corresponding to early failure type based on analysis using the Weibull distribution. Outcomes were recovery or remission for most cases; however, they were severe or caused death in some cases.
Conclusion: In the Japanese population, SARS-CoV-2 mRNA vaccination was significantly associated with the onset of myocarditis/pericarditis. The influencing factors included age of ≤30 years and male. Furthermore, although most adverse events occurred early after vaccination, overall outcomes were good.
Keywords: BNT162b2; Japanese Adverse Drug Event Report database; mRNA-1273; myocarditis; pericarditis.