Abstract：
OBJECTIVE: Bivalent COVID-19 mRNA vaccines, which contain two different components, were authorized to provide protection against both the original strain of SARS-CoV-2 and the Omicron variant as a measure to address the COVID-19 pandemic. Concerns regarding the risk of myocarditis/pericarditis associated with bivalent vaccination have been raised due to the observed superior neutralizing antibody responses. This study aimed to investigate the risk of myocarditis/pericarditis following bivalent COVID-19 mRNA vaccination compared to monovalent vaccination.
METHODS: The CDC COVID Data Tracker and the Vaccines Adverse Event Reporting System (VAERS) were analyzed between December 13, 2020 to March 8, 2023. Reporting rates were determined by dividing the number of myocarditis/pericarditis cases by the total number of vaccine doses administered. Disproportionality patterns regarding myocarditis/pericarditis were evaluated for various COVID-19 mRNA vaccinations using reporting odds ratios (RORs).
RESULTS: The reporting rate for myocarditis/pericarditis following original monovalent COVID-19 mRNA vaccination was 6.91 (95 % confidence interval [95 %CI] 6.71-7.12) per million doses, while the reporting rate for bivalent vaccination was significantly lower (1.24, 95%CI 0.96-1.58). Disproportionality analysis revealed a higher reporting of myocarditis/pericarditis following original vaccination with a ROR of 2.21 (95 %CI 2.00-2.43), while bivalent COVID-19 mRNA vaccination was associated with fewer reports of myocarditis/pericarditis (ROR 0.57, 95 %CI 0.45-0.72). Sub-analyses based on symptoms, sex, age and manufacturer further supported these findings.
CONCLUSIONS: This population-based study provides evidence that bivalent COVID-19 mRNA vaccination is not associated with risk of myocarditis/pericarditis. These findings provide important insights into the safety profile of bivalent COVID-19 mRNA vaccines and support their continued use as updated boosters.
METHODS: The CDC COVID Data Tracker and the Vaccines Adverse Event Reporting System (VAERS) were analyzed between December 13, 2020 to March 8, 2023. Reporting rates were determined by dividing the number of myocarditis/pericarditis cases by the total number of vaccine doses administered. Disproportionality patterns regarding myocarditis/pericarditis were evaluated for various COVID-19 mRNA vaccinations using reporting odds ratios (RORs).
RESULTS: The reporting rate for myocarditis/pericarditis following original monovalent COVID-19 mRNA vaccination was 6.91 (95 % confidence interval [95 %CI] 6.71-7.12) per million doses, while the reporting rate for bivalent vaccination was significantly lower (1.24, 95%CI 0.96-1.58). Disproportionality analysis revealed a higher reporting of myocarditis/pericarditis following original vaccination with a ROR of 2.21 (95 %CI 2.00-2.43), while bivalent COVID-19 mRNA vaccination was associated with fewer reports of myocarditis/pericarditis (ROR 0.57, 95 %CI 0.45-0.72). Sub-analyses based on symptoms, sex, age and manufacturer further supported these findings.
CONCLUSIONS: This population-based study provides evidence that bivalent COVID-19 mRNA vaccination is not associated with risk of myocarditis/pericarditis. These findings provide important insights into the safety profile of bivalent COVID-19 mRNA vaccines and support their continued use as updated boosters.
摘要：
目的：二价COVID-19mRNA疫苗，包含两种不同的成分，被授权对SARS-CoV-2的原始毒株和Omicron变体提供保护，作为应对COVID-19大流行的措施。由于观察到的优异的中和抗体应答,已经引起了对与二价疫苗接种相关的心肌炎/心包炎风险的关注。这项研究旨在调查与单价疫苗接种相比，二价COVID-19mRNA疫苗接种后心肌炎/心包炎的风险。
方法：在2020年12月13日至2023年3月8日之间对CDCCOVID数据跟踪器和疫苗不良事件报告系统（VAERS）进行了分析。通过将心肌炎/心包炎病例数除以施用的疫苗剂量总数来确定报告率。使用报告优势比（ROR）评估了各种COVID-19mRNA疫苗接种的心肌炎/心包炎的不成比例模式。
结果：初始单价COVID-19mRNA疫苗接种后心肌炎/心包炎的报告率为每百万剂6.91（95％置信区间[95CI]6.71-7.12），而二价疫苗接种的报告率显著较低(1.24,95CI0.96-1.58).不相称性分析显示，在最初的ROR为2.21（95CI2.00-2.43）的疫苗接种后，心肌炎/心包炎的报告较高，而二价COVID-19mRNA疫苗接种与心肌炎/心包炎的报告较少相关(ROR0.57,95CI0.45-0.72)。基于症状的子分析，性别,年龄和制造商进一步支持这些发现.
结论：这项基于人群的研究提供了证据，表明二价COVID-19mRNA疫苗接种与心肌炎/心包炎的风险无关。这些发现为二价COVID-19mRNA疫苗的安全性提供了重要见解，并支持其继续用作更新的助推器。
方法：在2020年12月13日至2023年3月8日之间对CDCCOVID数据跟踪器和疫苗不良事件报告系统（VAERS）进行了分析。通过将心肌炎/心包炎病例数除以施用的疫苗剂量总数来确定报告率。使用报告优势比（ROR）评估了各种COVID-19mRNA疫苗接种的心肌炎/心包炎的不成比例模式。
结果：初始单价COVID-19mRNA疫苗接种后心肌炎/心包炎的报告率为每百万剂6.91（95％置信区间[95CI]6.71-7.12），而二价疫苗接种的报告率显著较低(1.24,95CI0.96-1.58).不相称性分析显示，在最初的ROR为2.21（95CI2.00-2.43）的疫苗接种后，心肌炎/心包炎的报告较高，而二价COVID-19mRNA疫苗接种与心肌炎/心包炎的报告较少相关(ROR0.57,95CI0.45-0.72)。基于症状的子分析，性别,年龄和制造商进一步支持这些发现.
结论：这项基于人群的研究提供了证据，表明二价COVID-19mRNA疫苗接种与心肌炎/心包炎的风险无关。这些发现为二价COVID-19mRNA疫苗的安全性提供了重要见解，并支持其继续用作更新的助推器。
