Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Acumen, Burlingame, CA, USA.
Lancet. 2022 Jun 11;399(10342):2191-2199. doi: 10.1016/S0140-6736(22)00791-7.
BACKGROUND: Several passive surveillance systems reported increased risks of myocarditis or pericarditis, or both, after COVID-19 mRNA vaccination, especially in young men. We used active surveillance from large health-care databases to quantify and enable the direct comparison of the risk of myocarditis or pericarditis, or both, after mRNA-1273 (Moderna) and BNT162b2 (Pfizer-BioNTech) vaccinations. METHODS: We conducted a retrospective cohort study, examining the primary outcome of myocarditis or pericarditis, or both, identified using the International Classification of Diseases diagnosis codes, occurring 1-7 days post-vaccination, evaluated in COVID-19 mRNA vaccinees aged 18-64 years using health plan claims databases in the USA. Observed (O) incidence rates were compared with expected (E) incidence rates estimated from historical cohorts by each database. We used multivariate Poisson regression to estimate the adjusted incidence rates, specific to each brand of vaccine, and incidence rate ratios (IRRs) comparing mRNA-1273 and BNT162b2. We used meta-analyses to pool the adjusted incidence rates and IRRs across databases. FINDINGS: A total of 411 myocarditis or pericarditis, or both, events were observed among 15 148 369 people aged 18-64 years who received 16 912 716 doses of BNT162b2 and 10 631 554 doses of mRNA-1273. Among men aged 18-25 years, the pooled incidence rate was highest after the second dose, at 1·71 (95% CI 1·31 to 2·23) per 100 000 person-days for BNT162b2 and 2·17 (1·55 to 3·04) per 100 000 person-days for mRNA-1273. The pooled IRR in the head-to-head comparison of the two mRNA vaccines was 1·43 (95% CI 0·88 to 2·34), with an excess risk of 27·80 per million doses (-21·88 to 77·48) in mRNA-1273 recipients compared with BNT162b2. INTERPRETATION: An increased risk of myocarditis or pericarditis was observed after COVID-19 mRNA vaccination and was highest in men aged 18-25 years after a second dose of the vaccine. However, the incidence was rare. These results do not indicate a statistically significant risk difference between mRNA-1273 and BNT162b2, but it should not be ruled out that a difference might exist. Our study results, along with the benefit-risk profile, continue to support vaccination using either of the two mRNA vaccines. FUNDING: US Food and Drug Administration.
背景：几项被动监测系统报告称，COVID-19 mRNA 疫苗接种后，心肌炎或心包炎或两者均有较高风险，尤其是在年轻男性中。我们使用来自大型医疗保健数据库的主动监测来量化并能够直接比较 mRNA-1273（Moderna）和 BNT162b2（辉瑞-生物技术）疫苗接种后心肌炎或心包炎或两者均有的风险。
方法：我们进行了一项回顾性队列研究，使用国际疾病分类诊断代码在 18-64 岁的 COVID-19 mRNA 疫苗接种者中检测 1-7 天疫苗接种后出现的心肌炎或心包炎或两者均有的主要结局，使用美国健康计划索赔数据库进行评估。观察到的（O）发病率与每个数据库通过历史队列估计的预期（E）发病率进行比较。我们使用多变量泊松回归来估计特定于每种疫苗品牌的调整发病率和发病率比（IRR），比较 mRNA-1273 和 BNT162b2。我们使用荟萃分析来汇总数据库之间的调整发病率和 IRR。
结果：在接受 16912716 剂 BNT162b2 和 10631554 剂 mRNA-1273 的 18-64 岁人群中，共有 411 例心肌炎或心包炎或两者均有事件发生。在 18-25 岁的男性中，第二剂后合并发病率最高，BNT162b2 为每 10 万人天 1.71（95%CI 1.31-2.23），mRNA-1273 为每 10 万人天 2.17（1.55-3.04）。在两种 mRNA 疫苗头对头比较中，IRR 为 1.43（95%CI 0.88-2.34），与 BNT162b2 相比，mRNA-1273 接受者的超额风险为每百万剂 27.80（-21.88 至 77.48）。
解释：COVID-19 mRNA 疫苗接种后观察到心肌炎或心包炎风险增加，在接受疫苗第二剂的 18-25 岁男性中风险最高。然而，发病率很低。这些结果并不表明 mRNA-1273 和 BNT162b2 之间存在统计学意义上的风险差异，但不能排除可能存在差异。我们的研究结果以及获益-风险状况继续支持使用这两种 mRNA 疫苗中的任何一种进行疫苗接种。
资助：美国食品和药物管理局。
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