Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California, Oakland, CA, United States.
Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, United States.
Vaccine. 2022 Aug 19;40(35):5153-5159. doi: 10.1016/j.vaccine.2022.07.007. Epub 2022 Jul 12.
Evidence indicates that mRNA COVID-19 vaccination is associated with risk of myocarditis and possibly pericarditis, especially in young males. It is not clear if risk differs between mRNA-1273 versus BNT162b2. We assessed if risk differs using comprehensive health records on a diverse population.
Members 18-39 years of age at eight integrated healthcare-delivery systems were monitored using data updated weekly and supplemented with medical record review of myocarditis and pericarditis cases. Incidence of myocarditis and pericarditis events that occurred among vaccine recipients 0 to 7 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by conditional Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. Head-to-head comparison directly assessed risk following mRNA-1273 versus BNT162b2 during 0-7 days post-vaccination.
From December 14, 2020 - January 15, 2022 there were 41 cases after 2,891,498 doses of BNT162b2 and 38 cases after 1,803,267 doses of mRNA-1273. Cases had similar demographic and clinical characteristics. Most were hospitalized for ≤1 day; none required intensive care. During days 0-7 after dose 2 of BNT162b2, the incidence was 14.3 (CI: 6.5-34.9) times higher than the comparison interval, amounting to 22.4 excess cases per million doses; after mRNA-1273 the incidence was 18.8 (CI: 6.7-64.9) times higher than the comparison interval, amounting to 31.2 excess cases per million doses. In head-to-head comparisons 0-7 days after either dose, risk was moderately higher after mRNA-1273 than after BNT162b2 (RR: 1.61, CI 1.02-2.54).
Both vaccines were associated with increased risk of myocarditis and pericarditis in 18-39-year-olds. Risk estimates were modestly higher after mRNA-1273 than after BNT162b2.
有证据表明，mRNA COVID-19 疫苗接种与心肌炎和心包炎的风险相关，尤其是在年轻男性中。目前尚不清楚 mRNA-1273 与 BNT162b2 之间的风险是否存在差异。我们使用来自多元化人群的综合健康记录来评估风险是否存在差异。
在八个综合医疗服务系统中，年龄在 18-39 岁的成员使用每周更新的数据进行监测，并通过对心肌炎和心包炎病例的病历审查进行补充。在接种 mRNA 疫苗第 1 剂或第 2 剂后 0-7 天内，疫苗接种者发生心肌炎和心包炎事件的发生率与接种了同一日历日、最近一剂接种日期为 22-42 天前的疫苗接种同时对照者进行了比较。通过条件泊松回归估计率比（RR），并根据年龄、性别、种族和民族、健康计划和日历日进行调整。直接头对头比较评估了 mRNA-1273 与 BNT162b2 在接种后 0-7 天内的风险。
从 2020 年 12 月 14 日至 2022 年 1 月 15 日，在接种了 2891498 剂 BNT162b2 和 1803267 剂 mRNA-1273 后，共发生 41 例和 38 例。病例具有相似的人口统计学和临床特征。大多数患者住院时间不超过 1 天；没有患者需要重症监护。在 BNT162b2 第 2 剂接种后 0-7 天内，发病率比对照期高 14.3 倍（CI：6.5-34.9），相当于每百万剂疫苗额外发生 22.4 例病例；在接种 mRNA-1273 后，发病率比对照期高 18.8 倍（CI：6.7-64.9），相当于每百万剂疫苗额外发生 31.2 例病例。在头对头比较中，接种后 0-7 天内，mRNA-1273 的风险略高于 BNT162b2（RR：1.61，CI 1.02-2.54）。
两种疫苗都与 18-39 岁人群的心肌炎和心包炎风险增加有关。mRNA-1273 的风险估计值略高于 BNT162b2。
