Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Internal Medicine, Self-Defence Forces Central Hospital, Tokyo, Japan; NBC Countermeasure Medical Unit, Japan Ground Self-Defence Force, Tokyo, Japan.
Self-Defence Forces Tokyo Large-scale Vaccination Centre, Tokyo, Japan; Department of Emergency Medicine, Self-Defence Forces Central Hospital, Tokyo, Japan.
J Allergy Clin Immunol Pract. 2022 Oct;10(10):2667-2676.e10. doi: 10.1016/j.jaip.2022.07.027. Epub 2022 Aug 8.
With the implementation of mass vaccination campaigns against COVID-19, the safety of vaccine needs to be evaluated.
We aimed to assess the incidence and risk factors for immediate hypersensitivity reactions (IHSR) and immunization stress-related responses (ISRR) with the Moderna COVID-19 vaccine.
This nested case-control study included recipients who received the Moderna vaccine at a mass vaccination center, Japan. Recipients with IHSR and ISRR were designated as cases 1 and 2, respectively. Controls 1 and 2 were selected from recipients without IHSR or ISRR and matched (1 case: 4 controls) with cases 1 and cases 2, respectively. Conditional logistic regression analysis was used to identify risk factors associated with IHSR and ISRR.
Of the 614,151 vaccine recipients who received 1,201,688 vaccine doses, 306 recipients (cases 1) and 2478 recipients (cases 2) showed 318 events of IHSR and 2558 events of ISRR, respectively. The incidence rates per million doses were estimated as IHSR: 266 cases, ISRR: 2129 cases, anaphylaxis: 2 cases, and vasovagal syncope: 72 cases. Risk factors associated with IHSR included female, asthma, atopic dermatitis, thyroid diseases, and a history of allergy; for ISRR, the risk factors were younger age, female, asthma, thyroid diseases, mental disorders, and a history of allergy and vasovagal reflex.
In the mass vaccination settings, the Moderna vaccine can be used safely owing to the low incidence rates of IHSR and anaphylaxis. However, providers should be aware of the occurrence of ISRR. Although recipients with risk factors are associated with slightly increased risks of IHSR and ISRR, this is not of sufficient magnitude to warrant special measures regarding their vaccination.
随着针对 COVID-19 的大规模疫苗接种运动的实施，疫苗的安全性需要进行评估。
我们旨在评估 Moderna COVID-19 疫苗引起的即时过敏反应 (IHSR) 和与免疫接种相关的应激反应 (ISRR) 的发生率和危险因素。
这项嵌套病例对照研究纳入了在日本大规模疫苗接种中心接种 Moderna 疫苗的受种者。将出现 IHSR 和 ISRR 的受种者分别指定为病例 1 和病例 2。从无 IHSR 或 ISRR 的受种者中选择对照 1 和对照 2，并与病例 1 和病例 2 分别进行匹配（1 例：4 对照）。采用条件 logistic 回归分析来确定与 IHSR 和 ISRR 相关的危险因素。
在 614151 名接种了 1201688 剂疫苗的受种者中，有 306 名（病例 1）和 2478 名（病例 2）受种者出现了 318 次 IHSR 事件和 2558 次 ISRR 事件。每百万剂的发生率估计为 IHSR：266 例，ISRR：2129 例，过敏反应：2 例，血管迷走神经性晕厥：72 例。与 IHSR 相关的危险因素包括女性、哮喘、特应性皮炎、甲状腺疾病和过敏史；而与 ISRR 相关的危险因素包括年龄较小、女性、哮喘、甲状腺疾病、精神障碍和过敏史及血管迷走反射。
在大规模疫苗接种环境中，由于 IHSR 和过敏反应的发生率较低，因此可以安全使用 Moderna 疫苗。但是，医务人员应注意 ISRR 的发生。尽管具有危险因素的受种者与 IHSR 和 ISRR 的风险略有增加，但这不足以需要针对他们的疫苗接种采取特殊措施。
