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mRNA COVID-19 疫苗在亚洲军人中的不良反应和安全性概况。

Adverse reactions and safety profile of the mRNA COVID-19 vaccines among Asian military personnel.

机构信息

Headquarters Medical Corps, Singapore Armed Forces, Singapore.

出版信息

Ann Acad Med Singap. 2021 Nov;50(11):827-837. doi: 10.47102/annals-acadmedsg.2021345.

Abstract

INTRODUCTION

The use of novel mRNA platforms for COVID-19 vaccines raised concern about vaccine safety, especially in Asian populations that made up less than 10% of study populations in the pivotal vaccine trials used for emergency use authorisation. Vaccine safety issues also remain a concern in assessing the clinical risks and benefits of vaccine boosters, particularly in specific age groups or segments of the population. This study describes a vaccination exercise involving Asian military personnel, and the adverse reactions and safety events observed.

METHODS

Minor adverse reactions, hospitalisations and adverse events of special interest were monitored as part of the organisation's protocol for safety monitoring of COVID-19 vaccinations. All vaccine recipients were invited to complete an online adverse reaction questionnaire. Medical consults at the military's primary healthcare facilities were monitored for vaccine-related presentations. All hospitalisations involving vaccine recipients were analysed. Adverse reaction rates between doses, vaccines and age groups were compared.

RESULTS

A total of 127,081 mRNA vaccine doses were administered to 64,661 individuals up to 24 July 2021. Common minor adverse reactions included fever/chills, body aches and injection site pain. These were more common after dose 2. Younger individuals experienced minor adverse reactions more frequently. Rare cases of anaphylaxis, Bell's palsy and myocarditis/pericarditis were observed. No deaths occurred.

CONCLUSION

Minor adverse reactions were less common than reported in other studies, and rates of anaphylaxis, Bell's palsy and myocarditis/pericarditis were comparable. Our study supports the favourable safety profile of mRNA COVID-19 vaccines, which may help guide decisions about booster doses if required.

摘要

简介

新型 mRNA 平台在 COVID-19 疫苗中的应用引发了对疫苗安全性的担忧,尤其是在亚洲人群中,在用于紧急使用授权的关键疫苗试验中,亚洲人群不到研究人群的 10%。在评估疫苗加强针的临床风险和获益时,疫苗安全性问题仍然是一个关注点,特别是在特定年龄组或人群部分。本研究描述了一项涉及亚洲军人的疫苗接种活动,以及观察到的不良反应和安全事件。

方法

作为该组织 COVID-19 疫苗安全监测方案的一部分,监测了轻微不良反应、住院和特别关注的不良事件。所有疫苗接种者都被邀请填写一份在线不良反应问卷。监测军队初级保健设施的疫苗相关就诊情况。分析了所有涉及疫苗接种者的住院情况。比较了不同剂量、疫苗和年龄组之间的不良反应发生率。

结果

截至 2021 年 7 月 24 日,共向 64661 人接种了 127081 剂 mRNA 疫苗。常见的轻微不良反应包括发热/发冷、身体疼痛和注射部位疼痛。这些在第二剂后更为常见。年龄较小的个体更频繁地经历轻微不良反应。罕见的过敏反应、贝尔氏面瘫和心肌炎/心包炎病例被观察到。没有死亡发生。

结论

轻微不良反应比其他研究报告的要少,过敏反应、贝尔氏面瘫和心肌炎/心包炎的发生率相当。我们的研究支持 mRNA COVID-19 疫苗的良好安全性,这可能有助于指导是否需要加强针。

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