Bell's palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case-control study.
Bell's palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case-control study.
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DOI：
10.1016/s1473-3099(21)00451-5
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发表时间：
2022-01
期刊：
影响因子：
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通讯作者：
Wong ICK
中科院分区：
文献类型：
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作者：
Wan EYF;Chui CSL;Lai FTT;Chan EWY;Li X;Yan VKC;Gao L;Yu Q;Lam ICH;Chun RKC;Cowling BJ;Fong WC;Lau AYL;Mok VCT;Chan FLF;Lee CK;Chan LST;Lo D;Lau KK;Hung IFN;Leung GM;Wong ICK
贝尔麻痹症是COVID-19疫苗临床试验中罕见的不良事件。然而，据我们所知，没有基于人群的研究评估了灭活的SARS-CoV-2疫苗与贝尔麻痹之间的关系。本研究的目的是评估接种BNT162b2和CoronaVac疫苗后贝尔氏麻痹的风险。在香港进行的病例系列和巢式病例对照研究中，我们评估了接种BNT162b2（复星生物科技[相当于辉瑞生物科技]）或CoronaVac（来自香港科兴生物科技）后42天内贝尔氏麻痹的风险，使用的数据来自医院管理局自愿监测报告、所有医疗保健专业人员的COVID-19疫苗不良事件在线报告系统、以及医院管理局临床数据分析及报告系统的全港电子健康纪录。我们描述了已报告的贝尔麻痹病例，接种者（冠状病毒疫苗18-110岁，BNT162b2疫苗16-110岁）。我们比较了接种过CoronaVac或BNT162b2疫苗（发病前42天）的个体中临床确诊病例的估计年龄标准化发病率与人群中的背景发病率。一项嵌套病例对照研究也使用条件逻辑回归来估计贝尔麻痹和疫苗接种风险的比值比（OR）。病例和对照组按年龄、性别、入院地点和入院日期（1:4）匹配。在2021年2月23日至5月4日期间，45939人接受了第一剂CoronaVac， 537205人接受了第一剂BNT162b2。CoronaVac治疗后临床确诊贝尔麻痹28例，BNT162b2治疗后临床确诊贝尔麻痹16例。接种CoronaVac疫苗后，临床确诊贝尔麻痹的年龄标准化发病率为每10万人年66.9例（95% CI 37.2 ~ 96.6），接种BNT162b2疫苗后为每10万人年42.8例（19.4 ~ 66.1）。与背景人群相比，冠状病毒的发病率的年龄标准化差异为41.5 (95% CI为11.7至71.4)，BNT162b2的发病率为17.0 (95% CI为- 6.6至40.6)，相当于每10万人接种冠状病毒疫苗增加了1.8例，每10万人接种BNT162b2疫苗增加了2.0例。在巢式病例-对照分析中，298例病例与1181例对照，CoronaVac和BNT162b2的调整后ORs分别为2.385 （95% CI 1.415 ~ 4.022）和1.755 （95% CI 0.886 ~ 3.477）。我们的研究结果表明，接种冠状病毒疫苗后，贝尔氏麻痹的总体风险增加。然而，COVID-19灭活疫苗的有益和保护作用远远超过这种通常自限性不良事件的风险。需要在其他地区进行进一步的研究来证实我们的发现。中国香港特别行政区政府食物及卫生局。摘要的中文译文见补充资料部分。
Bell's palsy is a rare adverse event reported in clinical trials of COVID-19 vaccines. However, to our knowledge no population-based study has assessed the association between the inactivated SARS-CoV-2 vaccines and Bell's palsy. The aim of this study was to evaluate the risk of Bell's palsy after BNT162b2 and CoronaVac vaccination. In this case series and nested case-control study done in Hong Kong, we assessed the risk of Bell's palsy within 42 days following vaccination with BNT162b2 (Fosun–BioNTech [equivalent to Pfizer–BioNTech]) or CoronaVac (from Sinovac Biotech, Hong Kong) using data from voluntary surveillance reporting with the Hospital Authority, the COVID-19 Vaccine Adverse Event Online Reporting system for all health-care professionals, and the Hospital Authority's territory-wide electronic health records from the Clinical Data Analysis and Reporting System. We described reported cases of Bell's palsy among vaccine recipients (aged 18–110 years for CoronaVac and aged 16–110 years for BNT162b2). We compared the estimated age-standardised incidence of clinically confirmed cases among individuals who had received the CoronaVac or BNT162b2 vaccination (up to 42 days before presentation) with the background incidence in the population. A nested case-control study was also done using conditional logistic regression to estimate the odds ratio (OR) for risk of Bell's palsy and vaccination. Cases and controls were matched (1:4) by age, sex, admission setting, and admission date. Between February 23 and May 4, 2021, 451 939 individuals received the first dose of CoronaVac and 537 205 individuals received the first dose of BNT162b2. 28 clinically confirmed cases of Bell's palsy were reported following CoronaVac and 16 cases were reported following BNT162b2. The age-standardised incidence of clinically confirmed Bell's palsy was 66·9 cases per 100 000 person-years (95% CI 37·2 to 96·6) following CoronaVac vaccination and 42·8 per 100 000 person-years (19·4 to 66·1) for BNT162b2 vaccination. The age-standardised difference for the incidence compared with the background population was 41·5 (95% CI 11·7 to 71·4) for CoronaVac and 17·0 (−6·6 to 40·6) for BNT162b2, equivalent to an additional 4·8 cases per 100 000 people vaccinated for CoronaVac and 2·0 cases per 100 000 people vaccinated for BNT162b2. In the nested case-control analysis, 298 cases were matched to 1181 controls, and the adjusted ORs were 2·385 (95% CI 1·415 to 4·022) for CoronaVac and 1·755 (0·886 to 3·477) for BNT162b2. Our findings suggest an overall increased risk of Bell's palsy after CoronaVac vaccination. However, the beneficial and protective effects of the inactivated COVID-19 vaccine far outweigh the risk of this generally self-limiting adverse event. Additional studies are needed in other regions to confirm our findings. The Food and Health Bureau of the Government of the Hong Kong Special Administrative Region, China. For the Chinese translation of the abstract see Supplementary Materials section.