加拿大国家疫苗安全网络-COVID-19 疫苗（CANVAS-COVID）研究中参与者报告的免疫接种后神经系统事件

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2024-10-16 DOI:10.1016/j.vaccine.2024.126445

Karina A. Top , Hennady P. Shulha , Matthew P. Muller , Louis Valiquette , Otto G. Vanderkooi , James D. Kellner , Manish Sadarangani , Michael A. Irvine , Allison McGeer , Jennifer E. Isenor , Kimberly Marty , Phyumar Soe , Gaston De Serres , Julie A. Bettinger , for the Canadian Immunization Research Network Investigators

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引用次数: 0

摘要

导言加拿大国家疫苗安全网络（CANVAS）在COVID-19疫苗接种活动期间对接种后的不良事件进行了基于参与者的主动监测。本研究评估了接种 COVID-19 疫苗与神经系统不良事件之间的关联。方法邀请参与者完成在线调查，报告接种 COVID-19 疫苗后 7 天内或调查前 7 天内（未接种对照组）发生的妨碍日常活动和/或需要就医的健康事件；7 个月后进行随访调查。神经系统事件是指以下症状中最严重的症状≥1种的健康事件：麻木/刺痛、味觉或嗅觉丧失、视力减退、面部无力/麻痹、癫痫发作、手脚无力/麻痹、意识模糊、性格或行为改变、排尿或排便困难。从 CANVAS-COVID 数据库中提取数据进行分析。结果共收到 15,273 份未接种对照组、758,619 份第 1 剂接种者、406,884 份第 2 剂接种者和 126,586 份第 3 剂接种者填写的调查问卷。神经系统事件发生率从每 10,000 名剂量 1 ChAdOx1 接种者中有 15.9 例（95 % CI 13.6-18.4）到每 10,000 名剂量 3 mRNA-1273 和 BNT162b2 接种者中分别有 8.4 例（6.5-10.8）和 7.9 例（5.7-11.0）不等。经年龄、性别、既往 SARS-CoV-2 感染情况和基线健康状况调整后的多变量回归结果显示，ChAdOx1 第 1 剂接种者与对照组相比发生神经系统事件的风险增加（调整后 OR 2.3，95 % CI 1.2-4.3），但 mRNA 疫苗接种者在接种任何剂量后发生神经系统事件的风险均未增加。接种 ChAdOx1 第 1 剂后，发生麻醉/麻痹的风险增加（aOR 4.7，1.7-13.1），接种任何剂量的 mRNA 疫苗后，发生麻醉/麻痹的风险持续增加，但无统计学意义。与对照组相比，任何剂量的 mRNA 疫苗接种者发生嗅觉/味觉丧失的风险都有所降低。基于参与者的 AEFI 监测是上市后监测计划的有用组成部分。

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Participant-reported neurological events following immunization in the Canadian National Vaccine Safety Network-COVID-19 vaccine (CANVAS-COVID) study

Introduction

The Canadian National Vaccine Safety Network (CANVAS) conducted active participant-based surveillance for adverse events following immunization during the COVID-19 vaccine campaign. This study evaluated the association between COVID-19 vaccination and neurological adverse events.

Methods

Participants were invited to complete online surveys to report health events that prevented daily activities and/or required medical attention within 7 days after COVID-19 vaccination or 7 days prior to the survey (unvaccinated controls); follow-up surveys were sent 7 months later. Neurological events were health events where the most severe symptom reported was ≥1 of: numbness/tingling, loss of taste or smell, vision loss, facial weakness/paralysis, seizure, weakness/paralysis of arms or legs, confusion, change in personality or behavior, or difficulty with urination or defecation. Data were extracted from the CANVAS-COVID database for analysis.

Results

Completed survey responses were received from 15,273 unvaccinated controls, 758,619 dose 1 recipients, 406,884 dose 2 recipients, and 126,586 dose 3 recipients. Rates of neurological events ranged from 15.9 (95 % CI 13.6–18.4) per 10,000 dose 1 ChAdOx1 recipients to 8.4 (6.5–10.8) and 7.9 (5.7–11.0) per 10,000 dose 3 mRNA-1273 and BNT162b2 recipients, respectively. Multivariable regression adjusted for age, sex, previous SARS-CoV-2 infection, and baseline health status showed an increased risk of neurological event among ChAdOx1 dose 1 recipients versus controls (adjusted OR 2.3, 95 % CI 1.2–4.3), but not among mRNA vaccine recipients after any dose. Risk of anaesthesia/paresthesia were increased following ChAdOx1 dose 1 (aOR 4.7, 1.7–13.1), and consistently but not statistically significantly higher following any dose of either mRNA vaccine. Risk of loss of smell/taste was decreased among recipients of any dose of either mRNA vaccine versus controls.

Conclusions

The results support the safety of COVID-19 vaccines while confirming reported associations between ChAdOx1 dose 1 and neurological events. Participant-based AEFI surveillance is a useful component of post-market surveillance programs.

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来源期刊

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

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