Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands.
Drug Saf. 2022 Apr;45(4):319-331. doi: 10.1007/s40264-022-01151-w. Epub 2022 Mar 21.
The rapid rollout of coronavirus disease 2019 (COVID-19) vaccines for a large proportion of the population necessitates a strong emphasis on safety. Complementary to the existing spontaneous reporting system, The Netherlands Pharmacovigilance Centre Lareb conducted patient-reported cohort event monitoring (CEM).
The primary aim was to investigate differences in the frequencies of any and commonly reported, 'well-known', systemic adverse events following immunization (AEFIs) with four COVID-19 vaccines (Pfizer's Comirnaty, Moderna's Spikevax, AstraZeneca's Vaxzevria and the Janssen vaccine). As a secondary aim, we analyzed the frequencies of well-known systemic adverse events after the first and, if applicable, second COVID-19 vaccinations, taking into account age, sex and prior COVID-19 infection.
Patient-reported outcomes (PROs) in the Netherlands starting in February 2021 were analyzed using a prospective cohort design.
Data of 27,554 participants who received one vaccination and 20,682 participants who received complete immunization were analyzed. The percentage of patients reporting any AEFI was high and ranged from approximately 53% for the Pfizer vaccine to approximately 94% for the Moderna vaccine. The frequency of serious AEFIs was low, with the highest frequency found for the AstraZeneca vaccine (0.228%). AEFIs were most often experienced by participants receiving the first dose of the AstraZeneca and Janssen vaccines and the second dose of the Moderna vaccine; the Pfizer vaccine was associated with the lowest rate of AEFIs. Participants with a COVID-19 history before vaccination experienced commonly reported systemic AEFIs more frequently after the first vaccination than after the second vaccination. Women and young people experienced more AEFIs than men and older people, respectively.
The analysis of a large cohort provides important information about the rates of AEFIs across age groups, among brands of vaccines and between those with and without prior COVID-19 infection. Participants reported a high number of AEFIs in general, but the frequency of serious AEFIs was low.
由于 COVID-19 疫苗在很大一部分人群中的快速推出，因此必须高度重视安全性。除现有的自发报告系统外，荷兰药物警戒中心 Lareb 还开展了患者报告的队列事件监测（CEM）。
主要目的是调查在接种四种 COVID-19 疫苗（辉瑞的 Comirnaty、莫德纳的 Spikevax、阿斯利康的 Vaxzevria 和杨森疫苗）后，任何常见报告的全身不良事件（AEFI）的频率差异。次要目的是分析首次接种和（如适用）第二次 COVID-19 接种后常见全身不良事件的频率，同时考虑年龄、性别和既往 COVID-19 感染情况。
从 2021 年 2 月开始，使用前瞻性队列设计分析荷兰的患者报告结局（PRO）数据。
共分析了 27554 名接受一剂接种和 20682 名完成免疫接种的参与者的数据。报告任何 AEFI 的患者百分比较高，范围从辉瑞疫苗的约 53%到莫德纳疫苗的约 94%。严重 AEFI 的频率较低，阿斯利康疫苗的频率最高（0.228%）。接种阿斯利康和杨森疫苗的第一剂和莫德纳疫苗的第二剂后，AEFI 最常见；接种辉瑞疫苗的 AEFI 发生率最低。在接种疫苗前有 COVID-19 病史的参与者在首次接种后比第二次接种后更常经历常见的全身 AEFI。女性和年轻人比男性和老年人经历的 AEFI 更多。
对大型队列的分析提供了有关各年龄段、疫苗品牌以及既往 COVID-19 感染人群之间 AEFI 发生率的重要信息。一般来说，参与者报告了大量的 AEFI，但严重 AEFI 的频率较低。
