What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European "Covid Vaccine Monitor" Active Surveillance Study.

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Drug Safety Pub Date : 2024-10-01 Epub Date: 2024-06-22 DOI:10.1007/s40264-024-01449-x
Chiara Bellitto, Nicoletta Luxi, Francesco Ciccimarra, Luca L'Abbate, Monika Raethke, Florence van Hunsel, Thomas Lieber, Erik Mulder, Fabio Riefolo, Felipe Villalobos, Nicolas H Thurin, Francisco B Marques, Kathryn Morton, Fergal O'Shaughnessy, Simona Sonderlichová, Andreea Farcas, Giele-Eshuis Janneke, Miriam C Sturkenboom, Gianluca Trifirò
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引用次数: 0

Abstract

Background: The safety profile of COVID-19 vaccines in immunocompromised patients has not been comprehensively evaluated.

Aim: To measure the frequency of patient-reported adverse drug reactions (ADRs) related to the first/second/booster dose of COVID-19 vaccine in immunocompromised subject versus matched cohort. As a secondary objective, the time course, evaluated as time to onset (TTO) and time to recovery (TTR), of COVID-19 vaccine-related ADRs was explored.

Methods: A prospective cohort study, based on electronic questionnaires filled by vaccinees from 11 European countries in the period February 2021 to February 2023 was conducted. All immunocompromised vaccinees who provided informed consent and registered to the project's web-app within 48 h after first/booster vaccine dose administration of any EMA-authorised COVID-19 vaccine were recruited. Participants filled baseline and up to six follow-up questionnaires (FU-Qs) over 6 months from vaccination, collecting information on suspected COVID-19 vaccine-related ADRs. As a control group, non-immunocompromised vaccinees from the same source population were 1:4 matched by sex, age, vaccine dose, and brand. A descriptive analysis of demographic/clinical characteristics of vaccinees was conducted. Heatmaps of the frequency of solicited ADRs, stratified by gender and vaccine brand, were generated. Median TTO/TTR of reported ADRs were visualised using violin/box-plots.

Results: A total of 773 immunocompromised vaccines were included in the analyses. Most participants were females (F/M ratio: 2.1 and 1.6) with a median age of 56 (43-74) and 51 (41-60) years, at the first vaccination cycle and booster dose, respectively. Injection-site pain and fatigue were the most frequently reported ADRs in immunocompromised vaccinees with higher frequency than matched control, especially after the first dose (41.2% vs 37.8% and 38.2% vs 32.9%, respectively). For both cohorts, all solicited ADRs were more frequently reported in females than males, and in those who had received a first dose of the Vaxzevria vaccine. Dizziness was the most frequently reported unsolicited ADR after the first dose in both groups (immunocompromised subjects: 2.5% and matched controls: 2.1%). At the booster dose, lymphadenopathy (3.9%) and lymphadenitis (1.8%) were the most reported unsolicited ADRs for immunocompromised subjects and matched controls, respectively. A very low number of subjects reported adverse event of special interest (AESI) (2 immunocompromised, 3 matched controls) and serious ADRs (5 immunocompromised, 5 matched controls). A statistically significant difference among study cohorts was observed for median TTO after the booster dose, and for median TTR after the first vaccination cycle and booster dose (p < 0.001).

Conclusion: The overall safety profile of COVID-19 vaccines in immunocompromised people was favourable, with minor differences as compared to non-immunocompromised vaccinees. Participants mostly experienced mild ADRs, mainly reported after the first dose of Vaxzevria and Jcovden vaccines. Serious ADRs and AESI were rare.

Abstract Image

免疫力低下患者接种 COVID-19 疫苗的安全性如何?欧洲 "Covid 疫苗监测 "主动监测研究的结果。
背景:COVID-19疫苗在免疫功能低下患者中的安全性尚未得到全面评估:目的:测量免疫功能低下受试者与匹配队列相比,患者报告的与第一/第二/加强剂量COVID-19疫苗相关的药物不良反应(ADRs)的频率。作为次要目标,研究还探讨了与 COVID-19 疫苗相关的药物不良反应的时间过程,即发病时间(TTO)和恢复时间(TTR):方法:根据来自 11 个欧洲国家的疫苗接种者在 2021 年 2 月至 2023 年 2 月期间填写的电子问卷,开展了一项前瞻性队列研究。所有免疫力低下的疫苗接种者在接种任何一种欧洲药品管理局(EMA)授权的 COVID-19 疫苗首剂/加强剂后 48 小时内提供知情同意并在项目的网络应用程序上注册,均被纳入研究范围。参与者在接种后 6 个月内填写基线问卷和多达 6 份随访问卷 (FU-Q),收集疑似 COVID-19 疫苗相关不良反应的信息。作为对照组,来自同一来源人群的非免疫缺陷疫苗接种者按性别、年龄、疫苗剂量和品牌以1:4的比例进行配对。对接种者的人口统计学/临床特征进行了描述性分析。生成了按性别和疫苗品牌分层的ADR频率热图。使用小提琴/方框图对已报告 ADR 的中位 TTO/TTR 进行了可视化分析:共有 773 例免疫力低下的疫苗被纳入分析。大多数参与者为女性(男女比例分别为 2.1 和 1.6),第一个接种周期和加强剂量的中位年龄分别为 56(43-74)岁和 51(41-60)岁。注射部位疼痛和疲劳是免疫力低下的接种者最常报告的不良反应,其发生率高于匹配的对照组,尤其是首剂接种后(分别为 41.2% 对 37.8% 和 38.2% 对 32.9%)。在两组接种者中,女性比男性更常报告所有诱发的不良反应,而接种过第一剂 Vaxzevria 疫苗的接种者也更常报告不良反应。头晕是两组接种第一剂疫苗后最常报告的非主动ADR(免疫功能低下受试者:2.5%,匹配对照组:2.1%)。在加强剂量中,淋巴结病(3.9%)和淋巴结炎(1.8%)分别是免疫力低下受试者和匹配对照组报告最多的非主动不良反应。极少数受试者报告了特别关注的不良反应(AESI)(2 例免疫功能低下者,3 例匹配对照组)和严重不良反应(5 例免疫功能低下者,5 例匹配对照组)。在加强剂量后的中位TTO以及第一个接种周期和加强剂量后的中位TTR方面,研究队列之间存在统计学意义上的显著差异(p < 0.001):免疫功能低下者接种COVID-19疫苗的总体安全性良好,与非免疫功能低下者相比差异较小。接种者大多会出现轻微的不良反应,主要发生在接种第一剂 Vaxzevria 和 Jcovden 疫苗后。严重的不良反应和AESI很少见。
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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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