Relapse and New-Onset of Autoimmune or Inflammatory Diseases Following Vaccination With SPIKEVAX: Pharmacovigilance Overview From the French Spontaneous Reported System

IF 2.1 4区医学 Q3 PHARMACOLOGY & PHARMACY

Fundamental & Clinical Pharmacology Pub Date : 2025-06-01 DOI:10.1111/fcp.70027

Lucie Vettoretti, Célia Bouaskeur, Nadine Magy-Bertrand, Sophie Gautier, Marie Blanche Valnet Rabier

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引用次数: 0

Abstract

Background

COVID-19 vaccination raises questions in patients with autoimmune or inflammatory diseases (AIID), not included in clinical trials. Concern exists about the risk of activating the immune system or worsening the AIID. However, cases of AIID flare-ups or new-onset reported in literature are limited and do not allow conclusions to be drawn on the potential effect of vaccination.

Objective

To explore the clinical features of AIID that occurred after vaccination.

Methods

We performed a retrospective analysis of adverse event following immunization (AEFI) reported in the French National Pharmacovigilance Database (BNPV) following vaccination with SPIKEVAX (mRNA-1273/Moderna), regardless of the dose received, between Jan 31, 2021 and Jan 31, 2022.

Results

Among the 20 169 AEFI cases recorded in BNPV, 2594 cases identified with Standardized MedDRA Queries “Immune/Mediated/Autoimmune Conditions” were analyzed to select cases of interest. After review by two experts, 368 cases of AIID were finally retained for analysis [age 54 (42–69); female 234 (63.6%); onset median time 4 days (from < 24 h to 179d); serious cases 226 (61.4%)] and divided into two groups: AIID flare-ups (n = 174) and AIID new-onset (n = 194). SOCs “Musculoskeletal and connective tissue disorders” and “Nervous system disorders” recorded the most of AIID cases whatever flare-up or new-onset. Cases reported are mainly ankylosing spondylitis (n = 20), rheumatoid arthritis (n = 17), multiple sclerosis (n = 19) for flare-ups and Guillain-Barre syndrome (n = 27) for new-onset.

Conclusion

No safety concerns related to AIID following vaccination with SPIKEVAX were found after the reviewing of 368 French cases.

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接种SPIKEVAX后自身免疫性或炎症性疾病的复发和新发：来自法国自发报告系统的药物警戒概述

背景：在未纳入临床试验的自身免疫性或炎症性疾病（AIID）患者中接种COVID-19疫苗存在问题。人们担心会激活免疫系统或使艾滋病恶化。然而，文献中报道的艾滋病突发或新发病例是有限的，不能得出关于疫苗接种潜在效果的结论。目的探讨疫苗接种后发生艾滋病的临床特点。方法回顾性分析了2021年1月31日至2022年1月31日期间接种SPIKEVAX （mRNA-1273/Moderna）疫苗后，不论接种剂量如何，法国国家药物警戒数据库（BNPV）中报告的免疫不良事件（AEFI）。结果在BNPV记录的20169例AEFI病例中，2594例通过标准化MedDRA查询“免疫/介导/自身免疫性疾病”进行分析，以选择感兴趣的病例。经过两位专家的审查，最终保留368例AIID进行分析[年龄54岁（42-69岁）；女性234人（63.6%）；发病中位时间4天（从24小时到179d）；重症226例（61.4%）]，分为急性AIID发作组（n = 174）和新发AIID组（n = 194）。无论是急性发作还是新发，SOCs“肌肉骨骼和结缔组织疾病”和“神经系统疾病”记录了最多的艾滋病病例。报告的病例主要是强直性脊柱炎（n = 20），类风湿性关节炎（n = 17），多发性硬化症（n = 19）的突发和格林-巴利综合征（n = 27）的新发。结论在对368例法国病例进行审查后，未发现SPIKEVAX疫苗接种后与艾滋病相关的安全问题。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Fundamental & Clinical Pharmacology 医学-药学

CiteScore

5.30

自引率

6.90%

发文量

111

审稿时长

6-12 weeks

期刊介绍： Fundamental & Clinical Pharmacology publishes reports describing important and novel developments in fundamental as well as clinical research relevant to drug therapy. Original articles, short communications and reviews are published on all aspects of experimental and clinical pharmacology including: Antimicrobial, Antiviral Agents Autonomic Pharmacology Cardiovascular Pharmacology Cellular Pharmacology Clinical Trials Endocrinopharmacology Gene Therapy Inflammation, Immunopharmacology Lipids, Atherosclerosis Liver and G-I Tract Pharmacology Metabolism, Pharmacokinetics Neuropharmacology Neuropsychopharmacology Oncopharmacology Pediatric Pharmacology Development Pharmacoeconomics Pharmacoepidemiology Pharmacogenetics, Pharmacogenomics Pharmacovigilance Pulmonary Pharmacology Receptors, Signal Transduction Renal Pharmacology Thrombosis and Hemostasis Toxicopharmacology Clinical research, including clinical studies and clinical trials, may cover disciplines such as pharmacokinetics, pharmacodynamics, pharmacovigilance, pharmacoepidemiology, pharmacogenomics and pharmacoeconomics. Basic research articles from fields such as physiology and molecular biology which contribute to an understanding of drug therapy are also welcomed.