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. 2025 Aug;39(4):e70027.
doi: 10.1111/fcp.70027.

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

Lucie Vettoretti  1 , Célia Bouaskeur  1 , Nadine Magy-Bertrand  2 , Sophie Gautier  3   4 , Marie Blanche Valnet Rabier  1   4
Affiliations

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

Lucie Vettoretti et al. Fundam Clin Pharmacol. 2025 Aug.

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.

Keywords: autoimmune disease; mRNA COVID‐19 vaccine; new‐onset; relapse.

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References

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