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COVID-19

COVID-19 Vaccination and Autoimmune Diseases: New Study Reveals No Safety Concerns

Strategic Insights

— 1 min read

A new study from Besancon University Hospital in France has investigated the safety of COVID-19 vaccination in patients with autoimmune or inflammatory diseases (AIID). The research, which analyzed data from 20,169 adverse event following immunization (AEFI) cases recorded in the French National Pharmacovigilance Database, found no safety concerns related to AIID following vaccination with Spikevax. The study, which was published in Fundamental & Clinical Pharmacology, retrospectively analyzed 368 cases of AIID that occurred after vaccination with Spikevax, regardless of the dose received, between January 31, 2021, and January 31, 2022.

Key Takeaways:

  • The study analyzed data from 20,169 AEFI cases recorded in the French National Pharmacovigilance Database.
  • Of these cases, 2594 were identified as having "Immune/Mediated/Autoimmune Conditions" and were selected for further analysis.
  • After review by two experts, 368 cases of AIID were finally retained for analysis.
  • The study found no safety concerns related to AIID following vaccination with Spikevax.
  • The study's results suggest that vaccination with Spikevax does not trigger autoimmune or inflammatory diseases.
  • The study's findings have implications for the safety of COVID-19 vaccination in patients with pre-existing autoimmune or inflammatory diseases.

Statistics:

  • 20,169 AEFI cases were recorded in the French National Pharmacovigilance Database.
  • 2594 cases were identified as having "Immune/Mediated/Autoimmune Conditions".
  • 368 cases of AIID were finally retained for analysis.
  • The median age of patients with AIID was 54 years (range 42-69 years).
  • Female patients accounted for 63.6% of the AIID cases.
  • The median time to onset of AIID was 4 days (range 1-180 days).

Sources:

  • NewsRx. New Vaccination Study Results from Besancon University Hospital Described (Relapse and New-onset of Autoimmune or Inflammatory Diseases Following Vaccination With Spikevax: Pharmacovigilance Overview From the French Spontaneous Reported System). Medical Letter on the CDC & FDA. November 2, 2025; p 661.
  • Fundamental & Clinical Pharmacology. Relapse and New-onset of Autoimmune or Inflammatory Diseases Following Vaccination With Spikevax: Pharmacovigilance Overview From the French Spontaneous Reported System. 2025;39(4).

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