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Evaluating the safety of XBB.1.5-containing COVID-19 mRNA vaccines using a self-controlled case series study

Yuanyi Pan1,2,3, Yun Han4, Chuan Zhou5

  • 1Department of Radiology, People's Hospital of Guizhou Province, Guiyang, Guizhou Province, China.

Nature Communications
|July 15, 2025
PubMed

Insights

The XBB.1.5 COVID-19 mRNA vaccine showed a link to anaphylaxis. No other serious adverse events were significantly associated with this new COVID-19 vaccine in a large US study.

Area of Science:

  • Vaccinology
  • Immunology
  • Public Health

Background:

  • The emergence of new SARS-CoV-2 variants necessitates updated vaccine formulations.
  • Evaluating the safety of XBB.1.5-containing COVID-19 mRNA vaccines is crucial for public health.
  • The National COVID Cohort Collaborative (N3C) provides a valuable resource for real-world vaccine safety surveillance.

Purpose of the Study:

  • To assess the relative risk of 15 specific adverse events following XBB.1.5-containing COVID-19 mRNA vaccination.
  • To investigate the safety profile of the latest COVID-19 mRNA vaccine formulation.
  • To contribute to the ongoing evaluation of mRNA vaccine safety.

Main Methods:

  • A self-controlled case series study design was employed.
  • Data from 244,494 patients were analyzed from the N3C database (September 11, 2023, to June 1, 2024).
  • The study examined the association between XBB.1.5 vaccination and 15 pre-defined adverse events.

Main Results:

  • An increased risk of anaphylaxis was observed following XBB.1.5 vaccination.
  • The association with anaphylaxis was noted across different short-term risk periods post-vaccination.
  • No other investigated adverse events, including Guillain-Barré syndrome, myo/pericarditis, or thrombotic events, showed a significantly increased risk.

Conclusions:

  • XBB.1.5-containing COVID-19 mRNA vaccines appear to have a safety profile similar to previous formulations, with anaphylaxis as a rare identified risk.
  • The findings support the continued use of XBB.1.5-containing mRNA vaccines.
  • Real-world data from large collaborative networks are essential for robust vaccine safety monitoring.

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