A disproportionality analysis for the association of central nervous system demyelinating diseases with COVID-19 vaccination using the World Health Organization pharmacovigilance database

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Abstract

Background: Limited information is available on associations between COVID-19 vaccines and central nervous system (CNS) demyelinating diseases. Objectives: We investigated potential safety signals for CNS demyelinating diseases related to COVID-19 vaccines using the World Health Organization pharmacovigilance database. Methods: Disproportionality analyses of CNS demyelinating disease following COVID-19 vaccination were performed by calculating the information component (IC) or the reporting odds ratio (ROR) compared with those for the entire database and for all other viral vaccines. Results: We identified 715 cases of optic neuritis, 515 of myelitis, 220 of acute disseminated encephalomyelitis (ADEM), and 2840 total CNS demyelinating events adverse drug reactions from July 2020 through February 2022. For mRNA-based and ChAdOx1 nCoV-19 vaccines, there were no potential safety signals of disproportionality for optic neuritis (IC025 = −0.93, ROR025 = 0.38; IC025 = −1.76, ROR025 = 0.26), myelitis (IC025 = −0.69, ROR025 = 0.50; IC025 = −0.63, ROR025 = 0.53), ADEM (IC025 = −1.05, ROR025 = 0.33; IC025 = −1.76, ROR025 = 0.20), or overall CNS demyelinating disease events (IC025 = −0.66, ROR025 = 0.52; IC025 = −1.31, ROR025 = 0.34) compared with other viral vaccines. Conclusion: As with other viral vaccines, our disproportionality analyses indicate that the risk of COVID-19 vaccine-associated CNS demyelinating disease was low.

Original languageEnglish
Pages (from-to)2112-2123
Number of pages12
JournalMultiple Sclerosis Journal
Volume28
Issue number13
DOIs
StatePublished - Nov 2022

Bibliographical note

Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Education (grant number NRF-2021R1F1A1048113).

Publisher Copyright:
© The Author(s), 2022.

Keywords

  • acute disseminated encephalomyelitis
  • COVID-19
  • multiple sclerosis
  • myelitis
  • optic neuritis
  • vaccination

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