TY - JOUR
T1 - A disproportionality analysis for the association of central nervous system demyelinating diseases with COVID-19 vaccination using the World Health Organization pharmacovigilance database
AU - Kim, Jee Eun
AU - Park, Jin
AU - Song, Tae Jin
N1 - 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.
PY - 2022/11
Y1 - 2022/11
N2 - 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.
AB - 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.
KW - acute disseminated encephalomyelitis
KW - COVID-19
KW - multiple sclerosis
KW - myelitis
KW - optic neuritis
KW - vaccination
UR - http://www.scopus.com/inward/record.url?scp=85134219339&partnerID=8YFLogxK
U2 - 10.1177/13524585221109397
DO - 10.1177/13524585221109397
M3 - Article
C2 - 35822296
AN - SCOPUS:85134219339
SN - 1352-4585
VL - 28
SP - 2112
EP - 2123
JO - Multiple Sclerosis Journal
JF - Multiple Sclerosis Journal
IS - 13
ER -