Preprint Article Version 1 This version is not peer-reviewed

How Safe are COVID-19 Vaccines in Immune-Mediated Inflammatory Diseases? The SUCCEED Study

Olga Tsyruk
,
Gilaad G. Kaplan
,
Paul R Fortin
,
Carol A Hitchon
,
Vinod Chandran
,
Maggie J. Larché
,
Antonio Avina-Zubieta
,
Gilles Boire
,
Inés Colmegna
,
Diane Lacaille
,
Nadine Lalonde
,
Laurie Proulx
,
Dawn P Richards
,
Natalie Boivin
,
Christopher DeBow
,
Lucy Kovalova-Wood
,
Deborah Paleczny
,
Linda Wilhelm
,
Luck Lukusa
,
Daniel Pereira
,
Jennifer LF Lee
,
Sasha Bernatsky
*
Version 1 : Received: 2 August 2024 / Approved: 5 August 2024 / Online: 5 August 2024 (11:52:04 CEST)

How to cite: Tsyruk, O.; Kaplan, G. G.; Fortin, P. R.; Hitchon, C. A.; Chandran, V.; Larché, M. J.; Avina-Zubieta, A.; Boire, G.; Colmegna, I.; Lacaille, D.; Lalonde, N.; Proulx, L.; Richards, D. P.; Boivin, N.; DeBow, C.; Kovalova-Wood, L.; Paleczny, D.; Wilhelm, L.; Lukusa, L.; Pereira, D.; Lee, J. L.; Bernatsky, S. How Safe are COVID-19 Vaccines in Immune-Mediated Inflammatory Diseases? The SUCCEED Study. Preprints 2024, 2024080311. https://doi.org/10.20944/preprints202408.0311.v1 Tsyruk, O.; Kaplan, G. G.; Fortin, P. R.; Hitchon, C. A.; Chandran, V.; Larché, M. J.; Avina-Zubieta, A.; Boire, G.; Colmegna, I.; Lacaille, D.; Lalonde, N.; Proulx, L.; Richards, D. P.; Boivin, N.; DeBow, C.; Kovalova-Wood, L.; Paleczny, D.; Wilhelm, L.; Lukusa, L.; Pereira, D.; Lee, J. L.; Bernatsky, S. How Safe are COVID-19 Vaccines in Immune-Mediated Inflammatory Diseases? The SUCCEED Study. Preprints 2024, 2024080311. https://doi.org/10.20944/preprints202408.0311.v1

Abstract

We were tasked by Canada’s COVID-19 Immunity Task Force to describe severe adverse events (SAE) associated with emergency department (ED) visits and/or hospitalizations in immune-mediated inflammatory diseases (IMID). At 8 Canadian centres, data were collected from adults with rheumatoid arthritis (RA), axial spondyloarthritis (AxS), systemic lupus (SLE), psoriatic arthritis (PsA) and inflammatory bowel disease (IBD). We administered questionnaires, analyzing SAEs experienced within 31 days following SARS-CoV-2 vaccination. About two-thirds (63%) of 1556 participants were female; mean age was 52.5 years. BNT162b2 (Pfizer) vaccine was the most common, with mRNA-1273 (Moderna) being second. Forty-nine percent of participants had IBD, 27.4% RA, 14.3% PsA, 5.3% SpA, and 4% SLE. Twelve SAEs leading to ED visit or hospitalization were self-reported, occurring in 11 participants. SAEs included 6 ED visits (including one Bell’s Palsy 31 days after first vaccination) and 6 hospitalizations (including one Guillain-Barré syndrome 15 days after the first vaccination). Two SAEs involved pericarditis, one in SLE (considered a serious disease flare) and one in RA. Thus, in the 31 days after SARS-CoV-2 vaccination in IMID, though several serious AEs occurred, these were relatively few. As SARS-CoV2 continues to be a common cause of death, our findings may help optimize vaccination acceptance.

Keywords

COVID-19 vaccine safety,; immune mediated inflammatory diseases; serious adverse events

Subject

Public Health and Healthcare, Public Health and Health Services

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Download PDF

Comments (0)

We encourage comments and feedback from a broad range of readers. See criteria for comments and our Diversity statement.

Leave a public comment
Send a private comment to the author(s)
* All users must log in before leaving a comment
Views 0
Downloads 0
Comments 0
Metrics 0
Get PDF Cite Share 0
Bookmark BibSonomy Mendeley Reddit Delicious
×
Alerts
Notify me about updates to this article or when a peer-reviewed version is published.
We use cookies on our website to ensure you get the best experience.
Read more about our cookies here.