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How Safe Are COVID-19 Vaccines in Individuals with Immune-Mediated Inflammatory Diseases? The SUCCEED Study
Olga Tsyruk1, Gilaad G Kaplan2, Paul R Fortin3,4
1Department of Medicine, McGill University, Montreal, QC H4A 3J1, Canada.
Insights
Severe adverse events following COVID-19 vaccination are rare in patients with immune-mediated inflammatory diseases (IMIDs). This study found very few serious adverse events leading to emergency department visits or hospitalizations in IMID patients after SARS-CoV-2 vaccination.
Area of Science:
- Immunology
- Vaccinology
- Rheumatology
Background:
- Immune-mediated inflammatory diseases (IMIDs) affect numerous individuals globally.
- Concerns exist regarding the safety of SARS-CoV-2 vaccination in IMID patients.
- Understanding severe adverse events (SAEs) is crucial for vaccine acceptance in this population.
Purpose of the Study:
- To describe the incidence and nature of SAEs following SARS-CoV-2 vaccination in adults with IMIDs.
- To assess the safety profile of COVID-19 vaccines in a Canadian cohort with rheumatoid arthritis, axial spondyloarthritis, systemic lupus, psoriatic arthritis, and inflammatory bowel disease.
Main Methods:
- A prospective study involving 1556 adult participants with IMIDs across eight Canadian centers.
- Data collection via questionnaires on SAEs occurring within 31 days of SARS-CoV-2 vaccination.
- Analysis of SAEs leading to emergency department (ED) visits and/or hospitalizations.
Main Results:
- A total of 12 SAEs (0.77%) leading to ED visits or hospitalizations were reported in 11 participants.
- Six SAEs resulted in ED visits (0.39%), including Bell's Palsy and pericarditis.
- Six SAEs resulted in hospitalizations (0.39%), including Guillain-Barré syndrome and a serious disease flare in a patient with SLE.
Conclusions:
- The incidence of severe adverse events following SARS-CoV-2 vaccination in individuals with IMIDs is very low.
- These findings support the safety of COVID-19 vaccines in this patient population.
- Optimizing vaccination acceptance among IMID patients is important given the ongoing risks of SARS-CoV-2 infection.
Abstract:
We were tasked by Canada's COVID-19 Immunity Task Force to describe severe adverse events (SAEs) associated with emergency department (ED) visits and/or hospitalizations in individuals with immune-mediated inflammatory diseases (IMIDs). At eight 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; the mean age was 52.5 years. The BNT162b2 (Pfizer) vaccine was the most common, with mRNA-1273 (Moderna) being second. A total of 49% of participants had IBD, 27.4% had RA, 14.3% had PsA, 5.3% had SpA, and 4% had SLE. Twelve (0.77% of 1556 participants) SAEs leading to an ED visit or hospitalization were self-reported, occurring in 11 participants. SAEs included six (0.39% of 1556 participants) ED visits (including one due to Bell's Palsy 31 days after first vaccination) and six (0.39% of 1556 participants) hospitalizations (including one due to Guillain-Barré syndrome 15 days after the first vaccination). Two SAEs included pericarditis, one involved SLE (considered a serious disease flare), and one involved RA. Thus, in the 31 days after SARS-CoV-2 vaccination in our IMID sample, very few serious adverse events occurred. As SARS-CoV2 continues to be a common cause of death, our findings may help optimize vaccination acceptance.
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