Lupus & antiphospholipid syndrome
Safety and tolerance of vaccines against SARS-CoV-2 infection in systemic lupus erythematosus: results from the COVAD study
Authors' conclusion
While COVID-19 vaccination-related AEs were reported by four-fifths of SLE patients, those were mostly minor and comparable to AEs reported by healthy individuals, providing reassurance regarding COVID-19 vaccination safety in SLE.
Study context
- Population
- Respondents to the COVAD questionnaire, March-December 2021; SLE patients mean age 40.1 years, 94.5% females, 40.5% Asian, 42.9% Pfizer-recipients
- Participants
- 9,462 complete respondents
- Exposure
- SLE vs autoimmune rheumatic diseases (AIRDs), non-rheumatic autoimmune diseases (nrAIDs) and healthy controls (HC)
- SLEn = 583
- Outcome
- COVID-19 vaccine-related AEs
- Follow-up
- Seven-day post-vaccination period
Methodological detailsinternational online survey (COVAD questionnaire), multivariable regression adjusted for age, gender, ethnicity, vaccine type and background treatment
- International online survey (COVAD questionnaire)
- Multivariable regression adjusted for age, gender, ethnicity, vaccine type and background treatment
Main finding
As reported in the abstract
Vaccine-related AEs in SLE · 7 days post-vaccination
| Group | Value | Minor adverse events (AEs) | Major AEs | Hospitalization |
|---|---|---|---|---|
| SLE | 83.0% | 83.0% | 2.6% | 0.2% |
SLE
Value83.0%
Minor adverse events (AEs)83.0%
Major AEs2.6%
Hospitalization0.2%
Observational data: associations, not effects.
Further findings
| Outcome | OR (95% CI) | |
|---|---|---|
| RashesSLEvs HCMore frequent in SLE | 1.2 (1.0–1.5) | |
| ChillsSLEvs AIRDsLess frequent in SLE | 0.6 (0.4–0.8) | |
| ChillsSLEvs nrAIDsLess frequent in SLE | 0.5 (0.3–0.8) | |
| FatigueSLEvs nrAIDsLess frequent in SLE | 0.6 (0.4–0.9) | |
| AEs by vaccine type (Pfizer vs other vaccines)Pfizervs Other vaccinesOverall AE | 2.2 (1.1–4.2) | |
| AEs by vaccine type (Pfizer vs other vaccines)Pfizervs Other vaccinesInjection site pain | 2.9 (1.6–5.0) | |
| AEs by treatmentAntimalarial usersvs Non-usersChills | 0.5 (0.3–0.9) | |
| 0.20.5125Odds ratio (log scale) |
AEs by vaccine type (Pfizer vs other vaccines)
- Oxford/AstraZeneca-recipients more body ache, fever, chills (OR: 2.5, 3.0)
- Moderna-recipients more body ache, fever, chills, rashes (OR: 2.6, 4.3)
- Hospitalization frequencies similar across vaccine types
AEs by treatment
- AE frequencies similar across treatment groups
Original publication
Safety and tolerance of vaccines against SARS-CoV-2 infection in systemic lupus erythematosus: results from the COVAD study. Rheumatology (Oxford). Published 22 November 2022. doi:10.
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