Vasculitis & polymyalgia rheumatica

COVID-19 Vaccination as a Trigger of IgA Vasculitis: A Global Pharmacovigilance Study

J RheumatolPublished Pharmacovigilance study

Authors' conclusion

This study provides reassuring results regarding the safety of COVID-19 vaccines in the occurrence of IgAV compared to other vaccines.

Study context

Population
Cases of de novo igA vasculitis (IgAV) reported after COVID-19 vaccines in VigiBase, 24 countries330 COVID-19 vaccine IgAV cases · 24 countries
Comparison
COVID-19 vaccines vs all other drugs and vs other vaccines
  • COVID-19 vaccinesn = 330
  • Other vaccinesn = 996reference
Outcome
Disproportionate reporting of IgAV (IC)
Methodological detailsdisproportionality analysis of VigiBase, global, Bayesian information component
  • Disproportionality analysis of VigiBase
  • Global
  • Bayesian information component

Main finding

As reported in the abstract

Disproportionate reporting of IgAV

Information component (IC)

0.22

95% CrI 0.04–0.35

COVID-19 vaccines vs All other drugs · CrI; small significant increase

IC

−1.42

95% CrI −1.60 to −1.28

COVID-19 vaccines vs Other vaccines · CrI; no disproportionality signal

Further findings

Case characteristics (COVID-19 vaccines)

Female
163/328 (50%)
Median age, years (IQR 15-59)
32
Young (1-17 yrs)
84/254 (33%)
Median time to onset, days (IQR 2-16; n = 256)
7
mRNA vaccines
280/330 (85%)
Positive rechallenge
3 of 4 (75%)

mRNA vs viral vector COVID-19 vaccines

No significant difference

Overreporting by sex and age

Men and children had significant overreporting of IgAV vs women and adults, respectively

Safety

Seriousness and outcome of IgAV cases

Serious
188/324 (58%)
Recovered
95/147 (65%)
Died
2/147 (1%)

Original publication

COVID-19 Vaccination as a Trigger of IgA Vasculitis: A Global Pharmacovigilance Study. J Rheumatol. Published 15 November 2022. doi:10.3899/jrheum.220629

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