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COVID-19 vaccination as a trigger of IgA vasculitis: a global pharmacovigilance study.

OBJECTIVE
IgA vasculitis (IgAV) can occur after vaccination. We aimed to assess a potential safety signal on the association between COVID-19 vaccines and IgAV.


METHODS
Cases of IgAV involving COVID-19 vaccines were retrieved in Vigibase. Disproportionate reporting was assessed using the Bayesian information component with all other drugs and vaccines as control groups.


RESULTS
Three hundred and thirty de novo IgAV from 24 countries were included, mostly in United States (193/330, 58%). Fifty per cent were female (163/328), median age was 32 years [interquartile range (IQR), 15-59] of which 33% (84/254) were young (1-17 years). Median time to onset of IgAV was 7 days (IQR, 2-16; n=256) and 85% of patients (280/330) were vaccinated with mRNA vaccines. Seriousness was reported in 188 cases (58%). Ninety-five recovered (65%) and 2 died (2%). A positive rechallenge was reported for 3 of 4 patients (75%). A total of 996 cases of IgAV were identified with other vaccines. There was a small significant increase in IgAV reporting with COVID-19 vaccines compared with all other drugs (IC 0.22, credibility interval (CrI) from 0.04 to 0.35). No disproportionality signal was found between COVID-19 and other vaccines (IC -1.42, CrI from -1.60 to -1.28]). There was no significant difference between mRNA vaccines and viral vector COVID-19 vaccines. Men and children had a significant overreporting of IgAV compared with women and adults, respectively.


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