The development of systemic vasculitis, other than Behçet syndrome, is not increased among individuals who receive mRNA COVID-19 vaccines compared with those who receive influenza vaccines, according to study results published in Rheumatology (Oxford).
To evaluate a potential safety signal for the different types of vasculitis reported following administration of mRNA COVID-19 vaccines, the researchers used VigiBase, the World Health Organization global individual case safety report database that contains spontaneous reports of suspected adverse drug reactions collected by the national drug authorities in more than 130 different countries.
Among 2,499,457 spontaneous reports with mRNA COVID-19 vaccines in VigiBase through March 31, 2022, a total of 2125 cases of vasculitis were identified (8.5 per 10,000 reports). Of these cases, 61% were in women, and the median age was 58 years (range, 38 to 72 years).
Overall, mRNA vaccines were linked to an increased reporting in Behçet syndrome (reporting odds ratio [ROR], 1.7; 95% CI, 1.4-2.1), giant-cell arteritis (ROR, 4.5;
95% CI, 4.0-5.0), microscopic polyangiitis (ROR, 2.6; 95% CI, 1.8 to 3.7), livedoid vasculopathy (ROR, 4.1; 95% CI, 2.5-6.5), and urticarial vasculitis (ROR, 3.0; 95% CI, 2.4-3.7). None of the other types of vasculitis (eosinophilic granulomatosis polyangiitis, Henoch-Schonlein purpura, or polyarteritis nodosa) were associated with increased reporting following administration of COVID-19 vaccines.
Compared with the administration of influenza vaccines, disproportionate reporting was observed following mRNA COVID-19 vaccines for Behçet syndrome only (ROR, 4.2; 95% CI, 1.3-13.2). Among the 93 cases of Behçet’s syndrome reported, 82% (76 of 93) of them were in women, with a median age of 37 years (range, 30 to 43 years). The cases of Behçet syndrome reported were within the range of the expected epidemiology with the disease.
According to the researchers, although significant, “these results should be interpreted with caution, considering the small numbers of cases in the comparator group.” Environmental factors and infections are likely to play a role in the onset of systemic vasculitis, and administration of a vaccine might serve as an inflammatory trigger.
Limitations of the study included underreporting of cases, as well as heterogeneous causality evaluation among the reports. The importance of utilizing a relevant comparator for interpretation of these real-life data was emphasized.
The study authors concluded that additional analyses are warranted in order to confirm this signal and vaccine causality.
Disclosure: One of the study authors has declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of the author’s disclosures.
Mettler C, Terrier B, Treluyer JM, Chouchana L. Risk of systemic vasculitis following mRNA COVID-19 vaccination: a pharmacovigilance study. Rheumatology (Oxford). Published online May 31, 2022. doi:10.1093/rheumatology/keac323