A case-control study of autoimmune AEFIs following COVID-19 vaccination reported to VAERS

Abstract

Autoimmune adverse effects following immunisation (AEFIs) are widely regarded as a chief concern driving vaccine hesitancy. This case-control study seeks to shed light on the true risk of autoimmune AEFIs associated with the COVID-19 vaccine through a case-control analysis of VAERS reports. Reports of autoimmune aetiology were matched with reports of non-autoimmune controls. Statistical analysis reveals that the safety profile of COVID-19 vaccines with regard to autoimmune AEFIs is highly favourable. In particular, neuroautoimmune AEFIs have statistically significant reporting odds ratios below unity (Guillain-Barre syndrome: 0.35, multiple sclerosis: 0.70, transverse myelitis: 0.79), indicating a reduced association of reports of these conditions with the COVID-19 vaccine versus other vaccines. Only three autoimmune aetiologies exceed a ROR of 2.0 and thus present a potential signal. Of these, myasthenia gravis (ROR = 3.90, p < 0.001, 95% CI: 2.63-5.80) may be the result of epidemiological confounding factors not sufficiently controlled by matching, as the population most likely to develop myasthenia gravis was strongly prioritised in the COVID-19 vaccine's initial rollout. Immune thrombocytopaenia (ROR = 26.83, p < 0.001, 95% CI: 16.93-42.54) is a clear safety signal, confirming a large number of case reports and studies that indicate a risk of immune thrombocytopaenic events following the COVID- 19 vaccine. The lone strong safety signal of immune thrombocytopaenia notwithstanding, this study attests to the safety of the COVID-19 vaccine where autoimmune conditions are concerned. Through quantifying the risk of autoimmune disorders associated with COVID-19 vaccination, this study contributes to a growing body of evidence supporting the safety of such vaccines.

Safety of mRNA COVID‐19 vaccines in patients with well‐controlled myasthenia gravis

“…The cases reported in the VAERS and a single‐center case series of 22 patients using inactivated virus vaccines addressed the side effects of the COVID vaccination among myasthenic patients. 24 , 25 At the time of this writing, the VAERS website had recorded 75 exacerbations, 17 myasthenic crises, and 115 instances of new‐onset MG after COVID vaccination. 26 The incidence of reactogenicity in our cohort was significantly lower than in a V ‐ safe survey (V‐safe provides personalized and confidential health check‐ins via text messages and web surveys) that enrolled 3,643,918 healthy volunteers.…”

“…Age was the only risk factor for AEs. The cases reported in the VAERS and a single‐center case series of 22 patients using inactivated virus vaccines addressed the side effects of the COVID vaccination among myasthenic patients 24,25 . At the time of this writing, the VAERS website had recorded 75 exacerbations, 17 myasthenic crises, and 115 instances of new‐onset MG after COVID vaccination 26 .…”