Reactogenicity of the Messenger RNA SARS–CoV‐2 Vaccines Associated With Immunogenicity in Patients With Autoimmune and Inflammatory Disease

Abstract

Objective. Little is known regarding the reactogenicity and related SARS-CoV-2 vaccine response in patients with chronic inflammatory disease (CID). Our objective was to characterize the adverse event profile of CID patients following SARS-CoV-2 vaccination and understand the relationship between reactogenicity and immunogenicity of SARS-CoV-2 vaccines.Methods. CID patients and healthy controls eligible to receive messenger RNA (mRNA) SARS-CoV-2 vaccines participated in 3 study visits (pre-vaccine, after dose 1, and after dose 2) in which blood and clinical data were collected. Assessment of adverse events were solicited within 7 days of receiving each dose. Serum anti-SARS-CoV-2 spike IgG ± antibody titers were quantified following vaccination. Statistical analysis was performed utilizing mixed models and tobit regressions, with adjustment for covariates.Results. The present study included 441 participants (322 CID patients and 119 control subjects). Compared to controls, CID patients reported greater symptom severity after dose 1 (P = 0.0001), including more myalgia and fatigue (P < 0.05). For immunogenicity, a higher symptom severity after dose 1 and a higher number of symptoms after dose 2 was associated with higher antibody titers (P ≤ 0.05). Each increase of 1 symptom was associated with a 15.1% increase in antibody titer. Symptom association was strongest with site pain after dose 1 (105%; P = 0.03) and fatigue after dose 2 (113%; P = 0.004).Conclusion. Patients with CID have a distinct reactogenicity profile following SARS-CoV-2 vaccination compared to controls. Furthermore, there is an association between increased reactogenicity and increased vaccine response. This finding may speak to the more variable immunogenicity in CID patients and may be an important indicator of vaccine response to the novel SARS-CoV-2 vaccines.

Optic neuritis following COVID-19 vaccination: Do autoimmune diseases play a role?

“…The reactogenicity of COVID-19 mRNA vaccine in individuals suffering from immune-mediated diseases (having therefore a pre-existent dysregulation of the immune response) is yet to be elucidated and it is being increasingly investigated. 13 – 15 Our paper supports the hypothesis that patients who are already affected or predisposed (e.g. immunological and serological abnormalities in absence of clinical symptoms, familiarity for immune-mediated diseases) to autoimmune or autoinflammatory disorders should be carefully evaluated for the benefits and risks of COVID-19 mRNA vaccination.…”

Social media for research discourse, dissemination, and collaboration in rheumatology

“…Finally, the COVID-19 Vaccine Responses in Patients with Autoimmune Disease (COVaRiPAD) is a multi-center prospective patient-oriented study that was partially forged through GRA collaborations. This study of people with immune-mediated inflammatory diseases before and after vaccine doses has investigated the impact of specific immunosuppressants on vaccine immunogenicity, [ 42 ] reactogenicity, [ 43 ] and booster effects. [ 44 ] Thus, social media can be the catalyst for research studies that lead to impactful findings and research funding.…”

Reactogenicity and Related SARS-CoV-2 Vaccine Response in Patients With Chronic Inflammatory Disease

“…The researchers report that patients with chronic inflammatory disease (CID) had more numerous symptoms following the first dose of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines than healthy controls. (See Yang et al, 2022. )…”