Background/Purpose: Clinical trials on efficacy and safety of SARS-CoV-2 vaccines did not include patients with autoimmune diseases. We previously demonstrated that concerns of adverse events and disease exacerbations due to SARS-CoV-2 vaccinations are important reasons for vaccine hesitancy in this patient group. Consequently, data on effects of SARS-CoV-2 vaccinations on patients with autoimmune diseases are urgently needed. The primary objective was to compare the frequency and severity of adverse events following SARS-CoV-2 vaccinations between patients with autoimmune diseases and healthy controls. Secondary objectives were to assess whether autoimmune disease activity was influenced by SARS-CoV-2 vaccinations, and whether any vaccine (AstraZeneca, Pfizer/BionNTech or Moderna) would be preferable for patients with autoimmune diseases.

Methods: On April 14^th, 2021, a digital questionnaire evaluating consequences of SARS-CoV-2 vaccinations was sent to patients with systemic autoimmune diseases and healthy controls, who were enrolled in two ongoing prospective cohort studies of the Amsterdam Rheumatology & Immunology Center, Amsterdam and Amsterdam UMC (Netherlands Trial Register, trial ID NL8513 and NCT04498286). Mild adverse events were defined as annoying but not limiting daily activities, moderate adverse events as limiting daily activities, and severe adverse events as necessity of a visit to a medical expert. Multivariable logistic regression analyses were used to compare the occurrence of any adverse event, and the occurrence of moderate/severe adverse events following SARS-CoV-2 vaccinations between patients and controls. Effect modification was investigated for gender and vaccine type.

Results: On April 25^th, 2021, 501 patients (420 patients with rheumatic diseases and 81 patients with multiple sclerosis) and 184 healthy controls were vaccinated against SARS-CoV-2 and included for analyses. The mean age of patients and controls was 63 (SD 11) and 64 (SD 11) years respectively, and 329 (66 %) patients and 119 (65%) controls were female. AstraZeneca and Pfizer/BioNTech were the most commonly applied vaccines in both patients and controls. The majority of patients and controls experienced at least one mild adverse event (56% vs. 58%), a minority at least one moderate adverse event (23% vs. 21%), and severe adverse events were rare (1% vs. 0%). A small proportion of patients (5%) reported to experience a deterioration of their autoimmune disease following SARS-CoV-2 vaccination. Results of the regression analyses are shown in table 1. After adjusting for age, gender and vaccine type, the odds for patients and healthy controls to experience any, systemic or moderate/severe adverse event(s) following the first SARS-CoV-2 vaccination were comparable. No effect modification by gender or vaccine type was demonstrated.

Conclusion: Our data demonstrate that patients with autoimmune diseases are not at an increased risk of experiencing adverse events from vaccination with AstraZeneca, Moderna or Pfizer/BioNTech compared to the general population, and that the impact of these vaccines on autoimmune disease activity is minimal.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/adverse-events-of-first-sars-cov-2-vaccinations-are-comparable-for-patients-with-autoimmune-diseases-and-the-general-population/