Reatogenicidade local e sistêmica das vacinas Coronavac e Chadox-1 contra SARS-COV-2 em pacientes com lúpus eritematoso sistêmico: dados do estudo SAFER

Abstract

Introduction: Patients with Systemic Lupus Erythematosus (SLE) were excluded from the initial vaccine safety studies, leading to vaccine hesitancy among this population. Among the reported concerns was the risk of developing adverse reactions, highlighting the need for studies in this area. Objective: To evaluate the adverse events of COVID-19 vaccines in patients with SLE. Methods: These data are from the study “Safety and Efficacy on COVID-19 Vaccine in Rheumatic Diseases,” a Brazilian multicentric prospective study to evaluate COVID-19 vaccine in IMRDs in Brazil. Adverse events were assessed following two doses of the ChAdOx1 or CoronaVac vaccines. Inclusion criteria were age 18 or older and a diagnosis of SLE. Exclusion criteria included pregnancy, prior severe adverse events to any vaccine, primary immunodeficiencies, neoplasms, and thymic diseases. Adverse events were recorded via patient-completed diaries and actively monitored by investigators at follow-up centers. Results: A total of 336 SLE patients were evaluated. The most frequently reported adverse reactions after the first dose included injection site pain (56.6%), headache (48.4%), and fatigue (39.7%), with a higher prevalence among those vaccinated with ChAdOx1. After the second dose, the most common were injection site pain (42.6%), headache (32.4%), and arthralgia (29%), with no statistically significant differences between the vaccines. Multivariate analysis did not identify associations between age, medication use, comorbidities, antibody presence, and vaccine reactogenicity. Conclusion: ChAdOx1 was associated with a higher frequency of adverse reactions after the first dose. Both vaccines demonstrated safety, with no reports of severe events.