Safety of Coronavac and ChAdOx1 Vaccines Against SARS-CoV-2 in Patients with Rheumatoid Arthritis Data from the Brazilian Multicentric Study Safer

Abstract BACKGROUND Patients with immune-mediated rheumatic diseases (IMRDs) have been prioritized for COVID-19 vaccination to mitigate the infection severity risks. Patients with rheumatoid arthritis (RA) are at a high risk of severe COVID-19 outcomes, especially those under immunosuppression or with comorbidities associated. However, few studies in the literature assessed the safety of the COVID-19 vaccine in patients with RA. OBJECTIVE Evaluate the safety of vaccines against SARS-CoV-2 in patients with RA. METHODS These data are from the study “Safety and Efficacy on COVID-19 Vaccine in Rheumatic Diseases,” a Brazilian multicentric prospective phase IV study to evaluate COVID-19 vaccine in IMRDs in Brazil. Adverse events (AEs) in patients with RA of all centers were assessed after two doses of ChAdOx1 (Oxford/AstraZeneca) or CoronaVac (Sinovac/Butantan). Stratification of postvaccination AEs was performed using a diary, filled out daily and returned at the end of 28 days for each dose. RESULTS A total of 188 patients with RA were include in the study, most of them female. CoronaVac was used in 109 patients and ChAdOx1 in 79. Only mild AEs were observed, mainly after the first dose. The more common AEs after the first dose were pain at the injection (46,7%), headache (39,4%), arthralgia (39,4%), myalgia (30,5%) and fatigue (26,6%), and ChAdOx1 had a higher frequency of pain at the injection (66% vs 32%, p < 0.001) arthralgia (62% vs 22%, p < 0.001) and myalgia (45% vs 20%, p < 0.001) compared to CoronaVac. The more common AEs after the second dose were pain at the injection (37%), arthralgia (31%), myalgia (23%), headache (21%) and fatigue (18%). Arthralgia (41,42% vs 25%, p = 0.02) and pain at injection (51,43% vs 27%, p = 0.001) were more common with ChAdOx1. Only nonsevere AEs were related, and no patients had flare after the vaccination. CONCLUSION In the comparison between the two immunizers in patients with RA, the local reactions and musculoskeletal symptoms were more frequent with ChAdOx1 than in CoronaVac, especially in the first dose. In general, the AE occurred mainly after the first dose, and were mild, like previous data from others immunizing agents in patients with rheumatoid arthritis. Vaccination did not worsen the degree of disease activity.