Safety of Coronavac and ChAdOx1 Vaccines Against SARS-CoV-2 in Patients with Rheumatoid Arthritis Data from the Brazilian Multicentric Study Safer
Authors: Cruz Vitor Alves , Guimarães Camila , Rêgo Jozelia , Machado Ketty Lysie Libardi Lira , Miyamoto Samira Tatiyama , Burian Ana Paula Neves , Dias Laiza Hombre , Pretti Flavia Zon , Batista Danielle Cristina Filgueira Alves , Mill José Geraldo , de Oliveira Yasmin Gurtler Pinheiro , Gadelha Carolina Strauss Estevez , Gouveia Maria da Penha Gomes , Moulin Anna Carolina Simões , Souza Bárbara Oliveira , Aguiar Laura Gonçalves Rodrigues , Vieira Gabriel Smith Sobral , Grillo Luiza Lorenzoni , de Lima Marina Deorce , Pasti Laís Pizzol , Surlo Heitor Filipe , Faé Filipe , Moulaz Isac Ribeiro , Macabú Mariana de Oliveira , Ribeiro Priscila Dias Cardoso , Magalhães Vanessa de Oliveira , de Aguiar Mariana Freitas , Biegelmeyer Erika , Peixoto Flávia Maria Matos Melo Campos , Kayser Cristiane , de Souza Alexandre Wagner Silva , Castro Charlles Heldan de Moura , Ribeiro Sandra Lúcia Euzébio , Telles Camila Maria Paiva França , Bühring Juliana , de Lima Raquel Lima , Santos Sérgio Henrique Oliveira dos , Dias Samuel Elias Basualto , de Melo Natália Seixas , Sanches Rosely Holanda da Silva , Boechat Antonio Luiz , Sartori Natália Sarzi , Hax Vanessa , Dória Lucas Denardi , de Rezende Rodrigo Poubel Vieira , Baptista Katia Lino , Fortes Natália Rodrigues Querido , de Melo Ana Karla Guedes , Melo Tâmara Santos , Vieira Rejane Maria Rodrigues de Abreu , Vieira Adah Sophia Rodrigues , kakehasi Adriana maria , Tavares Anna Carolina Faria Moreira Gomes , de Landa Aline Teixeira , Costa Pollyana Vitoria Thomaz da , Azevedo Valderilio Feijó , Martins-Filho Olindo Assis , Peruhype-Magalhães Vanessa , Pinheiro Marcelo de Medeiros , Monticielo Odirlei André , Reis-Neto Edgard Torres dos , Ferreira Gilda Aparecida , de Souza Viviane Angelina , Teixeira-Carvalho Andréa , Xavier Ricardo Machado , Sato Emilia Inoue , Valim Valeria , Pileggi Gecilmara Salviato , Silva Nilzio Antonio da 
Published: November 2023

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.