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 , da Penha Gomes Gouveia Maria , 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 , de Moura Castro Charlles Heldan , Ribeiro Sandra Lúcia Euzébio , Telles Camila Maria Paiva França , Bühring Juliana , de Lima Raquel Lima , Dos Santos Sérgio Henrique Oliveira , Dias Samuel Elias Basualto , de Melo Natália Seixas , da Silva Sanches Rosely Holanda , 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 , de Abreu Vieira Rejane Maria Rodrigues , Vieira Adah Sophia Rodrigues , kakehasi Adriana maria , Tavares Anna Carolina Faria Moreira Gomes , de Landa Aline Teixeira , da Costa Pollyana Vitoria Thomaz , Azevedo Valderilio Feijó , Martins-Filho Olindo Assis , Peruhype-Magalhães Vanessa , de Medeiros Pinheiro Marcelo , Monticielo Odirlei André , Dos Reis-neto Edgard Torres , Ferreira Gilda Aparecida , de Souza Viviane Angelina , Teixeira-Carvalho Andréa , Xavier Ricardo Machado , Sato Emilia Inoue , Valim Valeria , Pileggi Gecilmara Salviato , da Silva Nilzio Antonio 
Published: August 2024

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 associated comorbidities. However, few studies have assessed the safety of the COVID-19 vaccine in patients with RA.

Objective
To evaluate the safety of vaccines against SARS-CoV-2 in patients with RA.

Methods
This 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, 90% female. CoronaVac was used in 109 patients and ChAdOx1 in 79. Only mild AEs were observed, mainly after the first dose. The most 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 (41,4% vs 25%, p = 0.02) and pain at injection (51,4% vs 27%, p = 0.001) were more common with ChAdOx1. No serious AEs were related. With Regard to RA activity level, no significant difference was observed between the three time periods for both COVID-19 vaccines.

Conclusion
In the comparison between the two immunizers in patients with RA, local reactions and musculoskeletal symptoms were more frequent with ChAdOx1 than with CoronaVac, especially after the first dose. In summary, 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.