key: cord-0915266-o8swaic7
authors: Araújo, Olga; Gómez-Cerquera, Juan Manuel; Espinosa, Gerard
title: VACOVEAS study, an observational survey on the adverse events associated with COVID-19 vaccines in patients with systemic autoimmune diseases
date: 2021-09-24
journal: Eur J Intern Med
DOI: 10.1016/j.ejim.2021.09.011
sha: 0c5ba4190444e0bfef90b240243dd6fae10b0938
doc_id: 915266
cord_uid: o8swaic7

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heterogeneous in terms of the number of patients included, the time they were carried out, and the type of AD analyzed, but most agree that patients with AD represent a risk group for SARS-CoV-2 infection. On the other hand, the risk factors for severe COVID-19 described in the general population, such as older age, and comorbidities are also described in patients with systemic AD (SAD) [1] . Furthermore, the use of high doses of glucocorticoids or rituximab have been identified as poor prognostic factors [1] .

Of the four COVID19 vaccines authorized by European regulatory agencies so far (Pfizer, Moderna, Astra-Zeneca and Janssen), only the clinical trials of the first included patients with rheumatological diseases [2] . However, they do not represent even 1% of all the individuals included and, furthermore, there are no data on this specific group. Therefore, to date there is no information on the safety and efficacy of vaccines against COVID19 in patients with AD. However, due to the design of vaccines, to their mechanism of action (promoting the immune response) and

to the scarcity of serious adverse effects in the general population, all scientific societies do recommend the vaccine against COVID19 in patients with AD [3, 4] .

Some studies based on questionnaires answered directly by patients and distributed by social media have highlighted the fear of adverse effects and that the vaccine could produce a flare of the disease as the most frequent causes of reluctance of patients to receive it. Therefore, it is important to know the frequency in real life of the adverse effects of the vaccines against COVID19 as well as the type of side effects produced by the vaccines to give accurate information to patients with AD [5] . The limitations of the study are those inherent to the methodology used (questionnaire answered by the patient), which includes a possible response bias (that patients with more serious adverse effects answer and that those with mild effects do not). On the other hand, there is no a control group and the data obtained will be compared with those of the general population (real-life studies) or those obtained from published clinical trials.

The VACOVEAS study aims to know the prevalence and type of adverse effects associated with vaccines against COVID19 in patients with SAD. In addition, it is expected to identify the risk factors related to these effects. After that, accurate information can be given to patients when they ask if they need to be vaccinated. The VACOVEAS survey will give the scientific community and the patients the answers they are looking for.

Factors associated with COVID-19-related death in people with rheumatic diseases: results from the COVID-19 Global Rheumatology Alliance physician-reported registry. Ann Rheum Dis Epub ahead of print

Safety and efficacy of the BNT162b mRNA COVID-19 vaccine

COVID-19 vaccine clinical guidance summary for patients with rheumatic and musculoskeletal diseases. Developed by the ACR COVID-19 vaccine clinical guidance task force

Enfermedades autoinmunes y vacunas contra la COVID-19. Toma de decisiones en escenarios de incertidumbre

Decision making in uncertain scenarios

The authors declare that they have no conflicts of interest concerning this article.