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VACOVEAS  study, an observational  survey on  the adverse events associated with COVID-19 vaccines in  patients with systemic autoimmune  diseases

  • Olga Araújo
    Affiliations
    Department of Autoimmune Diseases, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBPAS), Hospital Clinic, Universitat de Barcelona, Barcelona, Catalonia, Spain
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  • Juan Manuel Gómez-Cerquera
    Affiliations
    Department of Autoimmune Diseases, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBPAS), Hospital Clinic, Universitat de Barcelona, Barcelona, Catalonia, Spain
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  • Gerard Espinosa
    Correspondence
    Corresponding author at: Department of Autoimmune Diseases, Hospital Clínic, Villarroel 170, 08036-Barcelona, Catalonia, Spain.
    Affiliations
    Department of Autoimmune Diseases, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBPAS), Hospital Clinic, Universitat de Barcelona, Barcelona, Catalonia, Spain
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Published:September 23, 2021DOI:https://doi.org/10.1016/j.ejim.2021.09.011

      Keywords

      Dear Editor,
      Since the beginning of the COVID-19 outbreak, a significant number of studies have been published trying to compare the prevalence of this infection in patients with autoimmune diseases (AD) and the general population and to analyze whether this group of patients developed more serious conditions with greater mortality or morbidity. In general, the studies are very 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) [
      • Strangfeld AS
      • Schafer M
      • Gianfrancesco MA
      • Lawson-Tovey S
      • Liew JW
      • Ljung L
      • et al.
      Factors associated with COVID-19-related death in people with rheumatic diseases: results from the COVID-19 Global Rheumatology Alliance physician-reported registry.
      ]. Furthermore, the use of high doses of glucocorticoids or rituximab have been identified as poor prognostic factors [
      • Strangfeld AS
      • Schafer M
      • Gianfrancesco MA
      • Lawson-Tovey S
      • Liew JW
      • Ljung L
      • et al.
      Factors associated with COVID-19-related death in people with rheumatic diseases: results from the COVID-19 Global Rheumatology Alliance physician-reported registry.
      ].
      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 [
      • Polack FP
      • Thomas SJ
      • Kitchin N
      • Absalon J
      • Gurtman A
      • Lockhart S
      • et al.
      Safety and efficacy of the BNT162b mRNA COVID-19 vaccine.
      ]. 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 [

      American College of Rheumatology. COVID-19 vaccine clinical guidance summary for patients with rheumatic and musculoskeletal diseases. Developed by the ACR COVID-19 vaccine clinical guidance task force (updated February 8, 2021). En: https://www.rheumatology.org/Portals/0/Files/COVID-19-Vaccine-Clinical-Guidance-Rheumatic-Diseases-Summary.pdf (access June 14, 2021).

      ,].
      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 [
      • Cairoli E
      • Espinosa G.
      Enfermedades autoinmunes y vacunas contra la COVID-19. Toma de decisiones en escenarios de incertidumbre [Autoimmune diseases and vaccines against COVID-19. Decision making in uncertain scenarios.].
      ].
      For this reason, we have designed an international, single center, prospective, observational study based on an online survey directed to patients with SAD, the VACOVEAS study. The objectives of the study are to estimate the real-life prevalence of adverse effects related to the COVID19 vaccine in patients with SAD and to identify the risk factors associated with the development of these adverse effects.
      The survey is hosted on the enquesta.clinic.cat platform of the Hospital Clínic in Barcelona and the study has been approved by the Ethics and Drug Research Committee of the center (HCB/2021/0432); it is available for completion from May 18, 2021. The survey is being disseminated through patient associations and through specific actions on social media and will be available for 6 months. The variables collected include demographic data, type of autoimmune disease, usual treatment at the time of receiving the vaccine, history of COVID-19 infection, type of vaccine received, side effects and development of a flare of SAD or acute infection by COVID-19 after receiving the vaccination. No data is collected to identify the participant and it is a completely anonymous survey. Once the inclusion period is over, a descriptive analysis of the responses obtained will be done, to identify, if possible, the factors related to the development of adverse effects.
      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.

      Disclosure of Interest

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

      References

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        • Schafer M
        • Gianfrancesco MA
        • Lawson-Tovey S
        • Liew JW
        • Ljung L
        • et al.
        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. February 2, 2021; https://doi.org/10.1136/annrheumdis-2020-219498
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        • et al.
        Safety and efficacy of the BNT162b mRNA COVID-19 vaccine.
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      1. American College of Rheumatology. COVID-19 vaccine clinical guidance summary for patients with rheumatic and musculoskeletal diseases. Developed by the ACR COVID-19 vaccine clinical guidance task force (updated February 8, 2021). En: https://www.rheumatology.org/Portals/0/Files/COVID-19-Vaccine-Clinical-Guidance-Rheumatic-Diseases-Summary.pdf (access June 14, 2021).

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        • Cairoli E
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        Enfermedades autoinmunes y vacunas contra la COVID-19. Toma de decisiones en escenarios de incertidumbre [Autoimmune diseases and vaccines against COVID-19. Decision making in uncertain scenarios.].
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