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COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects

Author

Listed:
  • Abanoub Riad

    (Czech National Centre for Evidence-Based Healthcare and Knowledge Translation (Cochrane Czech Republic, Czech EBHC: JBI Centre of Excellence, Masaryk University GRADE Centre), Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Kamenice 5, 62500 Brno, Czech Republic
    Department of Public Health, Faculty of Medicine, Masaryk University, Kamenice 5, 62500 Brno, Czech Republic)

  • Holger Schünemann

    (Department of Health Research Methods, Evidence, and Impact, McMaster University Health Sciences Centre, Room 2C16, 1280 Main Street West, Hamilton, ON L8N 4K1, Canada)

  • Sameh Attia

    (Department of Oral and Maxillofacial Surgery, Justus-Liebig-University, Klinikstrasse 33, 35392 Giessen, Germany)

  • Tina Poklepović Peričić

    (Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000 Split, Croatia)

  • Marija Franka Žuljević

    (Department of Medical Humanities, University of Split School of Medicine, Šoltanska 2, 21000 Split, Croatia)

  • Mikk Jürisson

    (Department of Family Medicine and Public Health, University of Tartu, Ravila 19, 50411 Tartu, Estonia)

  • Ruth Kalda

    (Department of Family Medicine and Public Health, University of Tartu, Ravila 19, 50411 Tartu, Estonia)

  • Katrin Lang

    (Department of Family Medicine and Public Health, University of Tartu, Ravila 19, 50411 Tartu, Estonia)

  • Sudhakar Morankar

    (Faculty of Public Health, Institute of Health, Jimma University, Aba Jifar 1 Street, 378 Jimma, Ethiopia)

  • Elias Ali Yesuf

    (Faculty of Public Health, Institute of Health, Jimma University, Aba Jifar 1 Street, 378 Jimma, Ethiopia)

  • Mohamed Mekhemar

    (Clinic for Conservative Dentistry and Periodontology, School of Dental Medicine, Kiel University, Arnold-Heller-Str. 3, Haus B, 24105 Kiel, Germany)

  • Anthony Danso-Appiah

    (Department of Epidemiology and Disease Control, School of Public Health, University of Ghana, Accra LG 25, Ghana)

  • Ahmad Sofi-Mahmudi

    (Cochrane Iran Associate Centre, National Institute for Medical Research Development, Tehran 16846, Iran)

  • Giordano Pérez-Gaxiola

    (Department of Evidence Based Medicine, Sinaloa Pediatric Hospital, Cochrane Mexico, Calle Constitución 530, Jorge Almada, 80200 Culiacán, Mexico)

  • Arkadiusz Dziedzic

    (Department of Conservative Dentistry with Endodontics, Medical University of Silesia, 40-055 Katowice, Poland)

  • João Apóstolo

    (Health Sciences Research Unit: Nursing, Portugal Centre for Evidence-Based Practice: JBI Centre of Excellence, Nursing School of Coimbra, 3004-011 Coimbra, Portugal)

  • Daniela Cardoso

    (Health Sciences Research Unit: Nursing, Portugal Centre for Evidence-Based Practice: JBI Centre of Excellence, Nursing School of Coimbra, 3004-011 Coimbra, Portugal)

  • Janja Marc

    (Faculty of Pharmacy, University of Ljubljana, Aškerčeva Cesta 7, 1000 Ljubljana, Slovenia
    Institute of Clinical Chemistry and Biochemistry, University Medical Centre Ljubljana, Zaloška cesta 2, 1000 Ljubljana, Slovenia)

  • Mayte Moreno-Casbas

    (Nursing and Healthcare Research Unit (Investén-isciii), Instituto de Salud Carlos III, 28029 Madrid, Spain)

  • Charles Shey Wiysonge

    (Cochrane South Africa, South African Medical Research Council, Cape Town 7501, South Africa)

  • Amir Qaseem

    (American College of Physicians, 190 N Independence Mall W, Philadelphia, PA 19106, USA)

  • Anna Gryschek

    (Department of Nursing in Collective Health, School of Nursing, University of São Paulo, São Paulo 419, Brazil)

  • Ivana Tadić

    (Department of Social Pharmacy and Pharmaceutical Legislation, Faculty of Pharmacy, University of Belgrade, 11221 Belgrade, Serbia)

  • Salman Hussain

    (Czech National Centre for Evidence-Based Healthcare and Knowledge Translation (Cochrane Czech Republic, Czech EBHC: JBI Centre of Excellence, Masaryk University GRADE Centre), Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Kamenice 5, 62500 Brno, Czech Republic)

  • Mohammed Ahmed Khan

    (School of Pharmaceutical Education and Research, Jamia Hamdard, Hamdard Nagar, New Delhi 110062, India)

  • Jitka Klugarova

    (Czech National Centre for Evidence-Based Healthcare and Knowledge Translation (Cochrane Czech Republic, Czech EBHC: JBI Centre of Excellence, Masaryk University GRADE Centre), Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Kamenice 5, 62500 Brno, Czech Republic
    Department of Public Health, Faculty of Medicine, Masaryk University, Kamenice 5, 62500 Brno, Czech Republic
    Institute of Health Information and Statistics of the Czech Republic, Palackého náměstí 375/4, 128 01 Praha 2, Czech Republic
    Department of Nursing and Midwifery, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic)

  • Andrea Pokorna

    (Czech National Centre for Evidence-Based Healthcare and Knowledge Translation (Cochrane Czech Republic, Czech EBHC: JBI Centre of Excellence, Masaryk University GRADE Centre), Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Kamenice 5, 62500 Brno, Czech Republic
    Institute of Health Information and Statistics of the Czech Republic, Palackého náměstí 375/4, 128 01 Praha 2, Czech Republic
    Department of Nursing and Midwifery, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic)

  • Michal Koščík

    (Department of Public Health, Faculty of Medicine, Masaryk University, Kamenice 5, 62500 Brno, Czech Republic
    Czech Clinical Research Infrastructure Network, Department of Pharmacology, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic)

  • Miloslav Klugar

    (Czech National Centre for Evidence-Based Healthcare and Knowledge Translation (Cochrane Czech Republic, Czech EBHC: JBI Centre of Excellence, Masaryk University GRADE Centre), Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Kamenice 5, 62500 Brno, Czech Republic
    Department of Public Health, Faculty of Medicine, Masaryk University, Kamenice 5, 62500 Brno, Czech Republic
    Institute of Health Information and Statistics of the Czech Republic, Palackého náměstí 375/4, 128 01 Praha 2, Czech Republic
    Department of Nursing and Midwifery, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic)

Abstract

Background: Coronavirus disease (COVID-19) vaccine-related side effects have a determinant role in the public decision regarding vaccination. Therefore, this study has been designed to actively monitor the safety and effectiveness of COVID-19 vaccines globally. Methods: A multi-country, three-phase study including a cross-sectional survey to test for the short-term side effects of COVID-19 vaccines among target population groups. In the second phase, we will monitor the booster doses’ side effects, while in the third phase, the long-term safety and effectiveness will be investigated. A validated, self-administered questionnaire will be used to collect data from the target population; Results: The study protocol has been registered at ClinicalTrials.gov, with the identifier NCT04834869. Conclusions: CoVaST is the first independent study aiming to monitor the side effects of COVID-19 vaccines following booster doses, and the long-term safety and effectiveness of said vaccines.

Suggested Citation

  • Abanoub Riad & Holger Schünemann & Sameh Attia & Tina Poklepović Peričić & Marija Franka Žuljević & Mikk Jürisson & Ruth Kalda & Katrin Lang & Sudhakar Morankar & Elias Ali Yesuf & Mohamed Mekhemar & , 2021. "COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects," IJERPH, MDPI, vol. 18(15), pages 1-10, July.
    • Handle: RePEc:gam:jijerp:v:18:y:2021:i:15:p:7859-:d:600948
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