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

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, Anthony Danso-Appiah, Ahmad Sofi-Mahmudi, Giordano Pérez-Gaxiola, Arkadiusz Dziedzic, João Apóstolo, Daniela Cardoso, Janja Marc, Mayte Moreno-Casbas, Charles Shey Wiysonge, Amir Qaseem, Anna Gryschek, Ivana Tadić, Salman Hussain, Mohammed Ahmed Khan, Jitka Klugarova, Andrea Pokorna, Michal Koščík and Miloslav Klugar
Additional contact information
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
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
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
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
Michal Koščík: Department of Public Health, Faculty of Medicine, Masaryk University, Kamenice 5, 62500 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

IJERPH, 2021, vol. 18, issue 15, 1-10

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.

Keywords: cohort studies; cross-sectional studies; COVID-19; drug-related side effects and adverse reactions; health personnel; mass vaccination; prevalence (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2021
References: View complete reference list from CitEc
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