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Study Protocol

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

1
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
2
Department of Public Health, Faculty of Medicine, Masaryk University, Kamenice 5, 62500 Brno, Czech Republic
3
Department of Health Research Methods, Evidence, and Impact, McMaster University Health Sciences Centre, Room 2C16, 1280 Main Street West, Hamilton, ON L8N 4K1, Canada
4
Department of Oral and Maxillofacial Surgery, Justus-Liebig-University, Klinikstrasse 33, 35392 Giessen, Germany
5
Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000 Split, Croatia
6
Department of Medical Humanities, University of Split School of Medicine, Šoltanska 2, 21000 Split, Croatia
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Department of Family Medicine and Public Health, University of Tartu, Ravila 19, 50411 Tartu, Estonia
8
Faculty of Public Health, Institute of Health, Jimma University, Aba Jifar 1 Street, 378 Jimma, Ethiopia
9
Clinic for Conservative Dentistry and Periodontology, School of Dental Medicine, Kiel University, Arnold-Heller-Str. 3, Haus B, 24105 Kiel, Germany
10
Department of Epidemiology and Disease Control, School of Public Health, University of Ghana, Accra LG 25, Ghana
11
Cochrane Iran Associate Centre, National Institute for Medical Research Development, Tehran 16846, Iran
12
Department of Evidence Based Medicine, Sinaloa Pediatric Hospital, Cochrane Mexico, Calle Constitución 530, Jorge Almada, 80200 Culiacán, Mexico
13
Department of Conservative Dentistry with Endodontics, Medical University of Silesia, 40-055 Katowice, Poland
14
Health Sciences Research Unit: Nursing, Portugal Centre for Evidence-Based Practice: JBI Centre of Excellence, Nursing School of Coimbra, 3004-011 Coimbra, Portugal
15
Faculty of Pharmacy, University of Ljubljana, Aškerčeva Cesta 7, 1000 Ljubljana, Slovenia
16
Institute of Clinical Chemistry and Biochemistry, University Medical Centre Ljubljana, Zaloška cesta 2, 1000 Ljubljana, Slovenia
17
Nursing and Healthcare Research Unit (Investén-isciii), Instituto de Salud Carlos III, 28029 Madrid, Spain
18
Cochrane South Africa, South African Medical Research Council, Cape Town 7501, South Africa
19
American College of Physicians, 190 N Independence Mall W, Philadelphia, PA 19106, USA
20
Department of Nursing in Collective Health, School of Nursing, University of São Paulo, São Paulo 419, Brazil
21
Department of Social Pharmacy and Pharmaceutical Legislation, Faculty of Pharmacy, University of Belgrade, 11221 Belgrade, Serbia
22
School of Pharmaceutical Education and Research, Jamia Hamdard, Hamdard Nagar, New Delhi 110062, India
23
Institute of Health Information and Statistics of the Czech Republic, Palackého náměstí 375/4, 128 01 Praha 2, Czech Republic
24
Department of Nursing and Midwifery, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic
25
Czech Clinical Research Infrastructure Network, Department of Pharmacology, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic
*
Author to whom correspondence should be addressed.
Academic Editor: Paul B. Tchounwou
Int. J. Environ. Res. Public Health 2021, 18(15), 7859; https://doi.org/10.3390/ijerph18157859
Received: 27 May 2021 / Revised: 19 July 2021 / Accepted: 20 July 2021 / Published: 25 July 2021
(This article belongs to the Collection COVID-19 Research)
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. View Full-Text
Keywords: cohort studies; cross-sectional studies; COVID-19; drug-related side effects and adverse reactions; health personnel; mass vaccination; prevalence cohort studies; cross-sectional studies; COVID-19; drug-related side effects and adverse reactions; health personnel; mass vaccination; prevalence
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Figure 1

MDPI and ACS Style

Riad, A.; Schünemann, H.; Attia, S.; Peričić, T.P.; Žuljević, M.F.; Jürisson, M.; Kalda, R.; Lang, K.; Morankar, S.; Yesuf, E.A.; Mekhemar, M.; Danso-Appiah, A.; Sofi-Mahmudi, A.; Pérez-Gaxiola, G.; Dziedzic, A.; Apóstolo, J.; Cardoso, D.; Marc, J.; Moreno-Casbas, M.; Wiysonge, C.S.; Qaseem, A.; Gryschek, A.; Tadić, I.; Hussain, S.; Khan, M.A.; Klugarova, J.; Pokorna, A.; Koščík, M.; Klugar, M. COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects. Int. J. Environ. Res. Public Health 2021, 18, 7859. https://doi.org/10.3390/ijerph18157859

AMA Style

Riad A, Schünemann H, Attia S, Peričić TP, Žuljević MF, Jürisson M, Kalda R, Lang K, Morankar S, Yesuf EA, Mekhemar M, Danso-Appiah A, Sofi-Mahmudi A, Pérez-Gaxiola G, Dziedzic A, Apóstolo J, Cardoso D, Marc J, Moreno-Casbas M, Wiysonge CS, Qaseem A, Gryschek A, Tadić I, Hussain S, Khan MA, Klugarova J, Pokorna A, Koščík M, Klugar M. COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects. International Journal of Environmental Research and Public Health. 2021; 18(15):7859. https://doi.org/10.3390/ijerph18157859

Chicago/Turabian Style

Riad, Abanoub, Holger Schünemann, Sameh Attia, Tina P. Peričić, Marija F. Žuljević, Mikk Jürisson, Ruth Kalda, Katrin Lang, Sudhakar Morankar, Elias A. Yesuf, Mohamed Mekhemar, Anthony Danso-Appiah, Ahmad Sofi-Mahmudi, Giordano Pérez-Gaxiola, Arkadiusz Dziedzic, João Apóstolo, Daniela Cardoso, Janja Marc, Mayte Moreno-Casbas, Charles S. Wiysonge, Amir Qaseem, Anna Gryschek, Ivana Tadić, Salman Hussain, Mohammed A. Khan, Jitka Klugarova, Andrea Pokorna, Michal Koščík, and Miloslav Klugar. 2021. "COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects" International Journal of Environmental Research and Public Health 18, no. 15: 7859. https://doi.org/10.3390/ijerph18157859

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