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.

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

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

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

Cochrane South Africa South African Medical Research Council Cape Town 7501 South Africa

Czech Clinical Research Infrastructure Network Department of Pharmacology Faculty of Medicine Masaryk University Kamenice 5 625 00 Brno Czech Republic

Czech National Centre for Evidence Based Healthcare and Knowledge Translation Institute of Biostatistics and Analyses Faculty of Medicine Masaryk University Kamenice 5 62500 Brno Czech Republic

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

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

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

Department of Nursing and Midwifery Faculty of Medicine Masaryk University Kamenice 5 625 00 Brno Czech Republic

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

Department of Oral and Maxillofacial Surgery Justus Liebig University Klinikstrasse 33 35392 Giessen Germany

Department of Public Health Faculty of Medicine Masaryk University Kamenice 5 62500 Brno Czech Republic

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

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

Faculty of Pharmacy University of Ljubljana Aškerčeva Cesta 7 1000 Ljubljana Slovenia

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Health Sciences Research Unit Nursing Portugal Centre for Evidence Based Practice JBI Centre of Excellence Nursing School of Coimbra 3004 011 Coimbra Portugal

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Nursing and Healthcare Research Unit Instituto de Salud Carlos 3 28029 Madrid Spain

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

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ClinicalTrials.gov
NCT04834869