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(Masaryk University), Holger J. Schünemann(Health Sciences Centre), Sameh Attia(Justus-Liebig-Universität Gießen), Tina Poklepović Peričić(University of Split), Marija Franka Žuljević(University of Split), Mikk Jürisson(University of Tartu), Ruth Kalda(University of Tartu), Katrin Lang(University of Tartu), Morankar Sudhakar(Jimma University), Elias Ali Yesuf(Jimma University), Mohamed Mekhemar(Christian-Albrechts-Universität zu Kiel), Anthony Danso‐Appiah(University of Ghana), Ahmad Sofi‐Mahmudi(National Institute for Medical Research Development), Giordano Pérez‐Gaxiola(Pediatric Hospital of Sinaloa), Arkadiusz Dziedzic(Medical University of Silesia), João Apóstolo(Escola Superior de Enfermagem de Coimbra), Daniela Cardoso(Escola Superior de Enfermagem de Coimbra), Janja Marc(University of Ljubljana), Teresa Moreno‐Casbas(Instituto de Salud Carlos III), Charles Shey Wiysonge(South African Medical Research Council), Amir Qaseem(American College of Physicians), Anna Luíza de Fátima Pinho Lins Gryschek(Universidade de São Paulo), Ivana Tadić(University of Belgrade), Salman Hussain(Masaryk University), M. Reyasudin Basir Khan(Jamia Hamdard), Jitka Klugarová(Masaryk University), Andrea Pokorná(Masaryk University), Michal Koščík(Masaryk University), Miloslav Klugar(Masaryk University)
International Journal of Environmental Research and Public Health
July 25, 2021
10.3390/ijerph18157859
Cited by 68Open Access
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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.

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