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 J. Schünemann, Sameh Attia, Tina Poklepović Peričić, Marija Franka Žuljević, Mikk Jürisson, Ruth Kalda, Katrin Lang, Morankar Sudhakar, Elias Ali Yesuf, Mohamed Mekhemar, Anthony Danso‐Appiah, Ahmad Sofi‐Mahmudi, Giordano Pérez‐Gaxiola, Arkadiusz Dziedzic, João Apóstolo, Daniela Cardoso, Janja Marc, Teresa Moreno‐Casbas, Charles Shey Wiysonge, Amir Qaseem, Anna Luíza de Fátima Pinho Lins Gryschek, Ivana Tadić, Salman Hussain, M. Reyasudin Basir Khan, Jitka Klugarová, Andrea Pokorná, Michal Koščík, Miloslav Klugar
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.