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

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Authors

RIAD Abanoub SCHÜNEMANN Holger ATTIA Sameh POKLEPOVIĆ PERIČIĆ Tina ŽULJEVIĆ Marija Franka JÜRISSON Mikk KALDA Ruth LANG Katrin MORANKAR Sudhakar YESUF Elias Ali MEKHEMAR Mohamed DANSO-APPIAH Anthony SOFI-MAHMUDI Ahmad PÉREZ-GAXIOLA Giordano DZIEDZIC Arkadiusz APÓSTOLO Joao CARDOSO Daniela MARC Janja MORENO-CASBAS Mayte WIYSONGE Charles Shey QASEEM Amir GRYSCHEK Anna TADIĆ Ivana HUSSAIN Mohammad Salman KHAN Mohammed Ahmed KLUGAROVÁ Jitka POKORNÁ Andrea KOŠČÍK Michal KLUGAR Miloslav

Year of publication 2021
Type Article in Periodical
Magazine / Source International Journal of Environmental Research and Public Health
MU Faculty or unit

Faculty of Medicine

Citation
Web https://www.mdpi.com/1660-4601/18/15/7859
Doi http://dx.doi.org/10.3390/ijerph18157859
Keywords cohort studies; cross-sectional studies; COVID-19; drug-related side effects and adverse reactions; health personnel; mass vaccination; prevalence
Description 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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