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

• Main Authors: Abanoub Riad, Holger Schünemann, Sameh Attia, Tina Poklepović Peričić, Marija Franka Žuljević, Mikk Jürisson, Ruth Kalda, Katrin Lang, Sudhakar Morankar, Elias Ali Yesuf, Mohamed Mekhemar, Anthony Danso-Appiah, Ahmad Sofi-Mahmudi, Giordano Pérez-Gaxiola, Arkadiusz Dziedzic, João Apóstolo, Daniela Cardoso, Janja Marc, Mayte Moreno-Casbas, Charles Shey Wiysonge, Amir Qaseem, Anna Gryschek, Ivana Tadić, Salman Hussain, Mohammed Ahmed Khan, Jitka Klugarova, Andrea Pokorna, Michal Koščík, Miloslav Klugar
• Format: Article
• Language: English
• Published: MDPI AG 2021-07-01
• Series: International Journal of Environmental Research and Public Health
• Subjects: cohort studies; cross-sectional studies; COVID-19; drug-related side effects and adverse reactions; health personnel; mass vaccination
• Online Access: https://www.mdpi.com/1660-4601/18/15/7859
• ISSN: 1661-7827; 1660-4601

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.