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 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, 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

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.

Keywords: COVID-19; cohort studies; cross-sectional studies; drug-related side effects and adverse reactions; health personnel; mass vaccination; prevalence.

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Sample size of healthcare workers (HCWs) in the Czech Republic—Epi-Info TM version 7.2.4. Population size: Total number of healthcare workers in the Czech Republic in 2017 [30]. Expected frequency: The overall prevalence of side effects following COVID-19 vaccines ranged between 62% and 93%; therefore, 60% was assumed as a threshold. Acceptable margin of error: The permissible level for all CoVaST groups will be 5%. Design effect: One—per the recommendation of the CDC for simple sampling [29]. Clusters: One—per the recommendation of the CDC for simple sampling [29]. The pragmatic sample size is 368–635 (CI 95%–99%).

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Source: PubMed

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