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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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2021
COVID-19_Vaccines_Safety_pub_2021.pdf (560.9Kb)
Authors
Riad, Abanoub
Schünemann, Holger
Sameh, Attia
Poklepović Peričić, Tina
Franka Žuljević, Marija
Jürisson, Mikk
Kalda, Ruth
Lang, Katrin
Morankar, Sudhakar
Ali Yesuf, Elias
Mekhemar, Mohamed
Danso-Appiah, Anthony
Sofi-Mahmudi, Ahmad
Pérez-Gaxiola, Giordano
Dziedzic, Arkadiusz
Apóstolo, João
Cardoso, Daniela
Marc, Janja
Moreno-Casbas, Mayte
Shey Wiysonge, Charles
Qaseem, Amir
Gryschek, Anna
Tadić, Ivana
Hussain, Salman
Ahmed Khan, Mohammed
Klugarova, Jitka
Pokorna, Andrea
Koščík, Michal
Klugar, Miloslav
Article (Published version)
Metadata
Show full item record
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.
Source:
International Journal of Environmental Research and Public Health, 2021, 18, 15, 7859-
Publisher:
  • MDPI
Funding / projects:
  • This study protocol preparation was funded by Masaryk University, grant numbers MUNI/IGA/1543/2020 and MUNI/A/1608/20

DOI: 10.3390/ijerph18157859

ISSN: 1660-4601

WoS: 000681945000001

Scopus: 2-s2.0-85111058565
[ Google Scholar ]
46
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/4212
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Riad, Abanoub
AU  - Schünemann, Holger
AU  - Sameh, Attia
AU  - Poklepović Peričić, Tina
AU  - Franka Žuljević, Marija
AU  - Jürisson, Mikk
AU  - Kalda, Ruth
AU  - Lang, Katrin
AU  - Morankar, Sudhakar
AU  - Ali Yesuf, Elias
AU  - Mekhemar, Mohamed
AU  - Danso-Appiah, Anthony
AU  - Sofi-Mahmudi, Ahmad
AU  - Pérez-Gaxiola, Giordano
AU  - Dziedzic, Arkadiusz
AU  - Apóstolo, João
AU  - Cardoso, Daniela
AU  - Marc, Janja
AU  - Moreno-Casbas, Mayte
AU  - Shey Wiysonge, Charles
AU  - Qaseem, Amir
AU  - Gryschek, Anna
AU  - Tadić, Ivana
AU  - Hussain, Salman
AU  - Ahmed Khan, Mohammed
AU  - Klugarova, Jitka
AU  - Pokorna, Andrea
AU  - Koščík, Michal
AU  - Klugar, Miloslav
PY  - 2021
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/4212
AB  - 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.
PB  - MDPI
T2  - International Journal of Environmental Research and Public Health
T1  - COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects
VL  - 18
IS  - 15
SP  - 7859
DO  - 10.3390/ijerph18157859
ER  - 
@article{
author = "Riad, Abanoub and Schünemann, Holger and Sameh, Attia and Poklepović Peričić, Tina and Franka Žuljević, Marija and Jürisson, Mikk and Kalda, Ruth and Lang, Katrin and Morankar, Sudhakar and Ali Yesuf, Elias and Mekhemar, Mohamed and Danso-Appiah, Anthony and Sofi-Mahmudi, Ahmad and Pérez-Gaxiola, Giordano and Dziedzic, Arkadiusz and Apóstolo, João and Cardoso, Daniela and Marc, Janja and Moreno-Casbas, Mayte and Shey Wiysonge, Charles and Qaseem, Amir and Gryschek, Anna and Tadić, Ivana and Hussain, Salman and Ahmed Khan, Mohammed and Klugarova, Jitka and Pokorna, Andrea and Koščík, Michal and Klugar, Miloslav",
year = "2021",
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.",
publisher = "MDPI",
journal = "International Journal of Environmental Research and Public Health",
title = "COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects",
volume = "18",
number = "15",
pages = "7859",
doi = "10.3390/ijerph18157859"
}
Riad, A., Schünemann, H., Sameh, A., Poklepović Peričić, T., Franka Žuljević, M., Jürisson, M., Kalda, R., Lang, K., Morankar, S., Ali Yesuf, E., Mekhemar, M., Danso-Appiah, A., Sofi-Mahmudi, A., Pérez-Gaxiola, G., Dziedzic, A., Apóstolo, J., Cardoso, D., Marc, J., Moreno-Casbas, M., Shey Wiysonge, C., Qaseem, A., Gryschek, A., Tadić, I., Hussain, S., Ahmed Khan, M., Klugarova, J., Pokorna, A., Koščík, M.,& Klugar, M.. (2021). COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects. in International Journal of Environmental Research and Public Health
MDPI., 18(15), 7859.
https://doi.org/10.3390/ijerph18157859
Riad A, Schünemann H, Sameh A, Poklepović Peričić T, Franka Žuljević M, Jürisson M, Kalda R, Lang K, Morankar S, Ali Yesuf E, Mekhemar M, Danso-Appiah A, Sofi-Mahmudi A, Pérez-Gaxiola G, Dziedzic A, Apóstolo J, Cardoso D, Marc J, Moreno-Casbas M, Shey Wiysonge C, Qaseem A, Gryschek A, Tadić I, Hussain S, Ahmed Khan M, Klugarova J, Pokorna A, Koščík M, Klugar M. COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects. in International Journal of Environmental Research and Public Health. 2021;18(15):7859.
doi:10.3390/ijerph18157859 .
Riad, Abanoub, Schünemann, Holger, Sameh, Attia, Poklepović Peričić, Tina, Franka Žuljević, Marija, Jürisson, Mikk, Kalda, Ruth, Lang, Katrin, Morankar, Sudhakar, Ali Yesuf, Elias, Mekhemar, Mohamed, Danso-Appiah, Anthony, Sofi-Mahmudi, Ahmad, Pérez-Gaxiola, Giordano, Dziedzic, Arkadiusz, Apóstolo, João, Cardoso, Daniela, Marc, Janja, Moreno-Casbas, Mayte, Shey Wiysonge, Charles, Qaseem, Amir, Gryschek, Anna, Tadić, Ivana, Hussain, Salman, Ahmed Khan, Mohammed, Klugarova, Jitka, Pokorna, Andrea, Koščík, Michal, Klugar, Miloslav, "COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects" in International Journal of Environmental Research and Public Health, 18, no. 15 (2021):7859,
https://doi.org/10.3390/ijerph18157859 . .

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