. 2021 Jul 25;18(15):7859.

doi: 10.3390/ijerph18157859.

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^{1

2}, Holger Schünemann³, Sameh Attia⁴, Tina Poklepović Peričić⁵, Marija Franka Žuljević⁶, Mikk Jürisson⁷, Ruth Kalda⁷, Katrin Lang⁷, Sudhakar Morankar⁸, Elias Ali Yesuf⁸, Mohamed Mekhemar⁹, Anthony Danso-Appiah¹⁰, Ahmad Sofi-Mahmudi¹¹, Giordano Pérez-Gaxiola¹², Arkadiusz Dziedzic¹³, João Apóstolo¹⁴, Daniela Cardoso¹⁴, Janja Marc^{15

16}, Mayte Moreno-Casbas¹⁷, Charles Shey Wiysonge¹⁸, Amir Qaseem¹⁹, Anna Gryschek²⁰, Ivana Tadić²¹, Salman Hussain¹, Mohammed Ahmed Khan²², Jitka Klugarova^{1

2

23

24}, Andrea Pokorna^{1

23

24}, Michal Koščík^{2

25}, Miloslav Klugar^{1

2

23

24}

Affiliations

¹ Czech National Centre for Evidence-Based Healthcare and Knowledge Translation (Cochrane Czech Republic, Czech EBHC: JBI Centre of Excellence, Masaryk University GRADE Centre), Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Kamenice 5, 62500 Brno, Czech Republic.
² Department of Public Health, Faculty of Medicine, Masaryk University, Kamenice 5, 62500 Brno, Czech Republic.
³ Department of Health Research Methods, Evidence, and Impact, McMaster University Health Sciences Centre, Room 2C16, 1280 Main Street West, Hamilton, ON L8N 4K1, Canada.
⁴ Department of Oral and Maxillofacial Surgery, Justus-Liebig-University, Klinikstrasse 33, 35392 Giessen, Germany.
⁵ Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000 Split, Croatia.
⁶ Department of Medical Humanities, University of Split School of Medicine, Šoltanska 2, 21000 Split, Croatia.
⁷ Department of Family Medicine and Public Health, University of Tartu, Ravila 19, 50411 Tartu, Estonia.
⁸ Faculty of Public Health, Institute of Health, Jimma University, Aba Jifar 1 Street, 378 Jimma, Ethiopia.
⁹ Clinic for Conservative Dentistry and Periodontology, School of Dental Medicine, Kiel University, Arnold-Heller-Str. 3, Haus B, 24105 Kiel, Germany.
¹⁰ Department of Epidemiology and Disease Control, School of Public Health, University of Ghana, Accra LG 25, Ghana.
¹¹ Cochrane Iran Associate Centre, National Institute for Medical Research Development, Tehran 16846, Iran.
¹² Department of Evidence Based Medicine, Sinaloa Pediatric Hospital, Cochrane Mexico, Calle Constitución 530, Jorge Almada, 80200 Culiacán, Mexico.
¹³ Department of Conservative Dentistry with Endodontics, Medical University of Silesia, 40-055 Katowice, Poland.
¹⁴ Health Sciences Research Unit: Nursing, Portugal Centre for Evidence-Based Practice: JBI Centre of Excellence, Nursing School of Coimbra, 3004-011 Coimbra, Portugal.
¹⁵ Faculty of Pharmacy, University of Ljubljana, Aškerčeva Cesta 7, 1000 Ljubljana, Slovenia.
¹⁶ Institute of Clinical Chemistry and Biochemistry, University Medical Centre Ljubljana, Zaloška cesta 2, 1000 Ljubljana, Slovenia.
¹⁷ Nursing and Healthcare Research Unit (Investén-isciii), Instituto de Salud Carlos III, 28029 Madrid, Spain.
¹⁸ Cochrane South Africa, South African Medical Research Council, Cape Town 7501, South Africa.
¹⁹ American College of Physicians, 190 N Independence Mall W, Philadelphia, PA 19106, USA.
²⁰ Department of Nursing in Collective Health, School of Nursing, University of São Paulo, São Paulo 419, Brazil.
²¹ Department of Social Pharmacy and Pharmaceutical Legislation, Faculty of Pharmacy, University of Belgrade, 11221 Belgrade, Serbia.
²² School of Pharmaceutical Education and Research, Jamia Hamdard, Hamdard Nagar, New Delhi 110062, India.
²³ Institute of Health Information and Statistics of the Czech Republic, Palackého náměstí 375/4, 128 01 Praha 2, Czech Republic.
²⁴ Department of Nursing and Midwifery, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.
²⁵ Czech Clinical Research Infrastructure Network, Department of Pharmacology, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.

PMID: 34360156
PMCID: PMC8345554
DOI: 10.3390/ijerph18157859

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 et al. Int J Environ Res Public Health. 2021.

. 2021 Jul 25;18(15):7859.

doi: 10.3390/ijerph18157859.

Authors

Affiliations

¹ Czech National Centre for Evidence-Based Healthcare and Knowledge Translation (Cochrane Czech Republic, Czech EBHC: JBI Centre of Excellence, Masaryk University GRADE Centre), Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Kamenice 5, 62500 Brno, Czech Republic.
² Department of Public Health, Faculty of Medicine, Masaryk University, Kamenice 5, 62500 Brno, Czech Republic.
³ Department of Health Research Methods, Evidence, and Impact, McMaster University Health Sciences Centre, Room 2C16, 1280 Main Street West, Hamilton, ON L8N 4K1, Canada.
⁴ Department of Oral and Maxillofacial Surgery, Justus-Liebig-University, Klinikstrasse 33, 35392 Giessen, Germany.
⁵ Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000 Split, Croatia.
⁶ Department of Medical Humanities, University of Split School of Medicine, Šoltanska 2, 21000 Split, Croatia.
⁷ Department of Family Medicine and Public Health, University of Tartu, Ravila 19, 50411 Tartu, Estonia.
⁸ Faculty of Public Health, Institute of Health, Jimma University, Aba Jifar 1 Street, 378 Jimma, Ethiopia.
⁹ Clinic for Conservative Dentistry and Periodontology, School of Dental Medicine, Kiel University, Arnold-Heller-Str. 3, Haus B, 24105 Kiel, Germany.
¹⁰ Department of Epidemiology and Disease Control, School of Public Health, University of Ghana, Accra LG 25, Ghana.
¹¹ Cochrane Iran Associate Centre, National Institute for Medical Research Development, Tehran 16846, Iran.
¹² Department of Evidence Based Medicine, Sinaloa Pediatric Hospital, Cochrane Mexico, Calle Constitución 530, Jorge Almada, 80200 Culiacán, Mexico.
¹³ Department of Conservative Dentistry with Endodontics, Medical University of Silesia, 40-055 Katowice, Poland.
¹⁴ Health Sciences Research Unit: Nursing, Portugal Centre for Evidence-Based Practice: JBI Centre of Excellence, Nursing School of Coimbra, 3004-011 Coimbra, Portugal.
¹⁵ Faculty of Pharmacy, University of Ljubljana, Aškerčeva Cesta 7, 1000 Ljubljana, Slovenia.
¹⁶ Institute of Clinical Chemistry and Biochemistry, University Medical Centre Ljubljana, Zaloška cesta 2, 1000 Ljubljana, Slovenia.
¹⁷ Nursing and Healthcare Research Unit (Investén-isciii), Instituto de Salud Carlos III, 28029 Madrid, Spain.
¹⁸ Cochrane South Africa, South African Medical Research Council, Cape Town 7501, South Africa.
¹⁹ American College of Physicians, 190 N Independence Mall W, Philadelphia, PA 19106, USA.
²⁰ Department of Nursing in Collective Health, School of Nursing, University of São Paulo, São Paulo 419, Brazil.
²¹ Department of Social Pharmacy and Pharmaceutical Legislation, Faculty of Pharmacy, University of Belgrade, 11221 Belgrade, Serbia.
²² School of Pharmaceutical Education and Research, Jamia Hamdard, Hamdard Nagar, New Delhi 110062, India.
²³ Institute of Health Information and Statistics of the Czech Republic, Palackého náměstí 375/4, 128 01 Praha 2, Czech Republic.
²⁴ Department of Nursing and Midwifery, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.
²⁵ Czech Clinical Research Infrastructure Network, Department of Pharmacology, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.

PMID: 34360156
PMCID: PMC8345554
DOI: 10.3390/ijerph18157859

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.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflict of interest.

Figures

**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%).

See this image and copyright information in PMC

References

1. World Health Organization (WHO) COVID-19 Vaccine Country Readiness and Delivery. COVAX. [(accessed on 7 May 2021)]; Available online: https://www.who.int/initiatives/act-accelerator/covax/covid-19-vaccine-c....
1. Attia S., Howaldt H.-P. Impact of COVID-19 on the Dental Community: Part I before Vaccine (BV) J. Clin. Med. 2021;10:288. doi: 10.3390/jcm10020288. - DOI - PMC - PubMed
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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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

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References

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Medical