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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.
Riad, Abanoub; Schünemann, Holger; Attia, Sameh; Pericic, Tina Poklepovic; Zuljevic, 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, João; Cardoso, Daniela; Marc, Janja; Moreno-Casbas, Mayte; Wiysonge, Charles Shey; Qaseem, Amir; Gryschek, Anna; Tadic, Ivana; Hussain, Salman; Khan, Mohammed Ahmed; Klugarova, Jitka; Pokorna, Andrea; Koscík, Michal; Klugar, Miloslav.
  • Riad A; 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.
  • Schünemann H; Department of Public Health, Faculty of Medicine, Masaryk University, Kamenice 5, 62500 Brno, Czech Republic.
  • Attia S; Department of Health Research Methods, Evidence, and Impact, McMaster University Health Sciences Centre, Room 2C16, 1280 Main Street West, Hamilton, ON L8N 4K1, Canada.
  • Pericic TP; Department of Oral and Maxillofacial Surgery, Justus-Liebig-University, Klinikstrasse 33, 35392 Giessen, Germany.
  • Zuljevic MF; Department of Research in Biomedicine and Health, University of Split School of Medicine, Soltanska 2, 21000 Split, Croatia.
  • Jürisson M; Department of Medical Humanities, University of Split School of Medicine, Soltanska 2, 21000 Split, Croatia.
  • Kalda R; Department of Family Medicine and Public Health, University of Tartu, Ravila 19, 50411 Tartu, Estonia.
  • Lang K; Department of Family Medicine and Public Health, University of Tartu, Ravila 19, 50411 Tartu, Estonia.
  • Morankar S; Department of Family Medicine and Public Health, University of Tartu, Ravila 19, 50411 Tartu, Estonia.
  • Yesuf EA; Faculty of Public Health, Institute of Health, Jimma University, Aba Jifar 1 Street, 378 Jimma, Ethiopia.
  • Mekhemar M; Faculty of Public Health, Institute of Health, Jimma University, Aba Jifar 1 Street, 378 Jimma, Ethiopia.
  • Danso-Appiah A; Clinic for Conservative Dentistry and Periodontology, School of Dental Medicine, Kiel University, Arnold-Heller-Str. 3, Haus B, 24105 Kiel, Germany.
  • Sofi-Mahmudi A; Department of Epidemiology and Disease Control, School of Public Health, University of Ghana, Accra LG 25, Ghana.
  • Pérez-Gaxiola G; Cochrane Iran Associate Centre, National Institute for Medical Research Development, Tehran 16846, Iran.
  • Dziedzic A; Department of Evidence Based Medicine, Sinaloa Pediatric Hospital, Cochrane Mexico, Calle Constitución 530, Jorge Almada, 80200 Culiacán, Mexico.
  • Apóstolo J; Department of Conservative Dentistry with Endodontics, Medical University of Silesia, 40-055 Katowice, Poland.
  • Cardoso D; Health Sciences Research Unit: Nursing, Portugal Centre for Evidence-Based Practice: JBI Centre of Excellence, Nursing School of Coimbra, 3004-011 Coimbra, Portugal.
  • Marc J; Health Sciences Research Unit: Nursing, Portugal Centre for Evidence-Based Practice: JBI Centre of Excellence, Nursing School of Coimbra, 3004-011 Coimbra, Portugal.
  • Moreno-Casbas M; Faculty of Pharmacy, University of Ljubljana, Askerceva Cesta 7, 1000 Ljubljana, Slovenia.
  • Wiysonge CS; Institute of Clinical Chemistry and Biochemistry, University Medical Centre Ljubljana, Zaloska cesta 2, 1000 Ljubljana, Slovenia.
  • Qaseem A; Nursing and Healthcare Research Unit (Investén-isciii), Instituto de Salud Carlos III, 28029 Madrid, Spain.
  • Gryschek A; Cochrane South Africa, South African Medical Research Council, Cape Town 7501, South Africa.
  • Tadic I; American College of Physicians, 190 N Independence Mall W, Philadelphia, PA 19106, USA.
  • Hussain S; Department of Nursing in Collective Health, School of Nursing, University of São Paulo, São Paulo 419, Brazil.
  • Khan MA; Department of Social Pharmacy and Pharmaceutical Legislation, Faculty of Pharmacy, University of Belgrade, 11221 Belgrade, Serbia.
  • Klugarova J; 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.
  • Pokorna A; School of Pharmaceutical Education and Research, Jamia Hamdard, Hamdard Nagar, New Delhi 110062, India.
  • Koscík M; 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.
  • Klugar M; Department of Public Health, Faculty of Medicine, Masaryk University, Kamenice 5, 62500 Brno, Czech Republic.
Int J Environ Res Public Health ; 18(15)2021 07 25.
Article in English | MEDLINE | ID: covidwho-1325669
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Vaccines / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Year: 2021 Document Type: Article Affiliation country: Ijerph18157859

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Vaccines / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Year: 2021 Document Type: Article Affiliation country: Ijerph18157859