6
views
0
recommends
+1 Recommend
2 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

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

      methods-article
      1 , 2 , 3 , 4 , 5 , 6 , 7 , 7 , 7 , 8 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 1 , 22 , 1 , 2 , 23 , 24 , 1 , 23 , 24 , 2 , 25 , 1 , 2 , 23 , 24 , *
      International Journal of Environmental Research and Public Health
      MDPI
      cohort studies, cross-sectional studies, COVID-19, drug-related side effects and adverse reactions, health personnel, mass vaccination, prevalence

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          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.

          Related collections

          Most cited references39

          • Record: found
          • Abstract: found
          • Article: not found

          Vaccine hesitancy: the next challenge in the fight against COVID-19

          Vaccine hesitancy remains a barrier to full population inoculation against highly infectious diseases. Coincident with the rapid developments of COVID-19 vaccines globally, concerns about the safety of such a vaccine could contribute to vaccine hesitancy. We analyzed 1941 anonymous questionnaires completed by healthcare workers and members of the general Israeli population, regarding acceptance of a potential COVID-19 vaccine. Our results indicate that healthcare staff involved in the care of COVID-19 positive patients, and individuals considering themselves at risk of disease, were more likely to self-report acquiescence to COVID-19 vaccination if and when available. In contrast, parents, nurses, and medical workers not caring for SARS-CoV-2 positive patients expressed higher levels of vaccine hesitancy. Interventional educational campaigns targeted towards populations at risk of vaccine hesitancy are therefore urgently needed to combat misinformation and avoid low inoculation rates.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Attitudes Toward a Potential SARS-CoV-2 Vaccine: A Survey of U.S. Adults

            Once a vaccine for coronavirus disease 2019 becomes available, it will be important to maximize vaccine uptake and coverage. This national survey explores factors associated with vaccine hesitancy. The results suggest that multipronged efforts will be needed to increase acceptance of a coronavirus disease 2019 vaccine.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: found

              Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study

              Background The Pfizer-BioNTech (BNT162b2) and the Oxford-AstraZeneca (ChAdOx1 nCoV-19) COVID-19 vaccines have shown excellent safety and efficacy in phase 3 trials. We aimed to investigate the safety and effectiveness of these vaccines in a UK community setting. Methods In this prospective observational study, we examined the proportion and probability of self-reported systemic and local side-effects within 8 days of vaccination in individuals using the COVID Symptom Study app who received one or two doses of the BNT162b2 vaccine or one dose of the ChAdOx1 nCoV-19 vaccine. We also compared infection rates in a subset of vaccinated individuals subsequently tested for SARS-CoV-2 with PCR or lateral flow tests with infection rates in unvaccinated controls. All analyses were adjusted by age (≤55 years vs >55 years), sex, health-care worker status (binary variable), obesity (BMI <30 kg/m 2 vs ≥30 kg/m 2 ), and comorbidities (binary variable, with or without comorbidities). Findings Between Dec 8, and March 10, 2021, 627 383 individuals reported being vaccinated with 655 590 doses: 282 103 received one dose of BNT162b2, of whom 28 207 received a second dose, and 345 280 received one dose of ChAdOx1 nCoV-19. Systemic side-effects were reported by 13·5% (38 155 of 282 103) of individuals after the first dose of BNT162b2, by 22·0% (6216 of 28 207) after the second dose of BNT162b2, and by 33·7% (116 473 of 345 280) after the first dose of ChAdOx1 nCoV-19. Local side-effects were reported by 71·9% (150 023 of 208 767) of individuals after the first dose of BNT162b2, by 68·5% (9025 of 13 179) after the second dose of BNT162b2, and by 58·7% (104 282 of 177 655) after the first dose of ChAdOx1 nCoV-19. Systemic side-effects were more common (1·6 times after the first dose of ChAdOx1 nCoV-19 and 2·9 times after the first dose of BNT162b2) among individuals with previous SARS-CoV-2 infection than among those without known past infection. Local effects were similarly higher in individuals previously infected than in those without known past infection (1·4 times after the first dose of ChAdOx1 nCoV-19 and 1·2 times after the first dose of BNT162b2). 3106 of 103 622 vaccinated individuals and 50 340 of 464 356 unvaccinated controls tested positive for SARS-CoV-2 infection. Significant reductions in infection risk were seen starting at 12 days after the first dose, reaching 60% (95% CI 49–68) for ChAdOx1 nCoV-19 and 69% (66–72) for BNT162b2 at 21–44 days and 72% (63–79) for BNT162b2 after 45–59 days. Interpretation Systemic and local side-effects after BNT162b2 and ChAdOx1 nCoV-19 vaccination occur at frequencies lower than reported in phase 3 trials. Both vaccines decrease the risk of SARS-CoV-2 infection after 12 days. Funding ZOE Global, National Institute for Health Research, Chronic Disease Research Foundation, National Institutes of Health, UK Medical Research Council, Wellcome Trust, UK Research and Innovation, American Gastroenterological Association.
                Bookmark

                Author and article information

                Contributors
                Role: Academic Editor
                Journal
                Int J Environ Res Public Health
                Int J Environ Res Public Health
                ijerph
                International Journal of Environmental Research and Public Health
                MDPI
                1661-7827
                1660-4601
                25 July 2021
                August 2021
                : 18
                : 15
                : 7859
                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; abanoub.riad@ 123456med.muni.cz (A.R.); mohammad.hussain@ 123456med.muni.cz (S.H.); klugarova@ 123456med.muni.cz (J.K.); apokorna@ 123456med.muni.cz (A.P.)
                [2 ]Department of Public Health, Faculty of Medicine, Masaryk University, Kamenice 5, 62500 Brno, Czech Republic; koscik@ 123456med.muni.cz
                [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; schuneh@ 123456mcmaster.ca
                [4 ]Department of Oral and Maxillofacial Surgery, Justus-Liebig-University, Klinikstrasse 33, 35392 Giessen, Germany; sameh.attia@ 123456dentist.med.uni-giessen.de
                [5 ]Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000 Split, Croatia; tina.poklepovic@ 123456mefst.hr
                [6 ]Department of Medical Humanities, University of Split School of Medicine, Šoltanska 2, 21000 Split, Croatia; marija.franka.zuljevic@ 123456mefst.hr
                [7 ]Department of Family Medicine and Public Health, University of Tartu, Ravila 19, 50411 Tartu, Estonia; mikk.jurisson@ 123456ut.ee (M.J.); ruth.kalda@ 123456ut.ee (R.K.); katrin.lang@ 123456ut.ee (K.L.)
                [8 ]Faculty of Public Health, Institute of Health, Jimma University, Aba Jifar 1 Street, 378 Jimma, Ethiopia; morankarsn@ 123456yahoo.com (S.M.); elias.yesuf@ 123456gmail.com (E.A.Y.)
                [9 ]Clinic for Conservative Dentistry and Periodontology, School of Dental Medicine, Kiel University, Arnold-Heller-Str. 3, Haus B, 24105 Kiel, Germany; mekhemar@ 123456konspar.uni-kiel.de
                [10 ]Department of Epidemiology and Disease Control, School of Public Health, University of Ghana, Accra LG 25, Ghana; adanso-appiah@ 123456ug.edu.gh
                [11 ]Cochrane Iran Associate Centre, National Institute for Medical Research Development, Tehran 16846, Iran; sofimahmudi@ 123456research.ac.ir
                [12 ]Department of Evidence Based Medicine, Sinaloa Pediatric Hospital, Cochrane Mexico, Calle Constitución 530, Jorge Almada, 80200 Culiacán, Mexico; giordano@ 123456cochrane.mx
                [13 ]Department of Conservative Dentistry with Endodontics, Medical University of Silesia, 40-055 Katowice, Poland; adziedzic@ 123456sum.edu.pl
                [14 ]Health Sciences Research Unit: Nursing, Portugal Centre for Evidence-Based Practice: JBI Centre of Excellence, Nursing School of Coimbra, 3004-011 Coimbra, Portugal; apostolo@ 123456esenfc.pt (J.A.); dcardoso@ 123456esenfc.pt (D.C.)
                [15 ]Faculty of Pharmacy, University of Ljubljana, Aškerčeva Cesta 7, 1000 Ljubljana, Slovenia; janja.marc@ 123456ffa.uni-lj.si
                [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; mmoreno@ 123456isciii.es
                [18 ]Cochrane South Africa, South African Medical Research Council, Cape Town 7501, South Africa; charles.wiysonge@ 123456mrc.ac.za
                [19 ]American College of Physicians, 190 N Independence Mall W, Philadelphia, PA 19106, USA; aqaseem@ 123456acponline.org
                [20 ]Department of Nursing in Collective Health, School of Nursing, University of São Paulo, São Paulo 419, Brazil; gryschek@ 123456usp.br
                [21 ]Department of Social Pharmacy and Pharmaceutical Legislation, Faculty of Pharmacy, University of Belgrade, 11221 Belgrade, Serbia; ivana.tadic@ 123456pharmacy.bg.ac.rs
                [22 ]School of Pharmaceutical Education and Research, Jamia Hamdard, Hamdard Nagar, New Delhi 110062, India; drm.ahmedkhan@ 123456jamiahamdard.ac.in
                [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
                Author notes
                [* ]Correspondence: klugar@ 123456med.muni.cz ; Tel.: +420-549-49-5676
                Author information
                https://orcid.org/0000-0002-9174-6435
                https://orcid.org/0000-0002-4487-7045
                https://orcid.org/0000-0003-0281-5564
                https://orcid.org/0000-0003-4294-757X
                https://orcid.org/0000-0003-1747-0060
                https://orcid.org/0000-0001-6829-0823
                https://orcid.org/0000-0003-0022-8382
                https://orcid.org/0000-0002-3050-4264
                https://orcid.org/0000-0002-1425-885X
                https://orcid.org/0000-0001-9061-4628
                https://orcid.org/0000-0002-1273-4779
                https://orcid.org/0000-0001-5012-5977
                https://orcid.org/0000-0002-1691-8428
                https://orcid.org/0000-0002-1305-6455
                https://orcid.org/0000-0002-9243-6391
                https://orcid.org/0000-0002-2804-7295
                Article
                ijerph-18-07859
                10.3390/ijerph18157859
                8345554
                34360156
                92a59a25-e437-4d73-a72c-56de705952e4
                © 2021 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( https://creativecommons.org/licenses/by/4.0/).

                History
                : 27 May 2021
                : 20 July 2021
                Categories
                Study Protocol

                Public health
                cohort studies,cross-sectional studies,covid-19,drug-related side effects and adverse reactions,health personnel,mass vaccination,prevalence

                Comments

                Comment on this article