دورية أكاديمية
COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals.
| العنوان: | COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals. |
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| المؤلفون: | Faksova K; Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark. Electronic address: kfak@ssi.dk., Walsh D; Department of Statistics, University of Auckland, New Zealand; Global Vaccine Data Network, Global Coordinating Centre, Auckland, New Zealand., Jiang Y; Department of Statistics, University of Auckland, New Zealand; Global Vaccine Data Network, Global Coordinating Centre, Auckland, New Zealand., Griffin J; Global Vaccine Data Network, Global Coordinating Centre, Auckland, New Zealand., Phillips A; National Centre for Immunisation Research and Surveillance, Westmead, New South Wales, Australia., Gentile A; Department of Epidemiology, Ricardo Gutierrez Children Hospital, Buenos Aires University, Argentina., Kwong JC; ICES, Toronto, Ontario, Canada; Public Health Ontario, Toronto, Ontario, Canada; Department of Family and Community Medicine, Temerty Faculty of Medicine and the Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada., Macartney K; National Centre for Immunisation Research and Surveillance, Westmead, New South Wales, Australia; The University of Sydney, Australia., Naus M; British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada; School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada., Grange Z; Public Health Scotland, Glasgow, Scotland, United Kingdom., Escolano S; Université Paris-Saclay, UVSQ, Inserm, CESP, High Dimensional Biostatistics for Drug Safety and Genomics, Villejuif, France., Sepulveda G; Murdoch Children's Research Institute, Parkville, Victoria, Australia., Shetty A; Murdoch Children's Research Institute, Parkville, Victoria, Australia., Pillsbury A; National Centre for Immunisation Research and Surveillance, Westmead, New South Wales, Australia., Sullivan C; Public Health Scotland, Glasgow, Scotland, United Kingdom., Naveed Z; British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada; School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada., Janjua NZ; British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada; School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada., Giglio N; Department of Epidemiology, Ricardo Gutierrez Children Hospital, Buenos Aires University, Argentina., Perälä J; Department of Health Security, Finnish Institute for Health and Welfare, Helsinki, Finland., Nasreen S; ICES, Toronto, Ontario, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada; School of Public Health, SUNY Downstate Health Sciences University, Brooklyn, NY, USA., Gidding H; National Centre for Immunisation Research and Surveillance, Westmead, New South Wales, Australia; The University of Sydney, Australia., Hovi P; Department of Public Welfare, Finnish Institute for Health and Welfare, Helsinki, Finland., Vo T; Faculty of Social Sciences, Tampere University, Finland., Cui F; School of Public Health, Peking University, China., Deng L; National Centre for Immunisation Research and Surveillance, Westmead, New South Wales, Australia., Cullen L; Public Health Scotland, Glasgow, Scotland, United Kingdom., Artama M; Faculty of Social Sciences, Tampere University, Finland., Lu H; Department of Statistics, University of Auckland, New Zealand; Global Vaccine Data Network, Global Coordinating Centre, Auckland, New Zealand., Clothier HJ; Global Vaccine Data Network, Global Coordinating Centre, Auckland, New Zealand; Murdoch Children's Research Institute, Parkville, Victoria, Australia., Batty K; Auckland UniServices Limited at University of Auckland, New Zealand., Paynter J; School of Population Health, University of Auckland, New Zealand., Petousis-Harris H; Global Vaccine Data Network, Global Coordinating Centre, Auckland, New Zealand; School of Population Health, University of Auckland, New Zealand., Buttery J; Global Vaccine Data Network, Global Coordinating Centre, Auckland, New Zealand; Murdoch Children's Research Institute, Parkville, Victoria, Australia; University of Melbourne, Parkville, Victoria, Australia., Black S; Global Vaccine Data Network, Global Coordinating Centre, Auckland, New Zealand; School of Population Health, University of Auckland, New Zealand., Hviid A; Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark; Pharmacovigilance Research Center, Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. |
| المصدر: | Vaccine [Vaccine] 2024 Apr 02; Vol. 42 (9), pp. 2200-2211. Date of Electronic Publication: 2024 Feb 12. |
| نوع المنشور: | Observational Study; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Amsterdam, The Netherlands : Elsevier Science Original Publication: [Guildford, Surrey, UK] : Butterworths, [c1983- |
| مواضيع طبية MeSH: | COVID-19*/prevention & control , Guillain-Barre Syndrome*/chemically induced , Guillain-Barre Syndrome*/epidemiology , Myocarditis* , Pericarditis* , Sinus Thrombosis, Intracranial*, Humans ; 2019-nCoV Vaccine mRNA-1273 ; BNT162 Vaccine ; Cohort Studies ; COVID-19 Vaccines/adverse effects ; mRNA Vaccines ; Vaccination/adverse effects ; Male ; Female |
| مستخلص: | Background: The Global COVID Vaccine Safety (GCoVS) Project, established in 2021 under the multinational Global Vaccine Data Network™ (GVDN®), facilitates comprehensive assessment of vaccine safety. This study aimed to evaluate the risk of adverse events of special interest (AESI) following COVID-19 vaccination from 10 sites across eight countries. Methods: Using a common protocol, this observational cohort study compared observed with expected rates of 13 selected AESI across neurological, haematological, and cardiac outcomes. Expected rates were obtained by participating sites using pre-COVID-19 vaccination healthcare data stratified by age and sex. Observed rates were reported from the same healthcare datasets since COVID-19 vaccination program rollout. AESI occurring up to 42 days following vaccination with mRNA (BNT162b2 and mRNA-1273) and adenovirus-vector (ChAdOx1) vaccines were included in the primary analysis. Risks were assessed using observed versus expected (OE) ratios with 95 % confidence intervals. Prioritised potential safety signals were those with lower bound of the 95 % confidence interval (LBCI) greater than 1.5. Results: Participants included 99,068,901 vaccinated individuals. In total, 183,559,462 doses of BNT162b2, 36,178,442 doses of mRNA-1273, and 23,093,399 doses of ChAdOx1 were administered across participating sites in the study period. Risk periods following homologous vaccination schedules contributed 23,168,335 person-years of follow-up. OE ratios with LBCI > 1.5 were observed for Guillain-Barré syndrome (2.49, 95 % CI: 2.15, 2.87) and cerebral venous sinus thrombosis (3.23, 95 % CI: 2.51, 4.09) following the first dose of ChAdOx1 vaccine. Acute disseminated encephalomyelitis showed an OE ratio of 3.78 (95 % CI: 1.52, 7.78) following the first dose of mRNA-1273 vaccine. The OE ratios for myocarditis and pericarditis following BNT162b2, mRNA-1273, and ChAdOx1 were significantly increased with LBCIs > 1.5. Conclusion: This multi-country analysis confirmed pre-established safety signals for myocarditis, pericarditis, Guillain-Barré syndrome, and cerebral venous sinus thrombosis. Other potential safety signals that require further investigation were identified. Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Jeffrey C. Kwong reports financial support was provided by Centers for Disease Control and Prevention. Naveed Z. Janjua reports financial support was provided by Centers for Disease Control and Prevention. Anders Hviid reports financial support was provided by Global Vaccine Data Network. Helen Petousis-Harris reports financial support was provided by New Zealand Ministry of Health. Steven Black reports a relationship with GSK that includes: consulting or advisory. Jeffrey C. Kwong reports a relationship with Canadian Institutes of Health Research that includes: funding grants. Jeffrey C. Kwong reports a relationship with Public Health Agency of Canada that includes: funding grants. Naveed Z. Janjua reports a relationship with AbbVie Inc that includes: consulting or advisory and speaking and lecture fees. Naveed Z. Janjua reports a relationship with Gilead Sciences Inc that includes: speaking and lecture fees. Anders Hviid reports a relationship with Independent Research Fund Denmark that includes: funding grants. Anders Hviid reports a relationship with Lundbeck Foundation that includes: funding grants. Anders Hviid reports a relationship with Novo Nordisk Foundation that includes: funding grants. Anders Hviid reports a relationship with VAC4EU that includes: consulting or advisory. Finnish Institute for Health and Welfare (THL) conducts Public-Private Partnership with vaccine manufacturers and has received research funding from Sanofi Inc. Petteri Hovi has been an investigator in these studies, but has received no personal remuneration. Helen Petousis-Harris has served on expert advisory boards and had speaking engagements for Pfizer and GSK. She has also received research funding from GSK. She has not received any personal honoraria. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Adverse events following immunization; Adverse events of special interest; COVID-19; Observed vs. expected analysis; Pharmacovigilance; Vaccine safety surveillance |
| المشرفين على المادة: | EPK39PL4R4 (2019-nCoV Vaccine mRNA-1273) 0 (BNT162 Vaccine) 0 (COVID-19 Vaccines) 0 (mRNA Vaccines) |
| تواريخ الأحداث: | Date Created: 20240213 Date Completed: 20240408 Latest Revision: 20240408 |
| رمز التحديث: | 20240408 |
| DOI: | 10.1016/j.vaccine.2024.01.100 |
| PMID: | 38350768 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1873-2518 |
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| DOI: | 10.1016/j.vaccine.2024.01.100 |