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Article

COVID-19 Vaccine and Death: Causality Algorithm According to the WHO Eligibility Diagnosis

1
Department of Medical, Surgical and Advanced Technologies “G.F. Ingrassia”, University of Catania, 95121 Catania, Italy
2
Department of Clinical and Experimental Medicine, University of Foggia, 71122 Foggia, Italy
3
Clinical Molecular Medicine and Laboratory Medicine, Institute of Clinical Biochemistry, Department of Biomedicine, Neurosciences and Advanced Diagnostics, University of Palermo, 90127 Palermo, Italy
4
Department of Laboratory Medicine, AOUP “P. Giaccone”, 90127 Palermo, Italy
5
Central Laboratory of Advanced Diagnosis and Biomedical Research (CLADIBIOR), University of Palermo, 90128 Palermo, Italy
6
Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (Pro.M.I.S.E.), University of Palermo, 90128 Palermo, Italy
7
Clinical Pathology Unit, Garibaldi Centro Hospital, ARNAS Garibaldi, 95121 Catania, Italy
8
Department of Surgical, Oncological and Oral Science (Di.Chir.On.S.), University of Palermo, 90128 Palermo, Italy
9
Department of Anesthesia, Intensive Care and Emergency, Policlinico Paolo Giaccone, 90128 Palermo, Italy
10
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Department of Transfusion Medicine and Hematology, 20162 Milan, Italy
11
Department of Biomedicine and Neurosciences and Advanced Diagnostics, University of Palermo, 90127 Palermo, Italy
12
Tumor Immunology Unit, Department of Health Sciences, Human Pathology Section, University of Palermo School of Medicine Palermo, 90128 Palermo, Italy
13
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, 20162 Milan, Italy
14
Hub Center for Venous and Lymphatic Diseases Regione Emilia-Romagna, Sant’Anna University Hospital of Ferrara, 44124 Ferrara, Italy
*
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Academic Editor: Andreas Kjaer
Diagnostics 2021, 11(6), 955; https://doi.org/10.3390/diagnostics11060955
Received: 25 April 2021 / Revised: 20 May 2021 / Accepted: 24 May 2021 / Published: 26 May 2021
(This article belongs to the Special Issue Biomarkers of Vascular Diseases 2.0)
The current challenge worldwide is the administration of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines. Even if rarely, severe vascular adverse reactions temporally related to vaccine administration have induced diffidence in the population at large. In particular, researchers worldwide are focusing on the so-called “thrombosis and thrombocytopenia after COVID-19 vaccination”. This study aims to establish a practical workflow to define the relationship between adverse events following immunization (AEFI) and COVID-19 vaccination, following the basic framework of the World Health Organization (WHO). Post-mortem investigation plays a pivotal role to support this causality relationship when death occurs. To demonstrate the usefulness and feasibility of the proposed workflow, we applied it to two exemplificative cases of suspected AEFI following COVID-19 vaccination. Based on the proposed model, we took into consideration any possible causality relationship between COVID-19 vaccine administration and AEFI. This led us to conclude that vaccination with ChAdOx1 nCov-19 may cause the rare development of immune thrombocytopenia mediated by platelet-activating antibodies against platelet factor 4 (PF4), which clinically mimics heparin-induced autoimmune thrombocytopenia. We suggest the adoption of the proposed methodology in order to confirm or rule out a causal relationship between vaccination and the occurrence of AEFI. View Full-Text
Keywords: SARS-CoV-2; COVID-19; vaccine; immune thrombocytopenia; disseminated intravascular coagulation; deep vein thrombosis; vaccination campaign; standard protocol; autopsy; post-mortem investigation SARS-CoV-2; COVID-19; vaccine; immune thrombocytopenia; disseminated intravascular coagulation; deep vein thrombosis; vaccination campaign; standard protocol; autopsy; post-mortem investigation
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MDPI and ACS Style

Pomara, C.; Sessa, F.; Ciaccio, M.; Dieli, F.; Esposito, M.; Giammanco, G.M.; Garozzo, S.F.; Giarratano, A.; Prati, D.; Rappa, F.; Salerno, M.; Tripodo, C.; Mannucci, P.M.; Zamboni, P. COVID-19 Vaccine and Death: Causality Algorithm According to the WHO Eligibility Diagnosis. Diagnostics 2021, 11, 955. https://doi.org/10.3390/diagnostics11060955

AMA Style

Pomara C, Sessa F, Ciaccio M, Dieli F, Esposito M, Giammanco GM, Garozzo SF, Giarratano A, Prati D, Rappa F, Salerno M, Tripodo C, Mannucci PM, Zamboni P. COVID-19 Vaccine and Death: Causality Algorithm According to the WHO Eligibility Diagnosis. Diagnostics. 2021; 11(6):955. https://doi.org/10.3390/diagnostics11060955

Chicago/Turabian Style

Pomara, Cristoforo, Francesco Sessa, Marcello Ciaccio, Francesco Dieli, Massimiliano Esposito, Giovanni M. Giammanco, Sebastiano F. Garozzo, Antonino Giarratano, Daniele Prati, Francesca Rappa, Monica Salerno, Claudio Tripodo, Pier M. Mannucci, and Paolo Zamboni. 2021. "COVID-19 Vaccine and Death: Causality Algorithm According to the WHO Eligibility Diagnosis" Diagnostics 11, no. 6: 955. https://doi.org/10.3390/diagnostics11060955

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