TY - JOUR
T1 - Covid-19 vaccine and death
T2 - Causality algorithm according to the who eligibility diagnosis
AU - Pomara, Cristoforo
AU - Sessa, Francesco
AU - Ciaccio, Marcello
AU - Dieli, Francesco
AU - Esposito, Massimiliano
AU - Giammanco, Giovanni Maurizio
AU - Garozzo, Sebastiano Fabio
AU - Giarratano, Antonino
AU - Prati, Daniele
AU - Rappa, Francesca
AU - Salerno, Monica
AU - Tripodo, Claudio
AU - Mannucci, Pier Mannuccio
AU - Zamboni, Paolo
N1 - Funding Information:
The authors thank the Public Prosecutor's Office of Catania and Gela (Zuccaro, Asaro, Santonocito, Consoli, Leo, Scuderi). Moreover, the authors wish to thank Regional Ministry for Health of Sicily (R. Razza). The authors thank the Scientific Bureau of the University of Catania for language support.
Publisher Copyright:
© 2021 by the authors.
PY - 2021/6
Y1 - 2021/6
N2 - 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.
AB - 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.
KW - Autopsy
KW - COVID-19
KW - Deep vein thrombosis
KW - Disseminated intravascular coagulation
KW - Immune thrombocytopenia
KW - Post-mortem investigation
KW - SARS-CoV-2
KW - Standard protocol
KW - Vaccination campaign
KW - Vaccine
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U2 - 10.3390/diagnostics11060955
DO - 10.3390/diagnostics11060955
M3 - Article
AN - SCOPUS:85107750532
SN - 2075-4418
VL - 11
JO - Diagnostics
JF - Diagnostics
IS - 6
M1 - 955
ER -