ETD

Archivio digitale delle tesi discusse presso l'Università di Pisa

Tesi etd-09032021-122530


Tipo di tesi
Tesi di laurea magistrale LM5
Autore
BONASO, MARCO
URN
etd-09032021-122530
Titolo
Covid-19 vaccines-induced thrombosis with thrombocytopenia syndrome: a case series study of the openly accessible data of the Italian Pharmacovigilance national network
Dipartimento
FARMACIA
Corso di studi
FARMACIA
Relatori
relatore Prof. Fornai, Matteo
correlatore Dott. Tuccori, Marco
relatore Prof.ssa Martelli, Alma
Parole chiave
  • SARS-CoV-2
  • COVID-19 vaccines
  • Pharmacovigilance
  • VITT syndrome
  • Thrombosis with thrombocytopenia syndrome (TTS)
  • Vaccine-induced thrombotic immune thrombocytopenia
Data inizio appello
04/10/2021
Consultabilità
Non consultabile
Data di rilascio
04/10/2061
Riassunto
The COVID-19 pandemic, caused by the SARS-CoV-2 virus, has spread around the world with over 200 million confirmed cases and over 4 million deaths as at 26 August 2021. The extraordinary effort of the COVID-19 vaccination campaign is changing the course of this pandemic, drastically reducing the number of serious cases and deaths worldwide. As part of the enhanced surveillance of vaccines used against COVID-19, a continuous pharmacovigilance activity is ongoing to closely monitor the safety profile of available vaccines. This monitoring is based on reports made by healthcare professionals, vaccinated person or their families, with the aim of identify signals of potential adverse events that can allow regulatory agencies to issue appropriate risk minimization measures. In the first weeks of March 2021, several reports of unusual thrombotic events, in combination with thrombocytopenia after vaccination with the adenoviral vaccine Vaxzevria, caused concerns in the scientific community. Subsequent reports of similar cases also associated with the COVID-19 Janssen adenoviral vaccine reinforced the hypothesis that this new adverse event could have been triggered by adenovirus-based SARS-CoV-2 vaccines. This event is rare and characterized by cerebral and / or splanchnic venous thrombosis that can occurs even in healthy individuals. This clinical picture is often associated with thrombocytopenia and bleeding, and sometimes disseminated intravascular coagulation (DIC). Such new clinical entity has been termed vaccine-induced thrombotic immune thrombocytopenia (VITT) or thrombosis with thrombocytopenia syndrome (TTS). VITT was mainly observed in women under < 55 years-old within two weeks from vaccine administration, and it has a high mortality rate. The identification of this potential adverse event has prompted drug regulatory agencies to strengthen pharmacovigilance programs and provide some advice to limit the use of adenovirus-based vaccines to possibly sensible subjects. The present thesis is aimed at analyzing the reports collected in the Italian Pharmacovigilance database (National Pharmacovigilance Network [RNF]), concerning thrombotic events associated with thrombocytopenia following COVID-19 vaccination and providing a comprehensive review of the epidemiological problems, pathogenetic hypotheses and treatment strategies of this rare syndrome VITT.
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