"Abstract
... [T]his systematic review aims to clarify the major aspects of fatal adverse effects related to COVID-19 vaccines, with the goal of advancing our knowledge, supporting decisions, or suggesting changes in policies at local, regional, and global levels. Moreover, this review aims to provide key recommendations to improve awareness of vaccine safety. All studies published up to 2 December 2021 were searched using the following keywords: 'COVID-19 Vaccine', 'SARS-CoV-2 Vaccine', 'COVID-19 Vaccination', 'SARS-CoV-2 Vaccination', and 'Autopsy' or 'Post-mortem'. We included 17 papers published with fatal cases with post-mortem investigations. A total of 38 cases were analyzed: 22 cases were related to ChAdOx1 nCoV-19 administration, 10 cases to BNT162b2, 4 cases to mRNA-1273, and 2 cases to Ad26.COV2.S. Based on these data, autopsy is very useful to define the main characteristics of the so-called vaccine-induced immune thrombotic thrombocytopenia (VITT) after ChAdOx1 nCoV-19 vaccination: recurrent findings were intracranial hemorrhage and diffused microthrombi located in multiple areas. Moreover, it is fundamental to provide evidence about myocarditis related to the BNT162B2 vaccine...
4. Discussion
... It is interesting to note that the criteria for the diagnosis of vaccine-induced death have been adopted only by Pomara et al.: the authors adopted the proposed WHO algorithm to establish direct causality, confirming a direct link between vaccine administration and fatal adverse effects. As recently remarked by Mungmunpuntipamtip and Wiwanitkit, the criteria to establish a direct link between vaccination and fatal adverse effects should be standardized by the international community; in this way, the post-mortem investigation represents an essential tool to confirm all the data obtained during hospitalization.
The post-mortem investigation remains the gold standard to define the exact cause of death and the related pathophysiological processes . The COVID-19 vaccine campaign began in about December 2020, and, at the same time, monitoring of death associated with adverse effects started in all countries. Although different fatal events have been reported occurring at the same time as COVID-19 vaccine administration, only a few papers have been published describing the post-mortem findings...
5. Key Recommendations
On the basis of the discussed data, we want to suggest several key recommendations to improve awareness of vaccine safety:
- All pathologists should publish autopsy reports in peer-reviewed journals or alternatively, deposit these reports in national/international databases maintained by pathologist societies; in this way, it will be possible to examine the causality relationship worldwide, analyzing other vaccines;
- All pathologists should apply the WHO algorithm to define the causality relationship between vaccination and adverse effects. Analyzing the data of this review, this important tool was usually not applied, although its use is strongly encouraged to define the causality of an adverse event following vaccination (AEFI);
- The scientific community should consider the opportunity to create an international database with all data on adverse effects related to the COVID-19 vaccination that may be implemented and consulted by scientists worldwide."
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