Death after the Administration of COVID-19 Vaccines Approved by EMA: Has a Causal Relationship Been Demonstrated?

Abstract

More than eight billion doses of COVID-19 vaccines have been administered globally so far and 44.29% of people are fully vaccinated. Pre-authorization clinical trials were carried out and the safety of vaccines is still continuously monitored through post-commercialization surveillance. However, some people are afraid of vaccine side effects, claiming they could lead to death, and hesitate to get vaccinated. Herein, a literature review of COVID-19-vaccine-related deaths has been carried out according to the PRISMA standards to understand if there is a causal relationship between vaccination and death and to highlight the real extent of such events. There have been 55 cases of death after COVID-19 vaccination reported and a causal relationship has been excluded in 17 cases. In the remaining cases, the causal link between the vaccine and the death was not specified (8) or considered possible (15), probable (1), or very probable/demonstrated (14). The causes of deaths among these cases were: vaccine-induced immune thrombotic thrombocytopenia (VITT) (32), myocarditis (3), ADEM (1), myocardial infarction (1), and rhabdomyolysis (1). In such cases, the demonstration of a causal relationship is not obvious, and more studies, especially with post-mortem investigations, are needed to deepen understanding of the possible pathophysiological mechanisms of fatal vaccine side effects. In any event, given the scarcity of fatal cases, the benefits of vaccination outweigh the risks and the scientific community needs to be cohesive in asserting that vaccination is fundamental to containing the spread of SARS-CoV-2.

No-Fault Compensation and Anti-COVID-19 Compulsory Vaccination: The Italian Context in a Broad View

“…In the near future, the interest of the scientific community will focus on the evaluation of applications for access to the benefit, focusing on cases in which the presence of a causal link between vaccination and the damage suffered is actually recognized [ 77 ].…”

Clinical cardiovascular emergencies and the cellular basis of COVID-19 vaccination: from dream to reality?

“…The mean age was 52.74 years (range 22-91). The ratio of mortality from COVID-19 vaccination≤50 years to that>50 years was 0.8 ( Maiese et al, 2022 ).…”

SARS-CoV-2 and COVID-19: A Narrative Review

“…This data included 4110 deaths, a frequency of 0.0015%, which compares with the case fatality rate defined by the WHO (at the time) in those infected with SARS-CoV-2 of around 1.8% ( 78 ). However, of more than 8 billion doses of COVID-19 vaccines administered worldwide, Maiese and others found only 55 cases of death temporally correlated with vaccination, and in 17 of these a causal relationship has been excluded ( 79 ).…”