The purpose of this review is to update the key findings from the scientific literature that provide explanations
for many of the reported and analyzed adverse effects associated with the spike-based COVID-19 vaccination.
An overwhelming body of evidence supports the main mode of action of spike-based COVID-19 vaccines,
namely the downregulation of ACE2 by spikes. Direct spike effects, synergisms and RAAS-independent
responses complement and multiply the already deleterious effects on tolerability.
It has been repeatedly confirmed that the SARS-CoV spike protein alone is not only able to downregulate
ACE2, but also to induce cell fusion, activation of TLR4, of co-receptors and gastrointestinal responses. The
systemic and long-lasting detection of spikes after vaccination disproves the claimed regionally limited and
short-lasting spike production and efficacy.
The exceptionally broad spectrum, frequency and severity of the reported ADRs associated with spike-based
COVID-19 vaccination exceed the known level of conventional vaccinations.
According to ADR analyses, the spike-based vaccines possess an unacceptable class-specific, unique ADR/side
effect profile.
From a pharmacological point of view, spikes are highly active substances, but not harmless antigens. For this
reason, they are not appropriate for preventive immunization to avoid comparatively harmless infections.

The spectrum of side effects of spike-based COVID-19 vaccines is broader and more severe than generally recognised. Adverse cardiovascular events convincingly reflect the mode of action of the spikes, namely the downregulation of the cardiovascular protective angiotensin-converting enzyme 2
(ACE2), which leads to an increase in harmful angiotensin II concentrations and the associated consequences. A fundamental re-evaluation of the benefit-risk assessment of these novel vaccines is mandatory. Healthcare professionals should be educated about the consequences of spike-induced ACE2 downregulation, the resulting symptoms and therapeutic options.

Aims: The aim of this investigation was to determine whether the global and cardiovascular burden associated with spike-based Covid-19 vaccination has continued to increase.

Methods and results: An updated analysis of spontaneously reported individual cases with ADRs and their fatal outcomes associated with Covid-19 vaccines, as well as adverse cardiovascular events caused by the spike-inducing vaccine Tozinameran, was performed.

Data were retrieved from the EudraVigilance web reports of the European Medicines Agency (EMA). All evaluated adverse events correspond to the search terms of the EudraVigilance based on clinical characterisation.

The total number of individual cases (n=2256506; i.e. 2338/day) with adverse effects that were fatal in 2.3% (n=51740; i.e. 54 deaths/day), as well as the wide range of reports of cardiovascular adverse effects, have revealed the unusual magnitude and specificity of these events.

Tachycardia, arrhythmia, atrial fibrillation/flatter, bradyarrhythmia and impaired stimulus formation and conduction (n=57438 combined) dominated the cardiovascular side effect profile of Tozinameran, followed by blood pressure increase (n=25907), myo-/pericarditis (n=23775), heart failure, cardiomyopathy, cardiac flatter/fibrillation, cardiac arrest, circulatory collaps (n=16778 combined) and coronary artery disease/myocardial infarction (n=9912). The importance of acute cardiovascular reactions is underlined by the fact that deaths caused by them accounted for at least one third (35%) of all deaths associated with Tozinameran’s side effects

Based on individual assessment, ARBs are currently recommended in the treatment of spike-induced symptoms.

Conclusions: The spectrum of side effects of spike-based Covid-19 vaccines is more extensive and severe than is generally known, Adverse cardiovascular events convincingly reflect the mode of spike action, namely down-regulating of the cardiovascular protective enzyme ACE2 resulting in increasing Ang II concentrations. A fundamental re-evaluation of the benefit-risk assessment of these novel vaccines is mandatory. Health professionals should be educated about the consequences of spike-induced ACE2 downregulation, the resulting symptoms and therapeutic options.