ABSTRACT
The aim of this review is to provide explanations for many of the reported adverse reactions associated with spike-based Covid-19 vaccination and to draw appropriate conclusions.
Based on the comparatively disproportionate spectrum of adverse reactions of spike-based vaccines, an overwhelming body of evidence supports the consequences of the main mode of action of spike-based Covid-19 vaccines, namely the downregulation of angiotensin-converting enzyme 2 (ACE2) by spikes. This enzyme is a key protective counterregulator in the renin-angiotensin-aldosterone system. The renin-angiotensin-aldosterone system is not only responsible for cardiovascular homeostasis, but is also involved in pro-inflammatory, procoagulant, pro-fibrotic and immunological effects via its main vasoconstrictor effector, angiotensin II. This may explain the magnitude and diversity of the spectrum of side effects.
Other spike effects (cell fusion, binding to heparan sulphate, activation of Toll-like receptor 4), synergisms (increase in des-arg9-bradykinin, catecholamines) and impairment of intestinal amino acid uptake complement and multiply the already adverse effects of spike-related downregulation of ACE2 on tolerability.
Spike-based Covid-19 vaccines are characterised by a class-specific profile of adverse reactions. A causal relationship between an activated renin-angiotensin-aldosterone system and vasoconstrictive and ischaemic sequelae can be considered to be proven. Therefore, stimulation of the renin-angiotensin-aldosterone system and co-medication with vasoconstrictive, catecholaminergic or TLR4- and DABK-activating and heparan sulphate-inhibiting drugs should be avoided for the duration of spike efficacy.
It has been shown that vaccine spikes are distributed systemically and are detectable in the body for longer than previously thought. According to current knowledge, the time window for assessing a causal relationship between vaccination and adverse reactions can be extended to up to six months.
The variability of adverse effects is likely to be comparatively high, especially for spike-inducing vaccines, as the occurrence and severity of adverse reactions can be influenced by numerous individual factors and counter-regulatory mechanisms. There are no findings on this.
The exceptionally wide range, frequency and severity of reported adverse reactions associated with spike-based Covid-19 vaccination exceeds the known level of conventional vaccination and is a cause for serious concern. From a pharmacological point of view, spikes are highly potent substances, but they are not innocuous antigens. Therefore, they do not appear to be suitable for preventive immunisation against comparatively harmless infections.

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 purpose of this review is to update the key findings from the scientific literature that provide explanations for many of the reported and analysed adverse effects associated with the spike-based Covid-19 vaccination.

Principle results:

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 production volume of spikes, their dependencies and the non-neutralised spike proportion have so far remained unknown for unknown reasons.

Conclusions:

The exceptionally broad spectrum, frequency and severity of the reported side effects associated with spike-based Covid-19 vaccination exceed the known level of conventional vaccinations.

According to my side effect analyses, the spike-based vaccines possess an unacceptable class-specific, unique 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 immunisation 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.

The protective Angiotensin-Converting Enzyme 2 (ACE2) – essential part of the Renin-Angiotensin-Aldosterone System (RAAS) – is the target receptor for its physiological ligands Angiotensin I and II (Ang I/II) as well as for SARS-CoViruses and – spikes. It mediates Ang II degradation and is the precondition for SARS-CoVirus cell entry, spike-induced adverse reactions, and cytotoxic cell fusion. In spike-induced ACE2 downregulation, Ang II degradation is reduced with the consequence of increasing Ang II concentrations; the counter-regulatory protective Ang 1-7/AT2R/MAS axis is impaired.
The presented analysis provides a substantial body of evidence for the causal involvement of Ang II/activated RAAS in eliciting adverse reactions after application of spike-based vaccine. As an example, some serious organ disturbances or adverse reactions, in which the connection with an activated RAAS is obvious (cardiovascular and blood coagulation disorders, disorders of the nervous and muscular system, inflammatory reactions, auto-immunological, vascular and renal disorders), are presented and discussed.
Only a consistent refraining from any unfavorable influence on the highly complex RAAS enables harm avoidance. To limit or repair harm that has already occurred, RAAS inhibitors or recombinant ACE2 or ACE2 activators are suitable for spike-related symptoms. Based on individual assessment, the preference is currently for ARBs. An individualized approach depending on symptoms, individual conditions and differentiated diagnostics is essential.

Das protektive Angiotensin-Konversions-Enzym 2 (ACE2) – essentieller Bestandteil des Renin-Angiotensin-Aldosteron-Systems (RAAS) – ist Zielrezeptor sowohl für seine physiologischen Liganden Angiotensin I und II (Ang I/II), wie auch für SARS-CoViren und -Spikes. Es vermittelt den Abbau von Ang II und ist Voraussetzung für den SARS-CoVirus-Zelleintritt, für spike-ausgelöste Nebenwirkungen und die zytotoxische Zellfusion. Bei einer spike-bedingten ACE2-Funktionsbeeinträchtigung/Downregulation wird der Abbau  von Ang II reduziert mit der Folge steigender Ang II-Konzentrationen; die gegenregulatorisch wirksame, protektive Ang 1-7/AT₂R/MAS-Achse wird eingeschränkt.

Die vorliegende Analyse liefert eine Reihe von Beweisen für die kausale Involvierung von Ang II bzw. eines aktivierten RAAS in die Auslösung unerwünschter Reaktionen nach spike-induzierender mRNA-Applikation. Beispielhaft werden einige gravierende Organschädi-gungen bzw. Nebenwirkungen, bei denen der Zusammenhang mit einem aktivierten RAAS offenkundig ist (Herz-Kreislauf-Schädigungen, Blutgerinnungsstörungen, Störungen des Nerven-und muskulären Systems, Entzündungsreaktionen, auto-immunologische, vaskuläre, renale und metabolische  Störungen), vorgestellt und diskutiert.

Nur eine konsequente Unterlassung jeglicher ungünstiger Einflußnahme auf das hochkomplexe RAAS ermöglicht eine Schadensvermeidung. Zur Begrenzung oder Behebung bereits eingetretener Schäden eignen sich bei spike-bedingter Symptomatik RAAS-Hemmer oder rekombinantes ACE2 bzw. ACE2-Aktivatoren. Die Präferenz liegt nach individueller Einschätzung zur Zeit bei ARBs. Ein individualisiertes Vorgehen in Abhängigkeit von Symptomatik, individuellen Gegebenheiten und differenzierter Diagnostik ist unumgänglich. Klinische Studienergebnisse zur Bestätigung und zum Nachweis von Evidenz sind dringend erforderlich.

Dieser Brief ist eine Reaktion auf das unverhältnismäßige Aufforderungsschreiben des BGM an alle > 60-jährigen Bürger zur erneuten Impfung. > 60-Jährige sind gem. der mit Bundesmitteln gesponserter Studien seit Anfang 2022 gut geschützt (AK in bis zu 99% der untersuchten Fälle). Andererseits fällt eine Nutzen/Risiko-Einschätzung auf Grund des fehlenden präventiven Nutzens und der unverhältnismäßig hohen, z. T. schweren und tödlich endenden  Nebenwirkungen nicht zugunsten der spike-basierten mRNA-Impfstoffe aus. Verhinderung schwerer Infektionsfolgen durch weitere Boosterungen  ist  ein Trugschluß, weil zur Boosterung ohnehin nur noch  die wenig Empfindlichen bzw. Resistenten bereit sind, die nicht zu schweren Verläufen neigen.

Es besteht also kein Grund, >60-Jährige einem  weiteren Risiko als den bereits mit zunehmendem Lebensalter wachsenden Risiken  auszusetzen.

Anlaß für den Leserbrief waren drei Aspekte der Publikation von Schmiedel L. et al, Ärzteblatt Sachsen 6/2022 S. 14 ff.:

• Korrektur des beschriebenen und praktizierten  Nebenwirkungsmeldeverfahrens
• Bewertung von Nebenwirkungen im Vergleich
• zur Kausalität von Nebenwirkungen spike-basierter Covid-19 Impfstoffe.

Komprimierte Darstellung der häufigsten  organbezogenen Nebenwirkungen nach Applikation spike-basierter Covid-19 Wirk-/Impfstoffe beruhend auf Analysen der WebReports der EudraVigilance und wissenschaftlichen Literatur-Quellen