Article

Genetische Impfstoffe gegen COVID-19: Hoffnung oder Risiko?

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Abstract

Es wird häufig davon ausgegangen, dass sich das globale Sozialleben erst normalisieren wird, wenn ein effizienter Impfstoff gegen SARS-CoV2, den Erreger von COVID-19, zur Verfügung steht. Unter den Impfstoffkandidaten, die bei der Weltgesundheitsorganisation (WHO) registriert wurden, befindet sich mit Stand Juni 2020 ein signifikanter Anteil genetischer Impfstoffe (62 von 132 = 47 %), das heißt: Impfstoffe, die auf der Transduktion von Nukleinsäuren (DNA oder RNA) in die menschlichen Zielzellen basieren. Dieser Diskussionsbeitrag erläutert die biotechnologischen Grundlagen genetischer Impfstoffe und stellt deren spezifische Gesundheitsrisiken wie beispielsweise inflammatorische Autoimmunreaktionen und (im Fall der DNA-Plattform) potenzielle Aktivierung von Onkogenen dar. Es wird argumentiert, dass Vereinfachungen und Verkürzungen von Zulassungsverfahren, wie sie gegenwärtig diskutiert werden, einen Verstoß gegen das Vorsorgeprinzip darstellen würden.

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... Such an undesirable "Trojan Horse" effect is likely if the transferred nucleic acids designed to mimic human genes are actually integrated into human protein biosynthesis (Chiu et al., 2021;Mansuriya & Altintas, 2021;. Independent researchers examining genetic DiCoReTh-injections, therefore, point out that any short-cuts to clinical evaluations for the development of experimental injections against COVID-19, especially when based on the transduction of nucleic acids (themselves capable of unknown adjuvant-type "side-effects" such as thyroiditis; Pujol et al., 2021), would be a violation of the precautionary principle (Jiang, 2020;Arvay, 2020;Rosenthal and Cummings, 2021). In the long run, and as seen with SARS almost a decade ago, it is shocking, even potentially horrifying, to consider how the novel DiCoReTh-injections introduced into hundreds of millions of people may, over the coming weeks, months, and years, alter specific functions of the human body, especially by damaging the immune system. ...
... None of the foregoing outcomes should be surprising given the tumorigenicity of cell substrates used in the production of the constituents of the DiCoReTh-injections which may include the use of tumor allografts, transfer of known or unknown viruses, and the intentional incorporation of oncogenic agents or cell components that may produce de novo or re-ignite existing cancerous cells (Aubrit 2015;Arvay, 2020;Sumi et al., 2021;Goldman et al., 2021;VAERS, 2021 3 ...
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The engineered spike protein of SARS-COV-2, and the corresponding infectious disease COVID-19 attributed to it, hold in their grip a large portion of humanity. The global race for a counter strategy quickly turned into a search for a vaccine as the preferred means to contain the virus. An unusually rapid development of different and completely new classes of experimental therapies that would widely be referred to as “vaccines” raised questions about safety, especially with regard to emergency use approval (EUA) being granted with unprecedented urgency and hardly any critical scrutiny. At present, independent researchers, even some former proponents and insiders, of the currently ongoing global experiment represented as a “vaccination” campaign point primarily to the lack of public safety studies based on empirical datasets that should be obtainable for the tens of millions, even hundreds of millions, of doses of mRNA and DNA vector therapeutics being distributed as “vaccines”. Studies regarding efficacy and “side effects” (sometimes fatalities or permanent iatrogenic injuries) of these experimental therapies have been by-passed in favor of short-term field data from real patients which inevitably raises scientific and ethical questions particularly in view of the fact that the persons and entities responsible for public safety hold deep financial and other vested interests in speeding along the distribution of the experimental pharmaceutical products. The lack of an open discussion about the experimental therapies for COVID-19 now being applied across all age groups, even children hardly impacted by COVID-19, is worrying. The core principle of open debate without pre-conceptions or vested interests in outcomes has been and continues to be utterly ignored. We hope to engage scientific discussion that will help decision-makers, the general public, and the media alike to consider the subject-matter of what is at stake in a context of reason rather than panic.
... In effetti la trascrittasi inversa è stata documentata in due articoli appena pubblicato (Aldén et al., 2022, Musso et al., 2022 e si accompagna all'instabilità genomica del vaccinato, alla rottura cromosomica, ai salti genici indotti dai vettori attraverso il genoma e ciò si traduce in stress transgenico (iperespressione) che produce alterazione anche dell'epigenoma -come aveva previsto Mae-Wan Ho due decenni fa (Ho, 1999). Ricercatori indipendenti che esaminano le iniezioni genetiche di TeReCoMa quindi, sottolineano che eventuali scorciatoie alle valutazioni cliniche per lo sviluppo di iniezioni sperimentali contro il COVID-19, soprattutto quando basate sulla trasduzione di acidi nucleici (a loro volta capaci di "effetti" come la tiroidite; Pujol et al., 2021), costituirebbe una violazione del principio di precauzione (Jiang, 2020;Arvay, 2020;Rosenthal e Cummings, 2021). A lungo termine, e come si è visto con la SARS quasi un decennio fa, è scioccante, anche potenzialmente orribile, considerare come le nuove iniezioni di TeReCoMa introdotte in centinaia di milioni di persone possano, nelle prossime settimane, mesi e anni, alterare funzioni specifiche del corpo umano, soprattutto danneggiando il sistema immunitario. ...
... Stanno anche aumentando le prove che vaccinazioni ripetute con lo stesso antigene a brevi intervalli ("colpi di richiamo") destabilizzano il sistema immunitario in modo che siano innescati processi autoimmuni (Tsumiyama et al., 2009) in alcuni casi letali (Shimoyama et al., 2021). Nessuna delle citate evidenze dovrebbe sorprendere data la tumorigenicità dei substrati cellulari utilizzati nella produzione dei costituenti delle iniezioni di TeReCoMa che possono includere l'uso di allotrapianti tumorali, il trasferimento di virus noti o sconosciuti e l'incorporazione intenzionale di agenti oncogeni o componenti cellulari che possono produrre "de novo" o riaccendere cellule cancerose esistenti (Aubrit 2015;Arvay, 2020;Sumi et al., 2021;Goldman et al., 2021;VAERS, 2021) 3 . Potenziali eventi avversi gravi sorgono poiché il materiale di partenza per la produzione di iniezioni di TeReCoMa"si basa su linee cellulari animali in vitro. ...
Article
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La proteina ingegnerizzata spike della SARS-COV-2 e la corrispondente malattia infettiva COVID-19 attribuita ad essa tengono in pugno una gran parte dell'umanità. La corsa globale per una strategia di contrasto si è rapidamente trasformata nella ricerca di un vaccino come mezzo preferenziale per contenere il virus. Uno sviluppo insolitamente rapido di diverse classi completamente nuove di terapie sperimentali diffuse come "vaccini", ha sollevato interrogativi sulla sicurezza, in particolare per quanto riguarda l'approvazione dell'uso di emergenza (EUA) che è stata concessa con un'urgenza senza precedenti e priva di qualsiasi esame critico contrario. Attualmente, ricercatori indipendenti, come anche alcuni ex proponenti e addetti ai lavori dell'esperimento globale attualmente in corso e rappresentato come una campagna di "vaccinazione", sottolineano soprattutto la mancanza di studi sulla sicurezza della campagna vaccinale che ha finito invece per strutturarsi su set di dati empirici che verranno ottenuti attraverso decine di milioni, anche centinaia di milioni, di dosi di mRNA e terapie vettoriali del DNA distribuite col nome di "vaccini". Gli studi riguardanti l'efficacia e gli "effetti collaterali" (talvolta fatalità o lesioni iatrogene permanenti) di queste terapie sperimentali sono stati omessi a favore di dati a breve termine presi sul campo su pazienti reali. Questa evidenza solleva inevitabilmente questioni scientifiche ed etiche, in particolare in considerazione del fatto che le persone e gli enti responsabili per la sicurezza pubblica hanno vasti interessi finanziari e di altro tipo che li portano ad accelerare la distribuzione di questi prodotti farmaceutici sperimentali. La mancanza di una discussione aperta sulle terapie sperimentali per il COVID-19 ora applicate su tutte le fasce di età, anche i bambini, che difficilmente sono colpiti dal COVID-19, è preoccupante. Il principio fondamentale del dibattito aperto senza preconcetti o sugli interessi nei risultati è stato e continua ad essere completamente ignorato. Speriamo di impegnare una discussione scientifica al fine di aiutare chi deve decidere, l'opinione pubblica e i media a considerare l'oggetto di ciò che è in gioco in un contesto di ragione piuttosto che di panico.
... During the SARS-CoV-2 pandemic, new regulatory frameworks were put into place that allowed for expedited review of data and admission of new vaccines without adequate and sufficient safety data. [1][2][3] [4]). ...
Article
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Background: COVID-19 vaccines have had expedited reviews without sufficient safety data. We wanted to compare risks and benefits. Methods: We calculated the Number Needed to Vaccinate (NNTV) to prevent one death from a large Israeli field study. We accessed the Adverse Drug Reactions database of the Dutch National Register (Lareb) to extract the number of cases reporting severe side-effects and the number of cases reporting fatal side-effects.
... In the course of the SARS-CoV2 pandemic, new regulatory frameworks were put in place that allowed for the expedited review of data and admission of new vaccines without safety data [1]. Many of the new vaccines use completely new technologies that have never been used in humans before. ...
Article
Background: COVID-19 vaccines have had expedited reviews without sufficient safety data. We wanted to compare risks and benefits. Method: We calculated the number needed to vaccinate (NNTV) from a large Israeli field study to prevent one death. We accessed the Adverse Drug Reactions (ADR) database of the European Medicines Agency and of the Dutch National Register (lareb.nl) to extract the number of cases reporting severe side effects and the number of cases with fatal side effects. Result: The NNTV is between 200–700 to prevent one case of COVID-19 for the mRNA vaccine marketed by Pfizer, while the NNTV to prevent one death is between 9000 and 50,000 (95% confidence interval), with 16,000 as a point estimate. The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations. Currently, we see 16 serious side effects per 100,000 vaccinations, and the number of fatal side effects is at 4.11/100,000 vaccinations. For three deaths prevented by vaccination we have to accept two inflicted by vaccination. Conclusions: This lack of clear benefit should cause governments to rethink their vaccination policy.
... This could potentially lead to uncontrolled integration mechanisms. Critics of genetic vaccines therefore point out that any shortenings of clinical evaluations for the development of a vaccine against COVID-19, especially when based on the transduction of nucleic acids, would be a violation of the precautionary principle (Arvay, 2020;Jiang, 2020). This adverse potential arose as the source material for vaccine production uses animal cell lines in-vitro. ...
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Viral vectors are promising tools for gene therapy and vaccines. Viral vector-based vaccines can enhance immunogenicity without an adjuvant and induce a robust cytotoxic T lymphocyte (CTL) response to eliminate virus-infected cells. During the last several decades, many types of viruses have been developed as vaccine vectors. Each has unique features and parental virus-related risks. In addition, genetically altered vectors have been developed to improve efficacy and safety, reduce administration dose, and enable large-scale manufacturing. To date, both successful and unsuccessful results have been reported in clinical trials. These trials provide important information on factors such as toxicity, administration dose tolerated, and optimized vaccination strategy. This review highlights major viral vectors that are the best candidates for clinical use.
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DNA vaccines are based on the transfer of genetic material, encoding an antigen, to the cells of the vaccine recipient. Despite high expectations of DNA vaccines as a result of promising preclinical data their clinical utility remains unproven. However, much data is gathered in preclinical and clinical studies about the safety of DNA vaccines. Here we review current knowledge about the safety of DNA vaccines. Safety concerns of DNA vaccines relate to genetic, immunologic, toxic, and environmental effects. In this review we provide an overview of findings related to the safety of DNA vaccines, obtained so far. We conclude that the potential risks of DNA vaccines are minimal. However, their safety issues may differ case-by-case, and they should be treated accordingly.
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Feline infectious peritonitis virus (FIPV) causes a severe, immune-mediated disease called FIP in domestic and wild cats. It is unclear whether FIP transmits from cat to cat through the oral route of FIPV infection, and the reason for this includes that FIP is caused by oral inoculation with some FIPV strains (e.g., type II FIPV WSU 79-1146), but is not caused by other FIPV (e.g., type I FIPV KU-2 strain: FIPV-I KU-2). In this study, when cats passively immunized with anti-FIPV-I KU-2 antibodies were orally inoculated with FIPV-I KU-2, FIP was caused at a 50% probability, i.e., FIPV not causing FIP through oral infection caused FIP by inducing antibody-dependent enhancement. Many strains of type I FIPV do not cause FIP by inoculation through the oral route in cats. Based on the findings of this study, type I FIPV which orally infected cats may cause FIP depending on the condition.
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  • C Schmidt
Schmidt C. Genetic engineering could make a COVID-19 vaccine in months rather then years: candidates are speeding toward human trials. Scientific American, 29.4.2020 → scientificamerican.com. Letzter Aufruf: 30.4.2020.
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  • A Kelley
Kelley A. Bill Gates sees RNA vaccines as best options for quick coronavirus treatment. The Hill, 1.5.2020 → thehill.com. Letzter Aufruf: 29.4.2020.
The first modern pandemic: the scientific advances we need to stop COVID-19. Gates Notes
  • B Gates
Gates B. The first modern pandemic: the scientific advances we need to stop COVID-19. Gates Notes, 23.4.2020 → gatesnotes.com. Letzter Aufruf: 30.4.2020.
Inovio begins first human test of experimental coronavirus vaccine
  • N Pagliarulo
Pagliarulo N. Inovio begins first human test of experimental coronavirus vaccine. Biopharma Dive, 7.4.2020 → biopharmadive. com. Letzter Aufruf: 29.4.2020.
DNA vaccines: safety aspect assessment and regulation
  • T Medjitna
  • C Stadler
  • L Bruckner
  • C Griot
  • H Ottinger
Medjitna T, Stadler C, Bruckner L, Griot C und Ottinger H. DNA vaccines: safety aspect assessment and regulation. Developments of Biologicals. 2006;126:261-70 → ncbi.nlm.nih.gov. Letzter Aufruf: 29.4.2020.
Erste klinische Studie in Deutschland zugelassen
  • Karberg S Und
  • R Vogt
Karberg S und Vogt R. Erste klinische Studie in Deutschland zugelassen. Der Tagesspiegel, 22.4.2020 → tagesspiegel.de. Letzter Aufruf: 29.4.2020.
First US clinical human trial of potential coronavirus vaccine set to start Monday
  • D Etherington
Etherington D. First US clinical human trial of potential coronavirus vaccine set to start Monday. TechCrunch, 16.3.2020 → techcrunch.com. Letzter Aufruf: 29.4.2020.
UK COVID-19 vaccine to begin human testing
  • S Mckee
McKee S. UK COVID-19 vaccine to begin human testing. Pharma Times, 22.4.2020 → pharmatimes.com. Letzter Aufruf: 29.4.2020.
Three decades of messenger RNA vaccine development
  • R Verbece
  • I Lentacker
  • De Schmedt
  • S Und Dewitte
Verbece R, Lentacker I, De Schmedt S und Dewitte H. Three decades of messenger RNA vaccine development. NanoToday. 2019;28(100766) → sciencedirect.com. Letzter Aufruf: 30.4.2020.
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  • Bill Gates
  • Originalzitat Englisches
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  • B Gillmann
  • Sars-Impfstoffe
Gillmann B. SARS-Impfstoffe: Virologe Drosten: «Wir müssen Regularien für Impfstoffe ausser Kraft setzen». Handelsblatt, 19.3.2020 → handelsblatt.com. Letzter Aufruf: 29.4.2020.
Doubts over Oxford vaccine as it fails to stop coronavirus in animal trials. The Telegraph
  • P Newey S Und Nuki
Newey S und Nuki P. Doubts over Oxford vaccine as it fails to stop coronavirus in animal trials. The Telegraph, 18.5.2020 → telegraph. co.uk. Letzter Aufruf: 8.6.2020.