Last update and review: September 7, 2021.
A short summary.
There is a regulatory framework and national laws that impose strict safety requirements on gene therapies. The same strict requirements should apply to viral vector, DNA- and mRNA vaccines.
DNA from viral vector vaccines ALWAYS gets into the nucleus of the infected cell and modifies the host cell’s genome. mRNA from mRNA vaccines would also be able to get into the nucleus of the infected cell. Both vector vaccine particles and mRNA vaccines particles were detected in testes and ovaries of vaccinated laboratory animals.
Bureaucrats and “health professionals” have not followed the existing regulatory framework and laws. Instead, they force the uninformed population to submit to injections that can potentially modify the genome of future generations of humans.
All those bureaucrats, elected officials, and “health professionals” around the world who are participating in this disastrous mass-vaccination should be criminally investigated.
In 2014, Biontech founders, German researchers Ugur Sahin and Özlem Tureci, published an article on mRNA-based technologies (1). Biontech was acquired by Pfizer in 2020. Sahin and Tureci contributed significantly into the development of what became the Pfizer mRNA vaccine.
Photo: Biontech founders Ugur Sahin and Özlem Tureci.
The 2014 article by Sahin, Tureci, and another Biontech employee Katalin Karikó (1), is reasonably informative but contains several errors. Most importantly, Sahin, Tureci, and Kariko make an error when they state: “mRNA-based therapeutics, unlike plasmid DNA and viral vectors, do not integrate into the genome and therefore do not pose the risk of insertional mutagenesis”. There is a body of research that convincingly argues that nonretroviral mRNA can be integrated into the host genome. This would also be the case of the SARS-CoV-2 mRNA. Retroviruses and DNA viruses ALWAYS integrate the host cell genome.
“Replication of the majority of RNA viruses takes place solely in the cytoplasm, with the exception of retroviruses, which, using reverse transcription, create a DNA provirus in the nucleus of the host cell, that is ultimately incorporated into the genome of the host.”
Smith, 2010 (2):
“Adenovirus (AdV) is a relatively large nonenveloped dsDNA virus.
…The final destination of the virus genome is the nucleus.”
“We still have an incomplete understanding of adenovirus’s structure as well as of its multifactorial interactions with the host.”
Also, Smith, 2010 (2):
“We still have an incomplete understanding of AdV’s structure as well as its multifactorial interactions with the host.”
Regulatory framework for mRNA-based therapeutics and for other “gene therapies”.
Sahin, Koriko, Tureci, 2014 (1):
“Existing standard guidance for new molecular entities needs to be adapted to mRNA-based drugs. So far, no competent authority has officially stated its general position on how mRNA drugs will be classified, nor have any directions and guidelines been published. As the number of precedents is limited and the diversity of mRNA-based applications is broad, one cannot predict for each individual investigational mRNA drug how the United States, the European Union and European national competent authorities may viewin vitrotranscribed (IVT) mRNA from a regulatory perspective. One would expect the classification of an mRNA drug to be a biologic, a gene therapy or a somatic cell therapy. Most of the clinical trials using IVT mRNA have been initiated by European teams and have been performed in Europe. Thus, there are not many real-life examples of how mRNA-based therapeutics would be classified by the US Food and Drug Administration (FDA).”
The FDA definition of gene therapy is as follows: “… modification of the genetic material of living cells. Cells may be modified ex vivofor subsequent administration to humans, or may be altered in vivoby gene therapy given directly to the subject.
Sahin, Koriko, Tureci, 2014 (1):
“The FDA definition of gene therapy is as follows: “… modification of the genetic material of living cells. Cells may be modified ex vivofor subsequent administration to humans, or may be altered in vivoby gene therapy given directly to the subject. When the genetic manipulation is performed ex vivoon cells which are then administered to the patient, this is also a form of somatic cell therapy … Recombinant DNA materials used to transfer genetic material for such therapy are considered components of gene therapy.” As RNA does not result in “modification of the genetic material of living cells”, one would anticipate that its administration will not be classified as a gene therapy in the United States.”
In the European Union, “Gene therapy medicinal product means a biological medicinal product which has the following characteristics: (a) it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence; (b) its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence.”
Sahin, Koriko, Tureci, 2014 (1):
“In the European Union, mRNA-based therapies are most likely to fall under the European Medicines Agency (EMA)’s regulation for advanced therapy medicinal products (Directive 2009/120/EC), which covers gene therapies, engineered somatic cells and tissue engineered products. This regulation defines a gene therapy medicinal product as follows: “Gene therapy medicinal product means a biological medicinal product which has the following characteristics: “(a) it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence; (b) its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence.”
Rather arbitrarily, the EU bureaucrats granted an exception to gene therapy-like vaccines.
“Gene therapy medicinal products shall not include vaccines against infectious diseases.”
Sahin, Koriko, Tureci, 2014 (1), continue:
“In vivo administered mRNA drug products are presumably viewed as an added recombinant nucleic acid complying with the EU definition of a gene therapy product. An interesting exception is dendritic cells transfected ex vivowith IVT mRNA before administration to patients. The EMA’s Committee for Advanced Therapies (CAT) did not classify such a product as gene therapy because mRNA was considered to be degraded within the cells at the time of their adoptive transfer to the patient. The CAT classified this cell product as a somatic cell therapy product. Furthermore, mRNA drugs, which are used to vaccinate against infectious disease, are unlikely to be classified as gene therapy. According to Part IV of Annex I to Directive 2001/83/EC, gene therapy medicinal products do not include vaccines against infectious diseases. Moreover, the legal definition of gene therapy only relates to biological medicinal products. Consequently, products that have been manufactured by chemical means do not fulfil this definition. The guidelines established for gene therapies may provide a valuable roadmap for setting up the regulatory framework for RNA vaccines.”
“However, in contrast to DNA and viral vectors, mRNA does not contain promoter elements and does not integrate into the genome, and disruption of genes does not occur unless mRNAs encoding DNA-modifying enzymes are delivered. mRNA expression is dose-dependent and transient. Thus, there is no scientifically sound rationale to test for genome integration, germline transmission, genotoxicity or carcinogenicity of IMPs (investigational medicinal products), or carry out long-term observation of patients in clinical studies. Future guidance should take these features into consideration, as they clearly distinguish mRNA products from (other) gene therapies with respect to the anticipated risks.”
The regulatory framework and Common Sense require “to test for genome integration, germline transmission, genotoxicity or carcinogenicity of IMPs (investigational medicinal products), or carry out long-term observation of patients in clinical studies.”
Since, as already mentioned above, Pfizer-Biontech mRNA vaccine would also be able to integrate the host cell genome, the same strict safety requirements should apply to viral vector, DNA- and mRNA vaccines. However, nothing of what the regulatory framework, and, frankly, Common Sense require had been done before the vector vaccines based on DNA-viruses and mRNA vaccines were authorized and administered to hundreds of millions. Most of the required safety measures specific to gene therapies are NOT deployed anywhere in the world to this day. How come?
Universal Declaration on the Human Genome and Human Rights of November 11, 1997: “human genome is the heritage of humanity.”
Universal Declaration on the Human Genome and Human Rights from November 11, 1997 (3):
“Article 1:
The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity.”
“Treatment or diagnosis affecting an individual’s genome shall be undertaken only after rigorous and prior assessment of the potential risks and benefits pertaining thereto.”
“In all cases, the prior, free and informed consent of the person concerned shall be obtained.”
Universal Declaration on the Human Genome and Human Rights from November 11, 1997 (3):
“B. Rights of the persons concerned
Article 5
(a) Research, treatment or diagnosis affecting an individual’s genome shall be undertaken only after rigorous and prior assessment of the potential risks and benefits pertaining thereto and in accordance with any other requirement of national law.
(b) In all cases, the prior, free and informed consent of the person concerned shall be obtained.”
Universal Declaration on the Human Genome and Human Rights from November 11, 1997, was adopted by “UNESCO”, a “Globalist” organization. The Declaration has a lot of dubious content and promotes research. Only several passages are of interested and we cited some of them. But most of the countries have appropriate law put in place. Why the law is not followed anywhere? Why people have not been informed that their genome will be changed by vector vaccines and possibly by mRNA vaccines?
On day 56(!) after vaccination, low levels of Astra-Zeneca-Oxford vaccine were noted 1 of 3 samples of ovary and testes.
Katsura, 2019:
“5-8%(of human genome) is derived from viral sequences similar to infectious retroviruses. If integration of retrovirus occurs in germline, the integrated sequences are heritable.”
The above applies also to DNA-viruses and mRNA in vaccines. Thus, if integration of retrovirus, DNA virus used as vector in vaccines or mRNA from vaccines occurs in germline, the integrated sequences are heritable.
“Public Assessment Report – National procedure – Vaxzevria (previously COVID-19 Vaccine AstraZeneca, suspension for injection) COVID-19 Vaccine (ChAdOx1-S [recombinant])” for the UK’s Medicine and healthcare regulatory agency. “Last updated in July 2021” (4):
“On day 56(!), low levels (of Astra-Zeneca-Oxford vaccine) were noted in 1 sample of 6 for each of heart and liver, 1 of 3 for ovary and testes, and 3 of 6 lymph node samples at this timepoint”
“”Distribution (of Astra-Zeneca-Oxford vaccine) to some samples of all tissues was noted on day 2 and day 29.”
A lot” of injected mRNA ends in ovaries. 9% or 0.09%? Pfizer’s documents contain a lot of errors. But it appears to be 50% of mRNA that gets in spleen.”
The New Neander’s Medical on June 2, 2021:
“There is a document that is circulating on the networks that allegedly describes Pfizer COVID-19 vaccine’s pharamcokinetics. “A lot” of injected mRNA ends in ovaries. 9% or 0.09%? Pfizer’s documents contain a lot of errors. But it appears to be 50% of mRNA that gets in spleen.”
Conclusions.
Bureaucrats and “health professionals” have been ignoring the existing regulatory framework and laws. Instead, they force the uninformed population to submit to injections that can potentially modify the genome of future generations of humans.
All those bureaucrats, elected officials, and “health professionals” around the world who are participating in this disastrous mass-vaccination should be criminally investigated.
Selected references:
1. Ugur Sahin, Katalin Karikó, Özlem Türeci. mRNA-based therapeutics — developing a new class of drugs. . Nat Rev Drug Discov. 2014 Oct;13(10):759-80. doi: 10.1038/nrd4278. Epub 2014 Sep 19. PMID: 25233993.
2. Smith. Adenovirus. Curr Top Microbiol Immunol. 2010 ; 343: 195–224.
3. Universal Declaration on the Human Genome and Human Rights from November 11, 1997.
Available at:
http://unesdoc.unesco.org/images/0011/001102/110220e.pdf#page=47
Accessed on September 7, 2021.
4. “Public Assessment Report – National procedure – Vaxzevria (previously COVID-19 Vaccine AstraZeneca, suspension for injection) COVID-19 Vaccine (ChAdOx1-S [recombinant])” for the UK’s Medicine and healthcare regulatory agency. “Last updated in July 2021”.
Available at:
Accessed on September 7, 2021.
