COVID-19 mRNA shots: vaccines or gene therapy? — Part 1
'Ultimately, mRNA vaccines are an example of cell and gene therapy' — president of Bayer's pharmaceutical section
mRNA injections — gene therapy or vaccines?
Concerns abound about the presence of DNA plasmids, a residue from the unauthorized manufacturing changes made by pharma post-emergency use authorization. Some scientists are alarmed, stating that the plasmids have the potential to change the human genome.
However, it's essential to revisit a critical point: mRNA therapy has long been classified as gene therapy, way before the discovery of the DNA plasmids. This classification existed prior to COVID-19, but the desire to push the mass adoption of COVID-19 injections led regulatory agencies to “overlook” this inconvenient fact.
This first part of our coverage will explore the controversy surrounding the classification of mRNA shots (whether as gene therapy or vaccines). The second part will examine the positions adopted by regulatory agencies and other entities, as well as the actions that individual states are taking regarding mRNA injections.
Gene therapy — maybe, maybe not
In September 2014, an article published in the journal Nature titled, “mRNA-based therapeutics — developing a new class of drugs” noted that mRNA therapies need to be reviewed by regulatory agencies and that it could be potentially classified as gene therapy:
. . . 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 view in vitro transcribed (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.
However, Ugur Sahin, the lead author, and his team ultimately dismissed the expectation that mRNA “vaccines” will be categorized as gene therapy (see box 3). First, Sahin and co-authors did not expect that the mRNa shots would fall under the classification of gene therapy under FDA guidelines.
The FDA definition of gene therapy is as follows: “... modification of the genetic material of living cells. . . . 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.
The authors stated, though, that the shots would fall under the European Medicines Agency (EMA) guidelines for “regulation for advanced therapy medicinal products (Directive 2009/120/EC), which covers gene therapies, engineered somatic cells and tissue engineered products.”
They also noted that, according to the EMA, “[g]ene therapy medicinal products shall not include vaccines against infectious diseases.”
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[l] this definition. (Emphasis added.)
Sahin and co-authors also believed that the mRNA shots would not integrate into the genome:
[I]n 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.
As a result of this supposition, they stated that they could not be genotoxic or carcinogenic and that they did not need to be studied for long-term adverse effects in patients in clinical trials.
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. (Emphasis added.)
Their section titled “Safety Conclusions” states that mRNA shots for immunotherapy have no platform-inherent risks.
Clinical experience with IVT mRNA for immunotherapy has demonstrated an excellent tolerability and safety profile and showed that mRNA drugs have no platform-inherent major risks.
This distinction between vaccine and gene therapy was crucial as it shaped the regulatory approach to mRNA-based therapeutics.
Yes, it’s gene therapy — according to Moderna
Moderna contradicted this by asserting that mRNA shots would be considered gene therapy by the FDA. In June 2020, as the likelihood of an mRNA “vaccine” became more certain, Moderna told shareholders, in its quarterly report, that the FDA would classify mRNA injections as gene therapy, while distinguishing them from gene therapies that irreversibly alter cellular DNA.
Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA-based medicines are designed to not irreversibly change cell DNA; however, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite the differences in mechanism.
At the time, the company was uncertain about the regulatory approval process, as no product with mRNA as its primary ingredient had been approved before. They even speculated that they may be required to complete safety testing such as is required for gene therapy products.
In addition, because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain. The number and design of the clinical trials and preclinical studies required for the approval of these types of medicines have not been established, may be different from those required for gene therapy products, or may require safety testing like gene therapy products.
Not a vaccine — explains Dr. Mercola
In March 2021, Global Research reprinted Dr. Joseph Mercola’s article stating that properly categorizing mRNA shots as a gene therapy was important because a gene therapy cannot be mandated.
As I’ll explain below, there’s simply no way around this, and drug manufacturers and public health officials must be made to admit this fact. Why? Because it makes all the difference in the world. You cannot mandate a gene therapy against COVID-19 any more than you can force entire populations to undergo gene therapy for a cancer they do not have and may never be at risk for.
Mercola further showed that mRNA injections don’t fulfill the criteria for vaccines.
. . . According to the U.S. Centers for Disease Control and Prevention, a vaccine is:
“A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease.”
Immunity, in turn, is defined as:
“Protection from an infectious disease,” meaning that “If you are immune to a disease, you can be exposed to it without becoming infected.”
That’s the medical definition. The legal definition, in the few cases where it has been detailed, is equally unequivocal:
Iowa code2 — “Vaccine means a specially prepared antigen administered to a person for the purpose of providing immunity.”
Washington state code3,4 — “Vaccine means a preparation of a killed or attenuated living microorganism, or fraction thereof …” The statute also specifies that a vaccine “upon immunization stimulates immunity that protects us against disease …”
These definitions, both medical and legal, present problems for mRNA “vaccines,” since:
mRNA injections do not impart immunity. Moderna and Pfizer both admit that their clinical trials aren’t even looking at immunity. As such they do not fulfill the medical and/or legal definition of a vaccine.
They do not inhibit transmissibility of SARS-CoV-2 infection. As such they do not fulfill the medical and/or legal definition of a vaccine.
Yes, it’s gene therapy — according to Bayer
Bayer agrees with Dr. Mercola that mRNA technology is gene therapy. On October 24, 2021, at the opening ceremony of the World Health Summit, Stefan Oelrich, a member of the board of management at Bayer and president of its pharmaceutical section, spoke (video below) about the investment opportunity available to “rich countries” that fund innovative research and development (R&D). Oeilrich claims this will create “job security and prosperity” for them.
*Innovation—and we tend to forget this, especially in rich countries—is also sustainability at a totally different level. Those who take the leap to drive innovation in a meaningful way, invest, and take the risk to fund R&D will also achieve sustainability by creating job security and prosperity for those who make those investments.
One of the innovations that Bayer is investing in is cell and gene therapy.
. . . For us, therefore, we are really taking that leap. As a company, Bayer is invested in cell and gene therapy, which, to me, is one of the areas where we are truly going to make a difference moving forward.
He points out that mRNA vaccines are an example of cell and gene therapy and that before COVID-19, people were not open to gene therapy. The public may now be open to innovation, but is the public open to gene therapy? The mRNA injections were not marketed as gene therapy but as vaccines.
Ultimately, mRNA vaccines are an example of cell and gene therapy. I always say, if we had surveyed the public two years ago and asked, "Would you be willing to take a gene or cell therapy injection?" we would probably have had a 95% refusal rate. I think this pandemic has opened many people's eyes to innovation in ways that may not have been possible before. (Emphasis added.)
Stable?
Sahin and co-authors go on to state that mRNA is unstable, but that hurdle was subsequently overcome by substituting uridine for pseudouridine in the spike protein component so that it does not break down as natural mRNA would.
Can alter DNA — Swedish scientists
Researchers in Sweden discovered that the mRNA can be reverse-transcribed into DNA, with genetic implications. Markus Aldén and co-authors, in their paper “Intracellular Reverse Transcription of Pfizer BioNTech COVID-19 mRNA Vaccine BNT162b2 In Vitro in Human Liver Cell Line,” pointed out that the Pfizer trials showed reversible effects on the liver. Pfizer and BioNTech’s trials showed that animals that received the BNT162b2 injection (COVID-19 vaccine) had reversible changes to their livers.
Their in vitro study published in the journal Molecular Biology, went further and demonstrated that human liver cells exposed to “SARS-CoV-2 RNA can be reverse-transcribed and integrated into the genome of human cells” as fast as six hours after exposure.
Route 66 Post discussed the paper and included the following video by Dr. Peter McCullough on the implications of this finding.
Contains DNA plasmids after all
Additionally, several studies have found that the change in vaccine manufacture post-emergency use authorization has resulted in DNA fragments making their way into the cells along with the mRNA.
Plausible deniability?
Part 2 will explore how regulatory agencies and other entities have denied that mRNA injections are gene therapy—and how individual states are pushing back against their continued use.
Related articles:
Foreign DNA in COVID vaccines: The FDA's troubling silence on safety concerns