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Key to understanding COVID vaccines
Gene therapy, if true, explains why the "vaccines" are poorly regulated
By now all those who have followed pandemic truths as revealed in this newsletter and other sources know how unsafe and ineffective the COVID vaccines are.
The key question is how exactly the government has allowed these vaccines to be used and, even worse, pushed the use of them on everyone.
Here I want to question if the government has gotten away with allowing the vaccines even though they cause a very broad array of harmful vaccine health impacts, including death, in both the short and long term, as well as the devastating long COVID illness with a wide range of health impacts that ruin quality of life.
In short, there is some basis for believing that the vaccines are not really vaccines at all. But they have been regulated and promoted as if they are vaccines. If so, this is a sham, a crime and a total insult to medical history and ethics. The government and entire public health establishment has lied to the public and nearly all of the medical establishment has gone along with this very big and harmful lie, as has the mainstram news media.
A recent article brings attention to the key scientific point, namely that these mRNA COVID vaccines are really gene therapy products.
Here are some excerpts from this article:
However, “technically, Moderna, for example, has identified their mRNA product as a form of gene therapy in past investor disclosures, the mRNA vaccines purportedly don’t modify DNA or any genes. Rather the messenger RNA (mRNA) provides instructions to human cells to produce the SARS-COV-2 spike protein but doesn’t replace or inactivate any genes in the body according to expert after expert, at least in the mainstream.”
Robert Malone has addressed whether “mRNA COVID-19 vaccines were a form of gene therapy.”
His response: ““As I’ve said repeatedly, it came out of a gene therapy research program. These and the adenoviral vectors are absolutely gene therapy technology applied for the purposes of electing an immune response.””
“In the AP piece Dr. Louis Picker, professor and associate director of the Vaccine and Gene Therapy Institute at Oregon Health & Science University, reports, “It’s just a very different process.” Dr. Picker went on, “The point of gene therapy is to go in and change the actual coding in the DNA of a person’s cells.”
Examples he points to are products that swipe out a bad for a good gene, such as the recently approved product for hemophilia B.”
“But what does Moderna, arguably the leading pure play mRNA biopharma producer have to say about its technology? Let’s start with their annual statement to investors in 2018.
In the statement the Cambridge, Massachusetts company first offering advantages of its mRNA technology over traditional gene therapy declaring:
“mRNA allows for transient production of the encoded protein. mRNA therapies should also allow for dose titration and repeat dosing. This provides several advantages over gene therapy. Gene therapies typically result in a permanent change to cellular DNA that may result in uncontrolled or constant production of the desired protein in local tissue or in distant sites, which could cause local or systemic side effects. Further, some gene therapy delivery vehicles are associated with immune responses that limit the ability to repeat dose, preventing dose titration.”
But the company continues with its bombshell disclosure:
“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. 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 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. Moreover, the length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one pharmaceutical product to the next and may be difficult to predict.”
The same disclosure occurs in the 2019 disclosure. The FDA continues to deem mRNA a form of gene therapy.
Interestingly, in this disclosure Moderna also reports that “On august 17, 2018, the NIH issued a notice in the Federal Register and issued a public statement proposing changes to the oversight framework for gene therapy trials, including changes to the applicable NIH Guidelines to modify the roles and responsibilities of the RAC with respect to human clinical trials of gene therapy products and requesting public comment on its proposed modifications.”
These changes were memorized indicating the NIH was concerned about overly rigid categories inhibiting research advancement.
What about the company’s 2020 disclosure? Absolutely no changes. Moderna continues to disclose to investors that “Currently, mRNA is considered a gene therapy product by the FDA.” Interestingly, a change occurs in the 2021 annual statement filed with the Securities and Exchange Commission.
The company reports: “Some of our investigational medicines are classified as gene therapies by the FDA and the EMA. The association of our medicines with gene therapies could result in increased regulatory burdens, impair the reputation of our investigational medicines or negatively impact our platform or our business.””
“Moderna discloses that in the European Union mRNA is absolutely “characterized as a gene therapy medicinal product, which falls within a broader category known as Advanced Therapy Medicinal Products (ATMPs), which are subject to additional regulatory requirements.”
Moderna clearly delineates risk to investors in the 2021 statement, declaring:
“Notwithstanding the differences between mRNA medicines and gene therapies, the classification of some of our mRNA investigational medicines as gene therapies in the United States, the EU and potentially other countries could adversely impact our ability to develop our investigational medicines, negatively impacting our platform and our business. For instance, a clinical hold on gene therapy products may apply to our mRNA investigational medicines irrespective of the differences between gene therapies and mRNA.””
Moderna is worried about an impact on its ability to make billions from COVID vaccines if the government decided to stop the farce about COVID vaccines and instead regulate them as gene therapy products.
“Based on what actual mRNA vaccine producers disclose to their investors via regulatory necessity we must conclude that while the regulatory landscape is indeed evolving (likely in part influenced by power politics and money), the world’s leading pure play mRNA vendor is on the record as of 2020, that the FDA clearly classified their mRNA products as a form of gene therapy. Interestingly enough, this morphed in 2021, when the company suggested a more dynamic regulatory change in America (but still raising risk) while Europe was clearly still considering the products as squarely under the gene therapy category.”
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