At the end of December 2022, the Associated Press (AP) published a "fact check" titled "No, COVID-19 vaccines aren't gene therapy." In this piece, they argued the following:
"The COVID-19 vaccines do not change a person's genes, as gene therapy does...The shots from Pfizer and Moderna use messenger RNA, or mRNA, to instruct the body to create a protein from the coronavirus. The Johnson & Johnson vaccine, meanwhile, uses a modified adenovirus to trigger an immune response...
In recent day, social media posts have shared a claim that the vaccines are 'gene therapy'--which involves modifying a person's genes to treat or cure a disease, according to the U.S. Food and Drug Administration."
The FDA defined gene therapy in July 2018 and has not changed it since. Per the FDA website at the time of this writing:
"Human gene therapy seeks to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use. Gene therapy is a technique that modifies a person's genes to treat or cure disease..."
Did you catch what AP did? They only used ONE part of the FDA's definition of a gene therapy--the part about modifying expression of a gene. The full definition also includes the words "or to alter the biological properties of living cells," which is precisely what the mRNA COVID shots do.
The mRNA in the COVID jab are molecules that contain genetic instructions for making various proteins. mRNA COVID shots deliver synthetic mRNA with a genetic code that instructs your cells to produce a modified form of the SARS-CoV-2 spike protein. In other words, they "alter the biological properties of living cells for therapeutic use." Whether they modify your DNA is irrelevant. The FDA definition has an OR clause, which means it can be one or the other.
By the way, even the manufacturers confirmed that the mRNA jabs are gene therapies. Moderna's November 2018 Securities and Exchange Commission (SEC) registration statement also confirms that its mRNA injections are defined as gene therapy, clearly stating that "mRNA is considered a gene therapy product by the FDA."
The September 2019 SEC filing for BioNTech (its mRNA technology is used in the Pfizer vaccine) is equally clear, stating on page 21:
"...in the United States, and in the European Union, mRNA therapies have been classified as gene therapy medicinal products..."
Let's review. In the U.S. and the European Union, mRNA therapies, as a group, are classified as "gene therapy medicinal products." The AP is either lying to protect the industry or has gotten so inept they don't know how to do investigative journalism.
Another example of tomfoolery is the change in the definition of a vaccine. When the mRNA shots were rolled out in early 2021, they didn't meet the U.S. Centers for Disease Control and Prevention's definition of a vaccine. They only met the FDA's definition of gene therapy. The only reason they meet the definition of a vaccine now is that the CDC changed the definition of a vaccine.
Up until October 2021, the CDC defined a vaccine as a "product that stimulates a person's immune system to produce immunity to a specific disease, protecting the person from that disease." If you are immune to a disease, you can be exposed to it without becoming infected.
The new definition of "vaccine" is the following: "A preparation that is used to stimulate the body's immune system response against diseases." So a "vaccine" went from producing protective immunity to simply stimulating an immune response. The keywords "to produce immunity" were eliminated from the equation. The COVID shots fit the new definition, as they do not make you immune against COVID-19 and weren't designed to prevent infection in the first place.
Who fact-checks the "fact-checkers?" When it comes to your health and well-being, you have to get the facts yourself.
Up until October 2021, the CDC defined a vaccine as a "product that stimulates a person's immune system to produce immunity to a specific disease, protecting the person from that disease." If you are immune to a disease, you can be exposed to it without becoming infected.
The new definition of "vaccine" is the following: "A preparation that is used to stimulate the body's immune system response against diseases." So a "vaccine" went from producing protective immunity to simply stimulating an immune response. The keywords "to produce immunity" were eliminated from the equation. The COVID shots fit the new definition, as they do not make you immune against COVID-19 and weren't designed to prevent infection in the first place.
Who fact-checks the "fact-checkers?" When it comes to your health and well-being, you have to get the facts yourself.
So, the media made sure people understand that this vaccine does not modify nucleic DNA, therefore has no long-term effect of gene expression. People tend to associate gene therapy with long-term gene expression so, this is why they tailored the FDA definition to their needs.
Is it ethical what AFP did ? No. We could argue they misinformed people. Is it excusable in the name of a greater good ? Hmm.. if yes then we'd need a new definition for free press.
On a separate note, I still think this vaccine is an experiment done at scale.
I wonder about:
- is the delivery system (lipid nanoparticles) completely broken down in the body ?
- is all the mRNA used up in the cell to make spike protein or is other left floating around.
- is there absolutely 0 risk of having nucleic DNA express genes that produce the spike protein ?
- how toxic is the spike protein itself ?