Are COVID vaccines gene therapy?

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  • Big Pharma went to great lengths to make sure people don’t think of the shots as gene therapy because of the risk it would be to their bottom line (1).
  • The Associated Press published a “fact check” in which they argued that COVID shots are not gene therapy because they do not alter your genes
  • The AP misled readers by focusing on just one part of the FDA’s definition of a gene therapy — the part about modifying expression of a gene. But the full definition also includes the words “or to alter the biological properties of living cells,” which is precisely what the COVID shots do.  Moderna’s November 2018 Securities and Exchange Commission (SEC) registration statement5 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 …” (2) (3) (4) (5) (6)
  • When the mRNA shots were rolled out in 2021, they did not meet the U.S. Centers for Disease Control and Prevention’s definition of a vaccine. They only met the FDA’s definition of a gene therapy. (9) (10)
  • The only reason COVID shots meet the CDC’s definition of a vaccine now is because they changed the definition to prevent “COVID-19 deniers” from saying that “COVID-19 vaccines are not vaccines per CDC’s own definition”. (11)
  • The FDA’s guidance for the human gene therapy products industry, published in January 2020, also classified mRNA injections as gene therapy. Importantly, in this document the FDA stressed that gene therapy products that carry microRNA or cytokines can have “unknown pleotropic effects, including altered expression of host (human) genes that could result in unpredictable and undesirable outcomes.” (12)

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(1), (5), (8) Moderna’s SEC Form S-1 Registration Statement:

(2) AP December 23, 2022:

(3), (4) FDA Gene Therapy Definition:

(6) US SEC BioNTech 2019:

(7) SWF Institute January 25, 2021:

(9), (11) Pulse Stubstack November 9, 2021:

(10) CDC Immunizations: The Basics, Definition of Terms:

(12) FDA Guidance for Industry January 2020:

(13), (14) SSRN September 12, 2022:

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