All gene therapy products pose a risk of shedding, according to the FDA.
The topic of COVID-19 vaccine shedding has long been controversial, but now, some doctors say it is real.
“Shedding is unfortunately real,” said Dr. Pierre Kory at the Front Line COVID-19 Critical Care Alliance (FLCCC) conference in Phoenix, Arizona, in early February. “The FDA (U.S. Food and Drug Administration) knows that.”
Dr. Kory is a co-founder of the FLCCC, a non-profit advocacy group founded by physicians for the treatment of COVID-19, long COVID, and postvaccine syndromes. He is also the co-founder of the Leading Edge Clinic and has treated over a thousand long-COVID and postvaccine patients.
Mainstream fact-checkers have largely denied shedding on the basis of definition. The commonly cited definition comes from the U.S. Centers for Disease Control and Prevention (CDC) website, which defines shedding as the release of viruses, bacteria, and their components from live vaccines.
While mRNA and adenovirus vaccines are not live vaccines, they function similarly to gene therapy products.
All gene therapy products pose a risk of shedding, according to the FDA.
FDA Documents
In a 2015 document titled Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products, the FDA defines shedding as “the release of [viral or bacterial gene therapy products] … from the patient through one or all of the following ways: excreta (feces); secreta (urine, saliva, nasopharyngeal fluids etc.); or through the skin (pustules, sores, wounds).”
In the same document, the FDA also explains what gene therapy products are: “All products that mediate their effects by transcription and/or translation of transferred genetic material.”
The COVID-19 mRNA and adenovirus vaccines fall into this category. They mediate their effects by inducing the body to translate mRNA genetic information into spike proteins.
Some gene therapy products known to shed include an eye treatment branded as Luxturna. Luxturna uses an adenovirus carrier to deliver eye protein DNA to retina cells in patients.
The Luxturna adenovirus and its DNA have been found in patients’ tears, according to the product’s package insert.
Similarly, mRNA and adenovirus COVID-19 vaccines may cause vaccinated patients to release spike proteins or other vaccine components, Dr. Kory explained.
By Marina Zhang
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