Are COVID-19 vaccines gene therapy, and what potential risks do they pose, according to the FDA?

Mainstream scientists continue to insist that so-called COVID-19 vaccines are not gene therapy. The figure below is from the FDA and clearly shows that COVID-19 vaccines are actually gene therapy.

Mainstream scientists continue to insist that so-called COVID-19 vaccines are not gene therapy. The figure below is from the FDA and clearly shows that COVID-19 vaccines are actually gene therapy.

COVID-19 vaccines are RNA sequences that are packed in lipid nanoparticles used as a non-viral delivery vehicle.

The FDA website, where this is posted, includes a link to another important article “Long Term Follow-Up After Administration of Human Gene Therapy Products Guidance for Industry”, published in January 2020. Here are a few noteworthy quotes from it.

Similarly, transgenes encoding immune recognition factors may introduce the risk for autoimmune-like reactions (to self-antigens) upon prolonged exposure. For GT products that carry transcriptional regulatory elements (e.g., microRNA) or immune-modulatory proteins (e.g., cytokines) there is also the risk of unknown pleotropic effects, including altered expression of host (human) genes that could result in unpredictable and undesirable outcomes.

💡immune recognition factors are the spike proteins in COVID-19 vaccines.

💡Pleiotropic effects of a drug are actions other than those for which the agent was specifically developed. These effects may be related or unrelated to the primary mechanism of action of the drug, and they are usually unanticipated.

In addition to product-related factors, the long term risk profile of a GT product should also take into consideration the target cell/tissues/organ, and the patient population (age, immune status, risk of mortality etc.), and the relevant disease characteristics.

As discussed in section III.A of this document, product persistence heightens the risk of delayed adverse events following exposure to the GT product. Indeed, the longer the GT product persists, the greater the duration and degree of risk of delayed adverse events.

References

https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/what-gene-therapy#footnote1

https://www.fda.gov/media/113768/download

Please also read this related article.

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