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Intradermal, Naked Self-Replicating mRNA Vaccine Fails

Systemic Side Effects Not Controllable, Antibodies to Spike Protein Unimpressive

Peter A. McCullough, MD, MPH

By Peter A. McCullough, MD, MPH

With global use of Pfizer and Moderna mRNA vaccines, other companies have high aspirations for more products and record sales. The EXG-5003 vaccine was developed by Elixirgen Therapeutics, Inc. (Baltimore, MD, USA) as a strategy to inject a small quantity of naked mRNA in the skin with the hope that at lower skin temperature the mRNA would replicate and produce Spike protein but if absorbed into muscle or the bloodstream, the higher temperature would deactivate the product.

Given the horrific safety outcomes with the first generation and booster Pfizer and Moderna mRNA vaccines, the Elixirgen vaccine sounds too good to be true.  Koseki et alessentially showed that the company’s concept failed.

Koseki T, Teramachi M, Koga M, Ko MSH, Amano T, Yu H, Amano M, Leyder E, Badiola M, Ray P, Kim J, Ko AC, Achour A, Weng NP, Imai T, Yoshida H, Taniuchi S, Shintani A, Fujigaki H, Kondo M, Doi Y. A Phase I/II Clinical Trial of Intradermal, Controllable Self-Replicating Ribonucleic Acid Vaccine EXG-5003 against SARS-CoV-2. Vaccines (Basel). 2023 Nov 27;11(12):1767. doi: 10.3390/vaccines11121767. PMID: 38140172; PMCID: PMC10747308.

In this small trial there were considerable systemic effects, suggesting the mRNA, Spike protein, and inflammatory factors or some combination thereof enters systemic circulation. To make matters worse, the antibody responses against receptor binding domain of the Spike protein were unimpressive. The trial broke down when subjects went ahead and took the commercial products while still being in the study.

The company’s website does not mention the trial or the potential for their product in COVID-19 vaccination. No press release was issued on this study result. This represents a tacit admission of failure kept silent in a time of hubris and wild spending on vaccine gene transfer technology. 

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Peter A. McCullough, MD, MPH

President, McCullough Foundation

www.mcculloughfnd.org

Koseki T, Teramachi M, Koga M, Ko MSH, Amano T, Yu H, Amano M, Leyder E, Badiola M, Ray P, Kim J, Ko AC, Achour A, Weng NP, Imai T, Yoshida H, Taniuchi S, Shintani A, Fujigaki H, Kondo M, Doi Y. A Phase I/II Clinical Trial of Intradermal, Controllable Self-Replicating Ribonucleic Acid Vaccine EXG-5003 against SARS-CoV-2. Vaccines (Basel). 2023 Nov 27;11(12):1767. doi: 10.3390/vaccines11121767. PMID: 38140172; PMCID: PMC10747308.