On November 11, 2024, a clinical trial for a self-amplifying RNA influenza vaccine named ARCT-2304 was announced. The trial, titled "Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults," aims to test the vaccine's safety and immune response in healthy adults. There are significant concerns about why the product is called a vaccine and why it is being trialed despite existing issues with similar products.
ARCT-2304 is described as a genetically modified organism (GMO) and is based on an Alphavirus, which allows the RNA to replicate once inside a cell. The trial is authorized by the U. S. Food and Drug Administration (FDA) and is funded by the Biomedical Advanced Research and Development Authority (BARDA), intending to involve about 200 healthy adults in the U. S.
There are major concerns about the implications of using self-amplifying RNA technology, as it differs from modified RNA technology. It's noted that H5N1 is a flu virus, and some argue there is no need for a vaccine against seasonal flu viruses. Observations have been made about the timing of the trial alongside messages about future pandemics in Canada, with hopes of preparing the public for what is referred to as a "planned pandemic. "
The clinical trial consists of two parts, where 120 young adults and 80 older adults will receive two doses of the vaccine or a control vaccine. The primary outcomes will evaluate side effects and antibody levels. Inclusion and exclusion criteria for participants raise questions, particularly concerning those with prior reactions to COVID-19 vaccines.
The article criticizes the potential for the trial not to be transparent and raises alarm about the dangers of self-amplifying technology, the implications of using GMOs, and unresolved safety issues. There is uncertainty surrounding whether the manufacturers will seek the appropriate GMO licenses and if they will provide complete transparency about the risks and implications of their product.
Ultimately, there are deep concerns about the development and testing of self-amplifying RNA-based vaccines, paired with skepticism about the motives of pharmaceutical companies and regulatory bodies. The situation calls attention to the need for clarity and honesty regarding the safety and potential effects of these new technologies on public health.
https://brownstone.org/articles/theyre-trialing-self-amplifying-rna-lnp-based-products/
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