On November 11, 2024, an article was published online in Business Wire pertaining to the launch of a clinical trial NCT06602531 intended to test “Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults.”
Question: Why is the word “Pandemic” in the title?
The article provides information on the ARCT-2304 product which is a “sa-mRNA vaccine candidate formulated within a lipid nanoparticle (LNP).”
So. Many. Questions. For example, beyond the use of the word pandemic in the study title, why is this product being called a vaccine? Why is a new version of a product riddled with unresolved compendial standard issues being trialed?
ARCT-2304 is a gene-therapy-based prodrug that uses self-amplifying RNA technology (specifically, the RNA-dependent RNA polymerase (RdRP) gene, which allows it to replicate autonomously) that originates from an Alphavirus. Just so you know, this makes these products genetically-modified organisms (GMOs) and this is because of the fact that the coding template is a modified Alphavirus genome with the virus sub-genomic bits spiked out and the foreign flu genes ‘spiked in.’ The genetic material is capable of reproduction. The following slide shows how they did this for the Covid-19 version (KOSTAIVE® (ARCT-154) Monovalent: JN.1).
Hellbound and Down 