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They're trialing self-amplifying RNA-LNP-based products for H5N1 in humans
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https://jessicar.substack.com/p/theyre-trialing-self-amplifying-rna
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On November 11, 2024, an article was published online in businesswire 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).”1

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).


Use of GMOs require specific licensing application and procedures.

The author of the businesswire article writes:

Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has issued a “Study Can Proceed” notification for the Company’s Investigational New Drug (IND) application, ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus. The clinical study is funded by Biomedical Advanced Research and Development Authority (BARDA) and designed to enroll approximately 200 healthy adults in the United States.

It’s so telling to me how these pharma companies are always so interested in the ‘Nasdaq’ and allegedly not so much in potential harms of their products. You’d think the ‘value’ would reflect in the Nasdaq but apparently, it doesn’t. At least, not as it should if transparency was key. This probably has something to with hiding harms associated with commercial products that are sub-compendial standard.

MAJOR RED FLAGS

self-amplifying RNA-LNP technology is NOT the same as modified mRNA-LNP technology - it uses an Alphavirus genomic backbone making it a genetically-modified organism with the ability to self-copy it’s genetic material once inside a cell

H5N1 is a flu virus - no one needs to be vaccinated against flu viruses

BARDA?

To me, based on evidences collected over the past four years from peer-reviewed literature and FOIA requested data, it is more likely than not that this is the priming of/grooming of the public for the next “planned pandemic” (or “Plandemic” as some like to call it). I mean, it’s in the clinical trial name, isn’t it?

As Odessa Orlewicz recently pointed out, up in Canada Bonnie Henry has started propagating messages pertaining to the next round of pandemicemia based on H5N1 bird flu. Interesting how she’s so interested in the biosafety 4 lab in Winnipeg. By the way Bonnie, we owe whole genome sequencing ability that you seem to hold in such high regard partially to the work of our very own Kevin McKernan. Bonnie, perhaps you should start actually listening to what Kevin has been saying based on his recent findings and expertise pertaining to these new RNA-LNP based prodrugs?
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