They're trialing self-amplifying RNA-LNP-based products for H5N1 in humans

GMO products need GMO licensing - a cautionary tale

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

1. 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

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

3. 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?

It’s just a coincidence that this messaging is concurrent to the incumbent ‘readiness’ of new experimental prodrugs though, right?

The Phase 1 trial: NCT06602531 - Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults

Phase I trials follow animal studies. Question: Were these animal studies done and is this data available?

Here’s a synopsis of the trial:

Phase 1, first-in-human, randomized, controlled, observer blind, dose level and schedule-finding study, to evaluate the safety, reactogenicity, and immunogenicity of a self-amplifying mRNA pandemic influenza (H5N1) vaccine (ARCT-2304) when administered as a 2-dose vaccination series to healthy adults in comparison with an inactivated influenza vaccine.

Study drug (ARCT-2304 or control) will be administered as a 2-dose vaccination series as an intramuscular (IM) injection. The study comprises two parts.

In Part 1, 120 participants (young adults) will be randomized to one of the three dose levels of the ARCT-2304 vaccine or control vaccine. Participants will be further randomized to one of the two different vaccination schedules.

In Part 2, 80 participants (older adults) will be randomized to one of the three dose levels of the ARCT-2304 vaccine or control vaccine. Participants will be further randomized to one of the two different vaccination schedules.

So they’ve enrolled 200 people 18-80 years of age, who are allegedly healthy (although we have no data on how many COVID shots they got or if they are currently carrying a replicating Alphavirus) to get 2 doses of this self-amplifying-LNP-wrapped product), to determine primary outcome endpoints such as solicited and spontaneous local and systemic adverse events and antibody levels. There is a cut-off of 60 days pertaining to last COVID shot and and 90 days for last flu shot. This seems kind of pointless in the case of the latter since it’s been shown in the literature that there are long-term adverse effects from the COVID-19 modified mRNA-LNP shots including continued spike production.

As part of the anemic inclusion criteria list, they give a warning to the ‘childbearers’ among the participants to wear a condom during the trial. Isn’t that bizarre? Why wouldn’t this be listed as part of the exclusion criteria?

As part of the exclusion criteria list, they include people who had “significant adverse reactions” (such as anaphylaxis) in the context of the modified mRNA-LNP COVID-19 products.

Question: How would a determination of a significant adverse reaction in the context of the COVID modified mRNA-LNP products be made accurately since ‘the COVID shots don’t cause AEs’?

Just as a reminder, Phase I trials don’t ever need to proceed to Phase II if there is a demonstrated inability to overcome the primary outcome endpoints. This means that if too many people succumb to, let’s say, unsolicited systemic significant adverse reactions, then the trial should end. What do you think the chances that the former and/or the latter will ensue?

I’ll tell you one thing, if the data is not made entirely transparent as it comes in, then no conclusions could ever be made about the outcome of this Phase I trial.

I think trialing (and releasing in the case of the Japanese!) self-amplifying gene-based technology is appalling in so many ways. If you have not seen my presentation/slide deck on the potential dangers of self-amplifying tech please watch here. Thank you to the National Citizen’s Inquiry.

Besides the inherent dangers of this new technology with regard to potential recombination events, GMO-ness and forever copying, I personally don’t understand why the risk of developing this technology for use in mammals would ever be taken, especially in the context of a bloody coronavirus or a flu virus.

Regarding the GMO-ness of these products; it’s not up for debate: these products are GMOs and they will require GMO licensing if and when they get operation bioweapon-war-mongered-star-trekked through. It’s written right here on the Australian Government Department of Health and Aged Care Office of the Gene Technology Regulator website, and you can download the FOI 051 document here that addresses “The determination of self-amplifying mRNA (sa-mRNA) as a GMO” here. Here’s a page from the document that demonstrates this.

I am curious if the manufacturers have sought out or will seek the appropriate licenses and even if they do, will the people be told the truth about the GMO-ness and forever-copying-ness of these products? Will the remaining and unresolved compendial standard issues pertaining the potency and process-related impurities be addressed? Will the LNP toxicity issues be investigated properly and resolved?

That’s it for now.

1. https://www.businesswire.com/news/home/20241111138781/en/Arcturus-Therapeutics-Receives-Clearance-from-FDA-to-Begin-H5N1-Pandemic-Flu-Vaccine-Clinical-Trial