Japan to Roll Out New Self-Replicating samRNA COVID Shot That Produces Even More Toxic Spike Protein in the Body Than Regular mRNA Jabs
If spike protein in regular mRNA COVID jabs poses toxicity risk, then more spike protein produced in the body from self-copying samRNA shots could pose an even greater risk.
Meiji Seika Pharma announced plans on Tuesday to seek approval in Japan for its self-amplifying mRNA (samRNA) COVID-19 vaccine, Kostaive (ARCT-2301), with a goal of distributing it for the upcoming fall and winter seasons.
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Safety Concerns
Utilizing brand-new technology, Kostaive has no long-term safety data.
Safety data from Pfizer Inc. obtained through a Freedom of Information Act (FOIA) request and order of a Texas federal judge confirms COVID jabs using mRNA technology, like those rolled out during the COVID pandemic, are linked to more than 1,200 diseases.
mRNA jabs are associated with many problems that lead to negative health outcomes, including ingredients like pseudouridine being linked to cancer growth, frameshifting linked to immune system disorders, DNA contamination, and spike protein toxicity.
Toxicity
Regarding toxicity, a study published in January in Nature Reviews Drug Discovery confirms the toxicity risks associated with mRNA COVID jabs.
Moderna scientists stated in the study that “avoiding unacceptable toxicity with mRNA drugs and vaccines presents challenges” and that “[l]ipid nanoparticle structural components, production methods, route of administration and proteins produced from complexed mRNAs all present toxicity concerns.”
The new self-replicating technology causes the body to produce the COVID spike protein within cells, like regular mRNA jabs, but it also causes the body to produce an enzyme that makes copies of the original strand of vaccine RNA.
This leads to even more spike protein production in the body.
A study that was cited by the manufacturer indicates the new self-amplifying jab produces an even higher amount of spike protein in the body relative to the standard BNT162b2 (Pfizer-BioNTech) mRNA vaccine.
This was determined by measuring the geometric mean titers (GMT) of neutralizing antibodies.
Three months post-booster, the GMT in the samRNA group was significantly higher at 5,928 compared to 2,899 in the BNT162b2 group, with a GMT ratio of 2.04.
This pattern persisted and even increased at 6 months, with a GMT ratio of 2.21.
If spike protein in regular mRNA COVID jabs poses toxicity risk, then more spike protein produced in the body from these self-copying samRNA shots could pose an even greater risk.
Vaccine ‘Shedding’ Concerns
Moreover, it’s been shown that spike protein from regular mRNA COVID shots can “shed” onto and cause symptoms in others.
If the self-replicating samRNA jabs produce even more spike protein in the body, concerns are raised as to whether the new technology could cause even more shedding from the vaccinated onto the unvaccinated.
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Rollout Details
The self-replicating vaccine, developed using Arcturus Therapeutics’ technology, underwent a Phase 3 trial, where it demonstrated “non-inferiority in immunogenicity compared to Pfizer and BioNTech’s previously approved bivalent mRNA vaccine Comirnaty,” according to a report from Endpoints News.
Kostaive is a bivalent vaccine “based on the original strain and Omicron BA.4-5.”
Side effects and efficacy were analyzed based on the incidence of COVID infection, the report indicating the incidence of specific adverse events with ARCT-2301 was “comparable to Comirnaty,” Pfizer’s COVID jab.
Meiji Seika believes the self-amplifying mRNA vaccine platform they’ve developed will still work effectively even if the COVID virus mutates in significant ways, including changes that make the virus more dangerous or able to spread more easily.
“It has been confirmed that high immunogenicity and safety can be reproduced even if the manufacturing strain serving as the basis for the vaccine is changed due to the emergence of a new SARS-CoV-2 variant. We believe this establishes the Kostaive platform,” said Daikichiro Kobayashi, the CEO Meiji Seika’s pharmaceutical division. “We expect this platform to be applicable even in cases where the prevalent strain undergoes a major mutation or its pathogenicity changes significantly.”
In other words, the technology behind their sa-mRNA vaccine is reportedly flexible enough to be adjusted to respond to new strains of the virus, even if those strains are substantially different from earlier versions.
This raises a level of uncertainty about how these major mutations might affect the vaccine’s performance in real-world conditions.
Looking ahead, Meiji Seika plans to align its manufacturing strain with direction from the World Health Organization (WHO), Japan’s Ministry of Health, Labor and Welfare, and the National Institute of Infectious Diseases.
The company is preparing to submit an application for a partial change in Kostaive’s approval, targeting the 2024 fall/winter season.
Kobayashi also shared the company’s projections for vaccine distribution: “From fall 2024 onward, we will supply a vaccine based on the new prevalent strain. Approximately 28 million people in Japan received vaccinations in fall 2023, so we anticipate around 30 million people to be vaccinated annually going forward.”
Meiji Seika expects to manufacture and supply 4 million doses of Kostaive for the upcoming season.
The vaccine is slated to be stored frozen before being switched to refrigeration at vaccination sites or hospitals.
Back in December of last year, this website reported:
Biotech Company Developing Next-Generation Self-Copying 'sa-mRNA' COVID-19 Vaccine Funded by Biden Admin, Bill Gates
Gritstone Bio Inc. awarded $433-million U.S. contract to make new, "self-amplifying" vaccine despite significant unintended immune response triggered by mRNA COVID jab.
Last month, Japan’s Ministry of Health, Labor and Welfare (MHLW) granted approval for ARCT-154, a “self-amplifying mRNA” (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older.
Using “next generation mRNA technology,” these self-amplifying vaccines not only instruct the body’s cells to make the coronavirus spike protein—like the original mRNA COVID vaccines do—but they also instruct cells to make an enzyme that makes “copies of the original strand of RNA.”
This process leads to the production of even more spike protein within the body than first-generation mRNA COVID jabs produce.
Purported “benefits” of samRNA include extended duration (time) and magnitude (amount) of spike protein creation, a “strong” immune response, and requiring a smaller dose than original mRNA jabs.
But Japan is not the only country developing this technology.
On Thursday, the White House reiterated its agreements with CastleVax, Codagenix, and Gritstone Bio to develop three new COVID vaccines, as part of its ‘Project NextGen’ endeavor.
Gritstone Bio has been developing its own samRNA vaccine platform for some time now, the company being granted two new U.S. patents for the technology in December 2022.
The Biden administration then awarded the vaccine manufacturer a $433-million contract in September of this year “to conduct a mid-stage study of its self-amplifying mRNA COVID-19 vaccine candidate.”
The U.S. government’s sponsorship of samRNA COVID vaccines comes as researchers from the University of Cambridge recently discovered a significant unintended immune response triggered by the original mRNA COVID-19 vaccines in approximately one-third (25-30%) of recipients.
This negative response is attributed to a “glitch” in how the body interprets mRNA vaccines’ genetic instructions.
In a study published this month in Nature, Cambridge doctors revealed that the body’s cells often misread the vaccine mRNA roughly 10% of the time.
The glitch, called “frameshifting,” leads to the production of unintended “rogue” proteins that elicit an immune system “flare-up” response in which the body “attacks” itself.
“The safety concern for future mRNA medicines is that mis-directed immunity has huge potential to be harmful, so off-target immune responses should always be avoided,” Cambridge University’s Dr. James Thaventhiran warned.
If regular COVID jabs misread mRNA 10% of the time and cause immune system problems in a third of vaccine recipients, questions are raised as to how many more mRNA misreadings and immune system problems will be caused by the new samRNA jabs meant to produce even more copies of RNA.
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Insanity
I'm not convinced that 1) a spike protein exists or that 2) the body produces spike proteins after mRNA injection.
The reason being that no complete "virus" has been successfully isolated. If the only way to observe these purported pathogenic particles is to culture fluid from a human in a soup with green monkey kidney cells, fetal calf blood, antibiotics, and enzymes, then stain it and heat it up to view in a completely dry state removed from the reality of the body's environment under an electron microscope, then it can't be reasonably argued that it can be isolated and manipulated.
I think what the body might be dealing with isn't necessarily related to a spike or other protein, but toxicity from the lipid nanoparticles. If the intention was to poison recipients with the LNP, then disguising them as a delivery system for a mythical spike protein is pretty ingenious, indeed.