Close menu
October 8, 2024 COVID Toxic Exposures News

COVID

Japan Approves World’s First ‘Self-amplifying’ mRNA COVID Shot — Is the U.S. Next?

Japan will offer a self-amplifying mRNA COVID-19 vaccine to people 65 and over, and 60- to 64-year-olds with severe underlying conditions beginning this fall. Experts warn the technology — also being developed in the U.S. — is untested, risky and potentially dangerous.

covid vaccine bottle on the right with dna helix on the left

Listen to this article

0:00/

Japan is offering a self-amplifying mRNA vaccine as one of the five routine COVID-19 vaccines available to the public for the 2024-2025 fall and winter seasons.

Japanese regulators approved the ARCT-154 shot in November 2023. According to a press release, ARCT-154 is the world’s first self-amplifying mRNA COVID-19 vaccine. Japan’s Ministry of Health, Labour and Welfare approved the vaccine for adults. It is jointly produced by the biotechnology firm CSL and Arcturus Therapeutics.

“The approval is based on positive clinical data from several ARCT-154 studies … which achieved higher immunogenicity results and a favorable safety profile compared to a standard mRNA COVID-19 vaccine comparator,” CSL said.

Japan’s vaccination program will offer the vaccines to people 65 and over, and 60- to 64-year-olds with severe underlying conditions, at a maximum cost of 7,000 yen (approximately $47). People not in these two categories can also receive the shots, but the fee will not be capped.

Self-amplifying mRNA vaccines coming soon to U.S.

In December 2023, the Biden administration announced agreements with CastleVax, Codagenix and Gritstone Bio to develop the first three vaccines under Project NextGen.

Operated by the Administration for Strategic Preparedness & Response under the U.S. Department of Health and Human Services (HHS), Project NextGen says it, “Accelerates and streamlines the rapid development of the next generation of vaccines and treatments through public-private collaborations.”

According to investigative journalist Jon Fleetwood, one of the three companies awarded contracts, Gritstone Bio, has been developing a self-amplifying mRNA platform “for some time now.”

In September 2023, Gritstone Bio received a $433 million contract from HHS “to conduct a mid-stage study of its self-amplifying mRNA COVID-19 vaccine candidate.”

Gritstone Bio is owned by major investment firms BlackRock, Vanguard and State Street, “the same asset managers who own mRNA vaccine manufacturers Pfizer and Moderna,” Fleetwood wrote on his Substack.

Fleetwood also noted that BlackRock and State Street are official partners of the World Economic Forum and that Gritstone Bio has received funding from the Bill & Melinda Gates Foundation.

Magnifying glass and an envelope Magnifying glass and an envelope

Do you have a news tip? We want to hear from you!

Contact Us

‘Absolutely no long-term safety data on them’

Despite the Japanese health ministry’s approval based on ARCT-154 demonstrating positive results in clinical trials, some experts warn that the product — and self-amplifying mRNA injections more broadly — are untested, risky and potentially dangerous.

Epidemiologist Nicolas Hulscher told The Defender, “These products are completely new. There is absolutely no long-term safety data on them.”

“In the clinical trials for ARCT-154, injected participants experienced a 90% adverse event rate after the first dose in study Phases 1, 2, and 3a combined,” Hulscher said. Of these adverse events, 74.5% were systemic — meaning they occurred in a part of the body distant from the point of injection — and 15.2% required medical attention.

Karina Acevedo Whitehouse, Ph.D., a professor of microbiology at the Autonomous University of Querétaro in Mexico, told The Defender, “We do not know” the safety profile of the self-replicating vaccines. She said:

“There have been no studies on the potential of this technology to transform cells — that is, to render them cancerous or more prone to not repairing damage to DNA — or to lead to a self-inflammatory status, that can harbor all sorts of pathologies.

“There have also been no studies conducted on transgenerational effects — for instance, teratogenicity [birth defects] — of self-amplifying mRNA injections … We simply do not know what the consequences could be.”

Whitehouse said the lack of testing is similar to conventional mRNA products, such as the Pfizer and Moderna COVID-19 shots, which were introduced to the public despite insufficient testing and a lack of long-term data.

“There is now a myriad of studies that show the molecular consequences of synthetic mRNA being in our cells,” Whitehouse said. “Nothing of what was told to the public regarding the ‘safety’ of these products in terms of biodistribution, degradation, carcinogenicity, teratogenicity and immune exhaustion was backed by any type of study.”

Whitehouse said the lack of testing has led to a series of consequences for public health:

“The biodistribution assays provided to the regulators (conducted in rats, which have a much quicker metabolism than humans) showed that the mRNA+nanolipids of the injections were distributed to nearly all organs and tissues examined, including the brain and reproductive tissues.

“Also, persistence of the synthetic mRNA is much longer than originally thought, and there are published scientific studies that show that it is possible to detect the synthetic mRNA in the blood and other organs for months following vaccination.”

A study by Cambridge University researchers published in the journal Nature in December 2023 found that the original mRNA COVID-19 shots triggered an unintended immune response in one-third of recipients.

The study also found that the human body misreads the injected mRNA approximately 10% of the time. This process, called “frameshifting,” leads to the production of “unintended” proteins, which may elicit an autoimmune response.

Whitehouse said mRNA shots are also likely contributors to the increase in turbo cancers in recent years:

“Multiple independent studies now show that … many cellular pathways are impacted by the synthetic mRNA, and many of these pathways, when altered, can lead to cancer. This could help explain the marked increase in cancer observed since mid-2021 in most countries.”

Self-amplifying mRNA shots may be riskier than conventional mRNA shots

Hulscher told The Defender that the risks associated with self-amplifying mRNA vaccines “are likely far greater than the risks of conventional mRNA injections.”

Whitehouse explained how self-amplifying mRNA injections are different than synthetic mRNA injections. Synthetic mRNA vaccines contain foreign mRNA that the body’s cells translate into a protein.

Self-amplifying mRNA injections also contain a foreign protein — but in addition, they contain an enzyme that instructs the body on how to make more mRNA.

Whitehouse said, “The function of this enzyme — RNA-dependent RNA polymerase (RdRp) — is to copy RNA,” which means that “once the cell produces the RdRp, it will make new copies of the foreign mRNA as well as more copies of its own instructions.” likening this function to that of a photocopier.

She likened the process to how a photocopier works. “It keeps going and going and going, making more copies that, in turn, help make more copies,” Whitehouse said.

Hulscher compared self-amplifying mRNA vaccines to conventional mRNA injections “on steroids.” He said:

“These genetic products encode viral replicase genes and thus behave like a viral infection. Unlike conventional mRNA tech, replicons cause sustained antigen production resulting in a much higher amount being produced.”

Dr. Christof Plothe, a member of the World Council for Health steering committee, told The Defender:

“We need to monitor this technology for its incorporation into our genome and the consequences of long-term exposure to it. We already know that the body switches to ineffective IgG4 antibodies after the current injections, making people more susceptible to infection and problems with an infection.”

Self-amplifying mRNA vaccines coming for bird flu, Marburg virus?

Experts now warn that Big Pharma is seeking to develop self-amplifying mRNA injections for other diseases.

“The biopharmaceutical complex seeks to deploy replicon injections for future pandemics,” Hulscher said. “They have already developed them for COVID-19, H5N1 bird flu and Marburg.

Plothe said the technology “has the potential to change the fate of humanity” and plays on fears of new dangerous pathogens.

“Each time, only a vaccine is being presented as the solution,” Plothe said. “Financially speaking, this makes a lot of sense as you don’t have to wait for somebody to get sick but can sell your product to the entire population.”

Arguing that “choosing reason and intuition over fear tends to help people make good decisions,” Whitehouse called for caution — and for more testing.

“Rather than creating a panic, it seems sensible to demand that this technology not be used until there are adequate, non-biased, independent studies made by researchers with no conflicts of interest to ensure that the products are safe and that there is no risk of transmission to others,” she said.

Suggest A Correction

Share Options

Close menu

Republish Article

Please use the HTML above to republish this article. It is pre-formatted to follow our republication guidelines. Among other things, these require that the article not be edited; that the author’s byline is included; and that The Defender is clearly credited as the original source.

Please visit our full guidelines for more information. By republishing this article, you agree to these terms.