'Inhumane, Reckless': Critics Weigh in on Europe's Approval of Self-amplifying COVID mRNA Vaccines

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Tuesday, February 25th 2025 at 4:00 pm

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Children's Health Defense

Originally published on www.tdefender.substack.com by Suzanne Burdick, Ph.D.

The European Commission has approved a self-amplifying mRNA COVID-19 vaccine for ages 18 and up. The move drew criticism from scientists, who cited several concerns.

Europe has approved a self-amplifying mRNA COVID-19 vaccine for ages 18 and up. The move drew criticism from scientists, who cited several concerns, including high rates of serious side effects among clinical trial participants and no long-term safety data.

The European Commission, the European Union's primary executive body, on Feb. 14, granted marketing authorization for ARCT-154 -- marketed as KOSTAIVE -- a vaccine manufactured by CSL and Arcturus Therapeutics.

Japanese regulators were the first to approve the ARCT-154 shot, which the country made available for the 2024-25 season to people 65 and over, and 60- to 64-year-olds with severe underlying conditions.

Self-amplifying mRNA vaccines are similar to synthetic mRNA vaccines in that they both contain foreign mRNA that the body's cells translate into a protein. However, unlike synthetic mRNA vaccines, self-amplifying vaccines also contain an enzyme that instructs the body on how to make more mRNA.

"What makes self-amplifying mRNA technology so worrisome, is that the mRNA will perpetuate indefinitely," said Karl Jablonowski, Ph.D., senior research scientist at Children's Health Defense (CHD).

Jablonowski explained that with the traditional COVID-19 mRNA vaccines, "at least there is some solace in knowing the original mRNA will break down and stop production of the spike proteins."

Nicolas Hulscher, an epidemiologist with the McCullough Foundation who writes on Substack, called Europe's approval of ARCT-154 a "grave mistake."

"These products behave like a synthetic virus," Hulscher said. "The replicon mRNA is designed to encode not only the target antigen but also viral replicase, enabling the mRNA to replicate itself within the target cells. This replication machinery allows for an unknown period of toxic antigen production."

The antigen is the "active ingredient in all vaccines … that causes the immune system to begin producing antibodies," according to the Centers for Disease Control and Prevention.

Jablonowski said that being chronically exposed to an antigen -- "especially one as toxic as the COVID-19 spike protein" is "like being vaccinated every day for the rest of your life."

Plus, the product may not effectively target emerging COVID-19 variants, Jablonowski said:

"When a new variant emerges, as coronaviruses change constantly, would the strategy be another self-amplifying mRNA vaccine? Another factory that may never turn off? And so on? There will be a breaking point.

"The tragic short-sightedness of this strategy is that eventually the vaccinated will be creating spike protein to assault their own body to teach their immune system how to combat a virus that doesn't exist anymore."

Hulscher said long-term safety data on ARCT-154 is "non-existent." He also reported that 90% of clinical trial participants experienced adverse events after the first dose, with 74.5% reporting systemic reactions and 15.2% requiring medical attention.

Arcturus Therapeutics is one of at least nine vaccine developers working on self-amplifying mRNA products, according to a November 2024 analysis by Hulscher.

So far, none of the clinical trials for the product have "addressed the major concern of product shedding," Hulscher said.

Jablonowski also pointed out that the mRNA lipid nanoparticle technology has been shown to cross the placental barrier, making it "unconscionable that the European Commission would allow these products anywhere near a person who may become pregnant."

FDA approved clinical trial for self-amplifying bird flu vaccine

Although the U.S. has yet to approve a self-amplifying mRNA COVID-19 vaccine, the U.S. Food and Drug Administration last November gave the green light for Arcturus Therapeutics to launch clinical trials for a self-amplifying mRNA vaccine targeting the H5N1 virus, commonly known as bird flu.

The trials are funded by the U.S. government and the Bill & Melinda Gates Foundation. "The United States must REJECT this dangerous technology," Hulscher said.

Cardiologist Dr. Peter McCullough agreed.

"Vaccinologists have made a critical error in the design of genetic vaccines," McCullough said. "Injection of the genetic code for any foreign protein including parts of viruses causes the body to respond with an immune attack against its own cells."

"This leads to intense vaccine injury syndromes all through the human body," he said.

McCullough added, "Giving the vaccines their own 'life' with the ability to reproduce themselves is inhumane, reckless, and from the outset, should be flagged as dangerous and potentially lethal to the recipient."

Related articles in The Defender

• Japan Approves World's First 'Self-amplifying' mRNA COVID Shot -- Is the U.S. Next?
• 'Disaster Waiting to Happen': FDA Approves Phase 1 Trial of Gates-funded Self-amplifying Bird Flu Vaccine
• Rogan Rips Mainstream Media for Failure to Cover 'Real Numbers' of People Injured, Killed by COVID Shots
• U.S. Pumps $667 Million Into World Bank's Pandemic Fund

The Children’s Health Defense Team is devoted to the health of people and our planet. Our mission is to end the childhood health epidemics by working aggressively to eliminate harmful exposures, hold those responsible accountable, and establish safeguards so this never happens again. We do what we do for many reasons, but the one thing we all share is our passionate belief that we have public health policies and practices that are harming our children. For the future good health of our children and planet, we call for more research and transparency. Visit us at www.childrenshealthdefense.org