Arcturus Therapeutics announced earlier this week that the U.S. Food and Drug Administration (FDA) issued a "Study Can Proceed" notification for its investigational ARCT-2304 vaccine candidate.
Epidemiologist Nicolas Hulscher told The Defender the FDA's notification "means Arcturus Therapeutics can begin its "experiment of injecting humans with H5N1 bird flu replicon mRNA."
Self-amplifying mRNA injections contain an enzyme that instructs the body on how to make more mRNA. Arcturus says the vaccine is "formulated within a lipid nanoparticle" and "is designed to make many copies of mRNA within the host cell." This enables "lower doses than conventional mRNA vaccines."
Hulscher said the replication machinery of self-amplifying vaccines behaves "like a synthetic virus" and "allows for an unknown period of toxic antigen production."
Writing on Substack, immunologist and biochemist Jessica Rose, Ph.D., said the new vaccine has "major red flags." She told The Defender, "Self-amplifying mRNA products should not be used. This is an absolute disaster waiting to happen."
According to Karl Jablonowski, Ph.D., senior research scientist at Children's Health Defense, "Arcturus' self-replication platform has all the hazards of the other synthetic modified mRNA wrapped in a lipid nanoparticle, just much worse. With self-replication it can become immortal, forever antagonizing your — or your fetus' — immune system with antigens."
Christof Plothe, D.O., a member of the World Council for Health steering committee, questioned the introduction of self-amplifying mRNA vaccines amid ongoing safety concerns about conventional mRNA shots. He told The Defender:
"The self-replicating technology takes the mRNA vaccines to a new level. The vaccine contains the gene for the spike protein and the gene for a protein called replicase, which allows the RNA to replicate.
"After the rollout of the first global genetic experiment with mRNA technology ... it seems unbelievable that an even more aggressive attack on our body and genetics should be tried out."
On Substack, Rose wrote that self-amplifying vaccines are genetically modified, as "the coding template is a modified Alphavirus [a type of RNA virus] genome with the virus sub-genomic bits spiked out and the spike gene 'spiked in.'"
"Use of GMOs [genetically modified organisms] require specific licensing application and procedures," Rose wrote, questioning whether this is the case for self-amplifying vaccines.
Small dose of replicon mRNA likely 'more hazardous' than larger dose of conventional mRNA shot
Arcturus' Phase 1 clinical trial will enroll approximately 200 healthy adults in the U.S.
Rose questioned the clinical trial's enrollment criteria. She said the criteria include a warning to "childbearers" to wear condoms when engaging in intercourse during the trial period. People who experienced "significant adverse reactions" to the mRNA COVID-19 vaccines are excluded from enrollment.
Despite Japan's recent inclusion of a self-amplifying COVID-19 vaccine among the routine vaccines it offers to older adults during this year's cold and flu season, Hulscher said trials for that vaccine revealed significant safety signals.
In clinical trials for the self-amplifying COVID-19 vaccine offered in Japan, "five deaths occurred among the injected in study phase 3b. Injected participants experienced a 90% adverse event rate (74.5% systemic, 15.2% required medical attention) after the first dose in study phases 1, 2, and 3a combined," Hulscher said.
Hulscher said Arcturus' claims that vaccines using self-amplifying mRNA technology create the impression that those vaccines will be safer. He argued that this would not be the case.
"Because they self-replicate for an unknown period of time, a small dose of a replicon mRNA is expected to be more hazardous than a larger dose of conventional mRNA," Hulscher said.
According to Jablonowski:
"The difference between medicine and poison is dose — and you cannot dose the mRNA vaccines. Arcturus promotes 'smaller doses' as a feature, but the reality is that we have never been able to measure the antigen exposure from an mRNA vaccine.
"Even if we had a theory of how many protein antigens were produced per mRNA strand, we would never know how many times the mRNA self-replicated."
Jablonowski said other risks of self-amplifying vaccines include shedding and possible hybridization with other viruses.
"It's possible for exosomes to escape the human 'host' and transmit — or 'infect' — other humans or even animals," Jablonowski said. "A scary scenario involves hybridization where the self-replicating mRNA could be incorporated into an existing infectious virus. ... If the self-replicating mRNA teams up with a successful existing virus, it will alter Earth's virome."
Hulscher called for the withdrawal of all self-amplifying mRNA shots. He said:
"These experimental injections must not receive further regulatory approval for humans or animals if we are to prevent another public health disaster. All self-amplifying mRNA injections currently available for humans and animals should be immediately withdrawn until comprehensive, long-term safety studies are conducted."
However, Hulscher said, Big Pharma is pushing for their continued development. "With at least 33 self-amplifying mRNA injection candidates in development, they have invested far too much time and money to back off," Hulscher said.
Gates, Biden administration funding research into self-amplifying vaccines
The FDA's "Study Can Proceed" notification comes amid recent warnings that bird flu might cause the next pandemic.
Arcturus noted that the clinical study is funded by the Biomedical Advanced Research and Development Authority (BARDA) — a division of the U.S. Department of Health and Human Services (HHS) responsible for developing medical countermeasures.
"Arcturus is actively engaged with the U.S. government to prepare for the next pandemic," Joseph Payne, president and CEO of Arcturus Therapeutics, said in the company's statement. "Self-amplifying mRNA technology is a key step in this important process."
Not mentioned in Arcturus' press release is a 13-month, $928,563 grant the company received last month from the Gates Foundation for "vaccine development."
The Gates Foundation has supported mRNA bird flu vaccine research, including funding several studies and journal papers in the field in recent years.
In May, the foundation granted Imperial College London $227,360 "to investigate the translational relevance of self-amplifying RNA platform for rotavirus vaccine candidates."
The Biden administration has funded several initiatives to develop mRNA bird flu vaccines, including self-amplifying vaccines.
In July, BARDA awarded Moderna $176 million for late-stage development and testing of an mRNA bird flu vaccine. Last year, three companies received funding under Project NextGen, an HHS initiative, for the "rapid development of the next generation of vaccines and treatments."
One of these companies, Gritstone Bio, received $433 million "to conduct a mid-stage study of its self-amplifying mRNA COVID-19 vaccine candidate."
Experts who spoke with The Defender expressed concern about the involvement of government agencies like BARDA and private organizations like the Gates Foundation in developing these vaccines.
"Are we seeing the next lab creation to create global fear and suppression?" asked Plothe.
Rose addressed Arcturus' statement that it is developing "a mRNA-based platform for pandemic influenza vaccine development" — that "may make vaccines available much sooner than egg- and cell-based technologies."
"Why is the word 'Pandemic' in the title?" Rose asked on Substack. "It is more likely than not that this is the priming of/grooming of the public for the next 'planned pandemic.'"
In 2022, the Coalition for Epidemic Preparedness Innovations — funded by the Gates Foundation — launched its "100 Day Mission," to build the infrastructure for the development of a new vaccine within 100 days of the onset of a future pandemic.
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