Clinical trials — funded by the U.S. government and the Bill & Melinda Gates Foundation — are set to begin for a self-amplifying mRNA vaccine targeting the H5N1 bird flu virus.

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.