‘Disaster Waiting to Happen’: FDA Approves Phase 1 Trial of Gates-Funded Self-Amplifying Bird Flu Vaccine
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.”