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).
“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 itselfwithin the target cells. This replication machinery allows for an unknown period of toxic antigen production.”
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.
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