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.”
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