StoryRegulatory
EU approves KOSTAIVE, first self-amplifying mRNA vaccine
Arcturus TherapeuticsKOSTAIVE (sa-mRNA COVID-19 vaccine)
EC granted marketing authorization for KOSTAIVE, the first self-amplifying mRNA COVID-19 vaccine. Follows positive EMA CHMP opinion in December 2024. KOSTAIVE shows superior immunogenicity and antibody persistence vs. standard mRNA vaccines.
- First sa-mRNA vaccine approved globally
- EMA CHMP: Dec 12, 2024; EC: Feb 14, 2025
- Superior antibody persistence vs. standard mRNA at 12+ months
- Superior immunogenicity against multiple SARS-CoV-2 strains
- In Japan since October 2024; now approved in EU