Biotechnology firm CSL Ltd. (CSL.AX,CMXHF.PK) and sa-mRNA pioneer Arcturus Therapeutics Ltd. (ARCT) announced Friday that the European Commission has granted marketing authorization for KOSTAIVE (ARCT-154), a self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older.
KOSTAIVE is the first sa-mRNA COVID-19 vaccine to receive approval from the European Commission. KOSTAIVE is currently marketed in Japan against COVID-19.
KOSTAIVE represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials.
The European Commission approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on December 12, 2024. The centralized marketing authorization of KOSTAIVE is valid in all EU member states and in the EEA countries.
The approval is based on positive clinical data from several studies, including an integrated phase 1/2/3 study demonstrating KOSTAIVE's efficacy and tolerability, and Phase 3 COVID-19 booster trials, which achieved higher immunogenicity results compared to a conventional mRNA COVID-19 vaccine comparator.
A follow-up analysis evaluating a booster dose of KOSTAIVE also showed that the vaccine elicited superior immunogenicity and antibody persistence for up to 12 months post-vaccination against multiple SARS-CoV-2 strains in both younger and older adult age groups versus the same mRNA comparator.
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