The European Commission has granted marketing authorization for KOSTAIVE® (ARCT-154), marking a significant milestone as the first self-amplifying mRNA (sa-mRNA) COVID-19 vaccine approved in the European Union. The breakthrough vaccine, developed through a collaboration between global biotechnology leader CSL and sa-mRNA pioneer Arcturus Therapeutics, is authorized for use in individuals 18 years and older across all EU member states and EEA countries.
Clinical Evidence and Performance
The approval follows comprehensive clinical evaluation, including integrated phase 1/2/3 studies that demonstrated the vaccine's efficacy and tolerability. Phase 3 booster trials revealed particularly promising results, with KOSTAIVE achieving higher immunogenicity compared to conventional mRNA COVID-19 vaccines. Notably, follow-up analyses showed superior antibody persistence lasting up to 12 months post-vaccination against multiple SARS-CoV-2 strains in both younger and older adult populations.
"KOSTAIVE and sa-mRNA technology signify a major advancement in vaccine innovation, providing the potential for broader and more enduring protection," stated Joseph Payne, CEO of Arcturus. The vaccine's approval builds upon its existing market presence in Japan, where it is already being used to combat COVID-19.
Innovative Technology Platform
KOSTAIVE's distinguishing feature lies in its self-amplifying mRNA technology. Unlike traditional mRNA vaccines, sa-mRNA vaccines instruct cells to produce additional mRNA and proteins, potentially enhancing the immune response. This technological advancement could represent a significant step forward in vaccine development, offering more robust and sustained protection against viral infections.
Implementation and Future Development
Dr. Jonathan Edelman, Senior Vice President of CSL's Vaccines Innovation Unit, emphasized the company's commitment to optimization: "We are actively working to optimize KOSTAIVE's formulation to better meet the needs of healthcare professionals and their patients. As COVID-19 remains an unpredictable global threat, CSL is dedicated to completing these technical enhancements and making this innovative vaccine available in Europe as soon as possible."
The approval follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued in December 2024, reinforcing the vaccine's safety and efficacy profile through rigorous regulatory review.
