European Commission Approves CSL and Arcturus Therapeutics' KOSTAIVE®, the First Self-amplifying mRNA COVID-19 Vaccine

Core Insights - The European Commission has granted marketing authorization for KOSTAIVE, a self-amplifying mRNA COVID-19 vaccine developed by CSL and Arcturus Therapeutics, marking a significant advancement in vaccine technology [1][2][3] - KOSTAIVE demonstrates superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines [1][3] Company Overview - CSL is a global biotechnology company with a diverse portfolio of lifesaving medicines, including treatments for hemophilia, immune deficiencies, and vaccines for influenza, employing 32,000 people and operating in over 100 countries [5] - Arcturus Therapeutics, founded in 2013, specializes in mRNA medicines and vaccines, with a focus on self-amplifying mRNA technology and a robust pipeline that includes candidates for various diseases [7][8] Regulatory Milestones - The approval of KOSTAIVE follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on December 12, 2024, allowing its use across all EU member states and EEA countries [2][3] Clinical Data - KOSTAIVE's approval is based on positive clinical data from integrated phase 1/2/3 studies, demonstrating its efficacy and tolerability, as well as phase 3 booster trials showing higher immunogenicity compared to conventional mRNA vaccines [3][4]