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

Core Insights - 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 [1][3] Company Overview - CSL is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including treatments for hemophilia, immune deficiencies, and vaccines for influenza, employing 32,000 people and providing products to patients 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 pipeline that includes RNA therapeutic candidates for various diseases [7][8] Regulatory Milestones - The European Commission granted marketing authorization for KOSTAIVE, the first self-amplifying mRNA COVID-19 vaccine approved in Europe, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) [2][3] Clinical Data and Efficacy - Approval of KOSTAIVE is based on positive clinical data from integrated phase 1/2/3 studies, demonstrating higher immunogenicity and tolerability compared to conventional mRNA vaccines, with superior antibody persistence against multiple SARS-CoV-2 strains [3][4]