CSL and Arcturus’ KOSTAIVE® Self-amplifying mRNA COVID-19 Vaccine Approved by European Commission
CSL (ASX: CSL; USOTC: CSLLY), a global biotechnology leader, and Arcturus Therapeutics (Nasdaq: ARCT), a pioneer in self-amplifying mRNA (sa-mRNA) technology, have announced that the European Commission has granted marketing authorization for KOSTAIVE® (ARCT-154). This approval marks the first sa-mRNA COVID-19 vaccine to receive approval in the European Union for individuals aged 18 and older. Currently, KOSTAIVE is also marketed in Japan as a COVID-19 vaccine.
The European Commission has granted marketing authorization for KOSTAIVE® (ARCT-154), a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine developed by global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) in collaboration with Arcturus Therapeutics (Nasdaq: ARCT). This approval, which 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, is significant as KOSTAIVE becomes the first sa-mRNA COVID-19 vaccine authorized in the European Union (EU). The marketing authorization is valid across all EU member states as well as the European Economic Area (EEA) countries.
Jonathan Edelman, MD, Senior Vice President of the Vaccines Innovation Unit at CSL, expressed enthusiasm about the approval, stating, “The European Commission’s approval marks a significant milestone in our ongoing development program for KOSTAIVE. 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 of KOSTAIVE is backed by positive clinical data derived from several key studies, including an integrated Phase 1/2/3 trial. This study demonstrated that KOSTAIVE is both effective and well-tolerated. Additionally, Phase 3 COVID-19 booster trials showed that KOSTAIVE produced higher immunogenicity results compared to a conventional mRNA COVID-19 vaccine. A follow-up analysis of a booster dose also revealed that KOSTAIVE elicited superior immunogenicity and antibody persistence for up to 12 months post-vaccination, offering protection against multiple SARS-CoV-2 strains. This response was consistent across both younger and older adult populations, outperforming the conventional mRNA vaccine comparator
Joseph Payne, CEO of Arcturus, highlighted the importance of sa-mRNA technology, stating, “KOSTAIVE and sa-mRNA technology signify a major advancement in vaccine innovation, providing the potential for broader and more enduring protection. This approval highlights the clinical promise of KOSTAIVE and its ability to protect against the ever-changing COVID-19 virus.”
Self-amplifying mRNA (sa-mRNA) technology represents an evolution in mRNA vaccine design. While standard mRNA vaccines work by providing a blueprint for cells to create a specific protein that triggers an immune response, self-amplifying mRNA vaccines take this a step further. They instruct the body not only to produce the target protein but also to generate more mRNA, amplifying the immune response. This ability to produce additional mRNA and protein means the immune system is better primed to recognize and fight off the virus, leading to a potentially more durable immune response.
CSL is a global leader in biotechnology, known for its portfolio of lifesaving treatments for conditions such as hemophilia, immune deficiencies, and influenza. The company also provides therapies for iron deficiency and nephrology. Since its founding in 1916, CSL has been dedicated to saving lives using cutting-edge technologies. With three primary businesses—CSL Behring, CSL Seqirus, and CSL Vifor—the company operates in over 100 countries, employing 32,000 people globally. CSL’s strong commercial presence, coupled with a sharp focus on research and development (R&D), enables the company to deliver critical innovations to improve the lives of its patients.
The approval of KOSTAIVE in the EU marks an important step in the global fight against COVID-19. CSL and Arcturus continue to work on refining KOSTAIVE’s formulation to meet the evolving needs of the global healthcare landscape. The partnership between the two companies represents a commitment to advancing vaccine technology, with the goal of providing safer, more effective protection against infectious diseases like COVID-19.
KOSTAIVE is already marketed in Japan for COVID-19 and has now received approval in the EU, highlighting its potential as a global solution to the pandemic. This breakthrough marks a significant achievement for CSL and Arcturus in the ongoing effort to control the spread of COVID-19 and mitigate its impact on global health. With the approval of KOSTAIVE, individuals in the EU will have access to an innovative vaccine offering enhanced protection, reinforcing CSL’s position as a leader in global healthcare solutions.
