European Commission Approves KOSTAIVE®, the First Self-Amplifying mRNA COVID-19 Vaccine
Global biotechnology leader and self-amplifying mRNA (sa-mRNA) pioneer Arcturus Therapeutics (Nasdaq: ARCT) have announced that the European Commission (EC) has granted marketing authorization for KOSTAIVE® (ARCT-154), a breakthrough self-amplifying mRNA COVID-19 vaccine, for individuals aged 18 years and older. This approval marks a historic milestone as KOSTAIVE becomes the first sa-mRNA COVID-19 vaccine to receive authorization from the EC.
KOSTAIVE is already available in Japan as a preventive measure against COVID-19, demonstrating its established role in combating the global pandemic. The vaccine’s approval in Europe expands its potential reach, providing a novel option for immune protection against the virus.
Advancing Vaccine Innovation to Address a Persistent Threat
COVID-19 continues to pose a significant and unpredictable global challenge. CSL and Arcturus are committed to ensuring that KOSTAIVE remains at the forefront of vaccine technology by optimizing its formulation to better meet the evolving needs of healthcare professionals and patients.
“As COVID-19 remains an unpredictable global threat, CSL is dedicated to completing technical enhancements and making this innovative vaccine available in Europe as soon as possible,” said Jonathan Edelman, MD, Senior Vice President of the Vaccines Innovation Unit at CSL. “We are actively working to optimize KOSTAIVE’s formulation to ensure its effectiveness in protecting against current and emerging variants.”
Regulatory Approval and Clinical Data Supporting KOSTAIVE
The European Commission’s approval follows a positive recommendation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on December 12, 2024. This centralized marketing authorization is valid across all EU member states and the European Economic Area (EEA) countries, significantly expanding access to the vaccine.
The approval is based on robust clinical data from multiple studies, including a comprehensive integrated Phase 1/2/3 trial that evaluated KOSTAIVE’s efficacy and tolerability. In addition, results from Phase 3 booster studies demonstrated that KOSTAIVE produced stronger immune responses compared to conventional mRNA COVID-19 vaccines.
A follow-up study analyzing the booster effects of KOSTAIVE indicated that the vaccine induced superior immunogenicity and sustained antibody responses for up to 12 months post-vaccination. This protective effect was observed across various SARS-CoV-2 strains in both younger and older adult populations, reinforcing the long-term benefits of sa-mRNA technology.
What Makes Self-Amplifying mRNA (sa-mRNA) Vaccines Unique?
KOSTAIVE is based on an advanced self-amplifying mRNA platform that enhances the body’s immune response more efficiently than conventional mRNA vaccines. Unlike traditional mRNA vaccines, which deliver a fixed amount of antigen-encoding mRNA, sa-mRNA vaccines are designed to replicate within cells, producing more antigen over time. This allows for:
- Prolonged and stronger immune responses – The extended production of viral antigens triggers a more robust and longer-lasting immunity.
- Lower dose requirements – Because the mRNA amplifies itself, smaller doses may be needed to achieve comparable or superior immune protection.
- Enhanced adaptability – sa-mRNA technology offers a promising platform for rapid updates to address emerging viral variants.
“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. “This approval highlights the clinical promise of KOSTAIVE and its ability to protect against the ever-changing COVID-19 virus.”
Future Outlook: Expanding Access and Advancing Development
The European approval of KOSTAIVE represents a crucial step in expanding global access to next-generation vaccine solutions. CSL and Arcturus are working closely with regulatory bodies, healthcare providers, and manufacturing partners to ensure a smooth rollout across the region.
Looking ahead, the companies are exploring further applications of sa-mRNA technology in vaccine development, potentially targeting other infectious diseases beyond COVID-19. Given the platform’s ability to generate strong and durable immune responses, its broader application in global health remains an area of active research and development.
With the continued evolution of the SARS-CoV-2 virus, vaccines like KOSTAIVE will play an essential role in ongoing pandemic preparedness and response efforts. The approval by the European Commission paves the way for more widespread adoption of self-amplifying mRNA vaccines, which could redefine the landscape of infectious disease prevention.
