CSL and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor and Welfare (MHLW) has granted approval and authorization for their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®. The updated vaccine is designed to protect against the JN.1 lineage of Omicron subvariants in adults aged 18 and older, with distribution set to begin in October by Meiji Seika Pharma.
This approval marks a significant step in combating evolving COVID-19 variants and underscores the commitment of CSL and Arcturus Therapeutics to deliver innovative vaccine technology for viral respiratory diseases.
Clinical Evidence and Immunogenicity
The approval is based on robust clinical evidence demonstrating the safety and effectiveness of the sa-mRNA COVID-19 vaccine. Published data indicates superior immunogenicity against Omicron BA 4/5 compared to conventional mRNA COVID-19 vaccine boosters. Follow-up data also showed that the duration of immunity can last up to one year.
Emmanuelle Lecomte-Brisset, Senior Vice President and Head of Global Regulatory Affairs at CSL, stated, "We are pleased to receive the updated approval from Japan's Ministry of Health, Labor and Welfare, and remain on track to distribute KOSTAIVE® in time for the October COVID-19 vaccination campaign. We look forward to introducing KOSTAIVE® in Japan as a safe, tolerable and more durable option in protecting against COVID-19."
Self-Amplifying mRNA Technology
Self-amplifying mRNA (sa-mRNA) vaccines represent an advancement over traditional mRNA vaccines. While both types provide cells with a blueprint to produce proteins that trigger an immune response, sa-mRNA vaccines instruct the body to produce more mRNA and protein, thereby boosting the immune response more effectively.
Strategic Partnership and Distribution
Meiji Seika Pharma, CSL's exclusive partner in Japan, will handle the distribution of the updated vaccine. This partnership ensures that the vaccine will be available in time for the national immunization program, aligning with recommendations from both the Japanese health ministry and the World Health Organization (WHO).
Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL, commented, "We believe KOSTAIVE® has the potential to change the paradigm for COVID-19 vaccines in Japan. Today's approval further demonstrates CSL's promise to pursue, develop and deliver new innovative treatment options to protect public health."
Future Development
Arcturus Therapeutics is also looking to expand the availability of KOSTAIVE® to other countries. Joseph Payne, Chief Executive Officer of Arcturus Therapeutics, noted, "We are pleased that our sa-mRNA technology will be available to vaccinate people in Japan against COVID-19, which remains an ongoing risk to public health around the world. We look forward to continuing to work with CSL and regulators to explore the development of KOSTAIVE® in additional countries."
