Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and sa-mRNA pioneer Arcturus Therapeutics have announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®. This vaccine is designed to protect adults 18 years and older against the JN.1 lineage of Omicron subvariants.
CSL’s partner in Japan, Meiji Seika Pharma, will distribute the vaccine in time for Japan’s October COVID-19 vaccination campaign. This marks the first sa-mRNA COVID-19 vaccine to be commercially available for adults globally.
In May 2024, a health ministry panel in Japan recommended updating COVID-19 vaccines to target the JN.1 Omicron subvariants for the 2024/2025 national immunization program, aligning with recent World Health Organization recommendations.
Emmanuelle Lecomte-Brisset, Senior Vice President and Head of Global Regulatory Affairs at CSL, expressed satisfaction with the approval, stating, “We are pleased to receive the updated approval and remain on track to distribute KOSTAIVE® for the upcoming vaccination campaign. We are excited to introduce KOSTAIVE® as a safe, tolerable, and longer-lasting option in COVID-19 protection.”
Jonathan Edelman, M.D., Senior Vice President of CSL’s Vaccines Innovation Unit, emphasized KOSTAIVE®’s potential to revolutionize COVID-19 vaccination in Japan, highlighting CSL’s commitment to delivering innovative treatments to safeguard public health.
The approval is based on clinical evidence showing the vaccine’s safety and effectiveness. Studies indicate that CSL and Arcturus’ sa-mRNA vaccine demonstrates superior immunogenicity to Omicron BA 4/5 compared to traditional mRNA vaccine boosters, with immunity lasting up to one year.
Joseph Payne, CEO of Arcturus Therapeutics, shared his enthusiasm, noting, “We are pleased that our sa-mRNA technology will help protect people in Japan against COVID-19, which remains a significant public health risk. We look forward to further collaboration with CSL and regulators to expand KOSTAIVE® into other markets.
About sa-mRNA
mRNA vaccines help protect against infectious diseases by providing a blueprint for cells in the body to make a protein to help our immune systems recognize and fight the disease. Unlike conventional mRNA vaccines, self-amplifying mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response.
About CSL
CSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.
