Approval underscores CSL and Arcturus Therapeutics' commitment to delivering disruptive technologies to combat COVID-19 and other respiratory viral diseases to protect public health

• KOSTAIVE^®, the world's first self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, was approved for adults 18 years of age and older in November 2023
• The updated sa-mRNA COVID-19 vaccine is tailored to protect against the JN.1 lineage of Omicron subvariants
• Meiji Seika Pharma, CSL's exclusive partner in Japan, will begin vaccine distribution in time for the October COVID-19 vaccination campaign 
• CSL and Arcturus Therapeutics' partnership delivers on the promise to advance innovative vaccine technology for viral respiratory diseases

Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and sa-mRNA pioneer Arcturus Therapeutics today announced that Japan's Ministry of Health, Labor and Welfare (MHLWs) granted approval and authorization for their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE^®. The updated vaccine is targeted to protect against the JN.1 lineage of Omicron subvariants for adults 18 years of age and older.

CSL's exclusive partner in Japan, Meiji Seika Pharma, will begin distributing the updated vaccine in time for the October COVID-19 vaccination campaign, marking the world's first commercially available sa-mRNA COVID-19 vaccine for adults 18 and older.

In May 2024, a Japanese health ministry panel recommended that COVID-19 vaccines be updated to target the JN.1 lineage of Omicron subvariants for the 2024/2025 national immunization program. This aligns with recent recommendations from the World Health Organization.

"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," said Emmanuelle Lecomte-Brisset, Senior Vice President and Head of Global Regulatory Affairs, CSL. "We look forward to introducing KOSTAIVE^® in Japan as a safe, tolerable and more durable option in protecting against COVID-19."

"We believe KOSTAIVE^® has the potential to change the paradigm for COVID-19 vaccines in Japan," said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL. "Today's approval further demonstrates CSL's promise to pursue, develop and deliver new innovative treatment options to protect public health."

The approval is based on clinical evidence supporting the safety and effectiveness of CSL and Arcturus Therapeutics' sa-mRNA COVID-19 vaccine, including published data demonstrating superior immunogenicity to Omicron BA 4/5 compared to a conventional mRNA COVID-19 vaccine booster and follow-up data demonstrating duration of immunity lasting up to one year.

"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," said Joseph Payne, Chief Executive Officer of Arcturus Therapeutics. "We look forward to continuing to work with CSL and regulators to explore the development of KOSTAIVE^® in additional countries."