Press release
Japan's Ministry of Health, Labor and Welfare Approves CSL and Arcturus Therapeutics' Updated Self-amplifying mRNA COVID-19 Vaccine for Protection against JN.1 Strain, to be Distributed in Japan by Meiji Seika Pharma
Approval underscores CSL and Arcturus Therapeutics' commitment to delivering disruptive technologies to combat COVID-19 and other respiratory viral diseases
About this update from Arcturus Therapeutics Holdings Inc.
[{"type":"text","content":"Approval underscores CSL and Arcturus Therapeutics' commitment to delivering disruptive technologies to combat COVID-19 and other respiratory viral diseases to protect public health\nKOSTAIVE®, the world's first self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, was approved for adults 18 years of age and older in November 2023The updated sa-mRNA COVID-19 vaccine is tailored to protect against the JN.1 lineage of Omicron subvariantsMeiji 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 diseasesKING OF PRUSSIA, Pa. and SAN DIEGO, Sept. 13, 2024 /PRNewswire/ -- 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.\n\n \n \n \n \n \n \n\n \nCSL'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.\nIn 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.\n\"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.\"\n\"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 approv...