Press release
Japan's Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics' ARCT-154, the first Self-Amplifying mRNA vaccine approved for COVID in adults
Exclusive Partner in Japan, Meiji Seika Pharma advances regulatory approval This historic approval of the world's first Self-Amplifying messenger RNA
About this update from Arcturus Therapeutics Holdings Inc.
[{"type":"text","content":"Exclusive Partner in Japan, Meiji Seika Pharma advances regulatory approval\nThis historic approval of the world's first Self-Amplifying messenger RNA (sa-mRNA) COVID-19 Vaccine underscores CSL's promise to develop and deliver innovations when there is a public health needFirst marketing approval milestone for CSL and Arcturus Therapeutics since closing the Global Collaboration and Licensing agreement in 2022With the approval of ARCT-154, CSL now offers an even more comprehensive portfolio of innovative vaccines that combat respiratory viral diseases.KING OF PRUSSIA, Pa. and SAN DIEGO, Nov. 27, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval for ARCT-154, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older. \n\n \n \n \n \n \n \n\n \nHistoric approval of the world's first Self-Amplifying messenger RNA (sa-mRNA) COVID-19 Vaccine \"Self-amplifying mRNA technology has the potential to be an enduring vaccine option,\" said Nobel laureate Dr. Drew Weissman, \"I look forward to seeing this next generation mRNA technology protect many from COVID-19 and possibly other harmful infectious diseases.\"\n\"Today's approval marks a historic and exciting milestone as the first sa-mRNA vaccine in the world to be registered, and supports CSL's promise to protect global public health,\" said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL. \"We are committed to working with health authorities around the world to ensure this important vaccine technology will be available to people at risk for COVID-19.\" \nThe approval is based on positive clinical data from several ARCT-154 studies, including an ongoing 16,000 subject efficacy study performed in Vietnam as well as a Phase 3 COVID-19 booster trial, which achieved higher immunogenicity results and a favorable safety profile compared to a standard mRNA COVID-19 vaccine comparator. Initial study results have been published in MedRxiv and are expected to be published in a peer-reviewed journal by the end of the year.\n\"We are proud of the role that Arcturus has played in this collaboration to develop and validate the first approved sa-mRNA product in the world,\" sai...