KING OF PRUSSIA, PA — CSL and Arcturus Therapeutics have announced that ARCT-154, their self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, has received approval from Japan’s Ministry of Health, Labor and Welfare (MHLW). The vaccine, cleared for initial vaccination and booster use in adults aged 18 and older, marks a notable milestone in the global health landscape.
“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.”
The approval was based on encouraging clinical data from several ARCT-154 studies, including an ongoing efficacy study involving 16,000 subjects in Vietnam and a Phase 3 COVID-19 booster trial. The trials demonstrated high immunogenicity results and a favorable safety profile compared to a standard mRNA COVID-19 vaccine comparator. Initial study results are set to be published in a peer-reviewed journal by year-end.
Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL, celebrated the historic approval, asserting that it supports CSL’s commitment to protecting global public health. “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,” he said.
Joseph Payne, Chief Executive Officer of Arcturus Therapeutics, expressed pride in the role Arcturus played in this collaborative effort. “This approval for the sa-mRNA COVID-19 vaccine is a major achievement, and we are excited to embark on future endeavors that utilize our innovative sa-mRNA vaccine platform alongside our global exclusive partner, CSL,” he said.
CSL Seqirus, CSL’s vaccine business and one of the world’s largest influenza vaccine providers, has partnered exclusively with Meiji Seika Pharma for the distribution of the sa-mRNA COVID-19 vaccine, ARCT-154, in Japan.
Stephen Marlow, Senior Vice President and General Manager of CSL Seqirus, emphasized the company’s readiness to help reduce the burden of COVID-19. “Our expertise in seasonal and pandemic influenza positions us well to help the global community reduce the burden of COVID-19, and we look forward to playing a key role in helping protect the people of Japan,” he said.
This critical approval underscores the promising potential of mRNA technology in combating COVID-19 and possibly other infectious diseases, offering a beacon of hope in these challenging times.
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