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

Published December. 12. 2023
Vaciines Banner Japan's Ministry of Health

In a groundbreaking development that resonates with the promise of innovation during times of global health crises, CSL (ASX:CSL; USOTC:CSLLY), a global biotechnology leader, and Arcturus Therapeutics achieved a historic milestone with the approval of ARCT-154, the world’s first Self-Amplifying messenger RNA (sa-mRNA) COVID-19 vaccine by Japan’s Ministry of Health, Labor and Welfare (MHLW).

This significant achievement marks the first marketing approval for CSL and Arcturus since the closure of their Global Collaboration and Licensing agreement in 2022, reinforcing their commitment to advancing cutting-edge solutions to address public health needs. The approval underscores CSL’s dedication to developing and delivering innovative vaccines, particularly in the face of respiratory viral diseases.

The announcement, made on November 27, 2023, positions CSL at the forefront of vaccine technology. ARCT-154, designed for initial vaccination and booster administration in adults aged 18 and older, harnesses the potential of self-amplifying mRNA technology, a breakthrough lauded by Nobel laureate Dr. Drew Weissman.

Dr. Weissman, expressing his optimism about this next-generation mRNA technology, highlighted its potential as a lasting vaccine option. “I look forward to seeing this next-generation mRNA technology protect many from COVID-19 and possibly other harmful infectious diseases.”

Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL, echoed this sentiment, emphasizing the historic nature of the approval. “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.”

The approval is founded on robust clinical data from multiple studies, including a 16,000-subject efficacy study in Vietnam and a Phase 3 COVID-19 booster trial. The latter demonstrated superior immunogenicity results and a favorable safety profile compared to a standard mRNA COVID-19 vaccine comparator. Initial study results have been published in MedRxiv, with peer-reviewed journal publication expected by the year’s end.

Joseph Payne, Chief Executive Officer of Arcturus Therapeutics, expressed pride in the collaborative effort that led to the development and validation of the first approved sa-mRNA product globally. He emphasized the significance of this achievement and expressed excitement about future endeavors in collaboration with CSL.

CSL Seqirus, CSL’s vaccine business and one of the world’s largest influenza vaccine providers, played a pivotal role by exclusively partnering with Meiji Seika Pharma for the distribution of ARCT-154 in Japan. Stephen Marlow, Senior Vice President and General Manager of CSL Seqirus, highlighted their expertise in seasonal and pandemic influenza, positioning them to contribute significantly to reducing the burden of COVID-19 in Japan.

“We look forward to playing a key role in helping protect the people of Japan,” Marlow affirmed, encapsulating the shared commitment of CSL and its partners to global health and safety.


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