Japan Approves Updated CSL and Arcturus mRNA COVID-19 Vaccine for JN.1, Distributed by Meiji Seika

CSL and Arcturus Therapeutics have announced the approval of KOSTAIVE®, the world's first self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, by Japan's Ministry of Health, Labor and Welfare (MHLW). This updated vaccine, aimed at protecting adults aged 18 and older against the JN.1 lineage of Omicron subvariants, represents a significant advancement in the fight against COVID-19.

In a strategic partnership with Meiji Seika Pharma, CSL's exclusive partner in Japan, the distribution of KOSTAIVE® will commence in time for the October COVID-19 vaccination campaign. This effort underscores the global commitment to utilizing cutting-edge vaccine technologies to address public health challenges.

KOSTAIVE®'s approval follows a recommendation from a Japanese health ministry panel in May 2024, which advocated for COVID-19 vaccines to be updated to target the JN.1 lineage of Omicron subvariants for the national immunization program. This recommendation aligns with the World Health Organization's recent guidelines, emphasizing the necessity of updated vaccines to combat emerging variants.

Emmanuelle Lecomte-Brisset, Senior Vice President and Head of Global Regulatory Affairs at CSL, expressed pride in receiving the updated approval from MHLW. She emphasized that CSL is on track to distribute KOSTAIVE® in time for the upcoming vaccination campaign, highlighting the vaccine's safety, tolerability, and potential for providing a more durable protection against COVID-19.

Jonathan Edelman, M.D., Senior Vice President of the Vaccines Innovation Unit at CSL, remarked that KOSTAIVE® has the potential to revolutionize the COVID-19 vaccination landscape in Japan. He noted that the approval further demonstrates CSL's commitment to developing and delivering innovative treatments to safeguard public health.

The approval of KOSTAIVE® is based on substantial clinical evidence supporting its safety and effectiveness. Published data indicate that the sa-mRNA COVID-19 vaccine offers superior immunogenicity against Omicron BA 4/5 compared to conventional mRNA COVID-19 vaccine boosters. Additionally, follow-up data show that the vaccine provides immunity lasting up to one year.

Joseph Payne, CEO of Arcturus Therapeutics, expressed satisfaction that their sa-mRNA technology will soon be available in Japan. He emphasized that COVID-19 remains a significant public health threat globally and reiterated the commitment to working with CSL and other regulators to explore the development of KOSTAIVE® in additional countries.

Distinct from traditional mRNA vaccines, self-amplifying mRNA vaccines like KOSTAIVE® instruct the body to produce more mRNA and protein, thereby enhancing the immune response. This innovative approach promises greater efficiency in combating infectious diseases.

CSL, a global biotechnology leader, has been at the forefront of developing life-saving medicines and vaccines since its inception in 1916. With a diverse portfolio including treatments for hemophilia, immune deficiencies, influenza, and more, CSL operates in over 100 countries and employs 32,000 people. The company's dedication to innovation and excellence has enabled it to deliver significant advancements in public health.

Arcturus Therapeutics, founded in 2013 and based in San Diego, specializes in mRNA medicines and vaccines. The company's pioneering technologies and extensive patent portfolio have established it as a leader in the field. Arcturus's collaboration with CSL Seqirus and its joint venture in Japan, ARCALIS, highlight its commitment to advancing mRNA vaccine and therapeutic development.

Meiji Seika Pharma, CSL's partner in Japan, has a long history of providing high-quality pharmaceutical products. As a leader in infectious disease treatment, the company is poised to play a crucial role in the distribution and implementation of KOSTAIVE® in Japan. The approval and distribution of KOSTAIVE® mark a significant milestone in the global effort to combat COVID-19 and protect public health.