KING OF PRUSSIA, PA and SAN DIEGO, CA — CSL and Arcturus Therapeutics have announced that Japan’s Ministry of Health, Labor and Welfare has granted approval for their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®. This updated vaccine specifically targets the JN.1 lineage of Omicron subvariants and is approved for adults aged 18 and older. CSL’s partner, Meiji Seika Pharma, is set to distribute the vaccine in Japan, aligning with the October COVID-19 vaccination campaign. This marks the introduction of the first sa-mRNA COVID-19 vaccine for adults in Japan.
The approval comes after a recommendation from a Japanese health ministry panel in May 2024, which advised updating COVID-19 vaccines to address the JN.1 lineage for the 2024/2025 national immunization program. This move is consistent with global health guidelines, including those from the World Health Organization.
Emmanuelle Lecomte-Brisset, CSL’s Senior Vice President and Head of Global Regulatory Affairs, expressed satisfaction with the approval, noting, “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.”
Jonathan Edelman, M.D., Senior Vice President of the Vaccines Innovation Unit at CSL, emphasized the potential impact of KOSTAIVE®, stating, “We believe KOSTAIVE® has the potential to change the paradigm for COVID-19 vaccines in Japan.”
Joseph Payne, CEO of Arcturus Therapeutics, remarked on the significance of their technology, saying, “We are pleased that our sa-mRNA technology will be available to vaccinate people in Japan against COVID-19, which remains an ongoing risk to public health around the world.”
The approval is based on clinical evidence demonstrating the vaccine’s safety and effectiveness, including superior immunogenicity against Omicron BA 4/5 variants compared to conventional mRNA boosters, with immunity lasting up to one year.
Support the local news that supports Chester County. MyChesCo delivers reliable, fact-based reporting and essential community resources—free for everyone. If you value that, click here to become a patron today.