An updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine developed by Australian biotechnology company CSL and sa-mRNA pioneer Arcturus Therapeutics has been granted approval from Japan’s Ministry of Health, Labor and Welfare (MHLWs)
KOSTAIVE is an updated vaccine that is targeted to protect against the JN.1 lineage of Omicron sub variants for adults 18 years of age and older.
CSL’s exclusive partner in Japan, Meiji Seika Pharma, will begin distributing the updated vaccine in time for the October COVID-19 vaccination campaign.
This marks the world’s first commercially available sa-mRNA COVID-19 vaccine for adults 18 and older.
In May 2024, a Japanese health ministry panel recommended that COVID-19 vaccines be updated to target the JN.1 lineage of Omicron sub variants for the 2024/2025 national immunisation program.
This aligns with recent recommendations from the World Health Organization.
“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,” said senior vice president and head of Global Regulatory Affairs, CSL, Emmanuelle Lecomte-Brisset,
“We look forward to introducing KOSTAIVE® in Japan as a safe, tolerable and more durable option in protecting against COVID-19.”
“We believe KOSTAIVE® has the potential to change the paradigm for COVID-19 vaccines in Japan,” said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL. “Today’s approval further demonstrates CSL’s promise to pursue, develop and deliver new innovative treatment options to protect public health.”
The approval is based on clinical evidence supporting the safety and effectiveness of CSL and Arcturus Therapeutics’ sa-mRNA COVID-19 vaccine.
This included published data demonstrating superior immunogenicity to Omicron BA 4/5 compared to a conventional mRNA COVID-19 vaccine booster and follow-up data demonstrating duration of immunity lasting up to one year.
