CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics have announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®. The new vaccine is designed to protect against the JN.1 lineage of Omicron subvariants and is intended for adults aged 18 and older.
CSL’s exclusive partner in Japan, Meiji Seika Pharma, will distribute the updated KOSTAIVE® sa-mRNA COVID-19 vaccine starting with the October vaccination campaign. This marks the first commercially available sa-mRNA COVID-19 vaccine for adults 18 and older.
In May 2024, a Japanese health ministry panel recommended updating COVID-19 vaccines to target the JN.1 lineage of Omicron subvariants, aligning with recent World Health Organization guidelines.
Emmanuelle Lecomte-Brisset, Senior Vice President and Head of Global Regulatory Affairs at CSL, expressed satisfaction with the approval, noting, “We are on track to distribute KOSTAIVE® for the October campaign and are excited to offer a safe, effective option against COVID-19.”
Jonathan Edelman, M.D., Senior Vice President of CSL’s Vaccines Innovation Unit, highlighted the vaccine’s potential impact: “Today’s approval underscores CSL’s commitment to delivering innovative treatments for public health.”
The approval is supported by clinical data showing KOSTAIVE® provides superior immunity against Omicron BA 4/5 compared to traditional mRNA vaccines and maintains immunity for up to a year.
Arcturus Therapeutics CEO Joseph Payne added, “We are excited that our sa-mRNA technology will now protect people in Japan and look forward to expanding KOSTAIVE® to more countries.”
About sa-mRNA
Unlike conventional mRNA vaccines, self-amplifying mRNA vaccines enhance the immune response by instructing the body to produce more mRNA and protein.
About CSL
CSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology leader with a diverse portfolio, including treatments for haemophilia, vaccines for influenza, and therapies for iron deficiency and nephrology. Since its founding in 1916, CSL has focused on life-saving innovations and now operates in over 100 countries with 32,000 employees.
