CANBERA (dpa-AFX) - Australian biotechnology company CSL Ltd. (CSL.AX, CSLLY.PK) and sa-mRNA pioneer Arcturus Therapeutics, announced Friday that Japan's Ministry of Health, Labor and Welfare (MHLWs) granted approval and authorization for their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE.
KOSTAIVE, the world's first self-amplifying sa-mRNA COVID-19 vaccine, was approved for adults 18 years of age and older in November 2023 in Japan.
The updated vaccine is targeted to protect against the JN.1 lineage of Omicron subvariants 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, marking the world's first commercially available sa-mRNA COVID-19 vaccine for adults 18 and older.
The approval is based on clinical evidence supporting the safety and effectiveness of the sa-mRNA COVID-19 vaccine, including 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.
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