CSL and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval forARCT-154, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older. The approval is based on positive clinical data from several ARCT-154 studies, including an ongoing 16,000 subject efficacy study performed in Vietnam as well as a Phase 3 COVID-19 booster trial, which achieved higher immunogenicity results and a favorable safety profile compared to a standard mRNA COVID-19 vaccine comparison. Initial study results have been published in MedRxiv and are expected to be published in a peer-reviewed journal by the end of the year.

CSL's vaccine business, CSL Seqirus, one of the largest influenza vaccine providers in the world, partnered exclusively with Meiji Seika Pharma for distribution of the sa-mRNA COVID vaccine, ARCT 154, in Japan.