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CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor and Welfare has approved their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®, for adults 18 and older. The vaccine is tailored to protect against the JN.1 lineage of Omicron subvariants. Meiji Seika Pharma, CSL's exclusive partner in Japan, will distribute the vaccine for the October COVID-19 vaccination campaign.

KOSTAIVE® is the world's first commercially available sa-mRNA COVID-19 vaccine. Clinical evidence supports its safety and effectiveness, with data showing superior immunogenicity to Omicron BA 4/5 compared to conventional mRNA vaccines and immunity lasting up to one year. This approval aligns with recent World Health Organization recommendations and demonstrates CSL and Arcturus' commitment to innovative vaccine technology for viral respiratory diseases.

CSL and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor and Welfare has approved their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®, for adults 18 and older. The vaccine is tailored to protect against the JN.1 lineage of Omicron subvariants. Meiji Seika Pharma, CSL's exclusive partner in Japan, will distribute the vaccine for the October 2024 vaccination campaign.

KOSTAIVE® is the world's first commercially available sa-mRNA COVID-19 vaccine for adults. Clinical data showed superior immunogenicity to Omicron BA 4/5 compared to conventional mRNA vaccines and immunity lasting up to one year. This approval aligns with recent World Health Organization recommendations and demonstrates CSL and Arcturus' commitment to innovative vaccine technology for viral respiratory diseases.

CSL Seqirus, a CSL business, has commenced shipping its influenza vaccines for the 2024/25 flu season. The company is the only manufacturer in the U.S. to offer a differentiated range of influenza vaccines for individuals aged six months and older. This year, the vaccines are available in trivalent formulations following FDA guidelines. The portfolio includes FLUCELVAX®, a cell-based vaccine; FLUAD®, an adjuvanted vaccine for seniors; and AFLURIA®, an egg-based vaccine. CSL Seqirus aims to address the declining flu vaccination rates, which have dropped significantly in recent years, posing a public health risk. The CDC recommends annual flu vaccinations, especially for high-risk groups such as the elderly, pregnant individuals, and young children. The company is focused on reversing this trend and supporting healthcare providers in increasing vaccination rates.

CSL Seqirus has been awarded a contract by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to produce 4.8 million doses of pre-pandemic H5N1 vaccine for the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) program. This is the fourth such award for CSL Seqirus, reinforcing its role in pandemic preparedness. The company's Holly Springs, NC facility, built through a public-private partnership with BARDA, can produce up to 150 million doses within six months of a pandemic declaration. The facility is the largest cell-based influenza vaccine producer globally.

CSL and Arcturus Therapeutics announced pivotal data published in Nature Communications demonstrating the efficacy and tolerability of their novel self-amplifying (sa-mRNA) COVID-19 vaccine, ARCT-154. The vaccine, the first of its kind approved in Japan, showed 100% efficacy against severe COVID-19 in healthy adults aged 18-59 and over 90% efficacy in older adults or those with comorbidities. The study, covering phases 1 through 3b, indicated that two 5 μg doses were well-tolerated and provided robust protection against multiple strains, including Omicron BA 4/5. The results underline the potential of the sa-mRNA technology to offer long-lasting immunity and superior protection compared to traditional mRNA vaccines.

CSL and Arcturus Therapeutics announced that Nature Communications published results from an integrated phase 1/2/3a/3b study on ARCT-154, a self-amplifying mRNA COVID-19 vaccine. The study demonstrates that two 5 μg doses of ARCT-154 were well-tolerated and provided significant protection against multiple COVID-19 strains. The vaccine showed 100% efficacy against severe COVID-19 in healthy individuals aged 18-59 and over 90% efficacy in at-risk populations. These results add to previous findings showing superior immunogenicity to Omicron BA 4/5 and longer-lasting immunity compared to conventional mRNA boosters. The vaccine's approval in Japan marks a significant milestone in the fight against COVID-19.

CSL Seqirus, a business of CSL, announced a real-world evidence study showing that a cell-based quadrivalent influenza vaccine was more effective than egg-based vaccines in preventing test-confirmed influenza over three seasons. The study revealed a relative vaccine effectiveness of at least 10% higher for the cell-based vaccine across three flu seasons.