Japan Approves CSL and Arcturus’s sa-mRNA COVID-19 Vaccine, KOSTAIVE

CSL

KING OF PRUSSIA, PA — Japan’s Ministry of Health, Labor and Welfare recently granted approval for CSL and Arcturus Therapeutics’ self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®. This updated vaccine is designed to combat the JN.1 lineage of Omicron subvariants for adults aged 18 and over, marking it as the first commercially available sa-mRNA COVID-19 vaccine of its kind.

Meiji Seika Pharma, CSL’s exclusive partner in Japan, will handle the distribution of KOSTAIVE® during the upcoming October COVID-19 vaccination campaign. This development aligns with Japan’s health ministry panel’s May 2024 recommendation to update COVID-19 vaccines to target the JN.1 Omicron subvariants, a move supported by the World Health Organization’s guidance.

“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,” stated Emmanuelle Lecomte-Brisset, Senior Vice President and Head of Global Regulatory Affairs at CSL. The company emphasizes the vaccine’s role as a safe and durable option in enhancing COVID-19 protection.

Jonathan Edelman, M.D., Senior Vice President of the Vaccines Innovation Unit at CSL, remarked, “We believe KOSTAIVE® has the potential to change the paradigm for COVID-19 vaccines in Japan.” He highlighted the approval as a testament to CSL’s commitment to delivering innovative vaccines that uphold public health.

The decision follows robust clinical evidence showcasing the vaccine’s superior immunogenicity against Omicron BA 4/5 compared to traditional mRNA boosters, with data indicating immunity lasting up to a year. Joseph Payne, CEO of Arcturus Therapeutics, expressed enthusiasm about the technology’s availability in Japan, noting, “We are pleased that our sa-mRNA technology will be available to vaccinate people in Japan against COVID-19, which remains an ongoing risk to public health around the world.”

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This approval represents a pivotal step in advancing COVID-19 vaccine technology and distribution, with potential implications for global vaccine strategies.

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