CSL’s mRNA Covid-19 vaccine approved for sale in Japan

Japan’s Ministry of Health, Labor and Welfare has approved biotechnology manufacturer CSL and Arcturus Therapeutics’ new Covid-19 vaccine against the JN.1 strain of the disease.

The ministry approved for sale the two companies’ ‘updated self-amplifying mRNA Covid-19 vaccine for protection against JN.1 Strain’, to be distributed in Japan by Meiji Seika Pharma.

According to CSL the approval underscores CSL and Arcturus Therapeutics’ commitment to delivering disruptive technologies to combat Covid-19 and other respiratory viral diseases to protect public health.

CSL is the world’s second largest manufacturer of vaccines, and the traditional maker of vaccines in Australia since World War 1.

KOSTAIVE, the world’s first self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, was approved for adults 18 years of age and older in November 2023, with the updated sa-mRNA COVID-19 vaccine now approved tailored to protect against the JN.1 lineage of Omicron subvariants.

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 Senior Vice President and Head of Global Regulatory Affairs of CSL Emmanuelle Lecomte-Brisset said: “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

“We look forward to introducing KOSTAIVE in Japan as a safe, tolerable and more durable option in protecting against COVID-19.”

In May 2024, a Japanese health ministry panel recommended that COVID-19 vaccines be updated to target the JN.1 lineage of Omicron subvariants for the 2024/2025 national immunization programme. This aligns with recent recommendations from the World Health Organization.

CSL believes that the new vaccine has the potential to change the paradigm for COVID-19 vaccines in Japan’.

The approval is based on clinical evidence supporting the safety and effectiveness of CSL and Arcturus Therapeutics’ 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.

mRNA vaccines help protect against infectious diseases by providing a blueprint for cells in the body to make a protein to help the immune systems recognise and fight the disease. Unlike conventional mRNA vaccines, self-amplifying mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response.

Picture: CSL Seqirus