Japan's Ministry of Health, Labor and Welfare (MHLW) has granted approval and authorization for Kostaive, an updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine developed by CSL and Arcturus Therapeutics. This vaccine is specifically designed to protect against the JN.1 lineage of Omicron subvariants in adults aged 18 and older, addressing the evolving landscape of COVID-19. Meiji Seika Pharma, CSL's exclusive partner in Japan, will distribute the vaccine in time for the October COVID-19 vaccination campaign. This marks the world's first commercially available sa-mRNA COVID-19 vaccine for adults.
Clinical Evidence and Immunogenicity
The approval of Kostaive is based on robust clinical evidence demonstrating the safety and effectiveness of the sa-mRNA COVID-19 vaccine. Published data indicate that Kostaive exhibits superior immunogenicity to Omicron BA 4/5 compared to conventional mRNA COVID-19 vaccine boosters. Follow-up data further reveals that the duration of immunity can last up to one year, providing a more durable protection against COVID-19.
Self-Amplifying mRNA Technology
Kostaive utilizes self-amplifying mRNA (sa-mRNA) technology, which differs from conventional mRNA vaccines. While both types provide cells with a blueprint to produce proteins that trigger an immune response, sa-mRNA vaccines instruct the body to create more mRNA and protein, thereby boosting the immune response. This mechanism potentially leads to a more robust and longer-lasting immunity compared to traditional mRNA vaccines.
Alignment with Public Health Recommendations
The Japanese health ministry panel recommended in May 2024 that COVID-19 vaccines be updated to target the JN.1 lineage of Omicron subvariants for the 2024/2025 national immunization program. This recommendation aligns with recent guidance from the World Health Organization (WHO), reflecting a global effort to adapt vaccines to the evolving strains of the virus.
Industry Perspectives
Emmanuelle Lecomte-Brisset, senior vice president and head of global regulatory affairs at CSL, stated, "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."
Jonathan Edelman, M.D., senior vice president, vaccines innovation unit, CSL, added, "We believe Kostaive has the potential to change the paradigm for Covid-19 vaccines in Japan. Today’s approval further demonstrates CSL's promise to pursue, develop and deliver new innovative treatment options to protect public health."
Joseph Payne, chief executive officer of Arcturus Therapeutics, commented, "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. We look forward to continuing to work with CSL and regulators to explore the development of Kostaive in additional countries."
