Ministry of Health, Labour and Welfare in Japan approves partial change application for Moderna's COVID-19 mRNA vaccine targeting SARS-COV-2 Variant JN.1.

"We appreciate the Ministry of Health, Labour and Welfare approval decision for our updated COVID-19 mRNA vaccine," said Stéphane Bancel, Chief Executive Officer of Moderna. "It is important that people are vaccinated with the latest updated COVID-19 vaccines that can protect against circulating strains. With COVID-19 vaccination becoming a routine inoculation similar to seasonal flu vaccines, individuals will be able to receive their updated COVID-19 vaccine alongside their flu vaccine this fall."

In May 2024, a Japanese health ministry panel recommended that COVID-19 vaccines be updated to target the JN.1 family of Omicron subvariants for the 2024/2025 national immunization program (NIP). This guidance aligns with the recommendations from the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) on the use of a monovalent JN.1 lineage for COVID-19 vaccine antigen composition. The NIP in Japan will offer COVID-19 vaccination to individuals aged 65 and older, as well as qualifying individuals aged 60 to 64. Japan has the highest proportion of older adults worldwide, with approximately 30% of its population aged 65 and above. Given that respiratory viruses are a leading disease burden in people older than 65, NIPs are crucial in reducing the burden of disease and, ultimately, future pressure on the health system. Individuals requesting COVID-19 vaccination outside of the regular program will have the option of voluntary vaccination at their own expense.

In July, Moderna entered into an agreement with Mitsubishi Tanabe Pharma Corporation to support the co-promotion of Moderna's mRNA respiratory vaccine portfolio in Japan, including Moderna's COVID-19 vaccine, Spikevax.