Moderna’s updated COVID-19 vaccine gets approval in Japan

JAPAN— Moderna, Inc., a global pioneer in mRNA medication development, has been granted permission from Japan’s Ministry of Health, Labor, and Welfare (MHLW) for a partial change application.

This permission will allow Moderna to enhance a  version of its COVID-19 mRNA vaccine, Spikevax, which precisely targets the SARS-CoV-2 variant JN.1.

This decision comes after a Japanese health ministry panel recommended in May 2024 that COVID-19 vaccines be altered to target the JN.1 family of Omicron subvariants for the 2024/2025 National Immunization Program (NIP).

The panel’s recommendations are consistent with the World Health Organization’s (WHO) Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC), which advises for the use of a monovalent JN.1 lineage for COVID-19 vaccine antigen formulation.

Moderna stated in a statement that the improved vaccine will be available to those aged 65 and older as part of Japan’s National Immunization Program, as well as to qualifying adults aged 60 to 64.

Given Japan’s demographic profile, which includes nearly 30% of the population aged 65 and older, this update is very relevant.

Respiratory viruses continue to cause a substantial disease burden in older persons, making national immunization programs vital to lowering this burden and alleviating future demand on the healthcare system.

Theis updated COVID-19 vaccine will be available on a voluntary basis for those who are not enrolled in the usual immunization program, but at their own expense.

This technique allows for greater flexibility for people who want to get the vaccine but do not meet the NIP eligibility requirements.

Stéphane Bancel, Chief Executive Officer of Moderna, expressed gratitude for the MHLW’s approval of the updated COVID-19 mRNA vaccine.

Bancel emphasized on the importance of vaccination with the latest formulations, which are designed to protect against circulating strains.

She also highlighted that as COVID-19 vaccination becomes a routine inoculation, similar to seasonal flu vaccines, individuals will have the convenience of receiving their COVID-19 vaccine alongside their flu shot.

This announcement comes just a month after Moderna entered into a strategic agreement with Mitsubishi Tanabe Pharma Corporation.

This partnership aims to support the co-promotion of Moderna’s mRNA respiratory vaccine portfolio in Japan, which includes the Spikevax COVID-19 vaccine.

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