On May 31, 2022, Moderna and Takeda announced the transfer of the marketing authorization for Moderna’s COVID-19 vaccine SpikevaxTM (mRNA-1273) from Takeda to Moderna in Japan as of August 1, 2022.

Moderna assumed responsibility for all Spikevax™ activities, including import, local regulatory, development, quality assurance, and commercialization. Takeda continued to provide distribution support under the current national vaccination campaign for Moderna COVID-19 vaccines for a transitional period. Both companies were responsible for ensuring proper implementation of operations associated with this transfer.

Moderna’s COVID-19 vaccine Spikevax^TM has been granted authorization for special approval by the Ministry of Health, Labour and Welfare of Japan. In Japan, it is indicated for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. A dose may be given to people aged 12 years or older. A second dose should be given as soon as possible if more than four weeks have passed since the first vaccination. A booster dose may be given at least five months after the second dose for people aged 18 years and older. A fourth dose may be given at least five months after the third dose for the elderly etc. considering the benefits and risks.