On May 21, 2021, Moderna announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan granted special approval under article 14-3 of the Pharmaceuticals and Medical Devices Act for emergency use of Moderna’s mRNA COVID-19 vaccine, known as COVID-19 Vaccine Moderna Intramuscular Injection, in Japan. Distribution by Takeda in Japan began immediately.

The approval was based on Moderna’s Phase 3 COVE study results and positive initial clinical data from the Takeda-led placebo-controlled Phase 1/2 study. This study was designed to evaluate the safety and immunogenicity of two vaccinations of COVID-19 Vaccine Moderna Intramuscular Injection at the 100 μg dose level given 28 days apart in 200 participants aged 20 years and above in Japan. Initial results showed an immune response with results from Moderna’s Phase 3 COVE study conducted in the U.S. Binding and neutralizing antibody titers were elevated at 28 days after the second dose of the Moderna COVID-19 vaccine candidate in 100% of participants. The vaccine candidate was generally well tolerated with no significant safety concerns reported. Participants were followed through 12 months after the second vaccination.

Takeda and Moderna previously announced that Takeda will import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate starting in the first half of 2021. The companies have affirmed discussions reported by MHLW for an additional potential supply of 50 million doses from the beginning of 2022.