Takeda Submits NDA To Import And Distribute Moderna's COVID-19 Vaccine Candidate In Japan

(RTTNews) - Moderna Inc. (MRNA) said Friday that Takeda Pharmaceutical Co., Ltd (TAK) submitted a New Drug Application to the Government of Japan's Ministry of Health, Labour and Welfare or MHLW to import and distribute Moderna's vaccine candidate against COVID-19 (mRNA-1273 or TAK-919) in Japan.

TAK-919 is Takeda's development code for Moderna's COVID-19 vaccine candidate.

Takeda is conducting a placebo-controlled Phase 1/2 study designed to evaluate the safety and immunogenicity of two vaccinations of mRNA-1273 at the 100 µg dose level given 28 days apart in 200 participants aged 20 years and above in Japan. Participants will be followed through 12 months after the second vaccination.

Previously, the companies announced that Takeda would import and distribute 50 million doses of Moderna's COVID-19 vaccine candidate starting in the first half of 2021, pending licensure in Japan.