Policy & Regulation
Moderna files for NDA to import and distribute 50 million of COVID-19 vaccine candidate doses in Japan
8 March 2021 -

Biotechnology company Moderna Inc (Nasdaq:MRNA) said on Friday that it has submitted a New Drug Application to Japan's Ministry of Health, Labour and Welfare (MHLW) to import and distribute its vaccine candidate against COVID-19 ( mRNA-1273) in the nation.

This development is being initiated by Takeda Pharmaceutical Co Ltd (NYSE:TAK). The TAK-919 (mRNA-1273) 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. It has completed enrollment of this Phase 1/2 study in February 2021.

Upon availability, the Phase 1/2 study results will be submitted to the Japan Pharmaceuticals and Medical Devices Agency (PMDA), added Takeda.

Pending licensure in Japan, Takeda will import and distribute 50 million doses of Moderna's COVID-19 vaccine candidate starting in the first half of 2021.

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