Policy & Regulation
First Participant Dosed in Phase 1/2 Study of Moderna COVID-19 Vaccine in Japan Led by Takeda
21 January 2021 - - The first participant has been dosed in the Phase 1/2 study of US-based biotechnology company Moderna Inc's (NASDAQ: MRNA) vaccine candidate against COVID-19 (mRNA-1273 or TAK-919) in Japan, led by Japan-based Takeda Pharmaceutical Co., Ltd (NYSE: TAK), the company said.

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

This placebo-controlled Phase 1/2 study will evaluate the safety and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.

Takeda intends to enroll 200 participants aged 20 years and above in Japan. Each participant will be assigned to receive a placebo or a 100 μg dose at both vaccinations. Participants will be followed through 12 months after the second vaccination.

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

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA, to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed.

Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing.

Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.
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