Japan Launches Early Study of Moderna’s COVID-19 Vaccine

A Massachusetts-based biotechnology company pioneering messenger RNA (mRNA) vaccines announced that the first participant was recently dosed in the Phase 1/2 study of Moderna’s vaccine candidate against COVID-19 in Japan.

Moderna, Inc confirmed this clinical trial is led by Takeda Pharmaceutical Co., based in Osaka, Japan.

TAK-919 is Takeda’s development code for Moderna’s COVID-19 vaccine candidate, known as mRNA-1273.  

“This is the first clinical trial of a Moderna product in Japan, and we thank Takeda for partnering with us to potentially protect the Japanese population from COVID-19 with a vaccine,” said Stéphane Bancel, CEO of Moderna, in a press release.

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 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.

Announced on October 29, 2020, this effort is part of a three-way agreement among Takeda, Moderna, and the Government of Japan’s Ministry of Health Labour and Welfare.

On December 18, 2020, the U.S. FDA issued an emergency use authorization that enables the experimental Moderna COVID-19 Vaccine for use in individuals 18 years of age and older. The Moderna COVID‑19 Vaccine has not been approved or licensed by the FDA.

Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 230 years of distinguished history 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 (mRNA) to an enterprise with its first medicine that has treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities.

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