Japan Launches Study of Moderna's COVID-19 Vaccine
Massachusetts-based Moderna Inc. announced that the first participant had been dosed in the Phase 1/2 study of Moderna’s COVID-19 vaccine candidate (mRNA-1273) in Japan, led by Takeda Pharmaceutical Co., Ltd. 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.
“We are pleased that this Phase 1/2 study of our COVID-19 vaccine in healthy adults in Japan has begun. 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.
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.
On December 18, 2020, the U.S. FDA issued an emergency use authorization that enables the experimental Moderna COVID-19 Vaccine to be administered in the USA.