Moderna Announces New Drug Application Submitted to Import and Distribute Moderna’s COVID-19 Vaccine Candidate in Japan

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Takeda Pharmaceutical Co., Ltd (NYSE: TAK) submitted a New Drug Application to the Government of Japan’s Ministry of Health, Labour and Welfare (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.

“Submitting this NDA is an important step in the clinical development of our COVID-19 vaccine in Japan,” said Stéphane Bancel, Chief Executive Officer of Moderna. “The Phase 1/2 study is the first clinical trial of a…