Japan's Regulators Approve Moderna's COVID-19 Vaccine

The COVID-19 Vaccine Moderna Intramuscular Injection (TAK-919) was granted Special Approval in Japan by the Ministry of Health, Labour, and Welfare (MHLW) on May 21, 2021.

Osaka-based Takeda Pharmaceutical Company Limited announced the approval was based on positive clinical data from Takeda’s Phase 1/2 immunogenicity and safety clinical trial of Moderna’s COVID-19 vaccine in Japan.

The approval results from a three-way agreement announced on October 29, 2020, between Takeda, Moderna, and the Government of Japan’s MHLW to distribute 50 million doses of TAK-919 in Japan in the first half of 2021. 

“This is an important step in Takeda’s support of Japan’s pandemic response,” stated Rajeev Venkayya, president of the Global Vaccine Business Unit at Takeda, in a related press statement. 

“Moderna’s vaccine has demonstrated an excellent safety and effectiveness profile to date, and we are excited to make it available to the Japanese population.”

The COVID-19 Vaccine Moderna (mRNA-1273) is an mRNA vaccine targeted against the SARS-CoV-2 coronavirus encoding for a prefusion stabilized form of the Spike (S) protein.

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