Takeda Pharmaceutical Company has announced that the Ministry of Health, Labour and Welfare (MHLW) granted special approval under article 14-3 of the Pharmaceuticals and Medical Devices Act for emergency use of Moderna’s mRNA COVID-19 vaccine, TAK-919, now known as COVID-19 Vaccine Moderna Intramuscular Injection, in Japan.
The approval is based on positive clinical data from Takeda’s Phase 1/2 immunogenicity and safety clinical trial of Moderna’s COVID-19 vaccine in Japan, which showed an immune response consistent with results from Moderna’s pivotal Phase 3 COVE trial conducted in the United States. Takeda plans to begin distribution in Japan immediately.
“This is an important step in Takeda’s support of Japan’s pandemic response,” said Rajeev Venkayya, president of the Global Vaccine Business Unit at Takeda. “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 approval is the result of a three-way agreement announced in October 2020 with Moderna and Government of Japan’s Ministry of Health Labour and Welfare (MHLW) to distribute 50 million doses of TAK-919 in Japan in the first half of 2021. Takeda also entered into a collaboration with Novavax to develop, manufacture and commercialize Novavax’ COVID-19 vaccine candidate (TAK-019) in Japan.
