On Mar. 5, 2021,Takeda Pharmaceutical announced that it has submitted a New Drug Application to the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) to import and distribute Moderna’s mRNA COVID-19 vaccine candidate (TAK-919).

Takeda is currently conducting a Phase 1/2 immunogenicity and safety trial studying two vaccinations of TAK-919 given 28 days apart versus placebo in 200 healthy Japanese adults. Study results are expected to be available in May, at which point they will be submitted to the Japan Pharmaceuticals and Medical Devices Agency (PMDA). The submission today included safety and efficacy results from Moderna’s pivotal Phase 3 COVE trial conducted in the US.

In 2020, Takeda announced two partnerships to support the need for rapid and sustained access to COVID-19 vaccines in Japan. The three-way agreement with Moderna and the MHLW is to import and distribute 50 million doses of TAK-919 in Japan. The partnership with Novavax is for the development and commercialization based on manufacturing capacity of over 250 million doses of their COVID-19 vaccine candidate (TAK-019) in Japan. In both cases, Takeda will be the Marketing Authorization Holder in Japan if the vaccine candidates are approved.

Takeda’s efforts to bring Moderna’s and Novavax’ vaccine candidates to Japan are supported by the MHLW and the Japan Agency for Medical Research and Development (AMED).

Takeda is taking a comprehensive approach to treat and prevent COVID-19 through multiple activities and partnerships focused on advancing development of a variety of potential therapies and vaccines. Takeda co-founded the CoVig-19 Plasma Alliance and joined forces with other leading plasma companies to develop and manufacture a hyperimmune globulin medicine which is currently being evaluated in a clinical trial. The Alliance is also participating in The Fight Is In Us coalition and related convalescent plasma donation campaign.