Moderna, Inc. announced Friday that its mRNA COVID-19 vaccine has been approved in Japan for emergency use. Japan's Takeda Pharmaceutical Co. Ltd., which is in deal with Moderna, will begin the vaccine distribution in Japan immediately.
The Ministry of Health, Labour and Welfare or MHLW in Japan has granted special approval under article 14-3 of the Pharmaceuticals and Medical Devices Act for emergency use of Moderna's mRNA COVID-19 vaccine, now known as COVID-19 Vaccine Moderna Intramuscular Injection, in Japan.
Moderna's COVID-19 vaccine is authorized for emergency use in adults aged 18 years and older.
The latest approval is based on Moderna's Phase 3 COVE study results and positive initial clinical data from the Takeda-led placebo-controlled Phase 1/2 study. The results showed an immune response consistent with results from Moderna's pivotal Phase 3 COVE trial conducted in the United States.
Stphane Bancel, Chief Executive Officer of Moderna, said, "This is an important moment in Moderna's history as it is the first approval for a Moderna product in Japan."
Takeda and Moderna previously announced that Takeda will import and distribute 50 million doses of Moderna's COVID-19 vaccine candidate starting in the first half of 2021. The companies also confirmed discussions reported by MHLW last week for an additional potential supply of 50 million doses from the beginning of 2022.
Meanwhile, Takeda said it has also entered into a collaboration with Novavax to develop, manufacture and commercialize Novavax' COVID-19 vaccine candidate (TAK-019) in Japan.
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