Moderna said that the Ministry of Health, Labour and Welfare (MHLW) of Japan 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. Distribution by Takeda in Japan will begin immediately.
“This is an important moment in Moderna's history as it is the first approval for a Moderna product in Japan. We would like to thank the MHLW, the participants in the study, and Takeda for helping to protect the Japanese population from COVID-19 with our vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We look forward to building our local team in Japan to continue to bring mRNA science to address additional unmet medical needs.”
The 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. This study is designed to evaluate the safety and immunogenicity of two vaccinations of COVID-19 Vaccine Moderna Intramuscular Injection at the 100 μg dose level given 28 days apart in 200 participants aged 20 years and above in Japan, said the company.
Initial results showed an immune response with results from Moderna's Phase 3 COVE study conducted in the U.S. Binding and neutralizing antibody titers were elevated at 28 days after the second dose of the Moderna COVID-19 vaccine candidate in 100% of participants. The vaccine candidate was generally well tolerated with no significant safety concerns reported. Participants will be followed through 12 months after the second vaccination, said the company.
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 have affirmed discussions reported by MHLW last week for an additional potential supply of 50 million doses from the beginning of 2022.