Takeda Pharmaceutical Company Limited announced that the first subject was dosed in its Phase 1/2 immunogenicity and safety study of Novavax’ COVID-19 vaccine candidate (TAK-019) in Japan. Earlier this month, Takeda completed enrollment in the company’s Phase 1/2 immunogenicity and safety study of Moderna’s COVID-19 vaccine candidate (TAK-919) in Japan.
“Early in the pandemic, we made the decision to partner with other companies and leverage our substantial vaccine experience and capabilities to make COVID-19 vaccines available in Japan,” said Rajeev Venkayya, M.D., President of the Global Vaccine Business Unit, Takeda. “We have been pleased to see the outstanding Phase 3 efficacy data from the Moderna and Novavax programs and are excited to work with each company and the Government of Japan to help bring the pandemic to an end.”
Takeda previously announced its commitment to providing rapid and sustained access to COVID-19 vaccines in Japan through partnerships with Novavax and Moderna. Takeda will receive a manufacturing technology transfer from Novavax and will be responsible for the development and commercialization based on manufacturing capacity of over 250 million doses of TAK-019. The company will also import and distribute 50 million doses of TAK-919 as part of a joint partnership with Moderna and the Government of Japan’s Ministry of Health Labour and Welfare (MHLW).
Results from the TAK-919 study are expected in the first half of 2021 and results from the TAK-019 study in the second half of 2021. Once available, the study results will be submitted to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) as part of the NDA filing process. Pending regulatory approval, Takeda intends to start distributing TAK-919 in the first half of 2021 and aims to start distributing TAK-019 in late 2021.
TAK-919 clinical trial
This placebo-controlled Phase 1/2 study in Japan will evaluate the safety and immunogenicity of two vaccinations of TAK-919 given 28 days apart. Each participant was assigned to receive a placebo or a 0.5 ml dose of TAK-919 at both vaccinations. The trial completed enrollment of 200 participants aged 20 years and older on February 3, 2021. Participants will be followed for 12 months after the second vaccination.
TAK-019 clinical trial
This placebo-controlled Phase 1/2 study in Japan will evaluate the safety and immunogenicity of two vaccinations of TAK-019 given 21 days apart. The first subject in the TAK-019 trial was dosed in Japan on February 24, 2021 and Takeda intends to enroll 200 participants aged 20 years and older. Each participant will be assigned to receive a placebo or a 0.5 ml dose of TAK-019 at both vaccinations. Participants will be followed for 12 months after the second vaccination.
