15 December 2021 - Takeda submits application for TAK-019/NVX-CoV2373, the first protein-based COVID-19 vaccine candidate for new drug application, to Japan's Ministry of Health, Labour and Welfare.
Novavax today announced the submission of a new drug application to the Ministry of Health, Labour and Welfare (MHLW) in Japan for its COVID-19 vaccine by its partner Takeda.
Novavax' recombinant nanoparticle COVID-19 vaccine with Matrix-M adjuvant, known as TAK-019 in Japan and NVX-CoV2373 outside Japan, is the first protein-based COVID-19 vaccine to be submitted under an NDA in Japan.