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Novavax Announces Submission of New Drug Application in Japan for Approval of COVID-19 Vaccine
-- Takeda submits application for TAK-019/NVX-CoV2373, the first protein-based COVID-19 vaccine candidate for NDA, to Japan's Ministry of Health, Labour and
About this update from Novavax, Inc.
[{"type":"text","content":"-- Takeda submits application for TAK-019/NVX-CoV2373, the first protein-based COVID-19 vaccine candidate for NDA, to Japan's Ministry of Health, Labour and Welfare (MHLW)\n -- Interim data from Phase 1/2 trial in Japan demonstrate robust immune response and favorable tolerability with no serious adverse events\n\n\nGAITHERSBURG, Md., Dec. 15, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the submission of a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for its COVID-19 vaccine by its partner Takeda Pharmaceutical Company Limited (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.\nWith the support of the MHLW, the companies are working to establish the capability to manufacture TAK-019 at Takeda's facilities in Japan and aim to begin distribution in early 2022, pending regulatory approval. \n\"Today's submission marks further progress in our quest to ensure broad global access to our protein-based COVID-19 vaccine,\" said Stanley C. Erck, President and Chief Executive Officer of Novavax. \"Our partnership with Takeda reflects our shared commitment to tireless collaboration to deliver a COVID-19 vaccine, built on a well-understood vaccine platform.\"\nThe NDA submission includes an interim analysis from Takeda's ongoing Phase 1/2 immunogenicity and safety clinical trial of NVX-CoV2373/TAK-019 in Japan, in which the vaccine demonstrated a robust immune response and was well tolerated with no serious adverse events. Takeda submitted all available chemistry, manufacturing and controls (CMC), non-clinical and clinical data as of December 2021. Additional CMC data will be subsequently submitted to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) during the NDA review period.\nThe application also includes safety and efficacy data from Novavax' two pivotal Phase 3 trials: PREVENT-19, which included 30,000 participants in the U.S. and Mexico and demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against the predominantly circulating varia...