Novavax Files For Approval Of Its COVID-19 Vaccine In Japan

Novavax Inc NVAX has submitted a marketing application in Japan seeking approval for its COVID-19 vaccine by its partner Takeda Pharmaceutical Co Ltd TAK.

• The protein-based COVID-19 vaccine includes Matrix-M adjuvant and is known as TAK-019 in Japan and NVX-CoV2373 outside Japan.
• With the support of the MHLW, the companies are working to establish the capability to manufacture TAK-019 at Takeda's facilities in Japan. The companies aim to begin distribution in early 2022, pending regulatory approval.
• In addition to the submission in Japan, Novavax and Serum Institute of India Pvt Ltd recently received Emergency Use Authorization (EUA) for the vaccine in Indonesia and the Philippines.
• The companies have filed for EUA in India and Emergency Use Listing with the World Health Organization.
• The application also includes safety and efficacy data from Novavax's two Phase 3 trials: PREVENT-19, which included 30,000 participants and demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against the predominantly circulating variants of concern.
• Another trial of 15,000 participants in the U.K. demonstrated the efficacy of 96.4% against the strain, 86.3% against the Alpha (B.1.1.7) variant, and 89.7% efficacy overall.
• In both trials, NVX-CoV2373 demonstrated a reassuring safety and tolerability profile.
• Related Link: Serum Institute's CEO Expects To Launch Novavax Vaccine For Kids In Six Months: Reuters
• Price Action: NVAX shares are up 2.84% at $184.49 during the premarket session on the last check Thursday.