, pub-5475981771945671, DIRECT, f08c47fec0942fa0

Novavax Submits New Drug Application in Japan for Approval of COVID-19 Vaccine

Novavax Submits New Drug Application in Japan for Approval of COVID-19 Vaccine

GAITHERSBURG, Md., Dec. 16, 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.

With 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.

“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.”

The 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.

The 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 variants of concern and variants of interest, and 90.4% efficacy overall; and a trial of 15,000 participants in the U.K. that demonstrated efficacy of 96.4% against the original virus 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.

In addition to the submission of the NDA to MHLW in Japan, Novavax and Serum Institute of India Pvt. Ltd. (SII) recently received Emergency Use Authorization (EUA) for the vaccine in Indonesia and the Philippines, and the companies have filed for EUA in India and for Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax also announced regulatory filings for its vaccine in the United KingdomAustraliaNew ZealandCanadaSingaporeUnited Arab Emirates, and the European Union and with the WHO. Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA) submission to MFDS in South Korea. Novavax expects to submit its complete CMC data package to the U.S. FDA by the end of the year.