Novavax, Inc. (NVAX), a biotechnology company, announced late Wednesday that its the submission of a New Drug Application or NDA in Japan for its COVID-19 vaccine by its partner Takeda Pharmaceutical Co. Ltd. (TKPHF.PK,TAK).
The NDA was submitted to Japan's Ministry of Health, Labour and Welfare or MHLW.
Novavax stated that its 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. The companies aim to begin distribution in early 2022, pending regulatory approval.
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.
The companies have filed for EUA in India and for Emergency Use Listing with the World Health Organization.
Novavax also announced regulatory filings for its vaccine in the United Kingdom, Australia, New Zealand, Canada, Singapore, United Arab Emirates, and the European Union and with the WHO.
Additionally, Novavax and SK bioscience announced a Biologics License Application 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.
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