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Novavax: SK Bioscience Submits BLA For COVID-19 Vaccine Candidate, NVX-CoV2373, To South Korea' MFDS

Novavax Inc. (NVAX) said that SK bioscience has summited a biologics license application for NVX-CoV2373, the first protein-based COVID-19 vaccine candidate, to South Korea's Ministry of Food and Drug Safety.

NVX-CoV2373 is Novavax' recombinant nanoparticle COVID-19 vaccine with Matrix-M adjuvant.

In collaboration with Novavax, SK bioscience initiated the rolling submission process for NVX-CoV2373 to South Korea's Ministry of Food and Drug Safety in April of this year. The completion of a BLA submission to the agency marks the final review stage for authorization of NVX-CoV2373 in Korea.

SK bioscience finalized an advance purchase agreement with the Korean government to supply 40 million doses of NVX-CoV2373 to South Korea earlier this year.

Novavax recently announced authorization of its vaccine in Indonesia. The company also announced regulatory filings for its vaccine in the United Kingdom, Australia, New Zealand and Canada, as well as the complete submission of all data and modules in the European Union to support the final regulatory review of its dossier by the European Medicines Agency.

Novavax and the Serum Institute of India also announced filings in India and the Philippines in August. Novavax expects to submit the complete package to the U.S. FDA by the end of the year.

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