Novavax Submits BLA for COVID Vax in South Korea

Novavax, Inc., a biotechnology company dedicated to developing next-generation vaccines for serious infectious diseases, and SK bioscience, Co. Ltd., a biotechnology company in South Korea, have submitted a Biologics License Application (BLA) for Novavax’ COVID-19 vaccine to South Korea’s Ministry of Food and Drug Safety (MFDS). NVX-CoV2373, Novavax’ recombinant nanoparticle COVID-19 vaccine with Matrix-M adjuvant, is the first protein-based COVID-19 vaccine to be submitted for BLA in Korea.
 
In collaboration with Novavax, SK bioscience initiated the rolling submission process for NVX-CoV2373 to the MFDS in April of this year. The completion of a BLA submission to the MFDS marks the final review stage for authorization of NVX-CoV2373 in Korea.
 
Novavax and SK bioscience have an existing manufacturing and licensing collaboration that is intended to provide broad and equitable access to NVX-CoV2373 both in Korea and globally through the COVAX Facility. 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 UK, Australia, New Zealand and Canada, as well as the complete submission of all data and modules in the EU to support the final regulatory review of its dossier by the EMA. 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.