Novavax, Inc. (Nasdaq: NVAX) and SK bioscience, Co. Limited, a vaccine business subsidiary of Korea-based SK Group, has announced that South Korea’s Ministry of Food and Drug Safety (MFDS) has approved a Biologics License Application (BLA) from SK bioscience for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization in individuals 18 years of age and older for the prevention of COVID-19 caused by SARS-CoV-2. Nuvaxovid™, Novavax’ COVID-19 vaccine also known as NVX-CoV2373, is the first protein-based COVID-19 vaccine to be approved for commercial use in South Korea and will be manufactured and marketed in the country by SK bioscience.
“Novavax is proud to bring our COVID-19 vaccine to South Korea at a critical time in the pandemic as both the Delta and Omicron variants have taken hold,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We thank our partners at SK bioscience for their commitment to this public health challenge and the MFDS for its thorough assessment of our data as we look forward to helping address major obstacles to controlling the pandemic through the additional option of our protein-based vaccine.”
SK bioscience has an advance purchase agreement with the South Korean government to supply 40 million doses of Novavax’ vaccine. The companies also recently announced expanded collaboration and license agreements that are expected to increase manufacturing capacity and provide SK bioscience with additional non-exclusive territories.
Novavax’ vaccine also recently received conditional marketing authorization (CMA) in the European Union and emergency use listing (EUL) from the World Health Organization (WHO) under the brand name Nuvaxovid. The Novavax/Serum Institute of India Pvt. Ltd. vaccine (brand name, Covovax™) recently received emergency use authorization (EUA) in India, Indonesia and the Philippines, as well as WHO EUL. Together, the WHO EULs for the vaccine from both companies reflect the potential opportunity for authorization in over 170 countries. The vaccine is also currently under review by multiple additional regulatory agencies worldwide and the company expects to receive additional worldwide authorizations in the first half of 2022. This includes the submission of its complete chemistry, manufacturing and controls (CMC) data package to the U.S. Food and Drug Administration (FDA) at the end of 2021. The company expects to submit a request for EUA for the vaccine in the U.S. after one month in accordance with guidance from the FDA regarding submission of all EUA vaccines.
