Therapy Areas: Vaccines
Novavax and SK Group receive South Korean regulatory approval for Nuvaxovid COVID-19 Vaccine Biologics License Application
13 January 2022 -

Novavax Inc. (Nasdaq: NVAX), a US-based biotechnology company, and SK bioscience, Co. Limited, a vaccine business subsidiary of Korea-based SK Group, announced on Wednesday that they have received approval from South Korea's Ministry of Food and Drug Safety (MFDS) for a Biologics License Application (BLA) from SK bioscience for Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) for active immunisation in individuals 18 years of age and older for the prevention of COVID-19 caused by SARS-CoV-2.

The product is the first protein-based COVID-19 vaccine to be approved for commercial use in South Korea and it will be produced and marketed in the country by SK bioscience.

SK bioscience has signed an advance purchase contract with the South Korean government to provide 40 million doses of Novavax' vaccine. Both firms have expanded collaboration and license agreements that are likely to raise manufacturing capacity and provide SK bioscience with additional non-exclusive territories.