South Korea Approves Novavax COVID-19 Vaccine

Novavax, Inc. and SK bioscience, Co., a vaccine subsidiary of Korea-based SK Group, received approval from South Korea's Ministry of Food and Drug Safety (MFDS) for SK bioscience’s Biologics License Application ( bla ) for Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) for immunization in individuals 18 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.

SK bioscience has an advance purchase agreement with the South Korean government to supply 40 million doses of Novavax' vaccine. The companies also recently 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.

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. 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.