Novavax: South Korea Approves Nuvaxovid COVID-19 Vaccine

Covid-19 vaccine maker Novavax, Inc. (NVAX) and SK bioscience, Co. Limited, a vaccine business subsidiary of Korea-based SK Group, announced Wednesday that South Korea's Ministry of Food and Drug Safety or MFDS has approved Novavax COVID-19 Vaccine Nuvaxovid.

In pre-market activity on Nasdaq, Novavax shares were gaining around 1.3 percent to trade at $132.39.

MFDS has approved a Biologics License Application or 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, 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.

The company noted that 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 or CMA in the European Union and emergency use listing or 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 or EUA in India, Indonesia and the Philippines, as well as WHO EUL.

The company has submitted its complete chemistry, manufacturing and controls or CMC data package to the U.S. Food and Drug Administration at the end of 2021, and expects to submit a request for EUA for the vaccine in the U.S. after one month.

The brand name Nuvaxovid has not yet been authorized for use in the U.S. by the FDA.

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