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Updated Novavax COVID-19 Vaccine Is Submitted for Emergency Use Authorization in the Republic of Korea

2023.10.20

SK bioscience plans to introduce the only updated protein-based non-mRNA, COVID vaccine for South Korea.

With proven safety and efficacy, the vaccine is expected to extend the administration choice for the public in this winter vaccination season.


SK bioscience, an innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced on the 20th that the application of the updated Novavax COVID-19 vaccine (NVX-CoV2601), developed by Novavax, a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, has been submitted for Emergency Use Authorization (EUA) to the Korean Ministry of Food and Drug Safety(KMFDS).

The updated Novavax COVID vaccine received EUA from the U.S. Food and Drug Administration (FDA) for active immunization to prevent COVID-19 in individuals aged 12 and older on October 3, 2023.

It is the third updated COVID vaccine to be authorized in the United States against Omicron variant (XBB 1.5) and the only protein-based non-mRNA option in most major markets.

Recombinant protein vaccine technology has been used for development of current vaccines including influenza (flu), hepatitis B, and HPV, proving long-term safety and providing a wider option for administration. The Novavax vaccine can be stored between 2-8 degrees Celsius, making it suitable to use in countries where ultra-low cold chain channels are challenging or unavailable.

Upon authorization, SK bioscience plans to exclusively distribute the updated Novavax COVID vaccine in South Korea during the 2023-2024 winter season. This is based on an extended license agreement that provides SK bioscience with exclusive supply and commercialization rights to the updated Novavax COVID vaccine in South Korea and non-exclusive rights in Thailand and Vietnam.

Jaeyong Ahn, CEO of SK bioscience said, “COVID-19 still threatens high-risk groups such as the elderly and those with health condition. We are glad to be able to contribute to providing more vaccine options for Koreans. We will also accelerate developing on a universal Sarbecovirus vaccine to secure South Korea’s vaccine sovereignty and protect lives.”

In August 2023, SK bioscience made a strategic equity investment in Novavax to transition from a CMO/CDMO partnership formed during the pandemic to a long-term synergistic relationship in the endemic era.