Updated Novavax COVID-19 Vaccine Submitted for South Korea Emergency Use Authorization

SK Bioscience, an innovative vaccine and biotechnology company committed to promoting human health from prevention to treatment, announced on the 20th that the application of the updated version of Novavax COVID-19 vaccine (NVX-CoV2601) developed by Novavax, a global company advancing protein research and development, is based on Its Matrix-M™ adjuvanted vaccine 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) on October 3, 2023, for active immunization to prevent COVID-19 in individuals 12 years of age and older.

It is the third newer COVID-19 vaccine authorized in the U.S. against the Omicron variant (XBB 1.5) and the only protein-based, non-mRNA option in most major markets.

Recombinant protein vaccine technology has been used to develop current vaccines, including influenza, hepatitis B and HPV, demonstrating long-term safety and providing a wider range of dosing options. The Novavax vaccine can be stored between 2-8 degrees Celsius, making it suitable for use in countries where ultra-low cold chain access is challenging or unavailable.

Under authorization, SK bioscience plans to exclusively distribute the updated Novavax COVID vaccine in South Korea in the winter of 2023-2024. This is based on an expanded licensing agreement that provides SK bioscience with exclusive supply and commercialization rights for the updated Novavax COVID vaccine in South Korea, as well as non-exclusive rights in Thailand and Vietnam.

Jaeyong Ahn, CEO of SK Bioscience, said: “COVID-19 remains a threat to the elderly and high-risk groups with poor health conditions. We are pleased to contribute to providing more vaccine options to Koreans. “We will also accelerate the development of universal Sarbecovirus vaccine to ensure South Korea’s vaccine sovereignty and protect lives. “

In August 2023, SK Bioscience made a strategic equity investment in Novavax, transitioning from the CMO/CDMO partnership formed during the epidemic to a long-term collaborative relationship in the epidemic era.