SK bioscience said it has applied for emergency use authorization (EUA) for the improved Novavax’s Covid-19 vaccine (NVX-CoV2601), with the Ministry of Food and Drug Safety(MFDS).

SK bioscience submitted an emergency use approval application for Novavax’s updated Covid-19 vaccine to the Ministry of Food and Drug Safety.
SK bioscience submitted an emergency use approval application for Novavax’s updated Covid-19 vaccine to the Ministry of Food and Drug Safety.

The updated Novavax Covid-19 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 Oct. 3.

It is the third updated Covid vaccine to be 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 for the development of current vaccines, including influenza, hepatitis B, and human papillomavirus (HPV), proving long-term safety.

Also, 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 vaccine in Korea during the 2023-2024 winter seasons.

This is based on an extended license agreement that provides SK bioscience with exclusive supply and commercialization rights to the updated Novavax vaccine in Korea and non-exclusive rights in Thailand and Vietnam during a strategic equity investment in Novavax in August.

During that time, SK bioscience paid $85 million (approximately 112 billion won) to secure 6.5 million shares of common stock of Novavax through a private placement, equating to a 7 percent stake in Novavax.

“Covid-19 continues to pose a threat, especially to high-risk groups such as the elderly and those with underlying health conditions,” SK bioscience CEO Ahn Jae-yong said. “We are pleased to be able to contribute by offering more vaccine options for the Korean population.”

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