SK bioscience, an innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced that the updated COVID-19 vaccine (NVX-CoV2601) developed by Novavax, a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, has received an emergency use authorization (EUA) by the Ministry of Food and Drug Safety (MFDS) on November 29, 2023.

SK bioscience plans to deliver the updated vaccine to South Korea within this year. This marks the fourth global approval for Novavax’s protein-based non-mRNA updated COVID-19 vaccine, addressing XBB variants, following approvals in the U.S.,the EU and by the WHO. It also represents the first approval in Asia.

Novavax’s updated COVID-19 vaccine is based on a recombinant protein-based platform. This technology has been used in the development of current vaccines for influenza (flu), hepatitis B, and HPV, providing a proven safety profile and an additional option for administration. Novavax’s updated COVID-19 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.

Non-clinical data showed that Novavax´s updated COVID-19 vaccine induced functional immune responses against XBB.1.5, XBB.1.16, and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavax´s vaccine induced neutralizing antibody responses to subvariants BA.2.86, EG.5.1, FL.1.5.1, and XBB.1.16.6 as well as robust CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6.

Based on the data, the Novavax’s updated COVID-19 vaccine received EUA from the U.S. Food and Drug Administration (FDA) on October 3, 2023 and full approval from the European Commission on October 31, 2023 for active immunization to prevent COVID-19 in individuals aged 12 and older. On November 23, 2023, the vaccine was granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for active immunization to prevent COVID-19 in individuals aged 12 and older.

Upon authorization, SK bioscience plans to exclusively distribute Novavax’s updated COVID-19 vaccine in South Korea during the 2023-2024 season. This is based on an extended license agreement that provides SK bioscience with exclusive commercialization rights to Novavax’s updated COVID-19 vaccine in South Korea and non-exclusive rights in Thailand and Vietnam.

With the introduction of Novavax´s updated COVID-19 vaccine and the expansion of vaccination options, SK bioscience expects that this expansion will support the active implementation of the 2023-2024 COVID-19 vaccination program in South Korea. The Korea Disease Control and Prevention Agency (KDCA) recommends vaccination of updated COVID-19 vaccines suggesting that the currently authorized updated vaccines prevent the most recent variants and lower the risk of worsening to severe symptom or death.

The KDCA began updated COVID-19 vaccination for all age groups this month, including individuals aged 12 to 64 and high-risk groups such as children (aged 5 to 11) and infants (aged 6 months to 4 years).

John C. Jacobs, President and Chief Executive Officer, Novavax said, “Through our valued partnership with SK bioscience, we are proud to be able to offer the only protein-based non-mRNA COVID-19 vaccine option to the people of South Korea this vaccination season.”

Jaeyong Ahn, CEO of SK bioscience said, “We are pleased to supply a vaccine that will contribute to national immunization, especially as flu and COVID-19 variants spread simultaneously ahead of the winter season. As South Korea´s leading vaccine company, we will continue to rapidly develop and secure safe and effective vaccines to safeguard the daily lives of the people.”

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.