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 begun to be supplied to medical institutions in South Korea.

Novavax’s updated COVID-19 vaccine received an emergency use authorization (EUA) by the Ministry of Food and Drug Safety (MFDS) on November 29, 2023.

Vaccination with Novavax’s updated COVID-19 vaccination will begin on December 18. The vaccination is free for all individuals aged 12 and older, and the reservations can be made through the COVID-19 vaccination website (ncvr.kdca.go.kr).

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.

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 human papillomavirus (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.

As the vaccination options are expanded by the supply of the Novavax’s updated COVID-19 vaccine, the winter COVID-19 vaccination rate is expected to increase further. The recombinant protein-based vaccine, previously recommended for limited use only in cases where mRNA vaccines could not be administered during the last winter season, can now be administered in the same manner as mRNA vaccines.

Jaeyong Ahn, CEO of SK bioscience said, “COVID-19 is becoming prevalent again as winter comes. Novavax’s updated COVID-19 vaccine emerges as a new alternative for national immunization. We aim to proactively contribute by developing and securing the necessary vaccines in a timely manner to prevent infectious diseases that threaten people´s daily 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. Also, SK bioscience and Novavax made 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.