"Year-End Supply Expected" Novavax Improved COVID Vaccine Receives Domestic Emergency Use Authorization (Comprehensive)

The Ministry of Food and Drug Safety (MFDS) has granted Emergency Use Authorization (EUA) for Novavax's updated COVID-19 vaccine, paving the way for the supply of the long-validated synthetic antigen platform-based updated vaccine in South Korea. SK Bioscience, responsible for domestic distribution, plans to rapidly supply the vaccine within this year.

[Image source=Reuters Yonhap News]

On the 29th, the MFDS announced that it had granted EUA for the recombinant COVID-19 vaccine developed by Novavax in the United States, named ‘Novavax COVID-19 Vaccine 2023-2024 Composition,’ designed to respond to the Omicron subvariant (XBB.1.5).

Emergency Use Authorization is a system that allows the MFDS Commissioner to permit manufacturers or importers to produce or import medical products not yet approved domestically in response to public health emergencies such as infectious disease pandemics, upon request from heads of relevant central administrative agencies like the Korea Disease Control and Prevention Agency (KDCA). Approval is determined through expert consultations across various fields and review and resolution by the Public Health Emergency Medical Product Safety Management and Supply Committee, based on clinical and quality data submitted by the company. This Novavax vaccine EUA was granted following a request from the KDCA as part of the vaccination plan for COVID-19 prevention during the 2023-2024 winter season.

Currently, SK Bioscience holds exclusive rights until 2029 for the development, production, and sales of the COVID-19 vaccines developed by Novavax. Through this, the existing Novavax COVID-19 vaccines have been distributed domestically as contract manufacturing organization (CMO) products produced at SK Bioscience’s Andong plant. However, this vaccine introduction will be conducted by importing finished vaccines through its parent company, SK Chemicals.

SK Bioscience plans to rapidly supply the updated Novavax vaccine within this year. A company representative stated, "Given the urgency of the situation, this winter’s vaccination will involve importing finished vaccines rather than in-house production," adding, "We are reviewing options such as CMO and contract development and manufacturing organization (CDMO) for future strategies." Regarding importing through SK Chemicals instead of SK Bioscience, the representative explained, "Since SK Bioscience has produced all vaccines in-house, including CDMO, it did not have an import license for vaccines and pharmaceuticals. Therefore, the vaccine will be imported through SK Chemicals, which holds the necessary license, and distribution and sales will be handled by SK Bioscience."

Novavax’s vaccine is a synthetic antigen vaccine that directly injects antigen proteins produced using recombinant DNA technology to induce the production of antibodies that eliminate the virus. The Pfizer and Moderna vaccines currently used for winter vaccinations against XBB.1.5 are based on messenger RNA (mRNA) that expresses antigen proteins to induce immune responses, making Novavax’s vaccine the only synthetic antigen vaccine expected to be used.

SK Bioscience stated, "This vaccine is characterized by utilizing the synthetic antigen method," and added, "Vaccines for diseases such as influenza, hepatitis B, and human papillomavirus (HPV) have been used for a long time based on safety and efficacy data." They also noted that the vaccine can be stored under refrigerated conditions at 2?8 degrees Celsius, allowing distribution through existing vaccine logistics networks, and that no thawing or other processes are required at the administration stage, making it convenient to use.

Exterior view of SK Bioscience Andong L-HOUSE. [Photo by SK Bioscience]

Meanwhile, the Novavax vaccine has been used globally following EUA by the U.S. Food and Drug Administration (FDA) and approval by the European Medicines Agency (EMA) last month. South Korea became the third country in the world to receive the Novavax vaccine after the United States and Europe. It was also listed on the World Health Organization (WHO) Emergency Use Listing (EUL) earlier this month.

Novavax confirmed immune responses not only to XBB.1.5 but also to XBB 1.16 and XBB 2.3 through non-clinical trials. They also announced that the vaccine induced neutralizing antibody responses to newly emerging subvariants BA.2.86, EG.5.1, FL.1.5.1, and XBB.1.16.6, as well as CD4+ T cell responses involved in immunity against EG.5.1 and XBB1.16.6 variants.

John C. Jacobs, President of Novavax, said, “We are very proud to provide the only synthetic antigen-based non-mRNA COVID-19 updated vaccine to the Korean people during the winter vaccination season through our valuable partnership with SK Bioscience.” Jaeyong Ahn, President of SK Bioscience, also said, “We are pleased to supply vaccines that will contribute to national disease control at a time when health crises have resurfaced with the simultaneous spread of influenza and COVID-19 viruses ahead of winter. As a leading vaccine company in South Korea, we will continue to rapidly develop and secure safe and effective vaccines to protect the daily lives of our citizens.”