Novavax Updated Vaccine Receives Domestic Emergency Use Authorization... 'Only Recombinant Antigen Vaccine'

On the 29th, the Ministry of Food and Drug Safety announced that it has granted Emergency Use Authorization (EUA) for the recombinant COVID-19 vaccine “Novavax COVID-19 Vaccine 2023-2024 Composition,” developed by the U.S. company Novavax to respond to the COVID-19 Omicron subvariant (XBB.1.5).

[Image source=Reuters Yonhap News]

Emergency Use Authorization is a system that allows the Minister of Food and Drug Safety to permit manufacturers or importers to produce or import medical products not yet approved domestically in response to requests from heads of relevant central administrative agencies such as the Korea Disease Control and Prevention Agency, in order to appropriately respond to public health crises such as infectious disease pandemics. Approval is determined through expert consultations across various fields based on the review of clinical and quality data submitted by the company, followed by deliberation and resolution by the Public Health Crisis Response Medical Product Safety Management and Supply Committee. This Novavax vaccine was authorized following a request for EUA by the Korea Disease Control and Prevention Agency as part of the 2023-2024 winter COVID-19 vaccination plan.

Currently, SK Bioscience holds exclusive rights to develop, produce, and sell the COVID-19 vaccine developed by Novavax until 2029. Through this arrangement, 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 time, the vaccine will be imported as a finished product through its parent company, SK Chemicals.

An SK Bioscience official stated, “Given the urgency of the situation, this winter’s vaccination will involve importing finished vaccines rather than producing them in-house,” adding, “We are reviewing strategies such as CMO and contract development and manufacturing organization (CDMO) for the future.” Regarding importing through SK Chemicals instead of SK Bioscience, the official explained, “Since SK Bioscience has been producing all vaccines in-house, including CDMO, it did not have an import license for vaccines or 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 created using recombinant DNA technology to induce the production of antibodies that eliminate the virus. Unlike the Pfizer and Moderna XBB.1.5-targeting vaccines currently used for winter vaccination, which primarily consist of messenger RNA (mRNA) that expresses antigen proteins to induce immune responses, this vaccine is expected to be the only synthetic antigen vaccine.

SK Bioscience noted, “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.” It also explained that the vaccine can be stored under refrigerated conditions at 2?8 degrees Celsius, allowing distribution through existing vaccine logistics networks, and that it is convenient to use as no thawing or other processes are required during administration.

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

Meanwhile, the Novavax vaccine has been used worldwide following Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) and approval by the European Medicines Agency (EMA) last month. Novavax announced that non-clinical trials confirmed immune responses not only to XBB.1.5 but also to XBB 1.16 and XBB 2.3, and that neutralizing antibody responses were observed against newly emerging subvariants BA.2.86, EG.5.1, FL.1.5.1, and XBB.1.16.6. Additionally, it was reported that CD4+ T cell responses involved in immunity were induced against the EG.5.1 and XBB1.16.6 variants.

The Ministry of Food and Drug Safety stated, “The introduction of the Novavax vaccine domestically is significant in that it expands the types of vaccines available for selection in medical settings,” and added, “We will continue to strengthen safety management systems, including thorough quality control and adverse event monitoring for COVID-19 vaccines, to ensure that the public can receive vaccinations with confidence.”

This content was produced with the assistance of AI translation services.