MFDS Grants Emergency Use Authorization for Novavax Vaccine to Combat COVID-19 Variants

Recombinant Antigen Protein Vaccine
KCDC to Sequentially Introduce a Total of 320,000 Doses

The Ministry of Food and Drug Safety announced on the 30th that it has granted emergency use authorization for Novavax's 'COVID-19 JN.1 variant response vaccine (2024-2025 formulation)' from the United States.

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 approved domestically upon request from the heads of relevant central administrative agencies, in order to appropriately respond to public health crises such as infectious disease pandemics. The Ministry explained that this emergency use authorization was promptly reviewed and granted following a request from the Korea Disease Control and Prevention Agency as part of the COVID-19 vaccination plan for this winter season.

Unlike the Pfizer and Moderna vaccines, which were previously approved by the Ministry for the JN.1 variant response and use mRNA (messenger ribonucleic acid) as the main component to express antigen proteins that induce immune responses in the body, the Novavax COVID-19 vaccine is a vaccine that directly injects antigen proteins made using recombinant DNA technology into the body to induce the production of antibodies that eliminate the virus.

Ahn Jae-yong, CEO of SK Bioscience, said, "At a time when the COVID-19 epidemic situation is rapidly changing, we have expanded the vaccine options available to the public," adding, "We will do our best to ensure that the Novavax new variant vaccine, the only synthetic antigen type, is supplied stably and in a timely manner."

This Novavax vaccine will be imported by SK Chemicals and supplied domestically, with SK Bioscience, a subsidiary of SK Chemicals, responsible for supplying it to the Korea Disease Control and Prevention Agency and others. Following the Ministry of Food and Drug Safety's emergency use authorization, the Korea Disease Control and Prevention Agency introduced 100,000 doses of the Novavax JN.1 variant response vaccine on the same day, and plans to sequentially import a total of 320,000 doses including these.