The Omicron subvariant Covid-19 vaccine developed by Novavax and produced by SK bioscience has won emergency use authorization (EUA) in Korea.
The Ministry of Food and Drug Safety (MFDS) said Wednesday that it has decided to grant EUA for "Novavax COVID-19 Vaccine 2023-2024 Compound," a genetically recombinant COVID-19 vaccine developed by Novavax to counter the omicron subvariant (XBB.1.5).
The government began vaccinating people aged 65 and older and high-risk groups with the Covid-19 vaccine against the omicron subvariant (XBB 1.5) on Oct. 19 to prepare for the winter Covid-19 resurgence and prevent severe illness and death. It also expanded the vaccination to people aged 12 to 64 on Nov. 1.
The Korea Disease Control and Prevention Agency (KDCA) requested EAU by the vaccination plan to prevent Covid-19 in the 2023-2024 winter season.
SK chemicals imports and supplies the vaccine in Korea.
Novavax's vaccine directly injects an antigenic protein made by genetic recombination technology into the body to induce the production of antibodies that eliminate the virus. Pfizer's and Moderna's vaccines, previously introduced in Korea, are based on mRNA that expresses antigenic proteins that induce the body's immune response.
The MFDS said that the introduction of the Novavax vaccine in Korea means that the number of vaccine types that can be selected in the medical field will be expanded and that the ministry would continue to do its best to strengthen the safety management system, including thorough quality control of Covid-19 vaccines and collection of adverse events so that people can be vaccinated with the ease of mind.
SK bioscience also expressed its expectation regarding approving the emergency use of the Novavax vaccine. SK bioscience has exclusively secured the rights to supply and commercialize Novavax's improved Covid-19 vaccine in Korea through a licensing term extension agreement signed in August. It also acquired a stake in Novavax, making it the third largest shareholder.
SK bioscience emphasized that Novavax's Covid-19 vaccine was developed using a synthetic antigen approach that has been used for many years in influenza, hepatitis B, and human papillomavirus (HPV) vaccines and has proven its safety. The company plans to supply the Novavax-adapted vaccine in Korea within the year rapidly.
"Through this valuable partnership with SK bioscience, we are proud to offer the only synthetic antigen-based non-mRNA Covid-19 modified vaccine to the people of South Korea during the winter immunization season," Novavax President John C. Jacobs said.
SK bioscience President and CEO Ahn Jae-yong said, "We are pleased to be able to provide a vaccine that will contribute to the national defense at a time when the health crisis has become a hot topic, with both the flu and Covid-19 viruses spreading simultaneously ahead of the winter season.
As Korea's leading vaccine company, SK bioscience will continue to rapidly develop and secure safe and effective vaccines to protect people's daily lives, Ahn added.