SK bioscience, an innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced today that the first Korean cell culture-based influenza vaccine, ‘SKYCellflu’ has begun to be shipped from its manufacturing plant, L HOUSE in Andong.
SK bioscience has resumed the production of SKYCellflu in three years after focusing on the supply of the COVID-19 vaccine in response to the COVID-19 pandemic.
About 5 million doses of SKYCellflu will be distributed for domestic use for the 2023-2024 flu season, and the vaccination will be available at hospitals and clinics within the next month.
SKYCellflu is the world’s first cell culture-based influenza vaccine acquiring WHO’s PQ (Pre-Qualification), which certifies safety and efficacy by evaluating the manufacturing process, quality, and clinical trial results of vaccines. The vaccine is the only cell culture-based influenza vaccine currently available in Korea.
Compared to the fertilized chicken egg-based influenza vaccines, the cell culture-based vaccine can be safely administered to those who with egg anaphylaxis or egg allergy. Additionally, it has the advantage in being able to quickly respond to pandemics or the emergence of any variants due to its short production period.
The cell culture-based vaccine is produced in a state-of-the-art sterile incubator, and it does not require the administration of antibiotics or preservatives. It reduces the risk of hypersensitivity reactions after vaccination.
The cell-based vaccine is less likely to have viral mutations that can occur during production compared to the fertilized chicken egg-based vaccine. It helps the cell-based vaccine match the types of viruses used in the vaccine with the exact circulating viruses during the flu season.
According to the WHO’s study in February 2018, the types of viruses used in the cell-based influenza vaccine showed a 91% match to the circulating influenza A H3N2 virus during the flu season, and the fertilized chicken egg-based influenza vaccine showed only a 44% match.
The match difference in types of viruses results in a difference in effectiveness. According to the U.S. Food and Drug Administration (FDA) and CDC’s analysis for the 2017-2018 flu season, the cell-cultured quadrivalent flu vaccine was 11% more effective in preventing hospital encounters than the fertilized chicken egg-based quadrivalent flu vaccine.
The UK Joint Committee on Vaccination and Immunization (JCVI) recently recommended the cell culture-based quadrivalent influenza vaccine for those who aged 2-64 years based on the advantages of cell-based vaccines in its Vaccination Guidance for the 2023-2024 influenza season.
Separately, SK bioscience’s SKYCellflu Quadrivalent Prefilled Syringe has been led the influenza vaccine market in Korea in four years since its debut. It has been approved in 10 countries, including Malaysia, Thailand, Singapore, and Mongolia, and the company is working with the regulators in more than 10 other countries for further approval.
Lee Sang-gyun, Head of L HOUSE, said, “We will demonstrate the competitiveness of our own influenza vaccine and expand its global market by resuming the production of SKYCellflu, a fruit of Korea’s advanced vaccine technologies.”