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First cell-culture based influenza vaccine received WHO Prequalification

Geneva, April 8th 2019 - SKYCellflu Multidose, the cell-culture based influenza vaccine, manufactured by SK bioscience, received World Health Organization (WHO) prequalification. A cell-based flu vaccine was developed as an alternative to the egg-based manufacturing process. The influenza viruses used in the cell-based vaccine are grown in cultured cells of mammalian origin. “Cell culture technology is potentially more flexible than the traditional technology, which relies upon adequate supply of pathogen-free eggs. In addition, the cell-based flu vaccine that uses cell-based candidate vaccine viruses (CVVs) has the potential to offer better protection than traditional egg-based flu vaccines as a result of being more similar to flu viruses in circulation.” mentions the US Center for Disease Control and Prevention (cf. https://www.cdc.gov/flu/protect/vaccine/cell-based.htm ).

SK bioscience has commercialized the world’s first cell-culture influenza vaccine for children and adolescents between the ages of 6 months to 18 years, as well as the world’s second for adults. The company obtained national marketing authorization in December 2014 for SKYCellflu prefilled syringe introduction in South Korea.

A major advantage of cell culture technology includes the potential for a faster start-up of the vaccine manufacturing process in the event of a pandemic. Also, as described above, cellbased flu vaccines that are produced using cell-based candidate vaccine viruses have the potential to improve the effectiveness of cell-based flu vaccines. Cell-based flu vaccines have
been approved for use in multiple countries. With the prequalification, the WHO enables healthcare providers around the globe to stop the spread of influenza and access to the vaccine may also enhance patient care.