SEONGNAM, South Korea , Oct. 23, 2024 /PRNewswire/ — SK Biosciences, a global innovative vaccine and biotechnology company committed to promoting human health from prevention to treatment, today announced that it has been awarded the Indonesian Food and Drug Administration BPOM ( Badan Pengawas Obat dan) announced as follows: Makanan) has approved a Biologics License Application (BLA) for SKYCellflu Tetravalent Prefilled Syringe, the world’s first tetravalent cell culture influenza vaccine. This is the first time that a domestically produced influenza vaccine has been approved in Indonesia.
SKYCellflu Tetravalent Prefilled Syringe
Indonesia is the world’s fourth most populous country with over 280 million people, but its elongated geography straddles both the Northern and Southern Hemispheres, making it subject to the World Health Organization’s influenza vaccination guidelines for both regions. .
Following the approval of SKYCellflu for the northern hemisphere influenza strain, SK Biosciences is looking forward to rapid approval of the influenza vaccine for the southern hemisphere in Indonesia.
SKYCellFlu is the world’s first cell culture-based influenza vaccine to receive WHO Prequalification (PQ) certification and has demonstrated acceptable immunogenicity and safety across clinical trials. This is the only cell culture influenza vaccine currently available in South Korea.
Compared to egg-based vaccines, the shorter production schedule makes them better suited for rapid responses to pandemics and emerging variants. SKYCellflu also requires no antibiotics or preservatives.
Additionally, cell culture vaccines are less likely to mutate during the production process than vaccines produced in fertilized eggs, allowing them to more accurately match circulating influenza strains.
In SK Bioscience’s research, SKYCellflu production cells and fertilized eggs were subcultured 15 times. Subculturing is the removal of the medium and transfer of cells from a previous culture to a new growth medium, a procedure that allows for further growth of a cell line or lines.
As a result of the research, mutations were found in three proteins within the virus using the fertilized egg method, but no mutations were found in the cells used to manufacture SKYCellflu. These findings were presented at the 2019 Inter-Scientific Working Group on Korean Influenza (KIWI) Symposium.
SKYCellflu has already been approved in multiple countries in Asia, including Malaysia, Thailand, Myanmar, Iran, Singapore, Pakistan, Mongolia and Brunei. It was approved in Chile last year, making it the first approval in the South American market. SK Bioscience plans to pave the way for full-scale expansion into the global export market.
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Ahn Jae-young, CEO of SK Bioscience, said, “We are very encouraged that the vaccine developed by our company has been approved around the world. This is an important step in expanding our global export market. ” he said. He also said, “SK Bioscience has grown into a global vaccine brand that surpasses Korea as our vaccines, including those for shingles, chickenpox, and typhoid fever, have successively obtained WHO PQ certification and global approval. I am confident that we will continue to do so,” he added.
SK Bioscience Communication Team
Jin Changhyun (jin99@sk.com)
Jeannie S. Pak (j.pak@sk.com)
SK Bioscience (PRNewsfoto/SK Bioscience) Cision
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Source SK Bioscience
